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@HenryMuney
's excellent patent find from the European Patent Office is outstanding news for $nwbo eagle8 :@HenryMuney
$NWBO patent application with status "Grant of patent is intended" on February 16, 2024 by the European Patent Office (EPO) EP14859634 - "Combinations of checkpoint inhibitors and therapeutics to treat cancer"https://t.co/csOzR79JpO pic.twitter.com/U1ZwMZOvtq
— Henry (@HenryMuney) February 18, 2024
Single Stock
Re: None
Thursday, June 20, 2024 5:24:04 AM
Post#
699725
of 699733
JNJ's Janssen just dropped a licensing agreement with Xencor .
.....After paying them $100m ++up front in 2021
So our first deal with large pharma surely must be at least $100m in upfront cash.
Hopefully its already done pending announcement .
J&J drops CD20xCD3 T-cell engager from Xencor deal 20/6/24
Original Partnership PR [color=red][/color]
-- Xencor to receive $100 million upfront payment and $25 million equity investment and is eligible for a mid-teen to low-twenties percent royalty for plamotamab and potential milestone payments up to $1.188 billion --
#dcvax $nwbo #gbm
— Peter Davis (@peter_brit) June 19, 2024
Interesting article:
Immunologic Factors Associated with Differential Response to Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer
2024 May
Pawel Kalinski (co-authored)
"These results suggest that the biomarker-based selection of patients… pic.twitter.com/mTQZVBqOFs
Here is the description of transcriptomics. In Dr. Liau's publications transcriptomic analysis was mentioned a lot.
— d_stock (@d_stock07734) June 20, 2024
Transcriptomics is the study of the transcriptome, which is the complete set of RNA transcripts produced by the genome under specific circumstances or in a…
Labcorp has technology for transcriptomic analysis and the company happens to account for 15% of SIO's portfolio. I can picture SIO will load a lot of NWBO shares through the open market.
— d_stock (@d_stock07734) June 20, 2024
Sio Capital Management, LLC reports 36.81% increase in ownership of LH / Labcorp Holdings… pic.twitter.com/MolIOZphaH
If immunotherapy is destined to replace a large part of chemical cancer treatment, the merger of the Liau-Kalinski clinics could be humankind's best hope to further develop improvements in cell based cancer immunotherapies which increase survival and cures. Adding the MDSC technology developed by Kalinski to DC VAX L based combination therapies appears to be just a first of many steps.
I am trying to put together a list of the 10 best dendritic cancer vaccine research clinics in the world. I am starting with the Liau -Kalinski clinics at the top. I would be most appreciative with 8 other candidates for the list being posted here on
IHUB. A.E.K.
"Assuming MDSC-associated suppression is the reason for the in-licensing, IMO, the PR has very special implication. Here the types of solid tumors which have MDSC associated suppression from Chat GPT. GBM has TAM suppression. The PR may imply the targets that LP is going to set clinical trials for. LP must have concrete data to show clearly MDSC dominated suppression exists for certain targets. Just like what we saw from Dr. Liau's presentation. Green dots are TAMs."
https://nwbio.com/northwest-biotherapeutics-announces-exclusive-in-license-of-portfolio-of-dendritic-cell-technology-and-intellectual-property/
https://www.roswellpark.org/pawel-kalinski
$nwbo @alphavestcap @hoffmann6383 @metacollectiveG @BrianEgolf2 @SmithOnStocks1 @ATLnsider @hoffmann6383 :
— alphavestcapital.com (@alphavestcap) June 18, 2024
"Assuming the above trials are correct, $NWBO is investing in changing the tumor micro environment so that DCVax-L will be more effective when combined with a… https://t.co/mOsZ7oxzSW
IMO, everything is strategic. It has been over three months since it was mentioned that a case study was accepted for publication. Here is the latest case report from Dr. Keyoumars Ashkan. The time interval between acceptance for publication and publication is only about one… pic.twitter.com/NGaxLHgetg
— d_stock (@d_stock07734) June 18, 2024
Assuming MDSC-associated suppression is the reason for the in-licensing, IMO, the PR has very special implication. Here the types of solid tumors which have MDSC associated suppression from Chat GPT. GBM has TAM suppression. The PR may imply the targets that LP is going to set… pic.twitter.com/oW8BKqXzkB
— d_stock (@d_stock07734) June 18, 2024
$nwbo @alphavestcap #DCVax-L facts. Match the references to the items in the screenshot. 1. SAP https://t.co/yqspqdrGNR… 2. Contemporaneous External Controls https://t.co/iZvh62CrJT… 3. DCVax-L = ATL-DC https://t.co/5viNp6ViYZ… 4. Crossover arm https://t.co/AhQ8VxrrAK… 5.…
— alphavestcapital.com (@alphavestcap) June 19, 2024
Flaskworks news pending ?@flaskworks $nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) June 19, 2024
Flaskworks can also manufacture CAR-T at same time as DCVax-L. So will we see some type of collaboration with $GILD given they have no way to automate Yescarta? Hold onto your $NWBO shares!
ChatGPT 4o: Flaskworks,…
"We generate revenues by licensing our CDMA technology to other manufacturers of CDMA products (such as wireless phones and the hardware required to establish and operate a CDMA wireless network). These revenues are generated through licensing fees and royalties on CDMA-based…
— alphavestcapital.com (@alphavestcap) June 19, 2024
$nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) June 18, 2024
A quick post to answer a few questions on Anithama's list over at ihub. The post: https://t.co/CXYtTw6EWK… Do I agree with his list? I'll go through his/her list in order from top to bottom. 1st Trial✅ Same one I've listed. 2nd Trial📷 I disagree this…
"We generate revenues by licensing our CDMA technology to other manufacturers of CDMA products (such as wireless phones and the hardware required to establish and operate a CDMA wireless network). These revenues are generated through licensing fees and royalties on CDMA-based…
— alphavestcapital.com (@alphavestcap) June 19, 2024
"We generate revenues by licensing our CDMA technology to other manufacturers of CDMA products (such as wireless phones and the hardware required to establish and operate a CDMA wireless network). These revenues are generated through licensing fees and royalties on CDMA-based…
— alphavestcapital.com (@alphavestcap) June 19, 2024
Amongst the world's most accomplished dendritic cell cancer vaccine scientists , Liau and Kalinski rank in the top 10. Who are the other eight ?https://t.co/Cwqgae1oKa $nwbo @alphavestcap https://t.co/jPlzdYOU6jhttps://t.co/r4sFXIKh9Y
— alphavestcapital.com (@alphavestcap) June 18, 2024
Biology of dendritic cells (DC) and…
newman2021 $nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) June 18, 2024
MSDC! It does what CI does right - dealing ith the immunosuppressive layer; but no toxic is the key. And when combined with DcVax, LP is expecting it to do wonders ..... without the need of CIs to cure cancer. All imo.
georgebailey $nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) June 18, 2024
Re: ilovetech post# 699331
Tuesday, June 18, 2024 12:47:34 PM
ILT- yes Survax is a peptide vaccine conjugate and not a DC treatment thanks ILT.
News was flowing fast….
On another note, I’ve been comparing licensing business models DC…
hankmanhub $nwbo @alphavestcap @metacollectiveG @brianegolf2 @atlnsider @SmithOnStocks1 @hoffmann6383
— alphavestcapital.com (@alphavestcap) June 18, 2024
Tuesday, June 18, 2024 12:15:16 PM
Since LP saw fit to pay for the IP of Roswell Park I am sure there was something there that would be useful for NWBO and could be developed…
$nwbo @alphavestcap @metacollectiveG @hoffmann6383 @ATLnsider @BrianEgolf2 @peter_brit #dcvax $nwbo #gbmhttps://t.co/r4sFXIKh9Y
— alphavestcapital.com (@alphavestcap) June 18, 2024
Specializing In: Biology of dendritic cells (DC) and DC vaccines Biology of T cells and T cell targeting therapies of cancer Biology of natural…
$nwbo @alphavestcap @hoffmann6383 @metacollectiveG @BrianEgolf2 @SmithOnStocks1 @ATLnsider @hoffmann6383 :
— alphavestcapital.com (@alphavestcap) June 18, 2024
"Assuming the above trials are correct, $NWBO is investing in changing the tumor micro environment so that DCVax-L will be more effective when combined with a… https://t.co/mOsZ7oxzSW
If immunotherapy is destined to replace a large part of chemical cancer treatment, the merger of the Liau-Kalinski clinics could be humankind's best hope to further develop improvements in cancer survival and cures. Adding the MDSC technology developed by Kalinski appears to be just a first of many steps.
"Assuming MDSC-associated suppression is the reason for the in-licensing, IMO, the PR has very special implication. Here the types of solid tumors which have MDSC associated suppression from Chat GPT. GBM has TAM suppression. The PR may imply the targets that LP is going to set clinical trials for. LP must have concrete data to show clearly MDSC dominated suppression exists for certain targets. Just like what we saw from Dr. Liau's presentation. Green dots are TAMs."
Assuming MDSC-associated suppression is the reason for the in-licensing, IMO, the PR has very special implication. Here the types of solid tumors which have MDSC associated suppression from Chat GPT. GBM has TAM suppression. The PR may imply the targets that LP is going to set… pic.twitter.com/oW8BKqXzkB
— d_stock (@d_stock07734) June 18, 2024
$nwbo @alphavestcap @hoffmann6383 @metacollectiveG @BrianEgolf2 @SmithOnStocks1 @ATLnsider @hoffmann6383 :
— alphavestcapital.com (@alphavestcap) June 18, 2024
"Assuming the above trials are correct, $NWBO is investing in changing the tumor micro environment so that DCVax-L will be more effective when combined with a… https://t.co/mOsZ7oxzSW
IMO, everything is strategic. It has been over three months since it was mentioned that a case study was accepted for publication. Here is the latest case report from Dr. Keyoumars Ashkan. The time interval between acceptance for publication and publication is only about one… pic.twitter.com/NGaxLHgetg
— d_stock (@d_stock07734) June 18, 2024
Assuming MDSC-associated suppression is the reason for the in-licensing, IMO, the PR has very special implication. Here the types of solid tumors which have MDSC associated suppression from Chat GPT. GBM has TAM suppression. The PR may imply the targets that LP is going to set… pic.twitter.com/oW8BKqXzkB
— d_stock (@d_stock07734) June 18, 2024
$nwbo @alphavestcap #DCVax-L facts. Match the references to the items in the screenshot. 1. SAP https://t.co/yqspqdrGNR… 2. Contemporaneous External Controls https://t.co/iZvh62CrJT… 3. DCVax-L = ATL-DC https://t.co/5viNp6ViYZ… 4. Crossover arm https://t.co/AhQ8VxrrAK… 5.…
— alphavestcapital.com (@alphavestcap) June 19, 2024
Flaskworks news pending ?@flaskworks $nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) June 19, 2024
Flaskworks can also manufacture CAR-T at same time as DCVax-L. So will we see some type of collaboration with $GILD given they have no way to automate Yescarta? Hold onto your $NWBO shares!
ChatGPT 4o: Flaskworks,…
"We generate revenues by licensing our CDMA technology to other manufacturers of CDMA products (such as wireless phones and the hardware required to establish and operate a CDMA wireless network). These revenues are generated through licensing fees and royalties on CDMA-based…
— alphavestcapital.com (@alphavestcap) June 19, 2024
$nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) June 18, 2024
A quick post to answer a few questions on Anithama's list over at ihub. The post: https://t.co/CXYtTw6EWK… Do I agree with his list? I'll go through his/her list in order from top to bottom. 1st Trial✅ Same one I've listed. 2nd Trial📷 I disagree this…
"We generate revenues by licensing our CDMA technology to other manufacturers of CDMA products (such as wireless phones and the hardware required to establish and operate a CDMA wireless network). These revenues are generated through licensing fees and royalties on CDMA-based…
— alphavestcapital.com (@alphavestcap) June 19, 2024
"We generate revenues by licensing our CDMA technology to other manufacturers of CDMA products (such as wireless phones and the hardware required to establish and operate a CDMA wireless network). These revenues are generated through licensing fees and royalties on CDMA-based…
— alphavestcapital.com (@alphavestcap) June 19, 2024
Amongst the world's most accomplished dendritic cell cancer vaccine scientists , Liau and Kalinski rank in the top 10. Who are the other eight ?https://t.co/Cwqgae1oKa $nwbo @alphavestcap https://t.co/jPlzdYOU6jhttps://t.co/r4sFXIKh9Y
— alphavestcapital.com (@alphavestcap) June 18, 2024
Biology of dendritic cells (DC) and…
newman2021 $nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) June 18, 2024
MSDC! It does what CI does right - dealing ith the immunosuppressive layer; but no toxic is the key. And when combined with DcVax, LP is expecting it to do wonders ..... without the need of CIs to cure cancer. All imo.
georgebailey $nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) June 18, 2024
Re: ilovetech post# 699331
Tuesday, June 18, 2024 12:47:34 PM
ILT- yes Survax is a peptide vaccine conjugate and not a DC treatment thanks ILT.
News was flowing fast….
On another note, I’ve been comparing licensing business models DC…
hankmanhub $nwbo @alphavestcap @metacollectiveG @brianegolf2 @atlnsider @SmithOnStocks1 @hoffmann6383
— alphavestcapital.com (@alphavestcap) June 18, 2024
Tuesday, June 18, 2024 12:15:16 PM
Since LP saw fit to pay for the IP of Roswell Park I am sure there was something there that would be useful for NWBO and could be developed…
$nwbo @alphavestcap @metacollectiveG @hoffmann6383 @ATLnsider @BrianEgolf2 @peter_brit #dcvax $nwbo #gbmhttps://t.co/r4sFXIKh9Y
— alphavestcapital.com (@alphavestcap) June 18, 2024
Specializing In: Biology of dendritic cells (DC) and DC vaccines Biology of T cells and T cell targeting therapies of cancer Biology of natural…
$nwbo @alphavestcap @hoffmann6383 @metacollectiveG @BrianEgolf2 @SmithOnStocks1 @ATLnsider @hoffmann6383 :
— alphavestcapital.com (@alphavestcap) June 18, 2024
"Assuming the above trials are correct, $NWBO is investing in changing the tumor micro environment so that DCVax-L will be more effective when combined with a… https://t.co/mOsZ7oxzSW
$nwbo @alphavestcap @hoffmann6383 @metacollectiveG @BrianEgolf2 @SmithOnStocks1 @ATLnsider @hoffmann6383 :
— alphavestcapital.com (@alphavestcap) June 18, 2024
"Assuming the above trials are correct, $NWBO is investing in changing the tumor micro environment so that DCVax-L will be more effective when combined with a… https://t.co/mOsZ7oxzSW
IMO, everything is strategic. It has been over three months since it was mentioned that a case study was accepted for publication. Here is the latest case report from Dr. Keyoumars Ashkan. The time interval between acceptance for publication and publication is only about one… pic.twitter.com/NGaxLHgetg
— d_stock (@d_stock07734) June 18, 2024
Assuming MDSC-associated suppression is the reason for the in-licensing, IMO, the PR has very special implication. Here the types of solid tumors which have MDSC associated suppression from Chat GPT. GBM has TAM suppression. The PR may imply the targets that LP is going to set… pic.twitter.com/oW8BKqXzkB
— d_stock (@d_stock07734) June 18, 2024
$nwbo @alphavestcap #DCVax-L facts. Match the references to the items in the screenshot. 1. SAP https://t.co/yqspqdrGNR… 2. Contemporaneous External Controls https://t.co/iZvh62CrJT… 3. DCVax-L = ATL-DC https://t.co/5viNp6ViYZ… 4. Crossover arm https://t.co/AhQ8VxrrAK… 5.…
— alphavestcapital.com (@alphavestcap) June 19, 2024
Flaskworks news pending ?@flaskworks $nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) June 19, 2024
Flaskworks can also manufacture CAR-T at same time as DCVax-L. So will we see some type of collaboration with $GILD given they have no way to automate Yescarta? Hold onto your $NWBO shares!
ChatGPT 4o: Flaskworks,…
"We generate revenues by licensing our CDMA technology to other manufacturers of CDMA products (such as wireless phones and the hardware required to establish and operate a CDMA wireless network). These revenues are generated through licensing fees and royalties on CDMA-based…
— alphavestcapital.com (@alphavestcap) June 19, 2024
$nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) June 18, 2024
A quick post to answer a few questions on Anithama's list over at ihub. The post: https://t.co/CXYtTw6EWK… Do I agree with his list? I'll go through his/her list in order from top to bottom. 1st Trial✅ Same one I've listed. 2nd Trial📷 I disagree this…
"We generate revenues by licensing our CDMA technology to other manufacturers of CDMA products (such as wireless phones and the hardware required to establish and operate a CDMA wireless network). These revenues are generated through licensing fees and royalties on CDMA-based…
— alphavestcapital.com (@alphavestcap) June 19, 2024
"We generate revenues by licensing our CDMA technology to other manufacturers of CDMA products (such as wireless phones and the hardware required to establish and operate a CDMA wireless network). These revenues are generated through licensing fees and royalties on CDMA-based…
— alphavestcapital.com (@alphavestcap) June 19, 2024
Amongst the world's most accomplished dendritic cell cancer vaccine scientists , Liau and Kalinski rank in the top 10. Who are the other eight ?https://t.co/Cwqgae1oKa $nwbo @alphavestcap https://t.co/jPlzdYOU6jhttps://t.co/r4sFXIKh9Y
— alphavestcapital.com (@alphavestcap) June 18, 2024
Biology of dendritic cells (DC) and…
newman2021 $nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) June 18, 2024
MSDC! It does what CI does right - dealing ith the immunosuppressive layer; but no toxic is the key. And when combined with DcVax, LP is expecting it to do wonders ..... without the need of CIs to cure cancer. All imo.
georgebailey $nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) June 18, 2024
Re: ilovetech post# 699331
Tuesday, June 18, 2024 12:47:34 PM
ILT- yes Survax is a peptide vaccine conjugate and not a DC treatment thanks ILT.
News was flowing fast….
On another note, I’ve been comparing licensing business models DC…
hankmanhub $nwbo @alphavestcap @metacollectiveG @brianegolf2 @atlnsider @SmithOnStocks1 @hoffmann6383
— alphavestcapital.com (@alphavestcap) June 18, 2024
Tuesday, June 18, 2024 12:15:16 PM
Since LP saw fit to pay for the IP of Roswell Park I am sure there was something there that would be useful for NWBO and could be developed…
$nwbo @alphavestcap @metacollectiveG @hoffmann6383 @ATLnsider @BrianEgolf2 @peter_brit #dcvax $nwbo #gbmhttps://t.co/r4sFXIKh9Y
— alphavestcapital.com (@alphavestcap) June 18, 2024
Specializing In: Biology of dendritic cells (DC) and DC vaccines Biology of T cells and T cell targeting therapies of cancer Biology of natural…
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174623174
The JAMA article, the Nature article, the trust of Dr. Liau to join the SAB, the recent position by a new institutional investor and now the Roswell Institute signing a deal with them validate the company’s work and the dendritic cell vaccine effort. NCI grants to UCLA for this research, the MHRA licensing of the factory, all of these things are validating, but not necessarily money making for us. They might have been, but we all know what goes on here and that some funds or fund made a bad bet years ago that this was Dendreon 2 and now they have to post everywhere every day to keep this from being validated by the market. But for us longs too, there is never a guarantee that we’re going to be made wealthy when we want it or need it, in terms of timing. And how many times have I said we could just as easily lose it all in biotech, and not just because of technology but for reasons like the economy, lack of capital, and we all know the shorts are working overtime to destroy these companies so that they can scoop up patents for cheap and play at vulture capitalism. Even a buyer can mess up your timing, buying out a company just before you get the pop you wanted, at a cheap moment.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174623174
beachhyena
Re: ilovetech post# 699547
Wednesday, June 19, 2024 11:06:46 AM
699557
The slow death of a chemical driven health care system to a more biologic driven care system will begin to accelerate as more and more pharmaceutical companies are forced onto a path of finding cures rather than facilitating gross profit over human lives and suffering enacted by failed chemical drugs. IMO
Job cuts in the pharmaceuticals industry have surged in the first half of 2024, with large companies including Bristol Myers Squibb (BMS), Bayer and Pfizer seeing thousands of redundancies.
Bristol Myers Squibb is one of several big companies to initiate severe job cuts, making around 2200 people redundant by the end of 2025
BMS began a wave of restructuring that will see 2200 jobs cut – including 860 in Lawrenceville, US. The firm says the cuts will save $1.5 billion (£1.2 billion) in annual costs by the end of 2025. In March, Evonik said it had completed the first phase of a reorganization with a target of cutting €400 million (£340 million) annually by the end of 2026, including 2000 job cuts worldwide, of which 1500 will be in Germany.
Meanwhile, in the first three months of this year, Bayer cut over 1500 positions – mostly from management, as part of a three year ‘rejuvenation’ programme aimed at reducing bureaucracy in the face of challenges from patent expiries and litigation in the US arising from its takeover of Monsanto.
In the US, Japanese drugmaker Takeda is shutting a research centre in San Diego and cutting jobs at sites in Massachusetts this year. It also closed a plant for viral gene therapy in Austria, with the loss of almost 200 jobs.
‘A lot of these firms are facing some patent losses and some areas where they need to restructure and optimise,’ says Damien Conover, head of health equity strategy at Morningstar, a market analyst. ‘I wouldn’t expect too much pullback from oncology or immunology. Those are areas of pretty good focus,’ he adds. ‘You might see pullback in areas like respiratory, or women’s health.’
