I don't even know what this company does but they certainly do not have D-list VCs behind them. In fact they have become (as of 3/31/15) one of the largest holdings of the most successful fund over the last 2 years at least. So I wouldn't count them out just yet.
Would like to hear more from GNCA on the timeline for Phase III. I'm thinking this is a takeout target for a larger vaccine company, possibly even NVAX, although I'm not sure of their cash position...
Its hard to say without the Ph III results. NovaVax makes the Matrix-M technology for companies exactly like GNCA so I don't know why they wouldn't want to develop a solid partnership.
Primary endpoints like viral shedding certainly matter, especially when viral shedding is the only cause of lesions. Lesions cannot exist without viral shedding. So, once again, the placebo effect was mostly caused by a small patient population like the company said. The Phase 3 test will without a doubt cover a lot more patients, take more time, and be done with extra care as far as placebo control. But if the vaccine demonstrates what it has with the small patient population, it will eventually be approved. And again, there was no placebo effect on lesions in the Ph I/II study, which was studying general efficacy, not ideal dosing.
There never was any grey are with the placebo effect. The viral shedding, which was the only endpoint that actually matters, was reached. If those who received a placebo also saw a reduction in lesions, it means nothing. Without viral shedding, lesions cannot exist. Some people who had viral shedding may not have had lesions. It doesn't matter. As long as there is a significant reduction in viral shedding, there will be a significant reduction in lesions as well, which was the result of Ph 1 anyway. All the placebo nonsense was cleared up in the call if you listen to the results. Most of the garbage about the placebo was brought about by Vical investors, which was a company that missed its endpoint in viral shedding. GNCA is the only game in town now for HSV-2 as far as I know, and has a billion dollar market available and waiting for them if the vaccine continues to FDA approval as expected. They are also making progress in pnuemoccus. Everyone is focused or CAR- T cell technology so this small vaccine company has been over looked, but its technology is way ahead of some of these clinical oncology companies that have yet to even start or finish Ph I trials. Yet they now have 2-5B mkt caps.
Unless you are speaking in dollar terms I find it pretty hard to believe you would be able to get 40,000 shares to borrow and short on this stock considering it is mostly owned by insiders and large pharma and there are only 20 or so million shares outstanding.
Agreed. I'm surprised that we are seeing this kind of drop in front of ASCO. This stock should be hitting new highs with the current late stage pipeline.
I don't think in this particular trial they were collected by patients. Not sure if that is even possible because of possible contamination etc. But regardless, the placebo effect with lesions, meaning all the patients in the trial seemed to have less lesions doesn't really matter if the overall viral load and shedding was significantly reduced, because as we've talked about before, the virus needs to be present for the lesions to occur as far as I know. In the first Phase 1/2a trial, lesions did go down versus the placebo. So I think the company is being unfairly punished because of the placebo effect and should have had a much bigger pop off the Phase II results. One problem is the low number of outstanding shares, which over half are owned and probably not traded at all by institutional investors. The best outcome for investors of this company will be if a large pharma company buys them out and completes the Phase III trial themselves. That way they might get results before 2017, not have to offer more shares, etc. Not to mention get the expertise and benefits that the right big Pharma company can give to a smaller biotech. Its certainly possible, but GNCA's management has repeatedly said they believe the vaccine is worth over $1 B in sales in the U.S. and they are going to want a multiple of that number which is a very big jump from the current market cap.
OK, I agree with some of that. But, the chances that it is a placebo effect are much greater rather than the general efficacy of the vaccine. This was explained on the call. Because lesions cannot be present without the replication of the virus and viral shedding, in all likelihood based on the small amount of people in the trial and the way lesions were being reported, the reduction in viral shedding rates being highly significant is much more important at this stage. Could the trial maybe have added a 2nd placebo group to smooth the data? Possibly. But they are trying to move forward because they know they have efficacy where it matters. It was not a poorly designed trial and will certainly be enough for them to initiate a phase III which will have many more people. You are also missing that the vaccination concept if correct, will have to miss on viral shedding as well, because the virus being present is the basis for occurrence of lesions. People also do not want to infect others, so any significant reduction in shedding is major. I would listen to the call if I were you, they explain the placebo effect well. The other important factor is that with the same dose, in the first part of the trial Ph IIa, they already reached a significant reduction in lesion rates as reported by patients against the baseline against the placebo. Which makes it all the more likely the placebo effect was substantial in this case. They could not fake the swabs that doctors took from them. Also remember, this was the six month result. There will be more coming at 12 months. If the FDA wants GNCA to come up with a better way for the data on lesions to be collected in Ph III, they will incorporate that into the trial. Which will mean a lot more monitoring by doctors most likely.
If you listen to the conference call, the Placebo effect that was noted in the trial, is essentially meaningless as viral shedding is the critical parameter because it underpins the pathology of the disease. There is no transmission OR recurrence without viral shedding, which was the primary endpoint achieved by GNCA. Furthermore, being that this is the 2nd part of the Phase II trial (which will be revisited again in 6 months and 12 months), the first trial showed statistical significance with viral shedding as well as occurrence of lesions. Essentially, there can be no lesions without viral shedding, but there doesn't have to be lesions for viral shedding to occur. The trial was small, phase 3 will have many more patients and a placebo effect from a patient believing they are being treated (and reporting the lesions themselves, without being seen by a doctor) will be less likely. The swabs confirming the viral DNA are more important, which can easily be discerned by someone who realizes that without the virus present, lesions will not occur.
Take a look at yesterday's volume compared to the average of around 100,000 a day for the last 3 months. Its phase II data, on a company that is not very well known.
There are only 20 million shares outstanding, most of which are already held by institutional investors. The average volume is very low on the stock. All it says on the SEC site is that there was a placebo effect noticed with lesions. That means nothing. They hit their primary endpoint. I discussed it with other doctors that I work with and they agreed the data was fine. An observed placebo effect with lesions doesn't mean anything, the presence of viral DNA does. I don't know enough about VICAL to say whether or not they have something worthwhile, but their financial situation and pharma backing is not nearly as strong which tells you something. If it doesn't go above $1 it will eventually be de-listed from the Nasdaq. GNCA does not have enough shares outstanding, which means there will probably be a dilution but the data was and has been solid to say the least. Not to mention we are talking about an entire platform here GEN-003 is not the only thing they have going for them.
First of all, lesions CANNOT be present without viral shedding. Viral Shedding is the primary. Read the press release. There is a reason this company has Big Pharma backers, as well as Polaris Ventures, a group I am familiar with. They already showed significance with lesions as well, in the prior study, which was essentially Ph 2a. Lesions can only be reported by the patients. The data is in the presence of HSV-2 DNA, which cannot be reported only by the patients, it needs to be present on the swabs, obviously.
Also, just the fact that the viral DNA is present means much more than a patient reporting they have a "lesion". People have different thresholds of pain. They are also reporting these lesions themselves rather than giving the swabs that have the DNA on them that is required. I would listen to the call before I commented further
A prior Phase 1/2a clinical trial demonstrated, at the corresponding immediate post dosing 28-day observation period, a highly statistically significant 52 percent reduction in the viral shedding rate and a highly statistically significant 48 percent reduction in the genital lesion rate compared to baseline at a dose of 30 µg per protein/50 µg of Matrix-M2TM adjuvant.
This was the prior Phase IIa, this was Phase IIb.
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced positive top-line data from a Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. During the 28-day observation period immediately after completion of dosing, the best dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant demonstrated a highly statistically significant (p
Agreed. Very good news. Market should have reacted even better, but the stock is thinly traded and not followed very closely. J&J and Glaxo will notice though.