Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
So, far, tavo has had extremely positive results in refractory Melanoma, which occurs in about 10,000 patients/year. 40% complete response is amazing, with possibility of improving with multigene construct. Further, I believe Keytruda has only an 18% complete response rate in first-line melanoma, so I wouldn't be surprised to eventually see tavo/Keytruda (or Opdivo) tested against frontline monotherapy (Ketruda or Opdivo). Just in Melanoma, there is a lot of opportunity for tavo/CPI to be used in a large number of patients.
Tavo has also been tested with a CPI in Head and Neck Cancer and Merkel's cell carcinoma with intriguing results. And we just heard very positive, albeit in only 2 patients, anecdotal objective response results in triple-negative breast cancer (pre-treatment with tavo followed by Opdivo), so there is good potential to treat 3 additional cancers.
ONCS is also developing technology to treat deep tumors with EP IL-12, which opens up to treating many more cancer indications.
I don't think it is an accurate statement to state that tavo + CPI will be limited to treating only melanoma.
Here is a link to a study with modest improvement (24% ORR) in TNBC. The protocol was pre-treatment with chemo or radiation prior to Opdivo:
http://www.targetedonc.com/conference/esmo-2017/priming-immune-system-before-nivolumab-improves-response-in-metastatic-tnbc
" In patients with metastatic [TNBC], turning a nonimmunogenic (“cold”) tumor into an immunogenic (“hot”) tumor appears to be feasible, thereby improving sensitivity to immune therapy with nivolumab (Opdivo). "
...
“Ideally, for immune therapy, we would like a more inflamed microenvironment so we can stimulate immune cells that are already present,” she said.
...
" In the patients who experienced a response, the median TIL level in the baseline biopsy was 23%, compared with only 5% in nonresponders. “You need TIL presence to have a high likelihood to respond,” Kok said. The baseline CD8 level was also higher in responders versus nonresponders (51 vs 26/mm2). " [Looks like something we've learned from hschlauch!]
------------
EP IL-12 is off to a good start, although only 2 patients. Can't wait to see the results from a well-controlled trial of EP IL-12 and Opdivo.
First, it's NOT "cherry-picked". It is 2 of 2 patients.
This is so positive for many reasons (realizing that it's a small number):
- A 32 patient trial of Keytruda achieved only 18% ORR.
- The 2 patients achieved robust response with only pre-treatment with EP IL-12 followed by Opdivo. A well-planned trial, such as the melanoma study, will include multiple cycles of combination treatment with a checkpoint inhibitor (CPI) + EP IL-12.
- Pre-treatment with EP IL-12 followed by combo therapy of a CPI + EP IL-12 MAY produce even better results in the melanoma study. This may be the treatment modality going forward.
- This positive result is with a second checkpoint inhibitor, which means 2 competing large biopharmas should be interested in what ONCS has to offer.
1 share in a promising biotech for Alzheimer's Disease: $7
Seeing real improvement in Alzheimer's Disease patients: priceless
Good finds!
On as side note:
Halozyme (HALO) has effectively sold an exclusive license to BMY for it's Enhanze formulation that converts IV delivery of Opdivo to subcutaneous. This is a huge competitive advantage to BMY over MRK's Keytruda, because it's less expensive to administer, and insurance companies will favor Opdivo subcutaneous over Keytruda IV (assuming outcomes are similar).
What does this have to do with OncoSec?
If BMY or MRK approach OncoSec with an exclusive partnership deal for the EP IL-12, this could effectively lock out the competitor from marketing their product with EP IL-12. Would have to be an offer that OncoSec "can't refuse" in order for ONCS to sign an exclusive deal.
Things WILL get interesting, hopefully sooner rather than later.
This is intriguing:
The only trial I can find for TNBC for OncoSec is this one:
https://clinicaltrials.gov/ct2/show/NCT02531425?term=TNBC+OncoSec&rank=1
But this trial is a monotherapy trial of single-cycle (3 treatments) of "IT-pIL12-EP in patients with TNBC". That is, there was no planned follow-up treatment with a checkpoint inhibitor.
So, it appears they concluded the trial with the 5 patients, but they continued the follow-up on all 5 patients, 2 of which had subsequent treatment with Opdivo. On examination of those 2 patients, they observed the robust objective responses.