Cutting back after rapid growth
In October 2023, Pfizer began a multi-year drive to save around $4 billion by the end of 2024. This included cutting around 500 staff at its site in Sandwich, UK, with some parts of the development and manufacturing facility since acquired by Asymchem Laboratories. In a regulatory filing in May, the company outlined plans to reduce costs by an additional $1.5 billion by the end of 2027.
Pfizer had ramped up development and manufacture of Covid-19 vaccines during the pandemic, which drove a rise in profits (measured as net income) from $16 billion in 2019 to over $31 billion in 2022. Demand for its vaccine and antiviral combination Paxlovid (nirmatrelvir, ritonavir) have since fallen substantially, and the company reported net income of just $2 billion in 2023. The company also paid $43 billion for Seagen – a leader in antibody-drug conjugates – in December 2023, triggering some job losses and halting construction of a new Seagen plant in Switzerland.
Biotechs look a lot like big pharma now; they’re facing a lot more patent losses than in the previous decade
‘Pfizer is now in a cost-cutting mode after investing heavily,’ says Conover. ‘The magnitude of cuts was higher than what I was expecting, and it looks like it’s on track to achieve most of those cuts, which will really help profitability.’
‘The big companies are at the mercy of the markets, and the bean counters are looking avidly at where to save costs,’ says Chris Coe, head of life sciences at executive recruitment firm Kingsley Gate. ‘But overall the demand for talent has gone up,’ he asserts. ‘It is going to be tough for people being laid off,’ given the large numbers happening at once, he acknowledges, but it will also benefit medium sized businesses that are looking to grow.
Beyond the big firms
In the biotechnology sector, Genentech is cutting 436 jobs in San Francisco, US. Illumina also instigated layoffs as part of $100 million in cost cutting, following its failed attempt to acquire cancer test maker Grail.
News website Fierce Biotech has been tracking industry layoffs since 2022, recording 187 total layoffs among biotech companies last year, up from 119 in 2022. Companies announcing recent job cuts include Exscientia, Biomarin, Emergent BioSolutions, Benevolent, Amylyx and CureVac.
Small companies can have very different staffing requirements at different stages of product development, and can be strongly affected by individual project outcomes. Hence such layoffs ‘have some uniqueness, but there are also some general trends,’ says Conover. ‘These companies go through cycles where they’re losing exclusivity on certain products, and they need to pivot resources from those to new products.’
He adds, ‘if they lose exclusivity and don’t have a next wave of innovation, then you will see some cost cutting happen.’
There has also been a shift due to the maturity of the biopharma sector. ‘Biotechs look a lot like big pharma now, because they’re facing a lot more patent losses than they had in the previous decade,’ says Conover.
Investment lull
While there was abundant financing during the pandemic for pharma and biotech, there was a precipitous drop thereafter. ‘The financing windows are better than they were a year ago, but not as good as during Covid,’ says Conover.
Coe notes that fewer companies are floating on stock exchanges, for example. ‘We haven’t seen the access to capital really tick up,’ he explains. ‘The venture capitalists had been reasonably bullish about the middle of this year,’ but it has been slow to improve.
There has also been a wave of acquisitions, which can trigger some layoffs. Examples include big companies buying into radiopharmaceuticals and antibody-drug conjugates, but also Merck & Co buying immunology specialist Prometheus; AbbVie buying Cerevel, with its neuroscience pipeline; and Roche acquiring Telavant, targeting inflammatory and autoimmune conditions. Conover predicts that acquisitions will subside somewhat, but adds that he ‘would expect to see more acquisitions in the range of $1–5 billion’.
Anthony King
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Peter Davis
@peter_brit
#dcvax $nwbo #gbm
Interesting article:
Immunologic Factors Associated with Differential Response to Neoadjuvant Chemoimmunotherapy in Triple-Negative Breast Cancer
2024 May
Pawel Kalinski (co-authored)
"These results suggest that the biomarker-based selection of patients likely to derive the most benefit from neoadjuvant immunotherapy could help reduce potential debilitating immunologic adverse effects by curtailing unnecessary immunotherapy for patients outside this group"
"Use of immune checkpoint inhibitors is associated with the development of significant irAEs. Our recent clinical trial indicated the feasibility of enhancing the TME immunologic signature using novel systemic approaches, raising the question of whether the responses to neoadjuvant chemotherapy can be enhanced using additional low-toxicity approaches [50]. As above, there remains an unmet need to identify biomarkers to identify subsets of patients who could benefit from immunotherapy"
Conclusions
There was no difference in pCR rates between the NAC and NAC+I groups in our study. There was a trend toward higher pCR with NAC+I in tumors with higher cell proliferation and PD-L1 positivity, while lower cancer testis antigen expression was associated with a trend towards higher pCR in the NAC group. Importantly, there was a trend towards higher pCR in both the NAC and NAC+I groups with higher tumor inflammation. Our study highlights that future real-world studies are essential to evaluate the prognostic value of the immune, cell proliferation, and cancer testis antigen signatures employed in this study. More than simply restating the oncobiological adage that no two tumors are the same, these results suggest that, even in our small cohort, microenvironmental diversity presented by patients can result in different treatment outcomes, even for patients selected for particular therapies by traditional criteria. A multi-marker approach would significantly aid clinicians in deciding which patients are most likely to benefit from the addition of neoadjuvant immunotherapy to chemotherapy, sparing a subset of patients who may not benefit from the combination treatment due to immunologic toxicities. Thus, for these reasons, the development of predictive biomarkers of treatment response and their combined use to classify tumors based on the interplay between multiple microenvironmental factors is essential for the successful integration of immunotherapy with chemotherapy as a combination treatment strategy.
https://ncbi.nlm.nih.gov/pmc/articles/PMC11122407/
Chiugray
Re: dstock07734 post# 699483
Wednesday, June 19, 2024 1:59:05 AM
Dstock, I don't know much about those connections or about how immune suppressors can be modulated by inhibitor drugs.
I can only speculate generally from a layman's perspective about this one thought. Using an inhibitor drug to modulate a naturally induced immune suppression (by-passing the immune system's checks and balances) would theoretically introduce some level of side effect. But if there are enhanced versions of DCs that can modulate the level of immune suppression via reprogramming the tumor microenvironment, then that changes everything. That means modulation without side effects. I have no idea if that is the case here, but if it was, then it would be profound.
The technologies include enhanced versions of dendritic cells (DCs) and DC based therapies, as well as conditioning regimens designed to enhance patient responses and approaches to reprogram the tumor microenvironment to boost immune therapies and help overcome resistance to checkpoint inhibitors. - 6/17/24 NWBO PR
Re: Chiugray post# 699482
Tuesday, June 18, 2024 10:12:25 PM
I am not sure if SIO takes on the role of being supportive or if SIO sees a great investment opportunity. Assuming it is latter, then I suspect LP didn't give SIO C-share option and the maximum number LP can offer is 8m. SIO can keep loading on the open market if SIO is really serious.
Last quarter SIO invested in a company developing FGFR inhibitors to modulate immunosuppression from Treg Cells. Pawel Kalinski can provide solution on tacking immunosuppression from MDSCs. Plx3397 can overcome immunosuppression due to TAMs. Is that interesting?dstock07734
d_stock
Tuesday, June 18, 2024 8:57:49 PM
699470
Dr. Pawel Kalinski had $14.5M grant from NCI. According to the article, OmniSeq Inc is the company which will conduct molecular testing. The interesting part is that OmniSeq was acquired by a company called Labcorp in July 2021. SIO opened a position on Labcorp in May 2022 and held the small position for only short period of time. Then starting August 2023, SIO has been accumulating Labcorp shares and until the filing of the last quarter, Labcorp is the largest one in SIO's portfolio accounting for almost 15%. Is it just a coincidence?
OmniSeq Inc. will conduct advanced molecular diagnostic testing on participating patients’ tumor cells as part of the studies. AIM ImmunoTech Inc. has agreed to provide rintatolimod (brand name Ampligen), the chemokine-modulating agent to be incorporated into these studies.
https://www.onclive.com/view/roswell-parks-dr-pawel-kalinski-to-lead-145m-ncifunded-immunotherapy-effort
Labcorp expands oncology portfolio with OmniSeq® acquisition.
https://oncology.labcorp.com/cancer-care-team/news-events/labcorp-expands-oncology-portfolio-omniseqr-acquisition
dstock07734
Re: dstock07734 post# 699124
Tuesday, June 18, 2024 9:18:34 PM
Post#
699475
of 699522
Dr. Kalinski's NIH grants.
Targeting the Chemokine System to Sensitize Tumors to Immunotherapy
https://reporter.nih.gov/search/Iq7W4FhuI02dP0i2t5LCtg/project-details/10362635
Project 1: Combinatorial adjuvants promote uniform and selective intratumoral CTL infiltration in colorectal cancer
https://reporter.nih.gov/search/Iq7W4FhuI02dP0i2t5LCtg/project-details/10362700
Targeting complement to enhance antitumor immunity and control malignant effusions in patients with recurrent epithelial ovarian cancer
https://reporter.nih.gov/search/_uivwg8M9U6kGGPuEz-kMQ/project-details/10689822
Chiugray
Re: dstock07734 post# 699483
Wednesday, June 19, 2024 1:59:05 AM
Post#
699495
of 699525
Dstock, I don't know much about those connections or about how immune suppressors can be modulated by inhibitor drugs.
I can only speculate generally from a layman's perspective about this one thought. Using an inhibitor drug to modulate a naturally induced immune suppression (by-passing the immune system's checks and balances) would theoretically introduce some level of side effect. But if there are enhanced versions of DCs that can modulate the level of immune suppression via reprogramming the tumor microenvironment, then that changes everything. That means modulation without side effects. I have no idea if that is the case here, but if it was, then it would be profound.
The technologies include enhanced versions of dendritic cells (DCs) and DC based therapies, as well as conditioning regimens designed to enhance patient responses and approaches to reprogram the tumor microenvironment to boost immune therapies and help overcome resistance to checkpoint inhibitors. - 6/17/24 NWBO PR
ae kusterer
Re: None
Wednesday, June 19, 2024 8:57:48 AM
Post#
699521
of 699529
dstock07734
Re: Chiugray post# 699482
Tuesday, June 18, 2024 10:12:25 PM
I am not sure if SIO takes on the role of being supportive or if SIO sees a great investment opportunity. Assuming it is latter, then I suspect LP didn't give SIO C-share option and the maximum number LP can offer is 8m. SIO can keep loading on the open market if SIO is really serious.
Last quarter SIO invested in a company developing FGFR inhibitors to modulate immunosuppression from Treg Cells. Pawel Kalinski can provide solution on tacking immunosuppression from MDSCs. Plx3397 can overcome immunosuppression due to TAMs. Is that interesting?dstock07734
d_stock
Tuesday, June 18, 2024 8:57:49 PM
699470
Dr. Pawel Kalinski had $14.5M grant from NCI. According to the article, OmniSeq Inc is the company which will conduct molecular testing. The interesting part is that OmniSeq was acquired by a company called Labcorp in July 2021. SIO opened a position on Labcorp in May 2022 and held the small position for only short period of time. Then starting August 2023, SIO has been accumulating Labcorp shares and until the filing of the last quarter, Labcorp is the largest one in SIO's portfolio accounting for almost 15%. Is it just a coincidence?
OmniSeq Inc. will conduct advanced molecular diagnostic testing on participating patients’ tumor cells as part of the studies. AIM ImmunoTech Inc. has agreed to provide rintatolimod (brand name Ampligen), the chemokine-modulating agent to be incorporated into these studies.
https://www.onclive.com/view/roswell-parks-dr-pawel-kalinski-to-lead-145m-ncifunded-immunotherapy-effort
Labcorp expands oncology portfolio with OmniSeq® acquisition.
https://oncology.labcorp.com/cancer-care-team/news-events/labcorp-expands-oncology-portfolio-omniseqr-acquisition
dstock07734
Re: dstock07734 post# 699124
Tuesday, June 18, 2024 9:18:34 PM
Post#
699475
of 699522
Dr. Kalinski's NIH grants.
Targeting the Chemokine System to Sensitize Tumors to Immunotherapy
https://reporter.nih.gov/search/Iq7W4FhuI02dP0i2t5LCtg/project-details/10362635
Project 1: Combinatorial adjuvants promote uniform and selective intratumoral CTL infiltration in colorectal cancer
https://reporter.nih.gov/search/Iq7W4FhuI02dP0i2t5LCtg/project-details/10362700
Targeting complement to enhance antitumor immunity and control malignant effusions in patients with recurrent epithelial ovarian cancer
https://reporter.nih.gov/search/_uivwg8M9U6kGGPuEz-kMQ/project-details/10689822
Margin Buu
Re: Poor Man - post# 699481
Tuesday, June 18, 2024 10:45:57 PM
Post#
699485
of 699524
It’s highly probable after Cohen Milstein submits the amendment that the Motion to Dismiss is denied and then this goes to discovery. Have fun with that 😘
Here is the chronology of the lawsuit:
December 1, 2022 NWBO filed the lawsuit. It is being represented by the highly respected Cohen Milstein law firm.
April 10, 2023 NWBO filed the First Amended Complaint
July 12, 2023 Defendants responded with a Motion to Dismiss (MTD).
November 14, 2023 Oral arguments from plaintiff and defendants were heard.
December 29, 2023 Magistrate Judge Stein oversaw this opening phase of the law suit and issued an extensive 85 page Report and Recommendation (R&R) summarizing his findings.
February 14, 2024 District Judge Woods agreed with and adopted the R&R. The R&R was overall very favorable to NWBO. It concluded that the market makers through spoofing on numerous occasions had purposely manipulated the price of NWBO to cause it to decline. Judge Woods also adopted Judge Stein’s position that NWBO had not sufficiently pled loss causation and on that basis granted the Defendants’ MTD.
Importantly, the Court allowed leave to amend the complaint on the sole issue of loss causation emphasizing that such an amendment would not be futile. In the R&R, the Court laid out a clear roadmap on how NWBO could successfully address loss causation in which case the MTD would be denied and NWBO could proceed to discovery. This Second Amended Complaint is due on, or before March 15, 2024.
Bullish
BULLISH
My posts are my own opinion and do not represent investment, legal, or medical advice.
dstock07734
Re: Chiugray post# 699482
Tuesday, June 18, 2024 10:12:25 PM
I am not sure if SIO takes on the role of being supportive or if SIO sees a great investment opportunity. Assuming it is latter, then I suspect LP didn't give SIO C-share option and the maximum number LP can offer is 8m. SIO can keep loading on the open market if SIO is really serious.
Last quarter SIO invested in a company developing FGFR inhibitors to modulate immunosuppression from Treg Cells. Pawel Kalinski can provide solution on tacking immunosuppression from MDSCs. Plx3397 can overcome immunosuppression due to TAMs. Is that interesting?dstock07734
d_stock
Tuesday, June 18, 2024 8:57:49 PM
699470
Dr. Pawel Kalinski had $14.5M grant from NCI. According to the article, OmniSeq Inc is the company which will conduct molecular testing. The interesting part is that OmniSeq was acquired by a company called Labcorp in July 2021. SIO opened a position on Labcorp in May 2022 and held the small position for only short period of time. Then starting August 2023, SIO has been accumulating Labcorp shares and until the filing of the last quarter, Labcorp is the largest one in SIO's portfolio accounting for almost 15%. Is it just a coincidence?
OmniSeq Inc. will conduct advanced molecular diagnostic testing on participating patients’ tumor cells as part of the studies. AIM ImmunoTech Inc. has agreed to provide rintatolimod (brand name Ampligen), the chemokine-modulating agent to be incorporated into these studies.
https://www.onclive.com/view/roswell-parks-dr-pawel-kalinski-to-lead-145m-ncifunded-immunotherapy-effort
Labcorp expands oncology portfolio with OmniSeq® acquisition.
https://oncology.labcorp.com/cancer-care-team/news-events/labcorp-expands-oncology-portfolio-omniseqr-acquisition
dstock07734
Re: dstock07734 post# 699124
Tuesday, June 18, 2024 9:18:34 PM
Post#
699475
of 699522
Dr. Kalinski's NIH grants.
Targeting the Chemokine System to Sensitize Tumors to Immunotherapy
https://reporter.nih.gov/search/Iq7W4FhuI02dP0i2t5LCtg/project-details/10362635
Project 1: Combinatorial adjuvants promote uniform and selective intratumoral CTL infiltration in colorectal cancer
https://reporter.nih.gov/search/Iq7W4FhuI02dP0i2t5LCtg/project-details/10362700
Targeting complement to enhance antitumor immunity and control malignant effusions in patients with recurrent epithelial ovarian cancer
https://reporter.nih.gov/search/_uivwg8M9U6kGGPuEz-kMQ/project-details/10689822
Flaskworks news pending?
@flaskworks $nwbo @alphavestcap
— alphavestcapital.com (@alphavestcap) June 19, 2024
Flaskworks can also manufacture CAR-T at same time as DCVax-L. So will we see some type of collaboration with $GILD given they have no way to automate Yescarta? Hold onto your $NWBO shares!
ChatGPT 4o: Flaskworks, acquired by Northwest…
Bright Boy
Re: CapHillGuy post# 699198
Tuesday, June 18, 2024 1:24:21 AM
Post#
699219
of 699365
Totally agree!!! What a dream teak we have!!!! For an institution as revered as Roswell Parks(top 4% of grants given by NIH) to choose Northwest to show case their "Tumor microenvironment conditioner"' is a stunning testament to Northwest's Dendritic Cell Based Platform Technology"- DCVax-L and Direct!!!!
Cheers,
BB
georgebailey
Re: dstock07734 post# 699153
Tuesday, June 18, 2024 10:56:13 AM
Post#
699308
of 699356
Dstock I found this
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8365012/
dstock07734
Re: georgebailey post# 699308
Tuesday, June 18, 2024 11:11:16 AM
Post#
699311
of 699358
Thanks, George.
As a matter of fact, I was confused a little about the PR wondering what contribution would come from Pawel Kalinski. I read his paper about glioblastoma using dendritic cells to target blood vessel of the tumor. None of patients in the trial lived over three years. All the current clinical trials from his research are using outcome measures that in no way can be compared with those in the combo trial. But once I saw the MDSC stuff, it was my Eureka moment.
BTW, he also congratulated Dr. Bosch over Linkedin when JAMA paper was published.
georgebailey
Re: hankmanhub post# 699332
Tuesday, June 18, 2024 1:03:13 PM
Post#
699346
of 699351
Hankman- the DC platform IP moat-
the Roswell IP and its associated value to nwbo….” I a sure something was there”.
A simple explanation as to why is that, those Roswell patents could represent a work around of DC based treatments and complimentary DC IP such as MSDC ——-LP is building the DC platform IP moat when bringing in Roswell IP.
hankmanhub
Re: None
Tuesday, June 18, 2024 12:15:16 PM
Post#
699332
of 699344
Since LP saw fit to pay for the IP of Roswell Park I am sure there was something there that would be useful for NWBO and could be developed in the future once the DCVAX platform has been put on solid footing with approval in several jurisdictions.
What I would like to understand, is exactly what in particular are the points that Roswell's IP has, that NWBO wanted to develop further? NWBO already has a platform for all solid cancers. In what particulars does the new IP provide that helps with what NWBO already has, OR what new avenue does this IP open to NWBO that it does not have at the moment?
Member Level
Re: hankmanhub post# 699332
Tuesday, June 18, 2024 12:19:17 PM
Post#
699333
of 699345
hankman - Try Doc Logic's response to Vator below for information related to your question:
vator,
DCs require proper activation and maturation for any particular desired function. The combinations of this process are virtually limitless which creates safety in specificity. Specificity is created by signaling that often times creates on/off switching to genetic functions and pathways. There are different areas of study in this regard and this current announcement is basically pointing to a method for improved signaling that allows DCs to further educate and or prepare a clearer path for the rest of the immune system. What NWBO has is still primary but like I have said before, there are many ways to increase specificity and increase ability to access and destroy targets that otherwise might remain hidden.
The basic understanding shared on this board about the advantages seen from methylated status with regard to DC treatment vs non methylated status is just one example of the open pathway vs closed pathway that additional specificity with signaling could overcome. This currently would require an outside source of CSF-R1 in addition to DCVax-L and likely anti PD1 as well in some to many cases.
Bottom line is that there is synergy and this union is making it much more difficult for big pharma to get in the way of a pathway to a cure. Best wishes.
georgebailey
Re: ilovetech post# 699331
Tuesday, June 18, 2024 12:47:34 PM
Post#
699344
of 699345
ILT- yes Survax is a peptide vaccine conjugate and not a DC treatment thanks ILT.
News was flowing fast…..
On another note, I’ve been comparing licensing business models DC Platform/edens vs Qcom IP/chips. Qcom IP was centered on the technology CDMA used in 3g and today it’s used in 5g. Essentially Qcom owned 3g—-Mobile phone makers had to use CDMA and therefore license from Qcom. To get the license the phone maker had to use and purchase chips made by Qcom.
So, it’s possible that to license Nwbo DC platform a BP would need to use Eden’s. Wouldn’t that be something if LP can get this type of leverage! Will see about that but in the meantime so exciting to see what additional $$ collaborations get announced on approval.
maverick_1
Monday, June 17, 2024 9:16:03 AM
"After four years, she was hired at Enron, but left to launch her own venture capital firm in 1997 BEFORE the now-infamous scandal broke.
