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Sanofi hasn't garnered much attention here. I did, however, previously note that they appear to have been one of the beneficiaries of Humanigen's Original Issuance of Shares (OIS). As I recall, I think their stake was for less than 5% of our shares, and did not require the filing of a beneficial ownership statement. I mention them again because of their announced intention to spin-off their healthcare division, resulting in a separate listing later this year. So, it's a timing consideration regarding an entity that may have a long-standing knowledge of our objectives and capabilities that prompts me to mention them again.
But, something else that's been mentioned lately is a privately held pharmaceutical company, such as we were engaged with at one time with the objective of establishing a business combination. My thought at the time we announced that objective was that PCI Pharma may have been our prospective partner, and that may still be true. But another candidate for a business combination has developed. I'm referring to AstraZeneca. I think lenz would be compatible with their Covishield adenovirus vaccine. Another consideration would be that Gracell has now become a subsidiary of AstraZeneca.
"SAN DIEGO and SUZHOU, China and SHANGHAI, China, February 22, 2024 -- Gracell Biotechnologies Inc. (“Gracell” or the “Company”, Nasdaq: GRCL), a global clinical-stage biopharmaceutical company developing innovative cell therapies for the treatment of cancer and autoimmune disease, today announced the completion of its previously announced agreement to be acquired by AstraZeneca, in accordance with the terms and conditions of the Agreement and Plan of Merger, dated as of December 23, 2023 (the “Merger Agreement”), by and among the Company, AstraZeneca Treasury Limited, a private limited company incorporated under the laws of England and Wales (“Parent”), and Grey Wolf Merger Sub (“Merger Sub”), an exempted company with limited liability incorporated under the laws of the Cayman Islands and a wholly owned subsidiary of Parent. The acquisition was structured as a merger of Merger Sub with and into the Company with the Company surviving the merger as a wholly owned subsidiary of Parent (the “Merger”). As a result of the Merger, the Company ceased to be a publicly traded company and became a wholly owned subsidiary of Parent." The mechanics of this transaction fascinate me, too, if Humanigen uses one of their foreign subsidiaries, or Taran uses one of their subsidiaries, as a merger sub in bringing AZ and HGEN together.
https://www.sec.gov/Archives/edgar/data/1826492/000110465924026350/tm246846d1_ex99-1.htm
I continue to think, however, that Novavax offers the most synergy with Humanigen. I did not think that Novavax would survive without using lenz to enhance their prototype Covid vaccine. And they may not. But recent news is developing on two fronts that could have a profound impact on Humanigen's lenz for covid, AstraZeneca, Novavax, and Humanigen could all see dramatic increases in demand for their non-mRNA covid products if, for example, the Department of Defense, through our BARDA or CRADA agreements, has asked Humanigen for a stockpile of lenz (even if the House is also focused on Russia's possible deployment of nuclear missiles in outer space).
I have long said that I think lenz has the potential to stop, or to have stopped, millions of preventable covid deaths. Tough to do, if the Johns Hopkins covid data was correct, when they stopped collecting data in March of 2023, when they were reporting 6.9M covid deaths.
https://coronavirus.jhu.edu/map.html
But I am now seeing several sources, including Bret Weinstein and Steve Kirsch, using VAERS data and time modulated cohort analyses, report that the actual covid death toll in vaccinated patients has been in the range of 13M-17M people. Of course, factcheck.org disputes that.
🚨 Estimated 13 - 17 million deaths from the COVID vaccine, "It's over 13 million people easily."
— Tucker Carlson Network (@TCNetwork) February 23, 2024
Watch @TuckerCarlson and @stkirsch discuss the estimated death toll from the COVID vaccine: pic.twitter.com/c1u7lwPfvn
"Still in progress are developments regarding Baudax/Tera-Immune, and Humanigen/Taran."
Sometimes, the people who got you where you are, are not the people who will take you where you're going. But sometimes, they are the same. "ND" announced three days ago that they are looking for acquisitions.
I wish I had some information about the resolution of Dale's Appeal. Common sense tells me that he prevailed, since it appears that things appear to be progressing with Taran. But that Appeal could have significance in regards to "ND" developments. "Timing" is the only reason I hint at this, along with history.
"I track SEC filings everyday for Humanigen, Baudax, Gracell, and Novavax." Progress report.
Now, Form 25-NSE filings have been made for three of the above companies, to remove their stock from listing on the Nasdaq.
We know that news has now been reported for Novavax and Gracell.
