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Look at reports of the great majority of abstracts for P1 trials that suggest benefit. Most authors are extremely conservative with their claims. The data has to be unequivocally positive to claim benefit.
You have nailed it. CRs in pancreatic cancer with chemo are very rare. I can't add much to what you've said, but I will say this much. IMO people will be anxious to enter trials using Multi-TAA, either as an adjunct to chemo or as an adjuvant in the surgery setting. Why would they not. Absolutely nothing to lose and potentially so much to gain. We may get more of a hint this weekend or on Saturday as to how the adjuvant arm is doing. If they are not recurring it's very bullish. Alternatively if the ones that aren't recurring are showing T-cell expansion and epitope spreading, we'll know we're on the right track and Multi-TAA is active.
I just did. The data met my expectations.
Wouldn't read too much into who's presenting. I doubt that they expected much from pancreatic cancer initially. He may have stepped up to run the project when the senior people passed or delegated the work a couple of years ago and it just happened to "hit". It's his work/responsibiity and he should present it. Again, just more speculation on my part. i could be wrong.
My guess is they will either announce a pivotal trial, expansion of multi-TAA into other solid tumor indications, or expansion of the pep mix with additional antigens. I would love to see them announce a partnership with a major BP, but may be a bit much to ask at this juncture. They may just discuss the implications of the data in more general terms. Anyway, should be very interesting.
Why I think we'll see something of significance on Saturday:
1) The CEO intimated we would
2) The data was accepted for presentation
3) Why submit the data if it was not promising, which would only serve to divert attention away from the clear progress made in hematological malignancies?
4) A conference is scheduled following the data drop. Often an important signal.
5) The combination of immunotherapy and chemotherapy can be synergistic, for example with chemo and anti-PD! in lung cancer.
Although sell the news phenomenon is common, considering the broad based impact on cancer biology a clearly positive report on Saturday would have, it would be a buying opportunity. I'll be buying if that scenerio plays out if there's any sort of dip.
Correct 40% ORR not CR.
Sure. The question is will we get to the MC of IOVA before an increase in outstanding shares. Likely not.
3B divides by 400m = 7.5 7.5 multiplied by MRKR current SP of $9 = 67.5. Correct me if I'm wrong. Wouldn't include any dilution from warrants.
I should say that IOVA is targeting tumor types that are immunotherapy sensitive. Many of their patients have failed anti-PD1 treatment.
When you look at the cellular I-O landscape, IOVA probably has the most comparable technology to that of MRKR. IOVA is using non engineered TILs. IOVA has very impressive 40%+ CRs in cervical cancer and melanoma. The disadvantage to TIL treatment is a biopsy is necessary, which is often easy for melanoma with subcutaneous metastases however this can be problematic for other cancers requiring major surgery. MRKR uses a simple blood draw. Also, lymphodepleting preconditioning is standard with TIL treatment, which increases toxicity. Expense is also much greater than MRKR's treatment which uses TAAs in the pep mix that are shared between tumor types. There is no significant toxicity associated with MRKRs treatment.
MRKR's MC is ~400m vs 3B for IOVA. A comparable SP to IOVA for MRKR would be $68.
We know MRKR has impressive data for hematologic malignancies with durable responses. The missing piece here is whether we will see clear evidence of activity in solid tumors similar to that of IOVA. IOVA is targeting immunotherapy responsive tumors, at least to anti-PD1, whereas we will be seeing data in pancreatic cancer which has been PD1 resistant. It's therefore unlikely we'll see CR rates of 40% but any solid sign of response would be very bullish, especially when coupled with the data from hematologic malignancy. The low coast and absence of toxicity would facilitate rapid approval IMO even with a much more modest response rate than IOVA's.
What you say is correct. IND to approval took about 31/2 years for Pembro but the P1 had 1300 patients the largest ever). However, because MRKRs treatment has shown no side effects of consequence thus far, I think we could get approval sooner. There were anti-PD1 deaths in their trials.
PS CAR-T is another strategy that bypasses the need for MHC/HLA expression of antigenic peptides.
Possibly a major advance. If it can be shown that the shared cancer antigens are clinically valid targets with our Multi-TAA platform, it will be a big step in cancer medicine. Seems like we already have pretty good evidence that's the case with the hematologic malignancies and we'll likely find out if that is also the case for solid tumors next week. However, cancers can escape by down regulating MHC antigens, which makes them resistant to t-cell attack. This has been shown to happen in melanoma treated with and not responding checkpoint blockade, so more than one strategy is needed. NK cells kill tumors cells that don't express MHC, so that is one strategy. Oncolytic virus might also be more effective against tumors that don't express MHC, since presenting viral peptides on MHC/HLA is an important defense mechanism against spread of virus to other cells.