Here's the Buckets of Horse MANURE boomeranging on EXWANN, Poor Man & their growing DARK Forces brigade
Linda Powers: A keen eye for the right opportunities
By
Katie Wilmeth
August 11, 2006
Biotech has the longest time frame and one of the biggest risks, but at the same time biotech provides great returns,” she said
“My favorite thing is working with scientists and first-time entrepreneurs and helping them take some kind of research results and turn it into a real product for the real world,” she said
https://www.washingtonexaminer.com/news/business/1767398/linda-powers-a-keen-eye-for-the-right-opportunities/
$NWBO 4 Gen Wealth
BIG U TURN
As
1)MRK BMS bullied since 2014 to rake in >$100 BLN
2)Since 2014 DARK Forces aligned w/WallSt to Manipulate NWBO Shs with AFeuerstein & Hedge Funds to EXTINCTION
Everyone here for last decade were
DERELICT on their High Horse!
Roswell Park's Dr. Pawel Kalinski to Lead $14.5M NCI-Funded Immunotherapy Effort
Author(s):
Onclive Team
In Partnership With:
A team led by Pawel Kalinski, MD, PhD, of Roswell Park Comprehensive Cancer Center has earned a five-year, $14.54 million award from the National Cancer Institute to expand a promising immunotherapy platform.
Pawel Kalinski, MD, PhD
Pawel Kalinski, MD, PhD, Director of Cancer Vaccine and Dendritic Cell Therapies at Roswell Park
Pawel Kalinski, MD, PhD
A team led by Pawel Kalinski, MD, PhD, of Roswell Park Comprehensive Cancer Center has earned a five-year, $14.54 million award from the National Cancer Institute (NCI) to expand a promising immunotherapy platform. Funded through the NCI’s Program Project Grant program, this prestigious five-year grant will fund five clinical trials, all focused on a strategy for making some of the most common immunotherapies work for more cancer patients.
"Our goal with this project is to convert cancers that are traditionally checkpoint-resistant into treatable, 'hot' tumors so that more patients will be able to benefit from some of the most commonly prescribed immunotherapies," says Dr. Kalinski, who is Vice Chair for Translational Research, the Rustum Family Professor for Molecular Therapeutics and Translational Research and Director of Cancer Vaccine and Dendritic Cell Therapies at Roswell Park.
"This five-year National Cancer Institute grant continues a long tradition of groundbreaking immunotherapy research at Roswell Park Comprehensive Cancer Center," says Congressman Brian Higgins. "The research the clinicians at Roswell are conducting represents the next generation of transformational care for cancer patients."
"Cancer touches every family in one way or another," says Congressman Tom Reed. "We are pleased to see this critical grant funding delivered to right here in our backyard to promote innovative breakthroughs for cancer treatment. We will continue to be a constant advocate for Roswell Park in the halls of Congress."
Currently, depending on their cancer type and the genetic characteristics of their tumors, only about 20% of cancer patients are good candidates for a newer class of treatments called checkpoint inhibitors — drugs such as pembrolizumab (Keytruda), nivolumab (Opdivo) and ipilimumab (Yervoy). Even among those patients who are likely to respond initially to treatment with a checkpoint inhibitor, 60% to 70% are likely to have their cancers recur or progress.
"Dr. Kalinski and colleagues have built a compelling case in support of their out-of-the-box approach to cancer immunotherapy," says Kunle Odunsi, MD, PhD, FRCOG, FACOG, Deputy Director and Executive Director of the Center for Immunotherapy at Roswell Park Comprehensive Cancer Center. "All of us in the field will be eagerly following this elegant work, which involves combinations that would uniquely harness previously untapped properties of the human immune system, and accompanied by innovative translational science that should yield greater understanding of immune responses to solid tumors."
Dr. Kalinski has spent the last 15 years developing a unique approach to cancer immunotherapy, or cancer treatment strategies that engage the immune system — first as a faculty member at University of Pittsburgh Medical Center (UPMC), and more recently at Roswell Park.
The NCI grant, which involves partners from both UPMC and The Tisch Cancer Institute at Mount Sinai, will enable five new phase II or phase IIA clinical trials to assess the efficacy of this multipronged approach — two studies in patients with metastatic colorectal cancer, one in patients with checkpoint-resistant advanced melanoma and two in advanced ovarian cancer. Three of the five studies will be conducted at Roswell Park, with the two ovarian cancer studies to be led at UPMC’s Hillman Cancer Center, with participation from Roswell Park.
Chemokines are a type of signaling protein with the ability to control the movements and growth of many immune cells, including cancer-fighting cells called cytotoxic T lymphocytes (CTLs). Together, the trials will explore three complementary strategies for targeting chemokines to alter the tumor microenvironment, or cells surrounding cancer cells, to promote the attraction and activation of CTLs, the key antitumor immune cells.
"Based on our earlier studies both in the lab and in early-phase clinical trials, we have evidence that we can selectively promote entry of antitumor killer cells into tumor microenvironments and reduce local accumulation of suppressive cells in order to sensitize 'cold' tumors to immune checkpoint-inhibition therapy," notes Dr. Kalinski.
The clinical trials will employ a chemokine-modulating regimen targeting three separate pathways of immune response — the toll-like receptor-3, type-1 interferon and prostaglandin networks — as well as specialized dendritic-cell therapeutic vaccines.
The team will also work to assess the immunologic and clinical efficacy of this new therapeutic strategy; identify the biomarkers of response; and develop optimized treatment combinations for many patients with hard-to-treat ovarian and colorectal tumors. The program will also address the pressing challenge of determining the best treatment for patients with melanoma whose tumors recur or persist despite treatment with immunotherapy.
OmniSeq Inc. will conduct advanced molecular diagnostic testing on participating patients’ tumor cells as part of the studies. AIM ImmunoTech Inc. has agreed to provide rintatolimod (brand name Ampligen), the chemokine-modulating agent to be incorporated into these studies.
The clinical trials are not yet underway. Dr. Kalinski and team expect to open all five studies by year-end 2021. When active and open to accrual, the studies will be listed on both roswellpark.org/clinicaltrials and clinicaltrials.gov.
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Roswell Park has two treatment vaccines in the arsenal against cancer; more in the pipeline
When most people think of vaccines, they think of the routine shots you receive as part of modern healthcare to help prevent serious illnesses such as measles, mumps, influenza, shingles, COVID and more, that are caused by a virus or bacteria. Cancer vaccines are different in that they can be used for both prevention and treatment, and use the body’s immune system to find and fight off cells that shouldn’t be there.
“A typical vaccine against a virus or bacteria is looking for cells that look very different in the body than your normal cells. But cancer derives from your own cells, which makes it hard for the immune system to find it,” says Igor Puzanov, MD, Senior Vice President for Clinical Investigation, Director of the Center for Early Phase Clinical Trials and Chief of Melanoma at Roswell Park Comprehensive Cancer Center.
Dr. Puzanov was a key investigator in the earliest research that led to FDA-approval of several breakthrough immunotherapy drugs, including pembrolizumab (Keytruda), nivolumab (Opdivo) and talimogene laherparepvec (T-VEC) for melanoma. At Roswell Park, he oversees all clinical trials, which are the heart of cancer research and future progress in cancer care.
Cancer vaccines are a form of immunotherapy
The vaccine that helps prevent influenza contains an inactive piece of a single protein of flu virus. This tricks the immune system into mounting a defense against the virus so that when the body encounters the flu virus, it knows what to do to fight it off.
Cancer treatment vaccines use similar mechanisms to improve the immune system’s ability to fight off harmful cells. They use infusions or intratumoral injections of either modified cancer cells, parts of cancer cells combined with patients' healthy immune cells (dendritic cells) or pure proteins (called antigens). These may be specific to a certain type of cancer in general, such as glioblastoma , or to one patient at the time, which are personalized vaccines.
"Cancer treatment vaccines work like a piece of clothing with a scent that you give to a hunting dog. The dog will track the scent to its source and attack it. We are trying to train the immune system to recognize cancer, then find and destroy it,” Dr. Puzanov explains. “The trick is to find the right balance between stimulating the immune system and suppressing it.”
Making vaccines to treat an existing cancer is challenging on many fronts because cancer:
starts in healthy cells that can “hide” the cancer cells from the immune system
suppresses the immune system
is difficult to destroy in large or advanced tumors
is difficult to treat in people who are sick or older with a weakened immune system
However, advances in immunotherapy knowledge and technology have led to the development of dendritic-cell vaccines (DC vaccines) for some of the hardest-to-treat cancers, including pancreatic, melanoma, lung, breast and brain cancer. Currently available only through clinical trials, DC vaccines are used in combination with standard treatments such as surgery, chemotherapy and radiation.
“In order for cancer treatment vaccines to be successful alone, they should be administered as soon as possible after diagnosis, when the first cellular changes occur and the tumor burden is low,” says Dr. Puzanov.
How do DC vaccines work?
Dendritic cells are an important part of the immune system identified as professional antigen-presenting cells (APCs). They are highly mobile in the body, can migrate across impermeable barriers such as blood vessel (vascular) walls and are critical to presenting antigens on a cell surface to the fighter T-cells of the immune system. Dendritic cells are especially proficient in compelling T-cells to adapt their immune response to cancer- specific antigens and can be “loaded” with immunotherapy “cargo” — monoclonal antibody drugs like pembrolizumab and nivolumab — and deliver it to specific checkpoints on cancer cells to keep them from multiplying.
All vaccines incorporate some artificial stimulant to enable the immune system to respond against specific antigens (proteins) without making the host sick. “We are investigating a novel ‘two-signal’ theory to find a stimulant compatible with human T-cell antigen response that will train the immune system to attack a certain cancer or personalized cancer and remember that response,” Dr. Puzanov says.
Currently, Roswell Park has two cancer vaccines available to patients through clinical trials. A vaccine called SurVaxM was developed by neurosurgeon Robert Fenstermaker, MD, and scientist Michael Ciesielski, PhD, to treat glioblastoma, a rare and aggressive form of brain cancer. With standard of care therapies – surgery followed by chemotherapy and radiation — the median survival for people with glioblastoma is 15 months.
SurVaxM targets a protein called survivin found in glioblastoma cells and which helps keep the cancer cells alive. In phase 2 clinical trials, 63 patients with newly diagnosed glioblastoma received standard therapy plus SurVaxM. The study found the treatment was tolerated well and side effects were mild with low toxicity. Most promising — nearly all patients did not see their disease progress for six months and survival was extended for many. Some 51% of patients survived at least two years after diagnosis and 41% survived at least three years.
The study is now in phase 2B trials at 15 sites across the United States and China.
"Preliminary results suggest patients seem to be living longer with the novel treatment than with only standard glioblastoma treatment,” Dr. Puzanov says. "We have high hopes for advancement to an FDA-approved drug.”
Clinical trials of a cancer vaccine called CIMAvax also are underway at Roswell Park for patients with certain lung and head and neck cancers. The trials are evaluating whether giving CIMAvax, along with the immunotherapy drugs pembrolizumab and nivolumab, can improve outcomes for patients with non-small cell lung cancer or squamous head and neck cancer. CIMAvax targets a protein receptor called EGFR, which aids tumor growth and development.
Another vaccine in the pipeline at Roswell Park has shown promise in the laboratory. This dendritic-cell vaccine appears to improve the effectiveness of radiation therapy against some aggressive and treatment-resistant forms of breast cancer.
“The rapidly developing science of immunotherapy may lead us to add these and other vaccines soon into our cancer-fighting armamentarium,” Dr. Puzanov says.
Roswell Park Comprehensive Cancer Center (“Roswell Park”) takes steps to provide for the accessibility and usability of its websites, mobile applications, and all digital assets contained or offered therein (collectively, “Services”). To this end, Roswell Park works to provide Services that are compatible with commonly u
Tuesday, June 18, 2024 11:47:09 AM
Post#
699321
of 699329
Excellent post by antihama:
Don't think that's accurate. Here are 6 trials that are better candidates, IMO, including one previously described. Three of the trials are listed but recruiting estimated to start this year which I assume counts when the PR states "The technologies are already in Phase 2 clinical trials"
Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma
http://ClinicalTrials.gov ID NCT04093323
Sponsor Roswell Park Cancer Institute
Information provided by Roswell Park Cancer Institute (Responsible Party)
Last Update Posted 2024-05-30
Study Start (Estimated) 2024-06-20
Study Overview
Brief Summary
This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating patients with HLA-A2 positive (+) melanoma that has not responded to previous treatment (refractory). The aDC1 cell-based treatment contains white blood cells (dendritic cells or DCs) that stimulates the immune system. Interferon alpha-2 can improve the body's natural response to infections and other diseases. It can also interfere with the division of cancer cells and slow tumor growth. Rintalolimid may stimulate the immune system. Celecoxib is a drug that reduces pain. This study is being done to find out if the combination of the study cell-based treatment (aDC1 dendritic cells) and interferon alpha-2, rintatolimod, and celecoxib can prevent the growth and/or progression of melanoma.
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
http://ClinicalTrials.gov ID NCT04348747
Sponsor Roswell Park Cancer Institute
Information provided by Roswell Park Cancer Institute (Responsible Party)
Last Update Posted 2024-06-14
Study Start (Actual) 2022-12-19
Study Overview
Brief Summary
This phase IIa trial studies how well dendritic cell vaccines against Her2/Her3 and pembrolizumab work for the treatment of triple negative breast cancer or HER2+ breast cancer that has spread to the brain (brain metastasis). Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the cancer cells. . Pembrolizumab is an "immune checkpoint inhibitor" which is designed to either "unleash" or "enhance" the cancer immune responses that already exist by either blocking inhibitory molecules" or by activating stimulatory molecules. Giving dendritic cell vaccines and pembrolizumab may shrink the cancer.
Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma
http://ClinicalTrials.gov ID NCT04093323
Sponsor Roswell Park Cancer Institute
Information provided by Roswell Park Cancer Institute (Responsible Party)
Last Update Posted 2024-05-30
Study Start (Estimated) 2024-06-20
Study Overview
Brief Summary
This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating patients with HLA-A2 positive (+) melanoma that has not responded to previous treatment (refractory). The aDC1 cell-based treatment contains white blood cells (dendritic cells or DCs) that stimulates the immune system. Interferon alpha-2 can improve the body's natural response to infections and other diseases. It can also interfere with the division of cancer cells and slow tumor growth. Rintalolimid may stimulate the immune system. Celecoxib is a drug that reduces pain. This study is being done to find out if the combination of the study cell-based treatment (aDC1 dendritic cells) and interferon alpha-2, rintatolimod, and celecoxib can prevent the growth and/or progression of melanoma.
Pembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory Colorectal Cancer (CRC)
http://ClinicalTrials.gov ID NCT05518032
Sponsor Roswell Park Cancer Institute
Information provided by Roswell Park Cancer Institute (Responsible Party)
Last Update Posted 2024-04-12
Study Start (Estimated) 2024-10-01
Study Overview
Brief Summary
The phase II trial tests whether pembrolizumab and dendritic cell-based treatment works to shrink tumors in patients with colorectal cancer that does not respond to treatment (refractory). Pembrolizumab, also referred to as an immune checkpoint inhibitor drug, works by targeting molecules that act as a check and balance system for immune responses. Immune checkpoint inhibitor drugs are designed to either "unleash" or "enhance" the cancer immune responses that already exist by either (1) blocking inhibitory molecules or by (2) activating stimulatory molecules. Dendritic cell-based treatment works by boosting the immune system (a system in our bodies that protects us against infection) to recognize and destroy the cancer cells. This investigational treatment targets cancer cells and is made from the patient's own blood cells. Giving pembrolizumab and dendritic cell-based treatment may help shrink tumors in patients with colorectal cancer.
Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer
http://ClinicalTrials.gov ID NCT05539365
Sponsor Roswell Park Cancer Institute
Information provided by Roswell Park Cancer Institute (Responsible Party)
Last Update Posted 2024-04-12
Study Start (Estimated)
2024-10-01
Study Overview
Brief Summary
This phase II trial tests the safety, side effects, and whether dendritic cell-based treatment and pembrolizumab work in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). The term triple-negative breast cancer refers to the fact that the cancer cells don't have estrogen or progesterone receptors (ER or PR) and also don't make any or too much of the protein called HER2 (the cells test "negative" on all 3 tests). Dendritic cell-based treatment works by boosting the immune system (a system in our bodies that protects us against infection) to recognize and destroy the cancer cells. Pembrolizumab, is an immune checkpoint inhibitor drug, that works by targeting molecules that act as a check and balance system for immune responses. Immune checkpoint inhibitor drugs are designed to either "unleash" or "enhance" the cancer immune responses that already exist by either blocking inhibitory molecules or by activating stimulatory molecules. Giving dendritic cell-based therapy and pembrolizumab may decrease symptoms and improve quality of life in patients with triple negative breast cancer.
Autologous Dendritic Cell Vaccine in Kidney Cancer
http://ClinicalTrials.gov ID NCT05127824
Sponsor Jodi Maranchie
Information provided by Jodi Maranchie, University of Pittsburgh (Responsible Party)
Last Update Posted 2024-06-14
Study Start (Actual) 2023-07-06
Study Overview
Brief Summary
The purpose of this study is to estimate the probability of immune response for the combination treatment of dendritic cell vaccine with oral cabozantinib and characterize the safety profile of interventional therapy.
Detailed Description
Participants with newly diagnosed, non-metastatic, histologically confirmed, clear cell renal cell carcinoma (ccRCC) who have elected to undergo surgical resection, will receive neoadjuvant autologous Tumor Blood Vessel Antigen (TBVA)-Dendritic Cell Vaccine intradermally every 2 weeks x 2 (days 7(+/-3) and 21(+/-3)) prior to surgery on day 31(+7) with oral cabozantinib 20 mg daily for 10 days. We hypothesize that treated renal tumors will demonstrate maturation and organization of the tumor endothelium with normalization of endothelial markers and formation of tertiary lymphoid structure capable of promoting specific T-cell induction.
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3:55 AM · Jun 18, 2024
·
699
Views
University of Chicago Ovarian Cancer SPORE Clinical Trials
RESEARCH
Roswell Park - University of Chicago Ovarian Cancer SPORE
SPORE Overview
History of the Ovarian Cancer SPORE
Information for Patients
Clinical Trials
Faculty and Staff
Upcoming clinical trials
A Phase I/II study to investigate the safety, biologic and anti-tumor activity of oncolytic vaccinia virus armed with a CXCR4 antagonist in combination with pembrolizumab in patients receiving liposomal doxorubicin for recurrent or treatment refractory ovarian, fallopian tube or primary peritoneal cancer (expected early 2024).
A Phase I/II trial of patient-specific neoepitope-loaded autologous dendritic cells and PD-1 blockade in advanced ovarian cancer (expected late 2024).
View a list of all ovarian cancer clinical trials offered by cancer centers across the United States.
Fabulous post! Three immunosuppressive characteristics and MDSC is one of them. Plx3397 can take care of TAM. Seems like Pawel Kalinski can help to tackle MDSC.