I'm quite sure that BMY will be very interested in further exploring combination studies with OncoSec on this serendipitous finding.
Can't imagine why MRK wouldn't be quite interested, as well.
An exclusive development license with either of these large competing pharmas could be quite lucrative.
The responses to this article are priceless...basically saying the author may be intelligent, but is clueless when it comes to neuroscience.
"While your own motivation and intentions may be good, and you are clearly intelligent, I am quite surprised that the editors of Seeking Alpha would accept you as one of their Alzheimer’s researcher/commentators , when clearly you have no medical or neuroscience training at all. As far as I can tell from my perusing your background, you are a well-liked teacher of history at a college in Carson City, Nevada."
Triple Negative Breast Cancer treatment overview (Journal of Oncology Practice):
http://ascopubs.org/doi/full/10.1200/JOP.2017.023333
"Breast cancer is the most frequent tumor worldwide, and approximately 255,000 women will be diagnosed with breast cancer in the United States in 2017. Approximately 10% to 20% of these patients will be diagnosed with [triple-negative breast cancers or TNBC]"
"...[TNBCs] present with a varied natural history but are collectively associated with poor prognosis with high risk of relapse and short progression-free survival (PFS) and overall survival (OS). As many as 50% of patients diagnosed with early-stage TNBC (stages I to III) experience disease recurrence, and 37% die in the first 5 years after surgery."
"...indicating the pressing need for drug development for treating [TNBC]."
"Finally, immune therapy has gained unprecedented momentum with checkpoint inhibitors that show significant efficacy and favorable toxicity profile for the treatment of solid tumors. [TNBC] is thought to have a high frequency of genomic alteration and neoantigen formation. Pembrolizumab [Keytruda], however, which is a monoclonal anti-programmed cell death protein 1 (PD-1) antibody was tested in a phase Ib trial of 32 patients with programmed death ligand 1 (PD-L1)–positive [TNBC] and showed a modest response rate of 18.5%. Investigational strategies, including the combination of different checkpoint inhibitors and the development of antibody-drug conjugates, are ongoing."
This is significant. Responses in a 2nd solid tumor indication (Triple-Negative Breast Cancer, Melanoma), albeit in a small number of patients.
Patients were chemotherapy-refractory patients (heavily treated), had only a single cycle of treatment with IL-12, and 2 out of 5 patients experienced a robust objective response.
Note that this is also with a 2nd checkpoint inhibitor, Opdivo. Melanoma trials were with Keytruda.
This opens the door for potential bidding war for a partnership between $BMY and $MRK for $ONCS electroporation treatment.
Nice find, coach!
Wow--scientific evidence in favor of PKC-e diagnostic correlated to AD is black and white.
Where have I heard that phrase before??
One of the bloggers at stockgumshoe posted at about 1:45 today that he exited ONCS.
This caused the selloff to a low of 1.75, but ONCS had a decent recovery into the 1.80s.
Great description, coach.
I believe there is a skin test being developed which can determine PKC epsilon levels in the body.
Realizing that the FDA and insurance companies love biomarkers, I can envision a time when this biomarker testing for PKC-e is used to determine the sequencing of how frequently a maintenance dose of 20ug of Bryostatin is given to patients.
I agree with McMagyar that IV is a drawback, but ONLY if there is competition. If NTRP is able to get to market with the IV before competitors, uptake in moderate-to-severe will be significant. And, there should be time (and money) to convert to oral or SC. HALO looks interesting to me, too, but I have no idea if if it's even possible (PK/PD).
It does seem like they are going to focus on the AD study. Been thinking on Fragile-X. Perhaps they will run an exploratory (inexpensive and short-term) study? I wonder if endpoints are as easy to assess as AD (SIB)?
Certainly not in the case of every AD patient, but there are many family members/friends of patients who have debilitating diseases such as AD, who scour the internet for anything (new drugs, trials, etc) that will help the patient.
An estimated 5M people in the US have AD, so even if 25% of those have actively involved family/friends, that's over 1M patients.
I disagree...if the improvement is significant enough, trust me, sons/daughters/siblings will DEMAND Bryostatin for their parents/siblings/etc. Sons/daughters/siblings currently DEMAND Memantine--which only delays decline of AD--in spite of their side-effects (diarrhea). If it's possible for patients to improve enough to go from round-the-clock care to assisted living, and remember their kids names, then Bryostatin, in the absence of other competitors, will become the biggest selling drug ever, even if it's IV.