MHC down regulation aside, I think there is a decent chance MRKR is on to something important but we'll know more very soon.
They are simply saying the product did what they had hoped. The infused cells propagated/expanded in the patient, but as or more importantly, those T-cells created an immune response that recruited other T-cells directed at other tumor associated antigen targets than were not included in the original infused T-cell product. "i.e. epitope/antigen spreading"
I think they are using MAPP. Unless I a mistaken, Survivn may be the only TAA expressed in high concentration in pancreatic Ca. However, that is based on my own research and MRKR may well have contradicting data. For example, some of the cancer testis antigens being used are expressed on pancreatic cancer cell lines but not detected on tumors in vivo. However, It's possible that expression could be induced by treatment. I'm quite sure we'll hear more about this at their presentation. There is clearly a lot of room for improvement of the product for pancreatic cancer with addition of more antigens in the mix (e.g. WT-1, mesothelin, MUC-1). That said, the MAPP product candidate is certified safe and can immediately be applied to other solid tumors (especially if it is working for pancreatic cancer). The fact is that other solid tumors actually express more of the antigens in MAPP than pancreatic cancer. For example melanoma express the cancer testis antigens in high concentration and 2 are actually named because of there high expression in melanoma (MAGE and PRAME).
I think optimizing the pep mix refers to the tumor antigens selected. For example WT-1 is highly expressed on pancreatic cancer and is an excellent target, but was not included. I suspect it will be in the future. Fortunately survivin is also an excellent while the other cancer testis antigens included are more variably expressed if at all in pancreatic cancer, from what I can gather. MRKR may have some proprietary research that shows otherwise
Yes. Between the HIV, Zika, Hemorrhagic fever and oncology vaccines, this company has a good chance bringing a vaccine to market. Would be great to see a partnership with a major drug company.
HIV is already human trials (phase 2)
What do you mean by "looking quite good"?
The very impressive Zika and hemorrhagic fever results in animals are new talking points. Also, because major issues have arisen for Sanofi's Dengvaxia, the opportunities in the flavivirus area, given that GOVX anticipated and designed its Zika virus vaccine to avoid the problem (antibody dependent enhancement), may be opening up. This may interest a suitor.
I agree 100%. The difference between now and when the company had a high market cap is HIV vaccine (GOVX B-11) is farther along in development (people got tired of waiting) and there is very promising data for Zika and hemorrhagic fever vaccines. Also there appears to be growing interest in the company's vaccine platform for tumor vaccines.
I agree 100%. The difference between now and when the company had a high market cap is HIV vaccine (GOVX B-11) is farther along in development (people got tired of waiting) and there is very promising data for Zika and hemorrhagic fever vaccines. Also there appears to be growing interest in the company's vaccine platform for tumor vaccines.
Great advice. Given the age of the officers, I'm guessing what you outline is under consideration.
Very nice recent discussion of the advantages of PacBio machines for clinical applications:
Thanks for the clarification. Do you think the increased number of these options awarded this year suggests more faith within management in future financial prospects of the company?
The cutting edge CAR-T production technology just announced should propel this stock to new highs.
Yes, they are options but I'm reading the strike price at 0.05$ on the form 4. I could be wrong also.
Guessing because of the partnerships with INCY for the checkpoint antibodies and GSK for Stimulon, the Agentus funding and distribution of shares will depend on the evolution of the other company partnerships/agreements, which are likely interconnected. Maybe there will be news on this this quarter.
The number of shares awarded have increased significantly compared to the previous 2 years. Is that a positive sign?
Good thing officers are willing to defer a high salary for shares. Not a bad sign IMO. If they do well, we do well. Recent progress in hemorrhagic fever vaccines and Zika are promising and pending data analysis from the HIV boost trial are possible catalysts for a stock move.
This is an excellent assessment. What do you think the impact of the antibody dependent enhancement of dengue fever with the Sanaofi dengue vaccine will have on the Geovax Zika vaccine? Do you think this will prompt a partnership for development, since the Geovax scientists anticipated this problem with flavivirus vaccines and designed their Zika vaccine to avoid this?
Agree that's the right strategy. This company has been slowly building assets using very good science. This was recently confirmed with the apparent antibody dependent enhancement of dengue fever associated with the Sanofi vaccine in patients who did not have prior dengue exposure. Geovax approach to the sister Zika virus seems to circumvent this problem. This shows real prescience by Geovax scientists. Their approach to HIV has been similarly stepwise and methodical. This company is way undervalued IMO. They have been able to come remarkably far on grants, avoiding dilution, and the next step will be a partnership to take vaccines with very good prospects into final efficacy trials.