#dcvax $nwbo #gbm
Specializing In:
Biology of dendritic cells (DC) and DC vaccines Biology of T cells and T cell targeting therapies of cancer Biology of natural killer (NK) cells Biology of human myeloid-derived suppressor cells (MDSC) Regulation of chemokine production in tumor microenvironment (TME) TME and tumor-associated immune suppression In vitro modeling of human immune system Design and implementation of early phase clinical trialsSpecializing In:
Development and clinical evaluation of new cancer involving the modulation of patients' immune system Role of the immune system in the effectiveness of chemo- and radiotherapy Promoting interactions between clinical and laboratory researchers Development and clinical evaluation of therapeutic vaccines involving different subsets of “polarized” DCs (colorectal cancer, ovarian cancer, prostate cancer, melanoma, hematologic malignancies) Development and clinical evaluation of adoptive T cell therapies (ACT) using ex vivo-induced polyclonal CTLs (ovarian- & colorectal cancers and melanoma) Development and clinical evaluation of combinatorial approaches to enhance the effectiveness of vaccines, ACT an checkpoint blockers, but reprogramming tumor microenvironments for enhanced CTL infiltration and modulating intratumoral expression of PD-L1, Development of combinatorial adjuvants to modulate DC functions in situ Counteracting cancer-related immunosuppressive mechanisms and their use in transplantation and autoimmunity Role of the immune system in the effectiveness of oncolytic virotherapies Role of the immune system in the effectiveness of chemotherapy and radiotherapy of cancer Interplay between stress and cancer immunityResearch Interests:
About Pawel Kalinski
Biography:
The overall goal of my research is to advance the integration of immunotherapy within comprehensive cancer care, as a complementary modality to surgery, chemo and radiotherapy. My group develops new methods of using ex vivo-educated dendritic cells, DC-activated T cells, combinatorial adjuvants and checkpoint blockers, to promote selectively accumulation of type-1 immune cells (CTLs, Th1 and NK cells) in tumor lesions, without amplifying pre-existing Treg- and MDSC responses, in order to enhance local immune surveillance and enhance overall therapeutic outcomes. Our current projects include:Development and clinical evaluation of therapeutic vaccines involving different subsets of “polarized” DCs (colorectal cancer, ovarian cancer, prostate cancer, melanoma, hematologic malignancies)
Development and clinical evaluation of adoptive T cell therapies (ACT) using ex vivo-induced polyclonal CTLs (ovarian- & colorectal cancers and melanoma)
Development and clinical evaluation of combinatorial approaches to enhance the effectiveness of vaccines, ACT and checkpoint blockers, but reprogramming tumor microenvironments for enhanced CTL infiltration and modulating intratumoral expression of PD-L1, PD-L2 and other checkpoints (colorectal cancer, ovarian cancer, prostate cancer, melanoma, bladder cancer, HPV-associated cancers)
Development of combinatorial adjuvants to modulate DC functions in situ
Counteracting cancer-related immunosuppressive mechanisms and their use in transplantation and autoimmunity
Role of the immune system in the effectiveness of oncolytic virotherapies
Role of the immune system in the effectiveness of chemotherapy and radiotherapy of cancer
Interplay between psychologic stress and cancer immunity These interdisciplinary projects involving multiple clinical and laboratory teams, have been advanced as parts of the as multiple NIH-, DOD-, pharma and biotech-funded grants and program projects (single- and multi-institution P01s and P50/SPOREs; where I have been serving as the overall PI, overall co-PI or a Project Leader) and focusing on the therapy of melanoma, colon cancer, prostate cancer, ovarian cancer, and hematologic malignancies. Our current work includes phase I/II and phase II clinical testing of the resulting paradigms and methods in cancer patients, and development of similar treatments for patients with premalignant lesions and chronic infections resistant to standard forms of treatment.
https://roswellpark.org/pawel-kalinski
#dcvax $nwbo #gbm
Excellent post by Brightboy:
People, People, People!!! THIS A BIG, BIG ,TERRIFIC DEAL!!!!! How do you build a Franchise???? Well, the "Instruction Sheet" is in the PRESS RELEASE!!! For a "Song"($2.3 million and a 4% royalty on treatment sales for the 2 NEW and possibly a third cancer treatment, the company has now expanded its Franchise value from one treatment for GBM pending approval in the UK to 2 active clinical trials with one pending for 3 new cancers AND in doing so, has firmly established DCVax Technology as the "Go TO" technology for every dendritic cell based immunotherapy company in the world!!!! Not to mention the FACT that the company has the only manufacturing process that can make the product and scale to demand for every CI company in biotech to dramatically improve their treatment. Shoot, we have already become the "XEROX" of dendritic cell based immunotherapy or in the words of a company supporter, Northwest has "APPELIZED" healthcare!!!! BUT ALSO!!!! as is apparent in the PR, the company ain't stopping there!!! No, No, NO 111 The company's going for "All the marbles"!!! AND every CEO in big biotech knows that they have to license the DCVax Platform Technology to be competitive!! Hell, this deal is making "Screaming Kitty" or whatever the hell that guys name is, drool with envy. This ain't no flash in the pan like GME, this a "FLASHBULB, LIGHTING UP THE FUTURE OF THE ENTIRE HEALTHCARE LANDSCAPE!!!!!" Dudes and Dudettes, this deal has got legs!!!!!
AND by the way, Linda Powers and her band of experts have not been sittin on their ass like many have claimed, they've been workin their butts off for the last 2 years to pull this off!!! and BRAVO to them!!!! How much do you think the value of getting in on 3 clinical trials is??? Millions and millions!!!! THAT'S THE FRANCHISE VALUE THAT NORTHWEST HAS ADDED. Hundreds of millions in cost savings and billions in sales revenue!!!!!
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8:48 AM · Jun 17, 2024
·
1,237
Views
Northwest Biotherapeutics Announces Exclusive In-License of Portfolio of Dendritic Cell Technology and Intellectual Property
Complementary to Technology & IP Already Owned or In-Licensed; Significant Step in Building a Leading Dendritic Cell Franchise
BETHESDA, MD, June 17, 2024 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that on June 12, 2024 it entered into an exclusive license from Roswell Park Comprehensive Cancer Center for a portfolio of dendritic cell technologies and intellectual property (IP). The technologies are already in Phase 2 clinical trials, and the Company plans to collaborate with the lead scientist-clinician, Dr. Pawel Kalinski, on the further development of the technologies. The license is the culmination of more than 2 years of discussions and negotiations.
The license includes 5 new patent families that were just filed in 2023 and hence have their full potential patent life ahead of them. The technologies include enhanced versions of dendritic cells (DCs) and DC based therapies, as well as conditioning regimens designed to enhance patient responses and approaches to reprogram the tumor microenvironment to boost immune therapies and help overcome resistance to checkpoint inhibitors.
The DC based therapies include versions with tumor antigens loaded into the DCs and versions for intra-tumoral administration without pre-loading of antigens. Phase 2 trials involving the licensed technologies for two different cancers opened for enrollment earlier this year and are currently under way, and a third Phase 2 trial for a third cancer is pending. The trials are fully funded by grant funding and are being conducted as investigator led trials. The Company does not anticipate having to provide any funding or undertake any operational role for these trials.
As previously reported, over time the Company has been quietly in-licensing various technologies and IP from various institutions and entities which it believes can be valuable in building a leading franchise in dendritic cell therapies.
The portfolio in-licensed from Roswell Park is complementary to, and builds upon, a portfolio which the Company exclusively licensed from another institution last year. Together, the two portfolios encompass more than 20 years of work by one of the foremost groups of dendritic cell experts, led by Dr. Kalinski.
The portfolio in-licensed last year includes the foundational technologies and IP, and positive early-stage clinical trial results, developed by the Kalinski group over 17 years before coming to Roswell. The portfolio in-licensed now includes the further work during the last 7 years at Roswell. Taken together, the Company believes that the two portfolios comprise a whole that is greater than the sum of its parts and offer compelling synergies with the Company’s own portfolio. The Company plans to collaborate with Dr. Kalinski on the further clinical development of the combined technologies.
The Company believes that the infrastructure and systems it has developed, and experience it has gained, in producing and delivering personalized living-cell DC based therapies for large numbers of patients make it uniquely positioned to help accelerate the late-stage development of the licensed DC technologies. The Company’s 331-patient Phase 3 clinical trial remains one of the largest personalized cell therapy trials conducted to date, and the Company’s extensive experience treating compassionate use patients has added valuable ongoing “real world” experience.
“We are excited to join forces with Dr. Kalinski, one of the foremost experts on dendritic cell biology and therapies,” commented Linda Powers, the Company’s CEO. “We also greatly appreciate the supportiveness of the institutions throughout the long process of working out the arrangements to keep the Kalinski portfolios intact and to license them to NWBio. In the immediate term, we will continue to focus intensively on pursuing the approval and commercialization of DCVax®-L for glioblastoma, but we are excited to begin working on growth opportunities with the licensed technologies as well.”
The terms of the Roswell license include standard provisions for an upfront license fee and milestones related to the first Phase 2 trial, first Phase 3 trial, first product approval and first commercial sale. If all of the milestones are met, the payments would be approximately $2.3 million. The license terms also include royalties of 4% on product sales (potentially reduced to 3% in the event of royalty stacking).
ABOUT NORTHWEST BIOTHERAPEUTICS
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products that are designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company’s lead program involves DCVax®-L treatment for glioblastoma (GBM). GBM is the most aggressive and lethal form of primary brain cancer, and is an “orphan disease.” The Company has completed a 331-patient Phase III trial of DCVax-L for GBM, presented the results in scientific meetings, published the results in JAMA Oncology and submitted a MAA for commercial approval in the UK. The Company has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
DISCLAIMER
Statements made in this news release that are not historical facts, including statements concerning plans for DCVax are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in any forward-looking statement. Readers should not rely upon forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those anticipated, including, without limitation, risks related to delays or uncertainties in regulatory processes and decisions, risks related to the Company’s ability to achieve timely performance of third parties, risks related to whether the Company’s products, including products involving in-licensed intellectual property, will be viewed as demonstrating safety and efficacy, risks relating to funding or implementation of clinical trials, including trials involving in-licensed intellectual property, risks related to the Company’s ongoing ability to raise additional capital, and other risks included in the Company’s Securities and Exchange Commission (“SEC”) filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company’s results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual plans, results or timelines to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
*****
CONTACTS
Northwest Biotherapeutics
Dave Innes
804-513-4758
dinnes@nwbio.com
Les Goldman
240-234-0059
lgoldman@nwbio.com
#dcvax $nwbo #gbm
Excellent post by beartrap:
About Dr. Pawel Kalinski from 2020 research found at: [url][/url][tag]https://onclive.com/view/roswell-parks-dr-pawel-kalinski-to-lead-145m-ncifunded-immunotherapy-effort[/tag]
Obviously, I don't know if this is the technology that NWBO in-licensed.
A team led by Pawel Kalinski, MD, PhD, of Roswell Park Comprehensive Cancer Center has earned a five-year, $14.54 million award from the National Cancer Institute (NCI) to expand a promising immunotherapy platform. Funded through the NCI’s Program Project Grant program, this prestigious five-year grant will fund five clinical trials, all focused on a strategy for making some of the most common immunotherapies work for more cancer patients.
"Our goal with this project is to convert cancers that are traditionally checkpoint-resistant into treatable, 'hot' tumors so that more patients will be able to benefit from some of the most commonly prescribed immunotherapies," says Dr. Kalinski, who is Vice Chair for Translational Research, the Rustum Family Professor for Molecular Therapeutics and Translational Research and Director of Cancer Vaccine and Dendritic Cell Therapies at Roswell Park.
"This five-year National Cancer Institute grant continues a long tradition of groundbreaking immunotherapy research at Roswell Park Comprehensive Cancer Center," says Congressman Brian Higgins. "The research the clinicians at Roswell are conducting represents the next generation of transformational care for cancer patients."
"Cancer touches every family in one way or another," says Congressman Tom Reed. "We are pleased to see this critical grant funding delivered to right here in our backyard to promote innovative breakthroughs for cancer treatment. We will continue to be a constant advocate for Roswell Park in the halls of Congress."
Currently, depending on their cancer type and the genetic characteristics of their tumors, only about 20% of cancer patients are good candidates for a newer class of treatments called checkpoint inhibitors — drugs such as pembrolizumab (Keytruda), nivolumab (Opdivo) and ipilimumab (Yervoy). Even among those patients who are likely to respond initially to treatment with a checkpoint inhibitor, 60% to 70% are likely to have their cancers recur or progress.
"Dr. Kalinski and colleagues have built a compelling case in support of their out-of-the-box approach to cancer immunotherapy," says Kunle Odunsi, MD, PhD, FRCOG, FACOG, Deputy Director and Executive Director of the Center for Immunotherapy at Roswell Park Comprehensive Cancer Center. "All of us in the field will be eagerly following this elegant work, which involves combinations that would uniquely harness previously untapped properties of the human immune system, and accompanied by innovative translational science that should yield greater understanding of immune responses to solid tumors."
Dr. Kalinski has spent the last 15 years developing a unique approach to cancer immunotherapy, or cancer treatment strategies that engage the immune system — first as a faculty member at University of Pittsburgh Medical Center (UPMC), and more recently at Roswell Park.
The NCI grant, which involves partners from both UPMC and The Tisch Cancer Institute at Mount Sinai, will enable five new phase II or phase IIA clinical trials to assess the efficacy of this multipronged approach — two studies in patients with metastatic colorectal cancer, one in patients with checkpoint-resistant advanced melanoma and two in advanced ovarian cancer. Three of the five studies will be conducted at Roswell Park, with the two ovarian cancer studies to be led at UPMC’s Hillman Cancer Center, with participation from Roswell Park.
Chemokines are a type of signaling protein with the ability to control the movements and growth of many immune cells, including cancer-fighting cells called cytotoxic T lymphocytes (CTLs). Together, the trials will explore three complementary strategies for targeting chemokines to alter the tumor microenvironment, or cells surrounding cancer cells, to promote the attraction and activation of CTLs, the key antitumor immune cells.
"Based on our earlier studies both in the lab and in early-phase clinical trials, we have evidence that we can selectively promote entry of antitumor killer cells into tumor microenvironments and reduce local accumulation of suppressive cells in order to sensitize 'cold' tumors to immune checkpoint-inhibition therapy," notes Dr. Kalinski.
The clinical trials will employ a chemokine-modulating regimen targeting three separate pathways of immune response — the toll-like receptor-3, type-1 interferon and prostaglandin networks — as well as specialized dendritic-cell therapeutic vaccines.
The team will also work to assess the immunologic and clinical efficacy of this new therapeutic strategy; identify the biomarkers of response; and develop optimized treatment combinations for many patients with hard-to-treat ovarian and colorectal tumors. The program will also address the pressing challenge of determining the best treatment for patients with melanoma whose tumors recur or persist despite treatment with immunotherapy.
OmniSeq Inc. will conduct advanced molecular diagnostic testing on participating patients’ tumor cells as part of the studies. AIM ImmunoTech Inc. has agreed to provide rintatolimod (brand name Ampligen), the chemokine-modulating agent to be incorporated into these studies.
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8:58 AM · Jun 17, 2024
·
665
Views
Excellent post by antihama:
Don't think that's accurate. Here are 6 trials that are better candidates, IMO, including one previously described. Three of the trials are listed but recruiting estimated to start this year which I assume counts when the PR states "The technologies are already in Phase 2 clinical trials"
Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma
http://ClinicalTrials.gov ID NCT04093323
Sponsor Roswell Park Cancer Institute
Information provided by Roswell Park Cancer Institute (Responsible Party)
Last Update Posted 2024-05-30
Study Start (Estimated) 2024-06-20
Study Overview
Brief Summary
This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating patients with HLA-A2 positive (+) melanoma that has not responded to previous treatment (refractory). The aDC1 cell-based treatment contains white blood cells (dendritic cells or DCs) that stimulates the immune system. Interferon alpha-2 can improve the body's natural response to infections and other diseases. It can also interfere with the division of cancer cells and slow tumor growth. Rintalolimid may stimulate the immune system. Celecoxib is a drug that reduces pain. This study is being done to find out if the combination of the study cell-based treatment (aDC1 dendritic cells) and interferon alpha-2, rintatolimod, and celecoxib can prevent the growth and/or progression of melanoma.
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
http://ClinicalTrials.gov ID NCT04348747
Sponsor Roswell Park Cancer Institute
Information provided by Roswell Park Cancer Institute (Responsible Party)
Last Update Posted 2024-06-14
Study Start (Actual) 2022-12-19
Study Overview
Brief Summary
This phase IIa trial studies how well dendritic cell vaccines against Her2/Her3 and pembrolizumab work for the treatment of triple negative breast cancer or HER2+ breast cancer that has spread to the brain (brain metastasis). Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the cancer cells. . Pembrolizumab is an "immune checkpoint inhibitor" which is designed to either "unleash" or "enhance" the cancer immune responses that already exist by either blocking inhibitory molecules" or by activating stimulatory molecules. Giving dendritic cell vaccines and pembrolizumab may shrink the cancer.
Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma
http://ClinicalTrials.gov ID NCT04093323
Sponsor Roswell Park Cancer Institute
Information provided by Roswell Park Cancer Institute (Responsible Party)
Last Update Posted 2024-05-30
Study Start (Estimated) 2024-06-20
Study Overview
Brief Summary
This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating patients with HLA-A2 positive (+) melanoma that has not responded to previous treatment (refractory). The aDC1 cell-based treatment contains white blood cells (dendritic cells or DCs) that stimulates the immune system. Interferon alpha-2 can improve the body's natural response to infections and other diseases. It can also interfere with the division of cancer cells and slow tumor growth. Rintalolimid may stimulate the immune system. Celecoxib is a drug that reduces pain. This study is being done to find out if the combination of the study cell-based treatment (aDC1 dendritic cells) and interferon alpha-2, rintatolimod, and celecoxib can prevent the growth and/or progression of melanoma.
Pembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory Colorectal Cancer (CRC)
http://ClinicalTrials.gov ID NCT05518032
Sponsor Roswell Park Cancer Institute
Information provided by Roswell Park Cancer Institute (Responsible Party)
Last Update Posted 2024-04-12
Study Start (Estimated) 2024-10-01
Study Overview
Brief Summary
The phase II trial tests whether pembrolizumab and dendritic cell-based treatment works to shrink tumors in patients with colorectal cancer that does not respond to treatment (refractory). Pembrolizumab, also referred to as an immune checkpoint inhibitor drug, works by targeting molecules that act as a check and balance system for immune responses. Immune checkpoint inhibitor drugs are designed to either "unleash" or "enhance" the cancer immune responses that already exist by either (1) blocking inhibitory molecules or by (2) activating stimulatory molecules. Dendritic cell-based treatment works by boosting the immune system (a system in our bodies that protects us against infection) to recognize and destroy the cancer cells. This investigational treatment targets cancer cells and is made from the patient's own blood cells. Giving pembrolizumab and dendritic cell-based treatment may help shrink tumors in patients with colorectal cancer.
Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer
http://ClinicalTrials.gov ID NCT05539365
Sponsor Roswell Park Cancer Institute
Information provided by Roswell Park Cancer Institute (Responsible Party)
Last Update Posted 2024-04-12
Study Start (Estimated)
2024-10-01
Study Overview
Brief Summary
This phase II trial tests the safety, side effects, and whether dendritic cell-based treatment and pembrolizumab work in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). The term triple-negative breast cancer refers to the fact that the cancer cells don't have estrogen or progesterone receptors (ER or PR) and also don't make any or too much of the protein called HER2 (the cells test "negative" on all 3 tests). Dendritic cell-based treatment works by boosting the immune system (a system in our bodies that protects us against infection) to recognize and destroy the cancer cells. Pembrolizumab, is an immune checkpoint inhibitor drug, that works by targeting molecules that act as a check and balance system for immune responses. Immune checkpoint inhibitor drugs are designed to either "unleash" or "enhance" the cancer immune responses that already exist by either blocking inhibitory molecules or by activating stimulatory molecules. Giving dendritic cell-based therapy and pembrolizumab may decrease symptoms and improve quality of life in patients with triple negative breast cancer.
Autologous Dendritic Cell Vaccine in Kidney Cancer
http://ClinicalTrials.gov ID NCT05127824
Sponsor Jodi Maranchie
Information provided by Jodi Maranchie, University of Pittsburgh (Responsible Party)
Last Update Posted 2024-06-14
Study Start (Actual) 2023-07-06
Study Overview
Brief Summary
The purpose of this study is to estimate the probability of immune response for the combination treatment of dendritic cell vaccine with oral cabozantinib and characterize the safety profile of interventional therapy.
Detailed Description
Participants with newly diagnosed, non-metastatic, histologically confirmed, clear cell renal cell carcinoma (ccRCC) who have elected to undergo surgical resection, will receive neoadjuvant autologous Tumor Blood Vessel Antigen (TBVA)-Dendritic Cell Vaccine intradermally every 2 weeks x 2 (days 7(+/-3) and 21(+/-3)) prior to surgery on day 31(+7) with oral cabozantinib 20 mg daily for 10 days. We hypothesize that treated renal tumors will demonstrate maturation and organization of the tumor endothelium with normalization of endothelial markers and formation of tertiary lymphoid structure capable of promoting specific T-cell induction.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174614815
3:55 AM · Jun 18, 2024
·
699
Views
University of Chicago Ovarian Cancer SPORE Clinical Trials
RESEARCH
Roswell Park - University of Chicago Ovarian Cancer SPORE
SPORE Overview
History of the Ovarian Cancer SPORE
Information for Patients
Clinical Trials
Faculty and Staff
Upcoming clinical trials
A Phase I/II study to investigate the safety, biologic and anti-tumor activity of oncolytic vaccinia virus armed with a CXCR4 antagonist in combination with pembrolizumab in patients receiving liposomal doxorubicin for recurrent or treatment refractory ovarian, fallopian tube or primary peritoneal cancer (expected early 2024).
A Phase I/II trial of patient-specific neoepitope-loaded autologous dendritic cells and PD-1 blockade in advanced ovarian cancer (expected late 2024).
View a list of all ovarian cancer clinical trials offered by cancer centers across the United States.
Fabulous post! Three immunosuppressive characteristics and MDSC is one of them. Plx3397 can take care of TAM. Seems like Pawel Kalinski can help to tackle MDSC.