Further (and I haven't investigated this thoroughly yet as it pertains to Bryostatin), $HALO/EnHanze is combined with chemo and other drugs that are currently given IV so that they can be given SC. The uptake on $HALO/EnHanze is becoming significant with many major drug companies. It also has beneficial cost savings for insurance companies (SC vs IV). I believe $HALO/EnHanze charges ~4-5% royalty, but it also can give a competitive advantage, and of course is much easier for patients/medical staff.
Thanks you for your insights, hschlauch.
This sheds greater light on your earlier post on using a multigene construct with anti-CTLA-4:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=136115028
Looks like it to me.
OncoSec Medical Incorporated
NASDAQ: ONCS
United States
Tue, January 9 at 3:00 pm
Hilton/Yosemite A, Level Ballroom Level
hschlauch:
The following article may be pertinent to a prior discussion of yours, where you highlighted the high presence of Foxp3 correlates with non-responders in our EP IL-12 + Keytruda phase 2 trial:
https://biologydirect.biomedcentral.com/articles/10.1186/1745-6150-4-40
Pfizer Ends Hunt for Drugs to Treat Alzheimer’s and Parkinson’s – About 300 layoffs to take place after once-promising compounds failed during testing
https://www.wsj.com/articles/pfizer-ends-hunt-for-drugs-to-treat-alzheimers-and-parkinsons-1515267654
Pfizer Inc. said Saturday it will stop trying to discover new drugs for Alzheimer’s disease and Parkinson’s disease, abandoning costly but futile efforts to find effective treatments for the disorders.
The cutback will result in layoffs of 300 employees in Cambridge and Andover in Massachusetts and in Groton, Conn., over several months, according to a company statement.
The restructuring won’t affect later-stage drug development for pain treatments Lyrica and tanezumab, or research into drugs for rare neurological diseases, Pfizer said.
The company plans to use the savings to fund drug R&D in other areas. “This was an exercise to reallocate [spending] across our portfolio, to focus on those areas where our pipeline, and our scientific expertise, is strongest,” it said.
Pfizer also said it plans to establish a corporate venture fund to invest in promising neuroscience projects outside the company.
Like several peers, Pfizer has invested heavily in developing treatments for Alzheimer’s and Parkinson’s because of the huge need, but met disappointment when once-promising compounds failed to work during testing.
Notably, in 2012, Pfizer and partner Johnson & Johnson halted development of an Alzheimer’s drug called bapineuzumab after it failed to slow memory loss in test subjects.
Other companies, such as AstraZeneca PLC, BiogenInc. and Eli Lilly & Co., keep pursuing Alzheimer’s treatment, but analysts consider the projects very risky.
This is GREAT news!
I was really hoping there would be a legitimate reason why there wasn't a statistically significant response in the Phase 2 trial, when comparing the phase 2 to the compassionate use patients. Now we have a scientifically based plausible reason.
Now the hard work starts:
Designing this trial is going to be a bear for a few reasons, which is probably why they are bringing an academic institution on-board to design the trial.
First, will they do a trial that shows superiority or non-inferiority. Based on the post-hoc subgroup analysis, they will need to run some statistics to see which trial will do best. Non-inferiority will be more likely to succeed, but will probably require many more patients (longer, more expensive). BUT, if they run a non-inferiority trial, Bryostatin will not necessarily move to first-line treatment. IF they can run a trial that shows statistically superior results, Bryostatin moves to first-line treatment, which is obviously much better financially.
Second, Aricept and Namenda are oral drugs, and Bryostatin is IV. The problem here is, in order for this to be double-blind placebo-controlled, every patient will have to receive IV (drug or placebo) AND oral (drug or placebo). Doable, but a bit cumbersome.
Speaking of IV...is it possible to combine Bryostatin with EnHanze (Halozyme) to convert Bryostatin from an IV drug to subcutaneous (SC)? Anyone have a line to the company to suggest this? Would make Bryostatin much easier to use, but perhaps this is a consideration post-approval.
If they try to do a registrational trial (complex, expensive), I hope NTRP signs a lucrative partnership. As someone stated before this is probably the best path to get Bryostatin to market the quickest.