Novavax:
"Novavax settles dispute with international vaccine group Gavi
By Michael Erman
February 22, 20249:43 AM CST
Shares of the company rose 23.2% to $4.91 on Thursday.
Its stock has dropped nearly 60% since the company last year raised doubts about its ability to remain in business. Nearly half of Novavax's free float shares were in short position, as of Jan. 31."
https://www.reuters.com/business/healthcare-pharmaceuticals/novavax-settles-dispute-with-international-vaccine-group-gavi-2024-02-22/
Noteworthy are the recent beneficial ownership filings.
https://www.sec.gov/cgi-bin/browse-edgar?company=novavax&match=starts-with&filenum=&State=&Country=&SIC=&myowner=exclude&action=getcompany
https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/1000694/000110465924026225/tm246954d1_8k.htm
Gracell:
"SAN DIEGO and SUZHOU, China and SHANGHAI, China, February 22, 2024 -- Gracell Biotechnologies Inc. (“Gracell” or the “Company”, Nasdaq: GRCL), a global clinical-stage biopharmaceutical company developing innovative cell therapies for the treatment of cancer and autoimmune disease, today announced the completion of its previously announced agreement to be acquired by AstraZeneca, in accordance with the terms and conditions of the Agreement and Plan of Merger, dated as of December 23, 2023 (the “Merger Agreement”), by and among the Company, AstraZeneca Treasury Limited, a private limited company incorporated under the laws of England and Wales (“Parent”), and Grey Wolf Merger Sub (“Merger Sub”), an exempted company with limited liability incorporated under the laws of the Cayman Islands and a wholly owned subsidiary of Parent. The acquisition was structured as a merger of Merger Sub with and into the Company with the Company surviving the merger as a wholly owned subsidiary of Parent (the “Merger”). As a result of the Merger, the Company ceased to be a publicly traded company and became a wholly owned subsidiary of Parent."
https://www.sec.gov/Archives/edgar/data/1826492/000110465924026350/tm246846d1_ex99-1.htm
And again, we see a number of recently filed beneficial ownership statements for Gracell.
https://www.sec.gov/cgi-bin/browse-edgar?company=gracell&match=starts-with&filenum=&State=&Country=&SIC=&myowner=exclude&action=getcompany
I think the efficacy of both Gracell's CAR-T, and the Novavax prototype vaccine, may prove to have been greatly enhanced by using lenzilumab in those applications. We haven't seen evidence of that yet. However, we certainly saw game-changing enhancement of CMML treatment using lenz in the PREACH-M study.
"MedicalResearch.com: What are the next steps in this study?
Response: The PREACH-M trial is a phase 2/3 trial. We plan to unveil new data showing comprehensive clinical responses according to established criteria, somatic mutation frequencies and bone marrow plasma inflammatory cytokine levels at international meetings later this year.
Humanigen and SAHMRI are assessing regulatory pathways that may enable early results to support a regulatory submission and potential provisional registration or approval by the Therapeutic Goods Administration in Australia. We are also considering opening up PREACH-M, or a similar study in other countries such as the UK and the US, subject to resourcing and Humanigen’s corporate strategy."
https://medicalresearch.com/cancer-_-oncology/preach-m-trial-humanigen-study-evaluates-lenzilumab-and-azacitidine-for-cmml/#:~:text=The%20preliminary%20results%20from%20the,cells%20with%20RAS%2Dpathway%20mutations.
Still in progress are developments regarding Baudax/Tera-Immune, and Humanigen/Taran.
: a persistent false psychotic belief regarding the self or persons or objects outside the self that is maintained despite indisputable evidence to the contrary
You shouldn’t be!
Delusion
noun
de·?lu·?sion di-'lü-zh?n de-
Synonyms of delusion
1
a
: something that is falsely or delusively believed or propagated
under the delusion that they will finish on schedule
delusions of grandeur
b
psychology : a persistent false psychotic belief regarding the self or persons or objects outside the self that is maintained despite indisputable evidence to the contrary
the delusion that someone was out to hurt him
also : the abnormal state marked by such beliefs
2
: the act of tricking or deceiving someone : the state of being deluded
… accused the Bohemian of having practised the most abominable arts of delusion among the younger brethren.
—Walter Scott
Is Durrant getting an even bigger bang for his drug development bucks? I like the fact that Dale sold his Baudax shares, but that Intracoastal bought shares in the same time period. Will this present an opportunity for us regarding Tera-Immune?