#dcvax $nwbo #gbm
Specializing In:
Biology of dendritic cells (DC) and DC vaccines Biology of T cells and T cell targeting therapies of cancer Biology of natural killer (NK) cells Biology of human myeloid-derived suppressor cells (MDSC) Regulation of chemokine production in tumor microenvironment (TME) TME and tumor-associated immune suppression In vitro modeling of human immune system Design and implementation of early phase clinical trialsSpecializing In:
Development and clinical evaluation of new cancer involving the modulation of patients' immune system Role of the immune system in the effectiveness of chemo- and radiotherapy Promoting interactions between clinical and laboratory researchers Development and clinical evaluation of therapeutic vaccines involving different subsets of “polarized” DCs (colorectal cancer, ovarian cancer, prostate cancer, melanoma, hematologic malignancies) Development and clinical evaluation of adoptive T cell therapies (ACT) using ex vivo-induced polyclonal CTLs (ovarian- & colorectal cancers and melanoma) Development and clinical evaluation of combinatorial approaches to enhance the effectiveness of vaccines, ACT an checkpoint blockers, but reprogramming tumor microenvironments for enhanced CTL infiltration and modulating intratumoral expression of PD-L1, Development of combinatorial adjuvants to modulate DC functions in situ Counteracting cancer-related immunosuppressive mechanisms and their use in transplantation and autoimmunity Role of the immune system in the effectiveness of oncolytic virotherapies Role of the immune system in the effectiveness of chemotherapy and radiotherapy of cancer Interplay between stress and cancer immunityResearch Interests:
About Pawel Kalinski
Biography:
The overall goal of my research is to advance the integration of immunotherapy within comprehensive cancer care, as a complementary modality to surgery, chemo and radiotherapy. My group develops new methods of using ex vivo-educated dendritic cells, DC-activated T cells, combinatorial adjuvants and checkpoint blockers, to promote selectively accumulation of type-1 immune cells (CTLs, Th1 and NK cells) in tumor lesions, without amplifying pre-existing Treg- and MDSC responses, in order to enhance local immune surveillance and enhance overall therapeutic outcomes. Our current projects include:Development and clinical evaluation of therapeutic vaccines involving different subsets of “polarized” DCs (colorectal cancer, ovarian cancer, prostate cancer, melanoma, hematologic malignancies)
Development and clinical evaluation of adoptive T cell therapies (ACT) using ex vivo-induced polyclonal CTLs (ovarian- & colorectal cancers and melanoma)
Development and clinical evaluation of combinatorial approaches to enhance the effectiveness of vaccines, ACT and checkpoint blockers, but reprogramming tumor microenvironments for enhanced CTL infiltration and modulating intratumoral expression of PD-L1, PD-L2 and other checkpoints (colorectal cancer, ovarian cancer, prostate cancer, melanoma, bladder cancer, HPV-associated cancers)
Development of combinatorial adjuvants to modulate DC functions in situ
Counteracting cancer-related immunosuppressive mechanisms and their use in transplantation and autoimmunity
Role of the immune system in the effectiveness of oncolytic virotherapies
Role of the immune system in the effectiveness of chemotherapy and radiotherapy of cancer
Interplay between psychologic stress and cancer immunity These interdisciplinary projects involving multiple clinical and laboratory teams, have been advanced as parts of the as multiple NIH-, DOD-, pharma and biotech-funded grants and program projects (single- and multi-institution P01s and P50/SPOREs; where I have been serving as the overall PI, overall co-PI or a Project Leader) and focusing on the therapy of melanoma, colon cancer, prostate cancer, ovarian cancer, and hematologic malignancies. Our current work includes phase I/II and phase II clinical testing of the resulting paradigms and methods in cancer patients, and development of similar treatments for patients with premalignant lesions and chronic infections resistant to standard forms of treatment.
https://roswellpark.org/pawel-kalinski
#dcvax $nwbo #gbm
Excellent post by Brightboy:
People, People, People!!! THIS A BIG, BIG ,TERRIFIC DEAL!!!!! How do you build a Franchise???? Well, the "Instruction Sheet" is in the PRESS RELEASE!!! For a "Song"($2.3 million and a 4% royalty on treatment sales for the 2 NEW and possibly a third cancer treatment, the company has now expanded its Franchise value from one treatment for GBM pending approval in the UK to 2 active clinical trials with one pending for 3 new cancers AND in doing so, has firmly established DCVax Technology as the "Go TO" technology for every dendritic cell based immunotherapy company in the world!!!! Not to mention the FACT that the company has the only manufacturing process that can make the product and scale to demand for every CI company in biotech to dramatically improve their treatment. Shoot, we have already become the "XEROX" of dendritic cell based immunotherapy or in the words of a company supporter, Northwest has "APPELIZED" healthcare!!!! BUT ALSO!!!! as is apparent in the PR, the company ain't stopping there!!! No, No, NO 111 The company's going for "All the marbles"!!! AND every CEO in big biotech knows that they have to license the DCVax Platform Technology to be competitive!! Hell, this deal is making "Screaming Kitty" or whatever the hell that guys name is, drool with envy. This ain't no flash in the pan like GME, this a "FLASHBULB, LIGHTING UP THE FUTURE OF THE ENTIRE HEALTHCARE LANDSCAPE!!!!!" Dudes and Dudettes, this deal has got legs!!!!!
AND by the way, Linda Powers and her band of experts have not been sittin on their ass like many have claimed, they've been workin their butts off for the last 2 years to pull this off!!! and BRAVO to them!!!! How much do you think the value of getting in on 3 clinical trials is??? Millions and millions!!!! THAT'S THE FRANCHISE VALUE THAT NORTHWEST HAS ADDED. Hundreds of millions in cost savings and billions in sales revenue!!!!!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174611567
8:48 AM · Jun 17, 2024
·
1,237
Views
Northwest Biotherapeutics Announces Exclusive In-License of Portfolio of Dendritic Cell Technology and Intellectual Property
Complementary to Technology & IP Already Owned or In-Licensed; Significant Step in Building a Leading Dendritic Cell Franchise
BETHESDA, MD, June 17, 2024 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that on June 12, 2024 it entered into an exclusive license from Roswell Park Comprehensive Cancer Center for a portfolio of dendritic cell technologies and intellectual property (IP). The technologies are already in Phase 2 clinical trials, and the Company plans to collaborate with the lead scientist-clinician, Dr. Pawel Kalinski, on the further development of the technologies. The license is the culmination of more than 2 years of discussions and negotiations.
The license includes 5 new patent families that were just filed in 2023 and hence have their full potential patent life ahead of them. The technologies include enhanced versions of dendritic cells (DCs) and DC based therapies, as well as conditioning regimens designed to enhance patient responses and approaches to reprogram the tumor microenvironment to boost immune therapies and help overcome resistance to checkpoint inhibitors.
The DC based therapies include versions with tumor antigens loaded into the DCs and versions for intra-tumoral administration without pre-loading of antigens. Phase 2 trials involving the licensed technologies for two different cancers opened for enrollment earlier this year and are currently under way, and a third Phase 2 trial for a third cancer is pending. The trials are fully funded by grant funding and are being conducted as investigator led trials. The Company does not anticipate having to provide any funding or undertake any operational role for these trials.
As previously reported, over time the Company has been quietly in-licensing various technologies and IP from various institutions and entities which it believes can be valuable in building a leading franchise in dendritic cell therapies.
The portfolio in-licensed from Roswell Park is complementary to, and builds upon, a portfolio which the Company exclusively licensed from another institution last year. Together, the two portfolios encompass more than 20 years of work by one of the foremost groups of dendritic cell experts, led by Dr. Kalinski.
The portfolio in-licensed last year includes the foundational technologies and IP, and positive early-stage clinical trial results, developed by the Kalinski group over 17 years before coming to Roswell. The portfolio in-licensed now includes the further work during the last 7 years at Roswell. Taken together, the Company believes that the two portfolios comprise a whole that is greater than the sum of its parts and offer compelling synergies with the Company’s own portfolio. The Company plans to collaborate with Dr. Kalinski on the further clinical development of the combined technologies.
The Company believes that the infrastructure and systems it has developed, and experience it has gained, in producing and delivering personalized living-cell DC based therapies for large numbers of patients make it uniquely positioned to help accelerate the late-stage development of the licensed DC technologies. The Company’s 331-patient Phase 3 clinical trial remains one of the largest personalized cell therapy trials conducted to date, and the Company’s extensive experience treating compassionate use patients has added valuable ongoing “real world” experience.
“We are excited to join forces with Dr. Kalinski, one of the foremost experts on dendritic cell biology and therapies,” commented Linda Powers, the Company’s CEO. “We also greatly appreciate the supportiveness of the institutions throughout the long process of working out the arrangements to keep the Kalinski portfolios intact and to license them to NWBio. In the immediate term, we will continue to focus intensively on pursuing the approval and commercialization of DCVax®-L for glioblastoma, but we are excited to begin working on growth opportunities with the licensed technologies as well.”
The terms of the Roswell license include standard provisions for an upfront license fee and milestones related to the first Phase 2 trial, first Phase 3 trial, first product approval and first commercial sale. If all of the milestones are met, the payments would be approximately $2.3 million. The license terms also include royalties of 4% on product sales (potentially reduced to 3% in the event of royalty stacking).
ABOUT NORTHWEST BIOTHERAPEUTICS
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products that are designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company’s lead program involves DCVax®-L treatment for glioblastoma (GBM). GBM is the most aggressive and lethal form of primary brain cancer, and is an “orphan disease.” The Company has completed a 331-patient Phase III trial of DCVax-L for GBM, presented the results in scientific meetings, published the results in JAMA Oncology and submitted a MAA for commercial approval in the UK. The Company has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
DISCLAIMER
Statements made in this news release that are not historical facts, including statements concerning plans for DCVax are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in any forward-looking statement. Readers should not rely upon forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those anticipated, including, without limitation, risks related to delays or uncertainties in regulatory processes and decisions, risks related to the Company’s ability to achieve timely performance of third parties, risks related to whether the Company’s products, including products involving in-licensed intellectual property, will be viewed as demonstrating safety and efficacy, risks relating to funding or implementation of clinical trials, including trials involving in-licensed intellectual property, risks related to the Company’s ongoing ability to raise additional capital, and other risks included in the Company’s Securities and Exchange Commission (“SEC”) filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company’s results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual plans, results or timelines to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
*****
CONTACTS
Northwest Biotherapeutics
Dave Innes
804-513-4758
dinnes@nwbio.com
Les Goldman
240-234-0059
lgoldman@nwbio.com
#dcvax $nwbo #gbm
Excellent post by beartrap:
About Dr. Pawel Kalinski from 2020 research found at: [url][/url][tag]https://onclive.com/view/roswell-parks-dr-pawel-kalinski-to-lead-145m-ncifunded-immunotherapy-effort[/tag]
Obviously, I don't know if this is the technology that NWBO in-licensed.
A team led by Pawel Kalinski, MD, PhD, of Roswell Park Comprehensive Cancer Center has earned a five-year, $14.54 million award from the National Cancer Institute (NCI) to expand a promising immunotherapy platform. Funded through the NCI’s Program Project Grant program, this prestigious five-year grant will fund five clinical trials, all focused on a strategy for making some of the most common immunotherapies work for more cancer patients.
"Our goal with this project is to convert cancers that are traditionally checkpoint-resistant into treatable, 'hot' tumors so that more patients will be able to benefit from some of the most commonly prescribed immunotherapies," says Dr. Kalinski, who is Vice Chair for Translational Research, the Rustum Family Professor for Molecular Therapeutics and Translational Research and Director of Cancer Vaccine and Dendritic Cell Therapies at Roswell Park.
"This five-year National Cancer Institute grant continues a long tradition of groundbreaking immunotherapy research at Roswell Park Comprehensive Cancer Center," says Congressman Brian Higgins. "The research the clinicians at Roswell are conducting represents the next generation of transformational care for cancer patients."
"Cancer touches every family in one way or another," says Congressman Tom Reed. "We are pleased to see this critical grant funding delivered to right here in our backyard to promote innovative breakthroughs for cancer treatment. We will continue to be a constant advocate for Roswell Park in the halls of Congress."
Currently, depending on their cancer type and the genetic characteristics of their tumors, only about 20% of cancer patients are good candidates for a newer class of treatments called checkpoint inhibitors — drugs such as pembrolizumab (Keytruda), nivolumab (Opdivo) and ipilimumab (Yervoy). Even among those patients who are likely to respond initially to treatment with a checkpoint inhibitor, 60% to 70% are likely to have their cancers recur or progress.
"Dr. Kalinski and colleagues have built a compelling case in support of their out-of-the-box approach to cancer immunotherapy," says Kunle Odunsi, MD, PhD, FRCOG, FACOG, Deputy Director and Executive Director of the Center for Immunotherapy at Roswell Park Comprehensive Cancer Center. "All of us in the field will be eagerly following this elegant work, which involves combinations that would uniquely harness previously untapped properties of the human immune system, and accompanied by innovative translational science that should yield greater understanding of immune responses to solid tumors."
Dr. Kalinski has spent the last 15 years developing a unique approach to cancer immunotherapy, or cancer treatment strategies that engage the immune system — first as a faculty member at University of Pittsburgh Medical Center (UPMC), and more recently at Roswell Park.
The NCI grant, which involves partners from both UPMC and The Tisch Cancer Institute at Mount Sinai, will enable five new phase II or phase IIA clinical trials to assess the efficacy of this multipronged approach — two studies in patients with metastatic colorectal cancer, one in patients with checkpoint-resistant advanced melanoma and two in advanced ovarian cancer. Three of the five studies will be conducted at Roswell Park, with the two ovarian cancer studies to be led at UPMC’s Hillman Cancer Center, with participation from Roswell Park.
Chemokines are a type of signaling protein with the ability to control the movements and growth of many immune cells, including cancer-fighting cells called cytotoxic T lymphocytes (CTLs). Together, the trials will explore three complementary strategies for targeting chemokines to alter the tumor microenvironment, or cells surrounding cancer cells, to promote the attraction and activation of CTLs, the key antitumor immune cells.
"Based on our earlier studies both in the lab and in early-phase clinical trials, we have evidence that we can selectively promote entry of antitumor killer cells into tumor microenvironments and reduce local accumulation of suppressive cells in order to sensitize 'cold' tumors to immune checkpoint-inhibition therapy," notes Dr. Kalinski.
The clinical trials will employ a chemokine-modulating regimen targeting three separate pathways of immune response — the toll-like receptor-3, type-1 interferon and prostaglandin networks — as well as specialized dendritic-cell therapeutic vaccines.
The team will also work to assess the immunologic and clinical efficacy of this new therapeutic strategy; identify the biomarkers of response; and develop optimized treatment combinations for many patients with hard-to-treat ovarian and colorectal tumors. The program will also address the pressing challenge of determining the best treatment for patients with melanoma whose tumors recur or persist despite treatment with immunotherapy.
OmniSeq Inc. will conduct advanced molecular diagnostic testing on participating patients’ tumor cells as part of the studies. AIM ImmunoTech Inc. has agreed to provide rintatolimod (brand name Ampligen), the chemokine-modulating agent to be incorporated into these studies.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174611173
8:58 AM · Jun 17, 2024
·
665
Views
beartrap12: Please post the working link.Thanks.A.E.K.
Re: beartrap12 post# 698880
Monday, June 17, 2024 10:44:54 AM
Post#
698891
of 699292
About Dr. Pawel Kalinski from 2020 research found at: [url][/url][tag]https://www.onclive.com/view/roswell-parks-dr-pawel-kalinski-to-lead-145m-ncifunded-immunotherapy-effort[/tag]
Obviously, I don't know if this is the technology that NWBO in-licensed.
Re: beartrap12 post# 698880
Monday, June 17, 2024 10:44:54 AM
Post#
698891
of 699294
About Dr. Pawel Kalinski from 2020 research found at: [url][/url][tag]https://www.onclive.com/view/roswell-parks-dr-pawel-kalinski-to-lead-145m-ncifunded-immunotherapy-effort[/tag]
Obviously, I don't know if this is the technology that NWBO in-licensed.
A team led by Pawel Kalinski, MD, PhD, of Roswell Park Comprehensive Cancer Center has earned a five-year, $14.54 million award from the National Cancer Institute (NCI) to expand a promising immunotherapy platform. Funded through the NCI’s Program Project Grant program, this prestigious five-year grant will fund five clinical trials, all focused on a strategy for making some of the most common immunotherapies work for more cancer patients.
"Our goal with this project is to convert cancers that are traditionally checkpoint-resistant into treatable, 'hot' tumors so that more patients will be able to benefit from some of the most commonly prescribed immunotherapies," says Dr. Kalinski, who is Vice Chair for Translational Research, the Rustum Family Professor for Molecular Therapeutics and Translational Research and Director of Cancer Vaccine and Dendritic Cell Therapies at Roswell Park.
"This five-year National Cancer Institute grant continues a long tradition of groundbreaking immunotherapy research at Roswell Park Comprehensive Cancer Center," says Congressman Brian Higgins. "The research the clinicians at Roswell are conducting represents the next generation of transformational care for cancer patients."
"Cancer touches every family in one way or another," says Congressman Tom Reed. "We are pleased to see this critical grant funding delivered to right here in our backyard to promote innovative breakthroughs for cancer treatment. We will continue to be a constant advocate for Roswell Park in the halls of Congress."
Currently, depending on their cancer type and the genetic characteristics of their tumors, only about 20% of cancer patients are good candidates for a newer class of treatments called checkpoint inhibitors — drugs such as pembrolizumab (Keytruda), nivolumab (Opdivo) and ipilimumab (Yervoy). Even among those patients who are likely to respond initially to treatment with a checkpoint inhibitor, 60% to 70% are likely to have their cancers recur or progress.
"Dr. Kalinski and colleagues have built a compelling case in support of their out-of-the-box approach to cancer immunotherapy," says Kunle Odunsi, MD, PhD, FRCOG, FACOG, Deputy Director and Executive Director of the Center for Immunotherapy at Roswell Park Comprehensive Cancer Center. "All of us in the field will be eagerly following this elegant work, which involves combinations that would uniquely harness previously untapped properties of the human immune system, and accompanied by innovative translational science that should yield greater understanding of immune responses to solid tumors."
Dr. Kalinski has spent the last 15 years developing a unique approach to cancer immunotherapy, or cancer treatment strategies that engage the immune system — first as a faculty member at University of Pittsburgh Medical Center (UPMC), and more recently at Roswell Park.
The NCI grant, which involves partners from both UPMC and The Tisch Cancer Institute at Mount Sinai, will enable five new phase II or phase IIA clinical trials to assess the efficacy of this multipronged approach — two studies in patients with metastatic colorectal cancer, one in patients with checkpoint-resistant advanced melanoma and two in advanced ovarian cancer. Three of the five studies will be conducted at Roswell Park, with the two ovarian cancer studies to be led at UPMC’s Hillman Cancer Center, with participation from Roswell Park.
Chemokines are a type of signaling protein with the ability to control the movements and growth of many immune cells, including cancer-fighting cells called cytotoxic T lymphocytes (CTLs). Together, the trials will explore three complementary strategies for targeting chemokines to alter the tumor microenvironment, or cells surrounding cancer cells, to promote the attraction and activation of CTLs, the key antitumor immune cells.
"Based on our earlier studies both in the lab and in early-phase clinical trials, we have evidence that we can selectively promote entry of antitumor killer cells into tumor microenvironments and reduce local accumulation of suppressive cells in order to sensitize 'cold' tumors to immune checkpoint-inhibition therapy," notes Dr. Kalinski.
The clinical trials will employ a chemokine-modulating regimen targeting three separate pathways of immune response — the toll-like receptor-3, type-1 interferon and prostaglandin networks — as well as specialized dendritic-cell therapeutic vaccines.
The team will also work to assess the immunologic and clinical efficacy of this new therapeutic strategy; identify the biomarkers of response; and develop optimized treatment combinations for many patients with hard-to-treat ovarian and colorectal tumors. The program will also address the pressing challenge of determining the best treatment for patients with melanoma whose tumors recur or persist despite treatment with immunotherapy.
OmniSeq Inc. will conduct advanced molecular diagnostic testing on participating patients’ tumor cells as part of the studies. AIM ImmunoTech Inc. has agreed to provide rintatolimod (brand name Ampligen), the chemokine-modulating agent to be incorporated into these studies.
NET,NET: The patents in-licensed from Roswell are intended to further extend the survival of NWBO's solid tumor patients' survival.
Bright Boy
RE:https://nwbio.com/northwest-biotherapeutics-announces-exclusive-in-license-of-portfolio-of-dendritic-cell-technology-and-intellectual-property/
Re: Bright Boy post# 698924
Monday, June 17, 2024 1:01:27 PM
So that I'm not confusing how fantastic the Roswell Park technology is that Northwest just"In Licensed", the medically correct description is "It Conditions The Tumor Microenvironment"!!!
NWBO Announces Exclusive In-License of Portfolio of Dendritic Cell Technology and Intellectual Property🗞️
$NWBO
The Press Release
June 17, 2024 PR: https://nwbio.com/northwest-biotherapeutics-announces-exclusive-in-license-of-portfolio-of-dendritic-cell-technology-and-intellectual-property/
"Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that on June 12, 2024 it entered into an exclusive license from Roswell Park Comprehensive Cancer Center for a portfolio of dendritic cell technologies and intellectual property (IP). The technologies are already in Phase 2 clinical trials, and the Company plans to collaborate with the lead scientist-clinician, Dr. Pawel Kalinski, on the further development of the technologies....Phase 2 trials involving the licensed technologies for two different cancers opened for enrollment earlier this year and are currently under way, and a third Phase 2 trial for a third cancer is pending. The trials are fully funded by grant funding and are being conducted as investigator led trials." (emphasis added)
"The terms of the Roswell license include standard provisions for an upfront license fee and milestones related to the first Phase 2 trial, first Phase 3 trial, first product approval and first commercial sale. If all of the milestones are met, the payments would be approximately $2.3 million. The license terms also include royalties of 4% on product sales (potentially reduced to 3% in the event of royalty stacking)." (emphasis added)
Who is Dr. Pawel Kalinski?