Press release:
https://ir.oncosec.com/press-releases/detail/1931/oncosec-provides-2018-business-outlook
OncoSec Provides 2018 Business Outlook
Complete stage 1 enrollment of PISCES/KEYNOTE-695 clinical trial of ImmunoPulse® IL-12 in combination with KEYTRUDA® (pembrolizumab)
Present preliminary data from PISCES/KEYNOTE-695 at a medical meeting
Seek preliminary FDA feedback on accelerated approval pathway
Apply for advanced-therapy medicinal product (ATMP) classification in EU
SAN DIEGO, Jan. 3, 2018 /PRNewswire/ -- OncoSec Medical Incorporated ("OncoSec" or the "Company") (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, announced its anticipated operational milestones for 2018 and a review of business highlights for year-end 2017.
"The momentum we achieved in late 2017 provides the foundation for a transformational year in 2018," said Daniel J. O'Connor, Chief Executive Officer of OncoSec. "The year ahead is critical for OncoSec with preliminary data expected in key clinical programs; preliminary feedback from regulators on an accelerated approval pathway for ImmunoPulse® IL-12 in unresectable metastatic melanoma patients who have progressed or are progressing on an anti-PD-1 therapy; and advances in our intratumoral delivery platform."
He continued, "Operational execution will dominate 2018, with a focus on laying the groundwork for future BLA and IND filings. We plan to conduct a second clinical trial in triple negative breast cancer (TNBC), as well as two investigator sponsored trials in squamous cell carcinoma of the head and neck (SCCHN) and in the melanoma neoadjuvant setting. These trials will be in combination with anti-PD-1 therapy. We look forward to sharing progress toward our vision throughout the year: to have multiple products that will make a dramatic patient impact and an innovative pipeline driven by a sustainable product engine."
2018 OPERATIONAL MILESTONES
OncoSec anticipates the following operational milestones in 2018:
Clinical Operations
ImmunoPulse IL-12 Melanoma
Complete stage 1 enrollment of PISCES/KEYNOTE-695; a Phase 2b registration-directed clinical trial of ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or "tavo"] with electroporation), in combination with KEYTRUDA® (pembrolizumab) for patients with unresectable metastatic melanoma who have progressed or are progressing on an anti-PD-1 therapy
Present preliminary data from PISCES/KEYNOTE-695 at a medical meeting
Seek preliminary FDA feedback on an accelerated approval pathway for ImmunoPulse IL-12 Biologics License Application (BLA) in patients with unresectable metastatic melanoma who have progressed or are progressing on an approved anti-PD-1 therapy
Apply for classification as an Advanced-Therapy Medicinal Product (ATMP) for the treatment of unresectable metastatic melanoma who have progressed or are progressing on an approved anti-PD-1 therapy by the European Medicines Agency's Committee for Advanced Therapies (CAT)
Prepare to commercially launch ImmuoPulse IL-12 in the U.S.
Initiate a Phase 2 investigator-sponsored clinical trial in combination with an anti-PD-1 therapy in the neoadjuvant setting
ImmunoPulse IL-12 Triple Negative Brest Cancer (TNBC)
Provide update of preliminary clinical observations for OMS-I140 TNBC pilot study conducted in collaboration with the Stanford University Medical Center
Present preliminary data for OMS-I140 TNBC study at a medical meeting
Initiate a Phase 2 clinical trial in combination with an anti-PD-1 therapy in the recurrent and/or metastatic setting
ImmunoPulse IL-12 Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Initiate a Phase 2 investigator-sponsored clinical study in combination with two other immunotherapies in the recurrent and/or metastatic setting
Business Development
Seek partner for the development, registration and commercialization of ImmunoPulse IL-12 in metastatic melanoma in the U.S. and EU, as well as in other important regions
Pursue multiple partnerships and collaborations for cancer immunotherapy platform to enable additional research in combination with other cancer therapies and novel immunotherapies
Expanding Clinical Pipeline
Prepare an IND for a second product candidate utilizing our proprietary, multi-gene expression Polycistronic Interleukin-12 Immune Modulator (PIIM) platform technology
Enhanced Platform Engineering and Manufacturing
Advance second-generation proprietary GENESIS™ generator to be ready for introduction into the clinic
Advance proprietary applicators in cancer indications beyond cutaneous and subcutaneous tumors
Undertake technology transfers with partners and install new innovative technologies to improve the overall supply chain
2017 OPERATIONAL MILESTONE REVIEW
OncoSec achieved several important clinical, regulatory, business and operational milestones during 2017.