Much more importantly, I see where Novavax announced today that they have entered into a Settlement Agreement with Gavi, regarding an Advanced Purchase Agreement.
https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/1000694/000110465924026225/tm246954d1_8k.htm
https://www.cnbc.com/2024/02/22/novavax-to-settle-gavi-arbitration-over-canceled-covid-shot-purchase.html
The event that I am most looking forward to is the recall of our loaned shares, which may give me a brief moment to sell shares into a short squeeze.
But, the potential partnership that I am most looking forward to would be a stock-for-stock transaction with Novavax in a merger or business combination. I think that could lead to sustained annual revenue of over $67 per share, giving us a Market Cap in the $8B range.
The Gavi settlement greatly improves the outlook for Novavax to survive, and I hope it will prove another of the requirements for Humanigen to proceed with this venture (the first requirement was to significantly reduce R&D expense, which they have done). With the current institutional interest in Novavax, I am very excited about a possible pending announcement about a partnership with us.
It might be worth watching this development as it may relate to us. Too early to tell right now.
"Sanofi's consumer healthcare division draws private equity interest for spin-off. JPMorgan values it at $20B. Separate listing possible in Q4 2024. Other firms eyeing the unit."
Everything that Patheon wrote is 100% accurate.
Doesn't matter when the account was created or the motivation, all info was from the filing documents.
The only asset HGEN may still have are the NOL's.
I have not yet seen that determination.
Wow, Sorry for all your bitterness. You created an account today just to spew all this shot?
even music copyright like Justin Beibier etc .patents worth sold 200 million and LENZ biotech was sold for nothing
Humanigen potential 1 billion sales patent or intellectual property was sold for nothing whereas Justin Beibier's music catalogur or music was worth more than some life saving biotech molecule
if this company was an ADR or business operations was not in the US, the ticker would just get delisted and company don't even bother declaring chapter 11 and not file SEC reports. But because it's assets are registered in US and company employees are US citizens and bank is in the US it had no choice but to do the paper work. the asset LENZ is registered in US patent offices.
As for the technology of LENZ it's just an antidote.
Basically the LENZ intellectual property or any phase 3 drug patent Humanigen had was sold for nothing.
Justine Bieber sold his entire music catalogue for $200 million. The LENZ or any phase 3 drug patents that Humanigen sold for nothing to the stalking bidder. The stalking bidder with the 2 million dollar purchase gets 1.6 million cash accounts receivable and 400 million in cash and deposits and prepayments. it's like buying cash with cash. or buying 2 million worth of gold for 2 million worth of cash.
The law firm was billing humanigen $800/hour so any money this company still has like 12 million in legal liability insurance gets withdrawn quickly. That 2 million is to pay for the wages, and legal bills.. and nothing left for any creditor claims.
what is the point of the March 12 hearing for?
it took 2 months to file chapter 11. 155 documents. and they call this expedited.
and say regular chapter 11 takes 12 months.?
patheon's 25 million dollar creditor claim
chime's 7 million dollar creditor claim
all the creditor get discharged right? that is the point of chapter 11.
With chapter 11 conclusion, does all the fake creditor claim or genuine creditor claims of HGEN Q get discharged and void after emerging from chapter? The company after chapter 11 is a shell company with no employees other than option or claim on future potential profits or revenues of the LENS or ip it sold for nothing to the stalking bidder. a total potential payment of 12 million. assuming it gets FDA approval within 5 years.
The intellectual property or LENZ was acquired for free as the company value the assets as worthless and the market values the shares of HGENQ as worthless not more than 'shell value' for trading purposes.
As for the smuck insurance, HGENQ gets a total of 12 million payment only if the asset they sold becomes successful and makes 1 billion in sales.
As for the 40 million in creditor claims, does all the fake creditor claims get discharged and new emerged HGEN without the Q get zero debt and zero creditor claims
Where the emerged hgen have cash to pay anyone or any employee?
Sales of all assets closed on Feb 20, 2024
The stalking bidder gets all asset including 1.6 million in accounts receivable in Australia.
Basically the company got all the assets for free.
$138,627.14 cash
$348,109.48 deposits and prepayments that they can ask for refund
total assets purchased $486,736.89
What a good deal for the stalking bidder. The IP with so called potential of 1 billion in sales was purchased for nothing.
Management focused on diverse patient enrollment in the LIVE-AIR trial, and discovered an 8-fold improvement in treatment outcomes for Black and African-American patients. The NIH ignored that astounding find.