Roswell Park Comprehensive Cancer Center
✅Chair, Department of Immunology
✅Professor of Oncology
✅Chief, Translational Immuno-Oncology
✅Senior Vice President for Team Science
✅Jacobs Endowed Chair of Immunology
https://roswellpark.org/pawel-kalinski
Linkedin Profile: https://linkedin.com/in/pawel-kalinski-1b00b7b/
Dr. Kalinski's goal is to
"...convert cancers that are traditionally checkpoint-resistant into treatable, ‘hot’ tumors so that more patients will be able to benefit from some of the most commonly prescribed immunotherapies" (emphasis added)
https://roswellpark.org/newsroom/202003-roswell-parks-dr-pawel-kalinski-lead-145m-nci-funded-immunotherapy-effort
Roswell Park Comprehensive Cancer Center
"Roswell Park Comprehensive Cancer Center has earned its most highly rated grant from the National Cancer Institute (NCI). The NCI renewed Roswell Park’s status as a Comprehensive Cancer Center — a designation held by less than 4% of cancer centers..." (emphasis added)
"NCI Comprehensive Cancer Centers like Roswell Park — only 57 centers among more than 1,500 nationally — meet an even more exacting standard for leadership, resources, access to funding, collaboration, impact on health equity, multidisciplinary care, innovation in clinical trials, community outreach and scope of research." (emphasis added)
https://roswellpark.org/newsroom/202406-roswell-park-earns-exceptional-rating-national-cancer-institute-best-ever-core
What new trials are now part of $NWBO's pipeline?
The PR stated there are three Phase Two trials, two of which started recruitment in 2024.
This article points towards a melanoma trial that could be involved: https://physicianresources.roswellpark.org/news/roswell-park-clinical-trials-offer-novel-immunotherapies-for-advanced/metastatic-tumors-refractory-melanoma
Doing a search on http://clinicaltrials.gov and filtering the search for trials actively recruiting, listing NCI as a collaborator, Roswell Park Cancer Institute as a Sponsor, filter for phase two trials and then looking for a changed recruitment status in 2024 gives these three trials (one of which was mentioned in the above linked article).
**Speculative**
TRIAL 1
Title: Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma
Brief Summary: This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating patients with HLA-A2 positive (+) melanoma that has not responded to previous treatment (refractory). The aDC1 cell-based treatment contains white blood cells (dendritic cells or DCs) that stimulates the immune system. Interferon alpha-2 can improve the body's natural response to infections and other diseases. It can also interfere with the division of cancer cells and slow tumor growth. Rintalolimid may stimulate the immune system. Celecoxib is a drug that reduces pain. This study is being done to find out if the combination of the study cell-based treatment (aDC1 dendritic cells) and interferon alpha-2, rintatolimod, and celecoxib can prevent the growth and/or progression of melanoma.
Link: https://clinicaltrials.gov/study/NCT04093323?term=NCT04093323&rank=1&a=33&b=34
See Image 1 for recruitment update.
TRIAL 2
Title: Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer
Brief Summary: This phase II trial tests whether pembrolizumab combined with bevacizumab with or without agonist anti-CD40 CDX-1140 works to shrink tumors in patients with ovarian cancer that has come back (recurrent). Anti-CD40 CDX-1140 works by stimulating certain immune cells within the tumor and, when combined with other immunotherapy treatments, may increase antitumor antibody production. Immunotherapy with monoclonal antibodies, such as pembrolizumab and bevacizumab, may help the body's immune system, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab and bevacizumab with anti-CD40 CDX-1140 may decrease symptoms, prolonged survival, and improve quality of life in patients with ovarian cancer.
Link: https://clinicaltrials.gov/study/NCT05231122?spons=National%20Cancer%20Institute%20%5C(NCI%5C)&lead=Roswell%20Park%20Cancer%20Institute&aggFilters=phase:2,status:rec&rank=5&a=14&b=15
See Image 2 for recruitment update.
TRIAL 3
Title: Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer
Brief Summary: This phase I/IIa trial tests the safety, side effects, and best dose of chemokine modulation therapy (CKM) (rintatolimod, celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). CKM drugs such as rintatolimod and interferon alpha 2b work to modify the immune response and tumor-related processes, including tumor cell growth, blood vessel growth, and metastasis. Celecoxib is an anti-inflammatory drug that can cause cell death and may reduce the growth of blood vessels tumors need to grow and spread. Immunotherapy such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CKM therapy prior to pembrolizumab may direct the immune cells to the cancer cells and maximize the effectiveness of pembrolizumab in patients with metastatic or unresectable triple negative breast cancer.
Link: https://clinicaltrials.gov/study/NCT05756166?spons=National%20Cancer%20Institute%20%5C(NCI%5C)&lead=Roswell%20Park%20Cancer%20Institute&aggFilters=phase:2,status:rec&rank=1&a=7&b=8
See Image 3 for recruitment update.
THOUGHTS
Assuming the above trials are correct, $NWBO is investing in changing the tumor micro environment so that DCVax-L will be more effective when combined with a checkpoint inhibitor like Keytruda.
Not only is $NWBO investing in this area, but Roswell Park Comprehensive Cancer Center just showed the utmost confidence in $NWBO by the terms of this deal. The upfront payment of $2.3m is low. The 3-4% in royalties is where Roswell will make their money. Roswell has to have confidence that $NWBO will ultimately commercialize their technology for Roswell to realize any profit. Otherwise, why give away the development rights now when the trials are prefunded by the NCI.
This reminds me of the Flaskworks deal. Little press when the deal was cemented but it has the ability to completely change the landscape.
1:33 PM · Jun 17, 2024
·
12.7K
Views
Cheers,
BB
Bright Boy
Re: None
Monday, June 17, 2024 11:24:12 AM
Post#
698909
of 699212
People, People, People!!! THIS A BIG, BIG ,TERRIFIC DEAL!!!!! How do you build a Franchise???? Well, the "Instruction Sheet" is in the PRESS RELEASE!!! For a "Song"($2.3 million and a 4% royalty on treatment sales for the 2 NEW and possibly a third cancer treatment, the company has now expanded its Franchise value from one treatment for GBM pending approval in the UK to 2 active clinical trials with one pending for 3 new cancers AND in doing so, has firmly established DCVax Technology as the "Go TO" technology for every dendritic cell based immunotherapy company in the world!!!! Not to mention the FACT that the company has the only manufacturing process that can make the product and scale to demand for every CI company in biotech to dramatically improve their treatment. Shoot, we have already become the "XEROX" of dendritic cell based immunotherapy or in the words of a company supporter, Northwest has "APPELIZED" healthcare!!!! BUT ALSO!!!! as is apparent in the PR, the company ain't stopping there!!! No, No, NO 111 The company's going for "All the marbles"!!! AND every CEO in big biotech knows that they have to license the DCVax Platform Technology to be competitive!! Hell, this deal is making "Screaming Kitty" or whatever the hell that guys name is, drool with envy. This ain't no flash in the pan like GME, this a "FLASHBULB, LIGHTING UP THE FUTURE OF THE ENTIRE HEALTHCARE LANDSCAPE!!!!!" Dudes and Dudettes, this deal has got legs!!!!!
AND by the way, Linda Powers and her band of experts have not been sittin on their ass like many have claimed, they've been workin their butts off for the last 2 years to pull this off!!! and BRAVO to them!!!! How much do you think the value of getting in on 3 clinical trials is??? Millions and millions!!!! THAT'S THE FRANCHISE VALUE THAT NORTHWEST HAS ADDED. Hundreds of millions in cost savings and billions in sales revenue!!!!!
Cheers,
BB
Bright Boy
RE:https://nwbio.com/northwest-biotherapeutics-announces-exclusive-in-license-of-portfolio-of-dendritic-cell-technology-and-intellectual-property/
Re: Bright Boy post# 698924
Monday, June 17, 2024 1:01:27 PM
So that I'm not confusing how fantastic the Roswell Park technology is that Northwest just"In Licensed", the medically correct description is "It Conditions The Tumor Microenvironment"!!!
NWBO Announces Exclusive In-License of Portfolio of Dendritic Cell Technology and Intellectual Property🗞️
$NWBO
The Press Release
June 17, 2024 PR: https://nwbio.com/northwest-biotherapeutics-announces-exclusive-in-license-of-portfolio-of-dendritic-cell-technology-and-intellectual-property/
"Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that on June 12, 2024 it entered into an exclusive license from Roswell Park Comprehensive Cancer Center for a portfolio of dendritic cell technologies and intellectual property (IP). The technologies are already in Phase 2 clinical trials, and the Company plans to collaborate with the lead scientist-clinician, Dr. Pawel Kalinski, on the further development of the technologies....Phase 2 trials involving the licensed technologies for two different cancers opened for enrollment earlier this year and are currently under way, and a third Phase 2 trial for a third cancer is pending. The trials are fully funded by grant funding and are being conducted as investigator led trials." (emphasis added)
"The terms of the Roswell license include standard provisions for an upfront license fee and milestones related to the first Phase 2 trial, first Phase 3 trial, first product approval and first commercial sale. If all of the milestones are met, the payments would be approximately $2.3 million. The license terms also include royalties of 4% on product sales (potentially reduced to 3% in the event of royalty stacking)." (emphasis added)
Who is Dr. Pawel Kalinski?
Roswell Park Comprehensive Cancer Center
✅Chair, Department of Immunology
✅Professor of Oncology
✅Chief, Translational Immuno-Oncology
✅Senior Vice President for Team Science
✅Jacobs Endowed Chair of Immunology
https://roswellpark.org/pawel-kalinski
Linkedin Profile: https://linkedin.com/in/pawel-kalinski-1b00b7b/
Dr. Kalinski's goal is to
"...convert cancers that are traditionally checkpoint-resistant into treatable, ‘hot’ tumors so that more patients will be able to benefit from some of the most commonly prescribed immunotherapies" (emphasis added)
https://roswellpark.org/newsroom/202003-roswell-parks-dr-pawel-kalinski-lead-145m-nci-funded-immunotherapy-effort
Roswell Park Comprehensive Cancer Center
"Roswell Park Comprehensive Cancer Center has earned its most highly rated grant from the National Cancer Institute (NCI). The NCI renewed Roswell Park’s status as a Comprehensive Cancer Center — a designation held by less than 4% of cancer centers..." (emphasis added)
"NCI Comprehensive Cancer Centers like Roswell Park — only 57 centers among more than 1,500 nationally — meet an even more exacting standard for leadership, resources, access to funding, collaboration, impact on health equity, multidisciplinary care, innovation in clinical trials, community outreach and scope of research." (emphasis added)
https://roswellpark.org/newsroom/202406-roswell-park-earns-exceptional-rating-national-cancer-institute-best-ever-core
What new trials are now part of $NWBO's pipeline?
The PR stated there are three Phase Two trials, two of which started recruitment in 2024.
This article points towards a melanoma trial that could be involved: https://physicianresources.roswellpark.org/news/roswell-park-clinical-trials-offer-novel-immunotherapies-for-advanced/metastatic-tumors-refractory-melanoma
Doing a search on http://clinicaltrials.gov and filtering the search for trials actively recruiting, listing NCI as a collaborator, Roswell Park Cancer Institute as a Sponsor, filter for phase two trials and then looking for a changed recruitment status in 2024 gives these three trials (one of which was mentioned in the above linked article).
**Speculative**
TRIAL 1
Title: Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma
Brief Summary: This phase II trial studies how well polarized dendritic cell (aDC1) based therapy, interferon alpha-2, rintatolimod, and celecoxib work together in treating patients with HLA-A2 positive (+) melanoma that has not responded to previous treatment (refractory). The aDC1 cell-based treatment contains white blood cells (dendritic cells or DCs) that stimulates the immune system. Interferon alpha-2 can improve the body's natural response to infections and other diseases. It can also interfere with the division of cancer cells and slow tumor growth. Rintalolimid may stimulate the immune system. Celecoxib is a drug that reduces pain. This study is being done to find out if the combination of the study cell-based treatment (aDC1 dendritic cells) and interferon alpha-2, rintatolimod, and celecoxib can prevent the growth and/or progression of melanoma.
Link: https://clinicaltrials.gov/study/NCT04093323?term=NCT04093323&rank=1&a=33&b=34
See Image 1 for recruitment update.
TRIAL 2
Title: Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer
Brief Summary: This phase II trial tests whether pembrolizumab combined with bevacizumab with or without agonist anti-CD40 CDX-1140 works to shrink tumors in patients with ovarian cancer that has come back (recurrent). Anti-CD40 CDX-1140 works by stimulating certain immune cells within the tumor and, when combined with other immunotherapy treatments, may increase antitumor antibody production. Immunotherapy with monoclonal antibodies, such as pembrolizumab and bevacizumab, may help the body's immune system, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab and bevacizumab with anti-CD40 CDX-1140 may decrease symptoms, prolonged survival, and improve quality of life in patients with ovarian cancer.
Link: https://clinicaltrials.gov/study/NCT05231122?spons=National%20Cancer%20Institute%20%5C(NCI%5C)&lead=Roswell%20Park%20Cancer%20Institute&aggFilters=phase:2,status:rec&rank=5&a=14&b=15
See Image 2 for recruitment update.
TRIAL 3
Title: Rintatolimod, Celecoxib and Interferon Alpha 2b With Pembrolizumab For the Treatment of Patients With Metastatic or Unresectable Triple Negative Breast Cancer
Brief Summary: This phase I/IIa trial tests the safety, side effects, and best dose of chemokine modulation therapy (CKM) (rintatolimod, celecoxib, and interferon alpha 2b) in combination with pembrolizumab for the treatment of patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). CKM drugs such as rintatolimod and interferon alpha 2b work to modify the immune response and tumor-related processes, including tumor cell growth, blood vessel growth, and metastasis. Celecoxib is an anti-inflammatory drug that can cause cell death and may reduce the growth of blood vessels tumors need to grow and spread. Immunotherapy such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving CKM therapy prior to pembrolizumab may direct the immune cells to the cancer cells and maximize the effectiveness of pembrolizumab in patients with metastatic or unresectable triple negative breast cancer.
Link: https://clinicaltrials.gov/study/NCT05756166?spons=National%20Cancer%20Institute%20%5C(NCI%5C)&lead=Roswell%20Park%20Cancer%20Institute&aggFilters=phase:2,status:rec&rank=1&a=7&b=8
See Image 3 for recruitment update.
THOUGHTS
Assuming the above trials are correct, $NWBO is investing in changing the tumor micro environment so that DCVax-L will be more effective when combined with a checkpoint inhibitor like Keytruda.
Not only is $NWBO investing in this area, but Roswell Park Comprehensive Cancer Center just showed the utmost confidence in $NWBO by the terms of this deal. The upfront payment of $2.3m is low. The 3-4% in royalties is where Roswell will make their money. Roswell has to have confidence that $NWBO will ultimately commercialize their technology for Roswell to realize any profit. Otherwise, why give away the development rights now when the trials are prefunded by the NCI.
This reminds me of the Flaskworks deal. Little press when the deal was cemented but it has the ability to completely change the landscape.
1:33 PM · Jun 17, 2024
·
12.7K
Views
Cheers,
BB
Bright Boy
Re: None
Monday, June 17, 2024 11:24:12 AM
Post#
698909
of 699212
People, People, People!!! THIS A BIG, BIG ,TERRIFIC DEAL!!!!! How do you build a Franchise???? Well, the "Instruction Sheet" is in the PRESS RELEASE!!! For a "Song"($2.3 million and a 4% royalty on treatment sales for the 2 NEW and possibly a third cancer treatment, the company has now expanded its Franchise value from one treatment for GBM pending approval in the UK to 2 active clinical trials with one pending for 3 new cancers AND in doing so, has firmly established DCVax Technology as the "Go TO" technology for every dendritic cell based immunotherapy company in the world!!!! Not to mention the FACT that the company has the only manufacturing process that can make the product and scale to demand for every CI company in biotech to dramatically improve their treatment. Shoot, we have already become the "XEROX" of dendritic cell based immunotherapy or in the words of a company supporter, Northwest has "APPELIZED" healthcare!!!! BUT ALSO!!!! as is apparent in the PR, the company ain't stopping there!!! No, No, NO 111 The company's going for "All the marbles"!!! AND every CEO in big biotech knows that they have to license the DCVax Platform Technology to be competitive!! Hell, this deal is making "Screaming Kitty" or whatever the hell that guys name is, drool with envy. This ain't no flash in the pan like GME, this a "FLASHBULB, LIGHTING UP THE FUTURE OF THE ENTIRE HEALTHCARE LANDSCAPE!!!!!" Dudes and Dudettes, this deal has got legs!!!!!
AND by the way, Linda Powers and her band of experts have not been sittin on their ass like many have claimed, they've been workin their butts off for the last 2 years to pull this off!!! and BRAVO to them!!!! How much do you think the value of getting in on 3 clinical trials is??? Millions and millions!!!! THAT'S THE FRANCHISE VALUE THAT NORTHWEST HAS ADDED. Hundreds of millions in cost savings and billions in sales revenue!!!!!
Cheers,
BB
//bizjournals.com/buffalo/news/2024/06/07/roswell-park-national-cancer-institute-grant.amp.html… Re: None Monday, June 17, 2024 11:24:12 AM Post# of 698923 Go People, People, People!!! THIS A BIG, BIG ,TERRIFIC DEAL!!!!! How do you build a Franchise???? Well, the "Instruction Sheet" is in the PRESS RELEASE!!! For a "Song"($2.3 million and a 4% royalty on treatment sales for the 2 NEW and possibly a third cancer treatment, the company has now expanded its Franchise value from one treatment for GBM pending approval in the UK to 2 active clinical trials with one pending for 3 new cancers AND in doing so, has firmly established DCVax Technology as the "Go TO" technology for every dendritic cell based immunotherapy company in the world!!!! Not to mention the FACT that the company has the only manufacturing process that can make the product and scale to demand for every CI company in biotech to dramatically improve their treatment. Shoot, we have already become the "XEROX" of dendritic cell based immunotherapy or in the words of a company supporter, Northwest has "APPELIZED" healthcare!!!! BUT ALSO!!!! as is apparent in the PR, the company ain't stopping there!!! No, No, NO 111 The company's going for "All the marbles"!!! AND every CEO in big biotech knows that they have to license the DCVax Platform Technology to be competitive!! Hell, this deal is making "Screaming Kitty" or whatever the hell that guys name is, drool with envy. This ain't no flash in the pan like GME, this a "FLASHBULB, LIGHTING UP THE FUTURE OF THE ENTIRE HEALTHCARE LANDSCAPE!!!!!" Dudes and Dudettes, this deal has got legs!!!!! AND by the way, Linda Powers and her band of experts have not been sittin on their ass like many have claimed, they've been workin their butts off for the last 2 years to pull this off!!! and BRAVO to them!!!! How much do you think the value of getting in on 3 clinical trials is??? Millions and millions!!!! THAT'S THE FRANCHISE VALUE THAT NORTHWEST HAS ADDED. Hundreds of millions in cost savings and billions in sales revenue!!!!! Cheers, BB Bright Boy Re: Bright Boy post# 698909 Monday, June 17, 2024 11:52:32 AM And one other thing, the technology licensed from Roswell "Fertilizes The Field Of Action" for Dendritic cells to work better, better, better...... than medical science could ever have imagined!!!! "Boy O Boy}, Northwest is lookin pretty SHARP these days!!!! Cheers, BB georgebailey Re: Bright Boy post# 698909 Monday, June 17, 2024 11:31:44 AM Bright Boy agreed. AND nwbo has Eden’s as you state making Roswell a candidate to license Eden’s from Flaskworks. Think about how Roswell can utilize Eden’s in their vast pipeline of Immuno therapies. Re: georgebailey post# 698911 Monday, June 17, 2024 11:39:17 AM Post# of 698930 Go George, You "Nailed It" !!!!! Northwest has already'Paid The Bill" for all this fabulous technology!!! Now the company can license to every major medical firm in the world, allowing them to combine with DCVax "High Tech" and manufacture their combination at a pace suitable for their patient demand!!! Really cool stuff!!! Cheers, BBBright Boy Monday, June 17, 2024 1:42:40 PM attilathehunt Re: Bright Boy post# 698917 Monday, June 17, 2024 1:07:28 PM No wonder Advent has been hiring like crazy.... This deal was over two years in the making and I wonder if Roswell's clinical trials started using DCVax at the beginning (as they were negotiating this deal) thus explaining why we will benefit from the successful commercialization of the current trials. This well take a few days to sink in so now is a great entry point if you are new here or a great time to add if you are an existing shareholder. Kudo's to the TEAM!!!!https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174612777… $nwbo@alphavestcap@metacollectiveG@BrianEgolf2@hoffmann6383@ATLnsider@glen_bwrhr42@SmithOnStocks1From http://investorshub.advfn.com📷NorthWest Biotherapeutics Inc (NWBO): attilathehunt Re: Bright Boy post# 69...
https://nwbio.com/northwest-biotherapeutics-announces-exclusive-in-license-of-portfolio-of-dendritic-cell-t
17
JUN
2024
Northwest Biotherapeutics Announces Exclusive In-License of Portfolio of Dendritic Cell Technology and Intellectual Property
Complementary to Technology & IP Already Owned or In-Licensed; Significant Step in Building a Leading Dendritic Cell Franchise
BETHESDA, MD, June 17, 2024 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that on June 12, 2024 it entered into an exclusive license from Roswell Park Comprehensive Cancer Center for a portfolio of dendritic cell technologies and intellectual property (IP). The technologies are already in Phase 2 clinical trials, and the Company plans to collaborate with the lead scientist-clinician, Dr. Pawel Kalinski, on the further development of the technologies. The license is the culmination of more than 2 years of discussions and negotiations.
The license includes 5 new patent families that were just filed in 2023 and hence have their full potential patent life ahead of them. The technologies include enhanced versions of dendritic cells (DCs) and DC based therapies, as well as conditioning regimens designed to enhance patient responses and approaches to reprogram the tumor microenvironment to boost immune therapies and help overcome resistance to checkpoint inhibitors.