Clinical Operations
ImmunoPulse IL-12 Metastatic Melanoma
Presented updated positive long-term follow-up data from our Phase 2 trial of ImmunoPulse IL-12 in combination with KEYTRUDA (pembrolizumab) at the 2017 Society for Immunotherapy of Cancer Annual Meeting
Selected as a Late Breaking Abstract and Oral Poster Presentation, OncoSec presented updated clinical and correlative immune-focused biomarker data demonstrating a 57% progression free survival (PFS) rate at 15 months with 100% (11/11) duration of response, median PFS not yet reached, and a best overall response rate (BORR) of 50% (41% complete response [CR] rate) in patients selected to not respond to anti-PD-1 monotherapy
Data indicate that ImmunoPulse IL-12 coordinates innate and adaptive anti-tumor immune responses, converting "cold" tumors to "hot," which drives adaptive resistance and strongly suggests a synergistic relationship between ImmunoPulse IL-12 and anti-PD-1 combination.
Presented preclinical data demonstrating multigene platform for delivery of multiple cancer immunotherapies at the 2017 Society for Immunotherapy of Cancer Annual Meeting
Emerging data was presented from our novel, multi-gene (PIIM) expression platform, demonstrating enhanced therapeutic potential
Announced the initiation of global, multi-center, registration-directed open-label PISCES/KEYNOTE-695 Phase 2b clinical trial, evaluating the combination of ImmunoPulse IL-12 and pembrolizumab in patients with unresectable metastatic melanoma who have progressed or are progressing on an approved anti-PD-1 therapy
First patient dosed and multiple sites opened in the U.S. and Australia
Granted Orphan Drug Designation for ImmunoPulse IL-12 for the treatment of unresectable metastatic melanoma from U.S. Food and Drug Administration (FDA)
Granted Fast Track designation from the FDA for ImmunoPulse IL-12 in combination with pembrolizumab for stage III/IV melanoma patients who are progressing or who have progressed on either pembrolizumab or nivolumab treatment
Technology Access Program
Established the OncoSec Technology Access Program (TAP) using OncoSec's proprietary GENESIS™ research generator, which was developed specifically for gene electro-transfer and features customizable electroporation parameters for construct-specific optimization of expression. It is the only in vivo electroporation device enabled with TRACE™ Technology (Tissue-Based, Real-Time Adaptive Control Electroporation)
Entered into a preclinical agreement through TAP with Jounce Therapeutics, Inc., InhibRx, LP, and others
Corporate
Appointed Daniel J. O'Connor, JD, as Chief Executive Officer and Director
Expanded intellectual property estate for ImmunoPulse Platform
Completed two successful public offerings of common stock and warrant exercise, raising net proceeds of $17.5 million
Promoted Christopher G. Twitty, Ph.D. to Chief Scientific Officer
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
ImmunoPulse® is a registered trademark of OncoSec Medical Incorporated, San Diego, CA, USA.
About Metastatic Melanoma
Melanoma is a type of skin cancer that begins in skin cells called melanocytes. As the cancer progresses and begins to spreads beyond the skin, such as to the lymphatic system (metastatic disease), melanoma becomes more difficult to treat. Given its occurrence in young individuals, the potential years of life lost to melanoma can be higher when compared with other cancers. Although melanoma is a rare form of skin cancer, it accounts for over 75% of skin cancer deaths. The American Cancer Society estimates that approximately 87,000 new melanoma cases and 10,000 deaths from the disease will have occurred in the United States in 2017. Additionally, the World Health Organization estimates that approximately 132,000 new cases of melanoma are diagnosed around the world every year.
About PISCES (Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study)/KEYNOTE-695
PISCES/KEYNOTE-695 is a global, multicenter phase 2b, open-label trial of intratumoral plasmid-encoded IL-12 (tavokinogene telseplasmid or "tavo") delivered by electroporation in combination with intravenous pembrolizumab in patients with stage III/IV melanoma who have progressed or are progressing on either pembrolizumab or nivolumab treatment. The Simon 2-stage study of intratumoral tavo plus electroporation in combination with pembrolizumab will enroll approximately 48 patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease defined as Stage III or Stage IV. The primary endpoint will be the Best Overall Response Rate (BORR).