And now, as we have seen previously from NIH studies, we have this:
"Monday, February 19, 2024
275 million new genetic variants identified in NIH precision medicine data
Study details the unprecedented scale, diversity, and power of the All of Us Research Program...
While more research is needed before these findings can be used to tailor genetic testing recommendations for specific populations, researchers believe the difference in the number of these variants may be influenced by past studies’ limited diversity and their disease-focused approach to participant enrollment, rather than a difference in the prevalence of the variants."
https://www.nih.gov/news-events/news-releases/275-million-new-genetic-variants-identified-nih-precision-medicine-data
Hypocrites. They report their findings, but don't take steps to implement them.
I hope they have success with implementing genetic tests for diverse populations, but authorizing lenz could have a huge impact on diverse covid populations NOW.
https://www.nih.gov/news-events/news-releases/researchers-optimize-genetic-tests-diverse-populations-tackle-health-disparities
Preventable deaths, in our case, are an effect of the government's abuse of discretionary authority, which I was fighting even before my wife's cancer (and covid) diagnoses, and the skin and tissue damage that she suffered from the radiation, which led to a need for wound care.
Preventable covid deaths continue on a daily basis in the US and around the world, and as long as that continues, I will continue to support management's efforts to get lenz authorized or approved.
A thief may demand your money or your life. It takes a special kind of low for government agencies to cause the loss of both.
Watching as this continues to evolve.
Thank You cowtown jay for sharing that with me. I am so sorry to hear about your wife. That really is terrible that she had to suffer when there were treatments like lens being suppressed by the Government in order to push something else onto the masses.
Now I understand why your motivation for lenz to succeed, and why your support for the company remains so strong.
I do have some Good News for you. If you and your wife believe in Jesus Christ and trusted in him then you will see her again.
The next time you will see her again she will be in very good health and youthful again.
This I can promise you.
I've got multiple motivations for wanting lenz to succeed. As a shareholder, and like all of us here, I am financially motivated to see us succeed. But I also feel compelled to focus every bit of light that I can, on the government's abuse of their discretionary authority. This doesn't just apply to the SEC's failure to regulate our equity market, but also applies for the deadly abuse of discretionary authority by Regulatory agencies such as NIAID, the NIH, and the FDA. In addition, once my wife's wound care requirements progressed beyond the point that the visiting nurse could control the wound's progression, my wife had to return to the skilled nursing center in February of 2020. where she remained until her death in Nov 2020, exactly the period that covid arrived in the US, and stretched our health care system to the breaking point. As study after study began to appear thereafter, I knew lenz could have, at least, greatly improved the quality of her remaining life, and I will remain committed to seeing lenz authorized and approved around the world. I can't stand the thought that patients' families are suffering the preventable loss of their loved one's life.
So I remain hopeful to see lenz approved, and I feel confident that management has taken a steadfast, disciplined, methodical approach, to make that happen, against all Big Pharma and Regulatory odds.
I look forward to seeing how management may use their hollowed-out foreign subsidiary. Will this prove to be a merger entity for Taran, as I began talking about over the last month, or so?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173637775
I Need a Big Break in Life, and I am Praying You are correct about HGEN my Freind!
To be honest, I think it would take a lot more study for me to feel that I have confidence in making a deduction about HOW these guys have navigated during this bankruptcy. I can't wait to learn as much as I can.
But I have supreme confidence that management has provided the essential ingredients for our explosive success, to include the legal framework, product safety and efficacy, pending corporate structure, regulatory approval, and market penetration. Oh, and that little thing called the recall of our loaned shares. Maybe in the remainder of the week, and hopefully in just one more day, we will finally learn.
I agree and hope they spell it out better in what's going to become of the common shareholders.
There are Excluded Assets in the sale.
"1.2 Excluded Assets. Notwithstanding anything to the contrary in this Agreement, in
no event shall Seller sell, transfer, assign, convey or deliver, or be deemed to sell, transfer, assign,
convey or deliver, and Seller shall retain, all right, title and interest to, in and under any assets
other than the Acquired Assets (collectively, the “Excluded Assets”) including such right, title or
interest in the following:
(g) except with respect to the Foreign Subsidiary, all shares of capital stock,
limited liability company interests, or other equity interests of Seller and each of its respective
Subsidiaries or securities convertible into, exchangeable or exercisable for any such shares of
capital stock, limited liability company interests, or other equity interests;"
pp 45-46/95
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1061258&projectCode=HUM&docketNumber=155&source=DM
So I disagree with TwongStocks saying that Taran will not be acquiring any equity of HGENQ. I think the above says, in effect, that Taran WILL be acquiring HGEN shares held by Dale's entities.