The DC based therapies include versions with tumor antigens loaded into the DCs and versions for intra-tumoral administration without pre-loading of antigens. Phase 2 trials involving the licensed technologies for two different cancers opened for enrollment earlier this year and are currently under way, and a third Phase 2 trial for a third cancer is pending. The trials are fully funded by grant funding and are being conducted as investigator led trials. The Company does not anticipate having to provide any funding or undertake any operational role for these trials.
As previously reported, over time the Company has been quietly in-licensing various technologies and IP from various institutions and entities which it believes can be valuable in building a leading franchise in dendritic cell therapies.
The portfolio in-licensed from Roswell Park is complementary to, and builds upon, a portfolio which the Company exclusively licensed from another institution last year. Together, the two portfolios encompass more than 20 years of work by one of the foremost groups of dendritic cell experts, led by Dr. Kalinski.
The portfolio in-licensed last year includes the foundational technologies and IP, and positive early-stage clinical trial results, developed by the Kalinski group over 17 years before coming to Roswell. The portfolio in-licensed now includes the further work during the last 7 years at Roswell. Taken together, the Company believes that the two portfolios comprise a whole that is greater than the sum of its parts and offer compelling synergies with the Company’s own portfolio. The Company plans to collaborate with Dr. Kalinski on the further clinical development of the combined technologies.
The Company believes that the infrastructure and systems it has developed, and experience it has gained, in producing and delivering personalized living-cell DC based therapies for large numbers of patients make it uniquely positioned to help accelerate the late-stage development of the licensed DC technologies. The Company’s 331-patient Phase 3 clinical trial remains one of the largest personalized cell therapy trials conducted to date, and the Company’s extensive experience treating compassionate use patients has added valuable ongoing “real world” experience.
“We are excited to join forces with Dr. Kalinski, one of the foremost experts on dendritic cell biology and therapies,” commented Linda Powers, the Company’s CEO. “We also greatly appreciate the supportiveness of the institutions throughout the long process of working out the arrangements to keep the Kalinski portfolios intact and to license them to NWBio. In the immediate term, we will continue to focus intensively on pursuing the approval and commercialization of DCVax®-L for glioblastoma, but we are excited to begin working on growth opportunities with the licensed technologies as well.”
The terms of the Roswell license include standard provisions for an upfront license fee and milestones related to the first Phase 2 trial, first Phase 3 trial, first product approval and first commercial sale. If all of the milestones are met, the payments would be approximately $2.3 million. The license terms also include royalties of 4% on product sales (potentially reduced to 3% in the event of royalty stacking).
ABOUT NORTHWEST BIOTHERAPEUTICS
Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products that are designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company’s lead program involves DCVax®-L treatment for glioblastoma (GBM). GBM is the most aggressive and lethal form of primary brain cancer, and is an “orphan disease.” The Company has completed a 331-patient Phase III trial of DCVax-L for GBM, presented the results in scientific meetings, published the results in JAMA Oncology and submitted a MAA for commercial approval in the UK. The Company has also developed DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, plans to pursue Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
DISCLAIMER
Statements made in this news release that are not historical facts, including statements concerning plans for DCVax are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in any forward-looking statement. Readers should not rely upon forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those anticipated, including, without limitation, risks related to delays or uncertainties in regulatory processes and decisions, risks related to the Company’s ability to achieve timely performance of third parties, risks related to whether the Company’s products, including products involving in-licensed intellectual property, will be viewed as demonstrating safety and efficacy, risks relating to funding or implementation of clinical trials, including trials involving in-licensed intellectual property, risks related to the Company’s ongoing ability to raise additional capital, and other risks included in the Company’s Securities and Exchange Commission (“SEC”) filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company’s results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual plans, results or timelines to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
*****
CONTACTS
Northwest Biotherapeutics
Dave Innes
804-513-4758
dinnes@nwbio.com
Les Goldman
240-234-0059
lgoldman@nwbio.com
Follow us On: 📷 📷 📷 📷
Last edited
1:44 PM · Jun 17, 2024
·
531
Views
Bright Boy
Re: CapHillGuy post# 699068
Monday, June 17, 2024 5:23:30 PM
Post#
699098
of 699210
I'm glad you replied and I believe that Northwest has a very interesting future. In that you and I have led a few public companies in different industries, the biotech industry is not one that I have had the opportunity to manage. However, I do think I understand how the deal works for research institutions like Roswell Park, MD Anderson, Sloan Kettering… and the rest. Research institutions are funded by grants, contributions, donations…. The institutions' goal is to find a biotech company that can best represent their research technology by dispersing their technology throughout the biotech industry in a wide variety of treatments. That speaks volumes about what Roswell Park thinks about DCVAX Technology, especially after two years working to negotiate this transaction. The In-Licensing cost to Northwest bio of 2.3 million dollars and a 4% royalty on Northwest products sold in combination with Roswell Park Technology that conditions the tumor Micro environment for Dendritic cell expansion and efficacy is a very small percentage of the development costs associated with the Roswell Park technology. Therefore, relying solely on the 4% royalty means that Roswell Park is very confident that Northwest's DCVax dendritic cell based platform technology will be widely approved and accepted, thus distributing DCVax Technology and Roswell Park technology in a multitude of successful treatments, proving the patient demand in every aspect of dendritic cell based immunotherapy!!! AND proving Roswell Park's medical research and development capabilities, thus supporting Roswell's continued financing through grants, donations.....! AND SUPPORTING NORTHWEST BIO's REVENUE CREATION AND SUBSEQUENT EXPANSION OF THE COMPANY'S FRANCHISE VALUE THAT WILL BE FAVORABLY REFLECTED IN THE SHARE PRICE AS THE MARKET RAPIDLY ACCELERATES THE REALIZATION OF FUTURE NET REVENUES GENERATED BY ANTICIPATED GROWTH OF THE VAST ARRAY OF NEW PRODUCTS IN THE COMPANY'S EVER EXPANDING PRODUCT PIPELINE!!!
Cheers
BB
Bright Boy
Re: Bright Boy post# 698924
Monday, June 17, 2024 1:01:27 PM
Post#
698960
of 699211
So that I'm not confusing how fantastic the Roswell Park technology is that Northwest just"In Licensed", the medically correct description is "It Conditions The Tumor Microenvironment"!!!
Cheers,
BB
tryn2 :Yes, thank you for the clarification. And , yes, today's Roswell PR is turning naysayers and their ASM votes from no to yes, i.e. "for" management ..A.E.K.
Re: ae kusterer post# 699028
Monday, June 17, 2024 3:18:29 PM
Post#
699038
of 699082
Aek: the 625k share vote post was mine...🙂
ae kusterer
Re: None
Monday, June 17, 2024 2:56:52 PM
Post#
699028
of 699081
Re: Smitty5150 post# 698930
Monday, June 17, 2024 12:10:41 PM
Post#
698931
of 699024
Agreed...
Based on this morning's PR, I voted my 625k shares in favor of all items on the proxy...😎
Bullish
BULLISH
Re: None
Monday, June 17, 2024 2:14:24 PM
Post#
699006
of 699028
Margin Buu
Solidifies my YES vote for the upcoming ASM. Thank you.
My posts are my own opinion and do not represent investment, legal, or medical advice.StockFollower
Re: beartrap12 post# 698869
Monday, June 17, 2024 2:11:07 PM
Post#
699002
of 699005
A reminder per Beartrap12:
beartrap12
Re: Horseb4CarT post# 697125
Sunday, June 09, 2024 7:39:36 AM
Post#
697137
of 698998
Horse, this is the wonder of Linda's decision to take the company into the franchise business: Any bio company can come to NWBO and partner with us to find a cure for anything, including fungus, viruses, autoimmune, etc. They can add DCVax, in either form, L or Direct (once it's approved), and design and run the clinical trial, and pay us for our contribution. NWBO, with Dr. Liau on our scientific board, can continue to advance the knowledge of dendritic cells and expand DCVax's uses on its own, if it wants to.
Tremendous decision on management's part. Let's continue to pay them well!
Beartrap12 - oh how right you are!
SF
Chiugray
Re: beartrap12 post# 698944
Monday, June 17, 2024 12:57:49 PM
Post#
698955
of 699006
Your original post was quoting a different sentence in the PR. Minor point. I am also happily surprised and for the PR pointing out to us that NWBO has been in-licensing technology from multiple sources. Very strategic.
Smitty5150
Re: tryn2 post# 698931
Monday, June 17, 2024 2:10:26 PM
Post#
699001
of 699006
I still voted NO and that will not change until PPS appreciates to a meaningful level.
6/24:
BUFFALO, N.Y. (WIVB) — A jewel of the Queen City just got some major national recognition.
Roswell Park Comprehensive Cancer Center announced today that they’ve received the highest rating possible by the National Cancer Institute.
The “Exceptional” NCI rating is achieved by less than 4% of U.S. cancer centers.
“It’s huge because it tells patients that we are as good as we say we are,” said Dr. Candace Johnson, President and CEO of Roswell. “We didn’t do this review, people came from the outside and critically reviewed us. Trust me, it’s not a piece of cake.”
Roswell has also received the renewal of a federal grant, which will pay out $22.5 million over the next five years.
https://t.co/byJstrvAFz $nwbo @alphavestcap @metacollectiveG @BrianEgolf2 @hoffmann6383 @ATLnsider @glen_bwrhr42 @SmithOnStocks1 https://t.co/M6RH2BqYos
— alphavestcapital.com (@alphavestcap) June 17, 2024
Re: None Monday, June 17, 2024 11:24:12 AM Post# of 698923 Go People, People, People!!! THIS A BIG, BIG ,TERRIFIC…
$nwbo @alphavestcaphttps://t.co/Acvpa5D2nE https://t.co/VDYICRBFaohttps://t.co/y27YXihdcUhttps://t.co/w4BURgiRDKhttps://t.co/8hQ6jn6WkNhttps://t.co/NuJK3MV5Pohttps://t.co/rNggYWbc6r https://t.co/wql742nQzd
— alphavestcapital.com (@alphavestcap) June 17, 2024
https://t.co/WtQlDhvw0e $nwbo @alphavestcap https://t.co/r4sFXIKh9Yhttps://t.co/Acvpa5D2nE https://t.co/mOsZ7oxzSW
— alphavestcapital.com (@alphavestcap) June 17, 2024
https://t.co/xITAB7cqv2 $nwbo @alphavestcap https://t.co/bAaNCYP8iqhttps://t.co/eVQWNSSYfGhttps://t.co/D4B15LnrRYhttps://t.co/QgpCHGdcD4
— alphavestcapital.com (@alphavestcap) June 17, 2024
I expect $NWBO will buy@oncovir
or license PolyICLC for use in combination with DCVax. This will help turn cold tumors hot. CSF-1R… https://t.co/2YyV5Mfwc3
Re: Smitty5150 post# 698930
Monday, June 17, 2024 12:10:41 PM
Post#
698931
of 699024
Agreed...
Based on this morning's PR, I voted my 625k shares in favor of all items on the proxy...😎
Bullish
BULLISH
Re: None
Monday, June 17, 2024 2:14:24 PM
Post#
699006
of 699028
Margin Buu
Solidifies my YES vote for the upcoming ASM. Thank you.
My posts are my own opinion and do not represent investment, legal, or medical advice.StockFollower
Re: beartrap12 post# 698869
Monday, June 17, 2024 2:11:07 PM
Post#
699002
of 699005
A reminder per Beartrap12:
beartrap12
Re: Horseb4CarT post# 697125
Sunday, June 09, 2024 7:39:36 AM
Post#
697137
of 698998
Horse, this is the wonder of Linda's decision to take the company into the franchise business: Any bio company can come to NWBO and partner with us to find a cure for anything, including fungus, viruses, autoimmune, etc. They can add DCVax, in either form, L or Direct (once it's approved), and design and run the clinical trial, and pay us for our contribution. NWBO, with Dr. Liau on our scientific board, can continue to advance the knowledge of dendritic cells and expand DCVax's uses on its own, if it wants to.
Tremendous decision on management's part. Let's continue to pay them well!
Beartrap12 - oh how right you are!
SF
Chiugray
Re: beartrap12 post# 698944
Monday, June 17, 2024 12:57:49 PM
Post#
698955
of 699006
Your original post was quoting a different sentence in the PR. Minor point. I am also happily surprised and for the PR pointing out to us that NWBO has been in-licensing technology from multiple sources. Very strategic.
Smitty5150
Re: tryn2 post# 698931
Monday, June 17, 2024 2:10:26 PM
Post#
699001
of 699006
I still voted NO and that will not change until PPS appreciates to a meaningful level.
ATLnsider
Monday, June 17, 2024 11:13:05 AM
I believe the second institution that is referred to in the NWBio press release this morning, and that NWBio in-licensed dendritic cell IP from last year, is the University of Pittsburg:
The portfolio in-licensed from Roswell Park is complementary to, and builds upon, a portfolio which the Company exclusively licensed from another institution last year. Together, the two portfolios encompass more than 20 years of work by one of the foremost groups of dendritic cell experts, led by Dr. Kalinski.
Dr. Kalinski worked for the University of Pittsburg from 2007 to 2017, prior to going to work for the Roswell Park Comprehensive Cancer Center:
https://www.linkedin.com/in/pawel-kalinski-1b00b7b?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=ios_app
Bullish
BULLISH
This is a PSA to all manipulative and collusive Market Makers, Hedge Funds and Short Sellers:
TIME IS RUNNING OUT. THE CLOCK IS TICKING!!!
ATLnsider
Re: newman2021 post# 698961
Monday, June 17, 2024 1:32:07 PM
Post#
698975
of 699020
newman2021, not only is NWBio quite confident that NWBio will soon be commercializing the DCVax dendritic cell vaccine technology globally, including in the US, but the 3 institutions that licensed their patents and other IP to NWBio, are also confident in this prospect also.
These 3 institutions (that we know of so far) are also very confident, to the point of signing exclusive licensing agreements with NWBio.
These 3 reputable, renown and stellar institutions include: UCLA, University of Pittsburgh, and the Roswell Park Comprehensive Cancer Center.
Bullish
BULLISH
beartrap12
Re: Chiugray post# 698913
Monday, June 17, 2024 12:44:21 PM
Post#
698944
of 699019
Chiugray, actually, it reads:
The portfolio in-licensed from Roswell Park is complementary to, and builds upon, a portfolio which the Company exclusively licensed from another institution last year. Together, the two portfolios encompass more than 20 years of work by one of the foremost groups of dendritic cell experts, led by Dr. Kalinski.
Remember that Company with a capital C represent NWBO in the PR.
So I read that to mean:
"The portfolio (that NWBO just) in-licensed from Roswell Park is complementary to, and builds upon, a portfolio which the Company (NWBO) exclusively licensed from another institution last year. Together, the two portfolios encompass more than 20 years of work by one of the foremost groups of dendritic cell experts, led by Dr. Kalinski."
Both portfolios are the work of Dr. Kalinski, who up until recently work for U. of Pittsburg. Pittsburg licensed part of it to Roswell and part of it to us last year (or sometime in the past), then we just in-licensed the part that Roswell got so that we now have two big pieces (if not all???) of Dr. Kalinski's life-time of work.
Bullish
BULLISH
Margin Buu
Solidifies my YES vote for the upcoming ASM. Thank you.
My posts are my own opinion and do not represent investment, legal, or medical advice.StockFollower
Re: beartrap12 post# 698869
Monday, June 17, 2024 2:11:07 PM
Post#
699002
of 699005
A reminder per Beartrap12:
beartrap12
Re: Horseb4CarT post# 697125
Sunday, June 09, 2024 7:39:36 AM
Post#
697137
of 698998
Horse, this is the wonder of Linda's decision to take the company into the franchise business: Any bio company can come to NWBO and partner with us to find a cure for anything, including fungus, viruses, autoimmune, etc. They can add DCVax, in either form, L or Direct (once it's approved), and design and run the clinical trial, and pay us for our contribution. NWBO, with Dr. Liau on our scientific board, can continue to advance the knowledge of dendritic cells and expand DCVax's uses on its own, if it wants to.
Tremendous decision on management's part. Let's continue to pay them well!
Beartrap12 - oh how right you are!
SF
Chiugray
Re: beartrap12 post# 698944
Monday, June 17, 2024 12:57:49 PM
Post#
698955
of 699006
Your original post was quoting a different sentence in the PR. Minor point. I am also happily surprised and for the PR pointing out to us that NWBO has been in-licensing technology from multiple sources. Very strategic.
Smitty5150
Re: tryn2 post# 698931
Monday, June 17, 2024 2:10:26 PM
Post#
699001
of 699006
I still voted NO and that will not change until PPS appreciates to a meaningful level.
TTsr: Might you have a ranking of the top 10 cancer centers in the U.S..?
Re: brooktrail1933 post# 698968
Monday, June 17, 2024 1:54:17 PM
Post#
698991
of 698993
Great article from earlier this month when Roswell continued it’s designation by the NCI as a COMPREHENSIVE CANCER CENTER (Top 4% in the country)!
https://www.bizjournals.com/buffalo/news/2024/06/07/roswell-park-national-cancer-institute-grant.amp.html
Outside expert review panel rates Roswell Park’s programs as ‘Exceptional’
Roswell Park retains coveted NCI-designated Comprehensive Cancer Center status
Less than 4% of cancer centers nationwide hold the designation
BUFFALO, N.Y. — Roswell Park Comprehensive Cancer Center has earned its most highly rated grant from the National Cancer Institute (NCI). The NCI renewed Roswell Park’s status as a Comprehensive Cancer Center — a designation held by less than 4% of cancer centers — awarding Roswell Park the highest possible “Exceptional” rating as it renewed a grant Roswell Park has successfully competed for since 1972.
The five-year award is Roswell Park’s 13th consecutive Cancer Center Support Grant (CCSG) from the NCI. No cancer center has held NCI designation longer than Roswell Park, which is one of the model programs on which the Cancer Centers program was based. The achievement follows an in-depth review by cancer experts from around the country, and signifies the highest level of documented excellence in cancer research, patient care and community outreach.
“I could not be prouder of the Roswell Park team for demonstrating absolute excellence in the services we provide for our community,” says Candace S. Johnson, PhD, President, CEO and M&T Bank Presidential Chair in Leadership at Roswell Park, and director of its CCSG. “To be recognized as an elite and truly ‘Exceptional’ center — a distinction that only a handful of cancer centers have ever achieved — you have to demonstrate the knowledge, passion and commitment to be a positive and impactful resource for your region. You have to make a difference and show that you are improving people’s lives.”
“I applaud the Roswell Park family on their work to reach a new height of achievement with this ‘Exceptional’ grant renewal and historic redesignation as an NCI Comprehensive Cancer Center,” says Roswell Park Board of Directors Chair Leecia Eve, Esq. “Our community inspires in us the drive to be the best resource and partner we can be for our neighbors, our friends, our family, and this achievement is a testament to how deeply Roswell Park commits to that pledge.”
Infographic for Roswell Park
“Nya-weh Skeno — I am Thankful you are well — is a traditional Seneca greeting. Being a cancer survivor is a learning process for whoever is diagnosed with any and all types of this disease. Our families in this area of Western New York, which includes my home of the Seneca Nation, are in an area that has higher rates of cancer than the national average,” says Todd Gates, Turtle clan member from the Seneca Nation and former President of the Seneca Nation. “We are fortunate to have Roswell Park in our area. Not only for the research that is critical but the understanding of education and outreach programs for our communities. Access to screening in underserved areas and early diagnosis of cancer will result in better outcomes for us all.”
“Roswell Park Comprehensive Cancer Center provides state-of-the-art care to all that come through its doors,” says U.S. Senator Kirsten Gillibrand. “This recognition is well deserved and truly an honor. I am proud to consistently fight to get Roswell the resources it needs to continue providing this level of care to its patients.”
“Nearly everyone in Western New York can tell a story of how they or a loved one have been touched by Roswell Park Comprehensive Cancer Center,” says Congressman Tim Kennedy. “The heroes at Roswell Park are changing lives every day, so this designation from the National Cancer Institute should come as no surprise — it’s a reflection of the incredible work that has gone on here for over a century. I know that Roswell’s most impressive accomplishments are yet to come and this award from the NCI will help to bring that day about sooner. Congratulations to Dr. Johnson and the entire team.”
“We have seven National Cancer Institute-designated Cancer Centers here in New York State and I am proud to see this level of distinguished excellence through the Roswell Park Comprehensive Cancer Center, a flagship model for all other centers through cutting-edge technology, research and care, and a place where patients and families can have increased hope for positive outcomes,” says New York State Health Commissioner Dr. James McDonald.
“I offer my sincere congratulations to our friends at Roswell Park for earning the ‘Exceptional’ rating and maintaining its Comprehensive Cancer Center designation from the National Cancer Institute,” says New York State Senator Sean Ryan. “For decades, Roswell Park has been among the premier cancer centers in the country, advancing cancer research while providing first-rate care to patients here in Western New York. We are fortunate to have such a fine medical institution and steadfast partner to the community in the City of Buffalo.”
Roswell Park, founded in 1898 by Dr. Roswell Park as the first U.S. center dedicated to cancer research, remains the only NCI-designated Comprehensive Cancer Center in all of Western and Upstate New York.
NCI-Designated Cancer Centers are distinguished by their leadership in research to develop new and better approaches to preventing, diagnosing and treating cancer, and for their role in training tomorrow’s cancer research and treatment specialists. NCI Comprehensive Cancer Centers like Roswell Park — only 57 centers among more than 1,500 nationally — meet an even more exacting standard for leadership, resources, access to funding, collaboration, impact on health equity, multidisciplinary care, innovation in clinical trials, community outreach and scope of research.