To learn more about the trial, visit http://www.piscesclinicaltrial.com. Additional details can also be found at www.clinicaltrials.gov via NCT03132675.
About OncoSec Technology Access Program
The OncoSec GENESIS™ research generator was developed specifically for gene electro-transfer. It features customizable electroporation parameters for construct-specific optimization of expression, and it is the only in vivo electroporation device enabled with TRACE™ Technology (Tissue-Based, Real-Time Adaptive Control Electroporation.) TRACE™ technology incorporates an electrochemical tissue-sensing control system to automatically adjust pulse width and treatment duration in real time during the electroporation procedure. This feature enables tissue- and therapeutic-specific delivery optimization, maximizing uptake of the therapeutic while reducing unnecessary cell ablation or damage. In research models, GENESIS™ with TRACE™ has yielded higher and more consistent in vivo protein expression versus fixed-parameter electroporation, even in heterogeneous tissues.
Potential advantages of using GENESIS™ with TRACE™ for the objectives of animal immunization include cost savings versus recombinant protein administration, a shortened pre-immunization timeline relative to recombinant protein production, and display of the immunizing antigen in its native conformation. The latter benefit may be particularly relevant for certain therapeutic indications, including immuno-oncology, in which many key targets require functional agonism and/or structurally-complex therapeutic modalities such as multimeric forms. To date, OncoSec has generated multiple high-titer antibody libraries against immuno-therapeutic targets.
The OncoSec Technology Access Program makes OncoSec's electroporation technologies available to collaborators for preclinical research. Devices are available for intratumoral, intradermal, and intramuscular delivery. For more information, please contact bd@oncosec.com.
About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer. ImmunoPulse® is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as plasmid encoded IL-12 (tavokinogene telseplasmid or "tavo"). In Phase 1 and 2 clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile, evidence of anti-tumor activity in the treatment of various solid tumors, and the potential to reach beyond the site of local treatment to initiate a systemic immune response. OncoSec's lead program, ImmunoPulse IL-12, is currently in clinical development for metastatic melanoma and triple-negative breast cancer. The program's current focus is on the significant unmet medical need in patients with melanoma who are refractory or have relapsed on anti-PD-1 therapies. In addition to tavo, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse platform. For more information, please visit www.oncosec.com.
Good points coach...looking forward to the presentation.
hschlauch:
This is the reason I really like ONCS as a long-term investment. With the recently reported results (41% CR in R/R melanoma, better than results with other drugs), and a good opportunity with multigene constructs to significantly improve on that, there is a real possibility for ONCS drugs to become one of the premier treatments in melanoma.
Further, achieving similar results in trials in other cancers would transform ONCS from a niche player to a platform.
Biogen & Eisei with latest failure in Phase 2 Alzheimer's study:
https://endpts.com/looking-for-an-early-success-in-phii-alzheimers-study-biogen-and-eisai-just-racked-up-the-latest-setback/
"...anti-amyloid beta antibody BAN2401 flunked the 12-month primary endpoint..." (we know better, thanks to Dr. Alkon's research)
"With the potential earnings from any success generally ranking in the billions, though, don’t look for anyone in the field to slow down or stop."
hschlauch:
Thank you for your thorough analysis!
I, too, had concerns about systemic administration WRT hyaluronan in healthy tissue.
Let me re-read your post a few more times, and I'll get back with any other questions.
Thanks again!
Thank you, hschlauch.
Looking forward to your take on HALO. While HALO is very intriguing, my untrained view is that pegPh20 is an incremental improvement, while ONCS may well be a quantum leap. Especially if multigene constructs, like your ideas on CD4-positive T regs/FOXP3, leads to complete responses in nearly all melanoma patients.
hschlauch:
I'm relatively new to ONCS...I have a few questions that I hope you can help with:
1) In treating melanoma, it seems like there is a chance IL-12 + pembro could become first-line treatment for patients with exhausted phenotype < 30%. This seems really important, as first-line drugs can charge more for reimbursements from insurance companies.
2) Can immunopulse IL-12 + pembro be used successfully in other cancers, or will we have to wait for PIIM to treat other solid cancers?