I think this is saying that shares in HGEN stock are excluded from the the sale to Taran, EXCEPT for those shares held by Dale's entities. I could be wrong, this is a lot of information to process in a compressed time. But it is my best interpretation of what this means. I just hope that the conclusion of the bankruptcy brings about the recall of the loaned shares, and perhaps a bit of additional news.
I think the brokerages could buy-in their customers who are short, without needing current filings, based just on a recall of the loaned shares. The thing is, for me, I just think we are about to see movement on multiple fronts, including an uplisting. So we may, or may not, need news to get the most out of the recall or the uplisting. The delinquent filings could already be completed. We don't have enough details to be able to draw conclusions now. I wouldn't even be speculating at all, if it wasn't for a legitimate concern about the Asset Purchase Agreement. Going that route instead of a buyout never caused me any concern, but I can understand that others can be concerned about that.
I still think we'll have news about a partnership with Novavax, and I still think that an $8B market cap for Humanigen is feasible. And to go even further out on a limb, I still think that Astra-Zeneca could be looking at using lenz with their Covishield vaccine, not just with their and Gracell's CAR-T.
https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-to-acquire-gracell-furthering-cell-therapy-ambition-across-oncology-and-autoimmune-diseases.html
https://en.wikipedia.org/wiki/Oxford%E2%80%93AstraZeneca_COVID-19_vaccine
I hope they then file and bring us current again.
sosjtb,
The question is, what is Humanigen's most valuable asset? I think, for the very near term, it is having a float of 229M shares, which is 110M more shares in the market, than the company has issued. These shares are controlled by Dale's entities, which I view as our financing arm, and as we know, these shares are currently virtually worthless.
But the Asset Purchase Agreement, versus a Buy-Out, does not represent Durrant abandoning those shares, which have been loaned out. They are significantly beneficially owned by Humanigen. I think Humanigen owns 110M of those shares. So it may be that the recall of the loaned shares may be announced by Dale, if not Durrant.
Once, or as, the loaned shares have been recalled, I think we could announce a stock-for-stock merger or business consolidation with Novavax. That will then become our most valuable asset, as it could result in billions of annual revenue dollars, assuming that lenz was integrated into the Novavax prototype vaccine.
I feel like you're calling cadence, and have just ordered the first row of troops to execute a "to the rear, march" command. I certainly feel that positing what I have just sequenced is a dramatic change in course.
The share structure remains intact. You have 4.1M shares of HGENQ now, and you'll still have 4.1M shares of HGEN once the bankruptcy has closed (which will drop the Q suffix).
The way I’m seeing it, Durrant and Tarran get Lenz, we get the debt and what’s left in basically an empty shell.
So, the shares look to stay intact, but who will receive them?
Does the buyer get the shares?
Or do they remain behind under HGEN?
Yes, the deadline to get this wrapped up is Tuesday.
Wow it looks like things are moving along here:
https://stocktwits.com/TwongStocks/message/562064354
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1061258&projectCode=HUM&docketNumber=155&source=DM
Thank you for that, bencozey. I have followed this company since 2015, when they were known as Kalobios, and issued the first recall of their loaned shares. A few weeks after they became Humanigen in 2017, I bought and have maintained a small position here. In 2022 and 2023, I discontinued selling shares, but continued to add as I could. So I'm really looking forward to the recall of their loaned shares, and seeing my open sell orders filled.
One of the things I'm really going to look forward to will be the financial press interviews of Durrant after what will be our historic short squeeze. I'm sure the press will want to know about the reasons for our delayed regulatory approval, which could have saved millions of lives worldwide if approved earlier, and could have greatly alleviated the trillions of dollars in damage to the world's economies and societies. I'm also sure that the press will want to know how management acquired about a 90% control of the company, and how and why the company acquired that ownership.
The answers could shine a lot of light on the government's deadly abuse of their discretionary authority, and their willful/criminal negligence, in service to their Big Pharma sponsors.
Yes, you have to give Jay a little credibility on what is unfolding. After all, he lived through it once already and he can see it unfolding.