Working collaboratively, the centers that hold this designation make up an elite network that advances new areas of cancer research, expanding patients’ access to innovative cancer treatments. Numerous studies show that patients treated at NCI-Comprehensive Cancer Centers experience significantly better clinical outcomes and survival.
The NCI also looks at the technologies and resources a cancer center equips its teams with. Roswell Park’s shared resources include precision medicine tools that identify genetic characteristics unique to each individual; flow and image cytometry to document treatment effectiveness; highly specialized imaging and profiling equipment supporting identification of new biomarkers; and bioinformatics support to capture and interpret vast amounts of data.
“It’s never just one research area or one center working on its own,” says Dr. Johnson. “You can do so much more when you integrate resources and consciously work to bridge gaps and meet needs — that’s how you make real progress against cancer.”
Roswell Park’s CCSG program documents growth across four main areas — Cancer Stress Biology, Developmental Therapeutics, Population Sciences and Tumor Immunology & Immunotherapy — and also charts a plan for further achievement. Since its previous NCI Core Grant was awarded, Roswell Park demonstrated growth in personnel, research and numbers of community members served.
In its successful application for renewal, Roswell Park showcased across-the-board growth in every metric, demonstrating significant depth and breadth across every program area. From 2018 to 2023:
Number of patients served increased 26%
Clinical activities grew by 51%?
Education/outreach services were provided to more than 14,000 community members at elevated risk for cancer
Number of patients enrolled on clinical trials assessing new therapies or treatment strategies increased 53% ?
Number of cancer screening/early detection procedures increased 86%?
Staffing across the center grew 22%, with nurse staffing up 47%? and all clinical staffing up 28%
People from underrepresented communities now make up 27% of staff in leadership positions, and more than half of clinical and scientific trainees
Grant funding went up 50% to nearly $79 million, with 74% of those funds awarded through competitive NCI awards
29% of published studies are in top-tier, high impact journals — up nearly 20 percentage points?
The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), is the federal government’s principal agency for cancer research and training. The NCI leads, conducts and supports cancer research across the nation to advance scientific knowledge and help all people live longer, healthier lives.
For more information, see roswellpark.org/exceptional.
###
From the world’s first chemotherapy research to the PSA prostate cancer biomarker, Roswell Park Comprehensive Cancer Center generates innovations that shape how cancer is detected, treated and prevented worldwide. Driven to eliminate cancer’s grip on humanity, the Roswell Park team of 4,000 makes compassionate, patient-centered cancer care and services accessible across New York State and beyond. Founded in 1898, Roswell Park was among the first three cancer centers nationwide to become a National Cancer Institute-designated comprehensive cancer center and is the only one to hold this designation in Upstate New York. To learn more about Roswell Park Comprehensive Cancer Center and the Roswell Park Care Network, visit www.roswellpark.org, call 1-800-ROSWELL (1-800-767-9355) or email ASKRoswell@RoswellPark.org.
MEDIA CONTACT
Annie Deck-Miller, Director of Public Relations
716-845-8593; annie.deck-miller@roswellpark.org
attilathehunt
Re: Bright Boy post# 698917
Monday, June 17, 2024 1:07:28 PM
Post#
698963
of 698977
No wonder Advent has been hiring like crazy....
This deal was over two years in the making and I wonder if Roswell's clinical trials started using DCVax at the beginning (as they were negotiating this deal) thus explaining why we will benefit from the successful commercialization of the current trials.
This well take a few days to sink in so now is a great entry point if you are new here or a great time to add if you are an existing shareholder.
Kudo's to the TEAM!!!!
"Not unexpectedly, all four participants also had side effects from the treatment, explained the study’s lead investigator, Elias Sayour, M.D., Ph.D., a pediatric oncologist at the University of Florida and a member of the university’s McKnight Brain Institute. But although some side effects were serious, in all cases they could be successfully managed, Dr. Sayour said.
Several immunotherapy experts stressed that there’s still a long way to go before it’s known whether the vaccine is in fact safe and, as importantly, can help people live longer."
Experimental mRNA Vaccine Hints at Potential Against Glioblastoma
Subscribe
June 11, 2024, by Carmen Phillips
An illustration of an enzyme unwinding a DNA strand to produce an RNA strand.
An enzyme (blue) unwinding a DNA strand (purple) to produce an mRNA strand (red). mRNA-based cancer vaccines are being tested against many types of cancer.
Credit: iStock/selvanegra
Although immunotherapy is now a mainstay treatment for many cancers, it has yet to break through as a treatment for brain cancer, including the most common type, glioblastoma.
But recent results from several small clinical trials have hinted at the possibility of reversing this trend. Among them are findings from a very small trial testing a cancer treatment vaccine developed by researchers at the University of Florida.
Like two of the approved COVID vaccines and some other experimental cancer vaccines, this one uses genetic material called mRNA that is loaded into fat-coated nanoparticles. But it also has a unique design aspect compared with these other vaccines: the nanoparticles have layers of fat inside, making it possible to layer each one with large numbers of mRNA.
In a study published May 1 in Cell, the researchers reported that the vaccine was effective in pet dogs with naturally occurring brain cancers, allowing them to live much longer than would typically be expected.
They also reported some initial findings from a clinical trial involving four people with glioblastoma. Because it was the vaccine’s first time being used in humans, the trial’s primary goal was to ensure that the treatment was feasible and, secondarily, to look for evidence that it helps the immune system recognize and potentially attack tumors.
The trial largely succeeded on both fronts. The vaccine appeared to kick-start a robust immune response in all four participants, with rapid and dramatic changes in the levels and activity of immune system components needed to eliminate tumors.
Not unexpectedly, all four participants also had side effects from the treatment, explained the study’s lead investigator, Elias Sayour, M.D., Ph.D., a pediatric oncologist at the University of Florida and a member of the university’s McKnight Brain Institute. But although some side effects were serious, in all cases they could be successfully managed, Dr. Sayour said.
Several immunotherapy experts stressed that there’s still a long way to go before it’s known whether the vaccine is in fact safe and, as importantly, can help people live longer.
Dr. Sayour agreed. Although these initial findings are encouraging, “we’ve only treated four patients with a few [vaccine] doses,” he warned. “There are still a lot of unknowns to work through.”
They hope to address many of these questions in additional small clinical trials of the vaccine already in the works, he said, including one in children with brain cancers.
Alerting the immune system that something dangerous is happening
One of the most lethal types of brain cancer, glioblastoma is largely resistant to nearly all treatments researchers have thrown at it, including targeted therapies and, more recently, immunotherapies.
While interest in mRNA vaccines has skyrocketed in the wake of the COVID pandemic, studies of mRNA cancer treatment vaccines have been underway for more than a decade. When it came to developing an mRNA vaccine to test against glioblastoma, Dr. Sayour and his team felt that the standard approach wasn’t going to cut it.
“We felt like we needed [to try] new approaches that really shock the [immune] system,” he said.
Although the mRNA vaccines for COVID are remarkably effective, there’s a big gulf between launching an immune response against a virus trying to gain a foothold in the body and against large, established tumors tucked deep in the brain.
How nanoparticle-encapsulated cancer mRNA vaccines work
While there can be differences in how cancer mRNA vaccines that use lipid-coated nanoparticles work, in general they follow the same basic principles. After being introduced into the body, the nanoparticles are taken up by cells—largely those that are components of the immune system—which then use the instructions provided by the mRNA to make proteins.
These proteins, or antigens, are recognized by the immune system as foreign or dangerous, causing it to attack anything that has that protein on its surface—namely, cancer cells.
Unlike a virus in the early stages of infecting healthy cells, for example, these tumors have many ways to block the immune system from doing its job, explained Lesley Chaboub, Ph.D., a member of the Weissman lab at the University of Pennsylvania that focuses on developing mRNA vaccines.
To begin with, these tumors have surrounding environments full of molecular booby traps, blocking immune cells from reaching them or disarming them, Dr. Chaboub explained. And the cells that make up the tumors tend to be very different from one another and have few shared weaknesses to be exploited.
These and other factors have made it extremely difficult “to find the right way to push the immune system to target” these tumors, she said.
Dr. Sayour and his team approached the development of their mRNA vaccine with these challenges in mind.
That required some reconfiguring of the nanoparticles themselves. The nanoparticles used in most mRNA vaccines have a spherical core and, as a result, can only hold a small amount of mRNA. For their vaccine, Dr. Sayour and his team created a nanoparticle that—like the buttery sheets of a flaky French pastry—has layers of fat throughout it.
They could then sandwich many mRNA molecules into each layer, producing a nanoparticle with far more of these protein blueprints than those used in other mRNA vaccines, meaning it can produce far more abnormal proteins that draw the immune system’s attention.
They also designed the nanoparticles so they would clump together into structures that the research team called lipid particle aggregates. This was another feature intended to communicate to the immune system that something is amiss.
And, as has been done by some other research groups, they used mRNA taken from patients’ tumors as part of the vaccine “payload.” The idea behind the strategy is that those mRNA molecules represent many of the potential abnormal proteins, or antigens, produced by the tumor.
Taken as a whole, Dr. Sayour explained, the idea was to make this vaccine and its contents “look much more dangerous to the immune system” than has been attempted with other vaccines.
Promising findings in mice, dogs, and humans
The findings reported in Cell also covered experiments testing a form of the vaccine in mouse models of different cancers. In mice with a uniformly deadly brain cancer called diffuse midline glioma that largely occurs in children, for example, the vaccine produced strong and rapid immune responses, shrinking tumors and allowing mice to live for long periods.
An illustration of a synapse between two neurons
How Some Brain Tumors Hijack the Mind to Grow
Glioblastoma can redirect neurons in nearby areas of the brain to aid its survival.
For the canine trial, all the dogs had naturally occurring brain cancers. Dogs are ideal models in this case because, like humans, they spontaneously develop brain cancers. In addition, Dr. Chaboub explained, their tumors often have the same characteristics that make glioblastoma so difficult to treat in humans.
Within a few days of the dogs receiving the first vaccine dose—given intravenously, rather than into muscle—their tumors had undergone an immunological “reprogramming,” the researchers reported. Specifically, before vaccination, their tumors were “cold,” meaning there was little evidence of any immune system activity. But afterward, it was as if an arsonist had sparked a blaze: the tumors were now “hot” with bustling immune cells.
More importantly, the dogs lived much longer—nearly four times as long—as what is historically seen in dogs with brain cancer, they reported.
In the human trial, all four patients had glioblastoma tumors that could be surgically removed. After surgery, they were given standard treatment with chemotherapy and radiation. They then received up to four doses of the vaccine intravenously over the course of 6 weeks.
Similar to what occurred in the treated dogs, the researchers again saw multiple indicators of rapid and strong immune responses in the patients’ blood samples. Those indicators included spikes in levels of proteins involved in orchestrating the immune system’s response to a threat and in the levels of specific T cells involved in killing tumors cells.
Trial in children with brain tumors planned
The findings with this mRNA vaccine thus far are interesting, said James Gulley, M.D., Ph.D., co-director of NCI’s Center for Immuno-Oncology.
In particular, Dr. Gulley cited the results seen in the dogs treated with the vaccine, which suggest that the vaccine appears to have activity against brain tumors. But “it’s still very early,” he continued, and further studies are needed to definitively show that it’s safe and effective.
Dr. Sayour said his team is moving forward quickly but smartly. The upcoming trials of the vaccine, one involving adults and children and a second that would only include children, will be small (20 to 25 patients each) and still assess safety as their primary aim.
Both trials are being planned in conjunction with the international Pediatric Neuro-Oncology Consortium, which includes children’s hospitals throughout the United States.
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Anal Cancer Advances Open Door to Screening and Prevention
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EX:Sorry you missed these articles on poly iclc and dc vax l .
New research in @Nature from @UCLA: PICI Investigator Dr. Robert Prins & team showed combining a personalized dendritic cell vaccine w/ the immune boosting agent poly-ICLC significantly amplified anti-tumor immune response in malignant #gliomas. (1/2) https://t.co/43WnjuJKqF
— Parker Institute for Cancer Immunotherapy (@parkerici) May 21, 2024
EX:Sorry you missed these articles on poly iclc and dc vax l .
https://acir.org/journal-articles/innovative-methods/cancer-vaccine-delivery?entryId=81840
Matthew VandermastMatthew Vandermast
• 3rd+ • 3rd+
President at OncovirPresident at Oncovir
1mo • 1 month ago
Follow
This is a great summary of the role of Poly-ICLC in the UCLA. Notably "They discovered that poly-ICLC demonstrated superior effectiveness, triggering a stronger immune response compared to resiquimod or the vaccine alone. The researchers observed a marked increase in the activity of interferon genes and substantial alterations in immune cell behavior, indicative of enhanced antitumor activity."
https://oncodaily.com/64286.html
Mr Vandermast added, “Oncovir is uniquely positioned in the cancer and infectious disease market, we can add significant clinical value to new and approved vaccines, including dendritic cell vaccines.”
https://www.laweekly.com/oncovir-inc-is-pushing-the-boundaries-of-medical-innovation-with-hiltonol/
Oncovir, Inc. is Pushing the Boundaries of Medical Innovation With Hiltonol
WRITTEN IN PARTNERSHIP WITH AMIR BAKIANMARCH 8, 2024
Screenshot 2024 03 08 at 5.17.23?PM
Approximately 1,670 die a day from some form of cancer; in the United States, around 1.9 million cases of cancer were diagnosed in 2023. Those numbers are staggering, yet not surprising. We have become somewhat desensitized; it’s a normal part of life. Thankfully the team at Oncovir, Inc. aren’t desensitized. They are harnessing the potential of their groundbreaking immunomodulator, Hiltonol (Poly-ICLC), to develop important cancer therapies and antiviral treatments that activate the body’s immune system against diseases like cancer.
The origin of Hiltonol® can be traced back to the innovative efforts of its namesake, Hilton Levy. Levy pioneered the development of this groundbreaking immunomodulator with his partner Dr. Andres M. Salazar, MD. Both Levy and Salazar recognized the significant therapeutic properties of Hiltonol in addressing oncology and infectious diseases. Together they drove extensive research and formulation efforts to optimize its functionality and efficacy for medical applications.
President and Chief Operating Officer Matthew Vandermast highlighted the key attributes of Hiltonol, a synthetic dsRNA designed to activate the body’s defense mechanisms against viruses and tumors. “Oncovir’s clinical targets are solid tumors and infectious disease indications including HIV and COVID. We have especially exciting data developing around recurrent glioblastoma and prostate cancer.”
Hiltonol works by mimicking a virus and consequently activating a person’s immune system, essentially tricking the body into thinking it’s under attack. This prompts a powerful response from one’s immune system, including activating various immune cells like natural killer cells and B cells, as well as producing important signaling molecules like interferons and cytokines. Mr Vandermast added, “Oncovir is uniquely positioned in the cancer and infectious disease market, we can add significant clinical value to new and approved vaccines, including dendritic cell vaccines.”
Mr. Vandermast brings three decades of expertise in implementing business strategies across leading edge companies, both large and small. He possesses extensive knowledge in overseeing intricate projects related to technology, science, and the development of enterprise products. He is a veteran with the company and is spearheading the commercialization efforts of Hiltonol to ensure its widespread acceptance and market success.
Oncovir founder, Dr. Andres Salazar, has a distinguished career as a former Professor of Neurology at the Uniformed Services University, combined with an extensive research background in neurodegenerative diseases and oncology, thereby bringing invaluable expertise to the company.
The Oncovir team is joined by Vikas Moolchandani, PhD, as the VP CMC. As a Product Quality Reviewer at Chemistry, Manufacturing and Controls at the FDA he processes and conducts facility reviews of regulatory submissions. Dr. Moolchandani is key to guiding Oncovir’s late phase clinical trials in preparation for its commercialization.
The Oncovir, Inc. team is focused on collaboration and innovation. Despite geographical distances, the team stays connected daily to ensure the continued alignment and forward progress of their common goal of delivering transformative medical solutions to those in need.
Vandermast shares, “We are always working towards our mission. We have worldwide customers, so we sometimes have to stay up really late or get up real early. We have a lot of people working on projects in Europe and Asia. For a small team, we have a large worldwide footprint.”
As a pioneer in immunotherapy, Oncovir, Inc. continues to push the boundaries of medical innovation with its revolutionary immunomodulator, Hiltonol. As more and more trials uncover its vast potential, the team at Oncovir, Inc. stands ready to provide its cancer therapy and antiviral treatments across numerous use cases on a global scale and, more importantly, hope, hope for improved patient outcomes.
Read more about Oncovir Inc.’s commitment to advancing medical science and improving patient outcomes.
dstock07734
Re: Sir Pumpernickel post# 698685
Sunday, June 16, 2024 10:15:52 AM
Post#
698700
of 698711
Pathetic theorysuit needs to finish high school.
You are even more pathetic. You need to start from elementary level education.
You cannot write a normal sentence.
Let me put some common sense in your mind as a way to ebb away the stupidity instilled by Fraudstein.
Oncovir cannot live without DCVax-L. But now, never before has Oncovir become so ambitious. The family business has the world-renowned immunologist on board. The company has an acquisition exit legal counsel on board who has successful records in exit. The company is filing for approval globally. I am doubtful if you can read. By all means, give it a try to the following articles.
https://gritdaily.com/cancer-therapy-oncovirs-hiltonol/
https://www.laweekly.com/oncovir-inc-is-pushing-the-boundaries-of-medical-innovation-with-hiltonol/
exwannabe
Re: dstock07734 post# 698700
Sunday, June 16, 2024 10:33:39 AM
Post#
698707
of 698711
Oncovir cannot live without DCVax-L.
Oncovir discusses many partners on their website. None are NWBO, not even by some secret code name.. Even when they run DC vaccine trials they are using somebody other than NWBO. Even in their 2 glioma trials they are not working with NWBO.
The idea they are somehow tied to NWBO is whacko. It is possible that NWBO will elect to some sort of in-license deal with them where they pay Onco to use the drug, but it will be a minor deal, like others they have.
The company is filing for approval globally.
What company is that? NWBO is filing in UK because the FDA already told them they need another trial.
is d vax L the only dendritic cancer vaccine with the phase 3 data necessary to get RA approval with the 20 largest regulatory authorities in the next 10 years ?
DCVax is the most crucial cell-based vaccine. Indeed, #DCVax has enabled personalized targeting of several tumor antigens to achieve a potentially durable response.
— rj (@sharpie510) June 16, 2024
...mOS was 23.1 mos compared to 13–15 mos in pts receiving SOC alone.$nwbo #glioblastomahttps://t.co/CpNVWlMFZS pic.twitter.com/OHpz4umnNv
$NWBO @alphavestcap
— alphavestcapital.com (@alphavestcap) June 15, 2024
"LP runs everything. She’s the one doing the deals, the in licensing, the new trials. She’s visiting IRBs, discussing terms with licenses. She wrote the patents personally. She’s overseeing the law suit. She’s meeting with MHRA. When do you want her to take… https://t.co/XlMHXN7DAg
https://t.co/i4ftUWDdz8 $nwbo @alphavestcap https://t.co/DF0CHxXtHOhttps://t.co/7HfKsF1tPR@alphavestcap
— alphavestcapital.com (@alphavestcap) June 13, 2024
Promote
Northwest Biotherapeutics has been granted a patent for a cell culture cartridge designed to provide symmetrical fluid flow and avoid dead areas within the… https://t.co/booWHVc5Wz
https://t.co/i4ftUWDdz8 $nwbo @alphavestcap https://t.co/DF0CHxXtHOhttps://t.co/7HfKsF1tPR@alphavestcap
— alphavestcapital.com (@alphavestcap) June 13, 2024
Promote
Northwest Biotherapeutics has been granted a patent for a cell culture cartridge designed to provide symmetrical fluid flow and avoid dead areas within the… https://t.co/booWHVc5Wz
https://t.co/BYogOUYuYr@alphavestcap $nwbo
— alphavestcapital.com (@alphavestcap) June 14, 2024
LP runs everything. She’s the one doing the deals, the in licensing, the new trials. She’s visiting IRBs, discussing terms with licenses. She wrote the patents personally. She’s overseeing the law suit. She’s meeting with MHRA. When…
Is it a potential cure? Some patients are living a long time w/out recurrence. #DCVaxL #DCVax $NWBO #CancerVaccine #GBM #Glioblastoma @UCLAHealth #polyiclc
— Eco Biata (@EcoBiata) June 14, 2024
Read about this study in Nature article. https://t.co/A3cOwWBKK1
Previous phase 3 results: https://t.co/Fn15uHW5zx pic.twitter.com/28zjWZckgY
Tommy Bax 🇬🇧 🇹🇼
@TommyBaxendale
This list has been posted elsewhere before, but I felt in the lull period (read excruciating wait 😅) prior to the MHRA approval of DCVax-L it was prudent to make an update to keep in perspective the runway of potential catalysts that $NWBO have in store in the next ~18mths... 🧵
— Tommy Bax 🇬🇧 🇹🇼 (@TommyBaxendale) June 13, 2024
Tommy Bax
Tommy Bax 🇬🇧 🇹🇼 reposted
rj
@sharpie510
·
8h
#DCVax-L works especially well on the mesenchymal subtype (this subtype performs the WORST on SOC). Recurrent #Glioblastoma tumors tend to shift to mesenchymal which may explain why so many with recurrent #GBM are doing so well on the vaccine!
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$nwbo
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