3) I realize their MOA is different, and the comparison isn't apples-to-apples, but what is your view of HALO's PegPh20? They have successfully improved the efficacy of checkpoint inhibitors (Opdivo) when used in combination, by reducing high hyaluronan, a "protective" mechanism of some solid cancers, and thus improving the immune response of I/O drugs. Do you foresee EP IL-12 and PIIM making a much greater impact than HALO's PegPh20 and Enhanze?
Thanks for your input, and really appreciate all you contribute to this board!
Yes, the reply definitely sounded like someone promoting their company, but the original tweet was out-of-the-blue, giving insight into what NTRP concluded from the recent trial, and what they are pursuing to solve the problem. Probably no more than just hearsay or rumor.
Your source sounds more likely, unless they are looking at both routes as possibilities.
Posted on twitter by Zachary Prensky:
"At $CRL Cambridge, MA conference on pre-clin development. Ran into co peddling bryostatin, claims $NTRP failed b/c of poor choice of route admin (rerunning study using intranasal!!)"
Reply by Ari Isaacs:
"Not all that familiar with bryostatin, its MOA, or $NTRP, however the #Intranasal route of admin. can be a wise choice for many #CNS meds. We at #IPMED have a proprietary Intranasal drug delivery system that's shown an incredible ability to transport #drug directly to the #brain"
------------------
Not sure on the source of this, but if true, I'd like to see why NTRP has come to this conclusion.
Good to see you here, coach, biostudent!
A royalty like this may be tied to the economic benefits of synthetic material, once Bryostatin is approved.
For instance, hypothetically, let's say it costs $5,000 to extract enough Bryostatin from the Bugula neritina to treat an Alzheimer's patient for one year (we know from past articles that it's very expensive to extract and refine).
But, it costs $1,000 to synthesize (large scale) enough drug to treat an Alzheimer's patient for a year.
If NTRP charges $10,000 wholesale to treat a patient for a year, the gross profit using the marine extract is $5,000.
Using the synthetic drug, the gross profit is $9,000 per patient.
Paying a $200-400 royalty per patient is well worth it to gross $4,000 more per patient per year!!!
------------------------
As long as the production costs are lower using the synthetic process, the royalty is money well spent!
Great news from ONCS/SITC in refractory melanoma. Impressive responses, good duration, excellent side-effect profile.
Can someone explain the economic potential of Tavo?
ONCS states there are 10,000/yr potential US patients to be treated with Tavo/electroporation. How much can Tavo be sold for on top of the cost of Keytruda ($150,000/yr)? How much can the electroporation device be sold for?
Personally, I think whichever big pharma gets exclusive rights to Tavo and other ONCS immunotherapy drugs will have a competitive/reimbursement advantage over competitors, which probably leads to interest in a buyout.
ONCS needs to get other solid cancers in development ASAP in order to prevent a low-ball buyout. Good news that warrants were exercised early to raise capital...hopefully we see an acceleration of programs in other solid cancers.
While the Phase 2b didn't meet expectations, there were still positives.
And, I think it's significant that we haven't had a raise before or after results.
Finally, getting a late-breaking ORAL presentation suggests the industry thinks they have some intriguing data.
Seems like a long hiatus, but glad we're almost there.
Since we're all coming clean, albeit after-the-fact, I went long at $6.00 on June 7th...LOL
Wrong. PSEN1 AD mutation, which Jenni had, is known to have a high incidence of seizure.
You're really contradicting yourself with your statements:
"Very fishy how poorly the placebo group fared in this Ph 2b compared to other similar trials where placebo group barely fell below baseline at 3 months."
"After 3 months, those drugs have lost their punch and scores decline, so I doubt they're doing much of anything by the time someone reaches the moderate to severe stage"
So what is your point?
Adcs-adl was mentioned in the Monday NR. It met the pre-specified p-value endpoint of .1 (.082) in the completer group, but not in the mITT.
If NTRP had failed miserably, NTRP would have gone below $5, and most likely they would have done a cash raise at $3/share.
So, clearly they didn't fail miserably. There is something significant in the data that NTRP just released, albeit not the statistical significance that bulls hoped for (p<.05).
Management not doing a cash raise means:
- They think the 17-week data will significant, perhaps enough to get over $12 and get some of those warrants exercised.
- They think there will be something in the full data set that is significant
- They have enough cash to get to the next meaningful data.