Actually I think it fits perfectly into what Jay has been saying. The share structure is in place and the company has not shut the doors. The company will have future revenues. Next step, call in the loaned shares. I didn't believe Jay, but as time goes by, it does seem recalling the shares is probable
Here are 95 pages telling us we are screwed.
https://document.epiq11.com/document/getdocumentsbydocket/?docketId=1061258&projectCode=HUM&docketNumber=155&source=DM
Taran will pay only 12 million in milestone payments if Lenz is approved…..$12 million! That values HGEN shares at about .10 if all milestone are met and payed within 7 years.
This is toast.
I'm curious about Intracoastal Capital's beneficial ownership statement filed for Baudax, in the week before Dale sold his Baudax shares, which was one day ahead of the Baudax delisting. Will this somehow translate into a gateway for Humanigen to acquire an interest in Tera-Immune through Intracoastal Capital?
https://www.sec.gov/cgi-bin/browse-edgar?company=baudax&match=starts-with&filenum=&State=&Country=&SIC=&myowner=exclude&action=getcompany
I just think that Humanigen has a real interest in Tera-Immune's novel Treg-based cell therapies for autoimmune diseases.
https://www.baudaxbio.com/news-and-investors/press-releases/detail/267/baudax-bio-acquires-teraimmune-inc
The timing is worth noting. If there is a connection between these transactions, maybe we'll find out on or before Monday, when the market is closed. It wouldn't be the first time the company announced major news on a day when the market is closed.
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Humanigen, Inc. is a clinical-stage biopharmaceutical company developing its portfolio of next-generation cell and gene therapies for the treatment of cancers via its novel, GM-CSF neutralization and gene-knockout platforms. As a leader in GM-CSF pathway science, we believe that we have the ability to transform CAR-T therapy and a broad range of other T-cell engaging therapies, including both autologous and allogeneic cell transplantation. There is a direct correlation between the efficacy of CAR-T therapy and the incidence of life-threatening toxicities (referred to as the efficacy/toxicity linkage). We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with serious and potentially life-threatening CAR-T therapy-related side effects while preserving and potentially improving the efficacy of the CAR-T therapy itself, thereby breaking the efficacy/toxicity linkage. Clinical correlative analysis and pre-clinical in vivo evidence points to GM-CSF as the key initiator of the inflammatory cascade resulting in CAR-T therapy’s side-effects. Pre-clinical in vivo data on the neutralization of GM-CSF using antibody or gene KO indicates that it is not required for CAR-T cell activity. Our strategy is to continue to pioneer the use of GM-CSF neutralization and GM-CSF gene knockout technologies to improve efficacy and prevent or significantly reduce the serious side-effects associated with CAR-T therapy.
We believe that our GM-CSF pathway science, assets and expertise create two technology platforms to usher in next-generation CAR-T therapies. Lenzilumab, our proprietary Humaneered® anti-GM-CSF immunotherapy, has the potential to be used in combination with any FDA-approved or development stage CAR-T therapy, as well as in combination with other cell therapies such as HSCT, to make these treatments safer and more effective. In addition, our GM-CSF knockout gene-editing platform has the potential to create next-generation CAR-T therapies that may inherently avoid any efficacy/toxicity linkage, thereby potentially preserving the benefits of the CAR-T therapy while altogether avoiding its serious and potentially life-threatening side-effects.
The company’s immediate focus is combining FDA-approved and development stage CAR-T therapies with lenzilumab, the company’s proprietary Humaneered® anti-human-GM-CSF immunotherapy, which is its lead product candidate. A clinical collaboration with Kite, a Gilead Company, was recently announced to evaluate the use of lenzilumab with Yescarta®, axicabtagene ciloleucel, in a multicenter clinical trial in adults with relapsed or refractory large B-cell lymphoma. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. The company is also developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, T cell engaging, and immunotherapy treatments to break the efficacy/toxicity linkage including the prevention and/or treatment graft-versus-host disease (GvHD) in patients undergoing allogeneic HSCT. The company has established several partnerships with leading institutions to advance its innovative cell and gene therapy pipeline.
June 15, 2020
Phase 3 Study to Evaluate Efficacy and Safety of Lenzilumab in Hospitalized Patients With COVID-19 Pneumonia
https://clinicaltrials.gov/ct2/show/NCT04351152
Anti-GM-CSF antibodies expected to show better effect in Covid-19 than cytokine-specific targets
July 27, 2020
https://discoverysedge.mayo.edu/2021/06/22/cancer-to-covid-19/
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