Does anyone seriously think the U.S. government is going to approve the Vical vaccine for mass inoculations against H1N1 flu this winter? I mean, I own stock and would like that to be true, but let's be realistic. Although in theory plasmid vaccines have advantages, they have never been used in humans other than in trials. Think about it. If you weren't trying to make a buck by having the stock of Vical go up, would you have your three-year old daughter or granddaughter get an injection next week? The positive news for Vical is that scientists and the government are interested in the potential of the technology and in Vical's other products. However, there is no way the CDC is going to use a completely new vaccine technology on 50 million people in the next few months to protect against a comparatively mild flu virus.
I am sure this will stir up those who want this stock at $100 by Christmas.
for my views on realism, read my posts about expected lift due to H1N1, followed by A7 and PAD PR in coming months.
By January I would not be surprised to see Vical in the low teens. Once interim results are reported on Vical's DNA cancer vaccine are reported in Spring, 2010, the stock could see a 2-4X bounce from its value at that time.
I could see 20 or so for Vical when its Phase III A7 trial is A) fully enrolled in global trial locations and B) shows both efficacy and safety consistent with the Phase III trial design.
A7 is the BIG DEAL for Vical. H1N1 is simply raising awareness of Vical's platform technologies and IP, including the Vaxfectin adjuvant...which COULD BECOME front page news by Thanksgiving.
gofor, I'm surprised you consider A-7 THE big deal for VICL as compared to A big deal, especially when the prospects for melanoma tend to turn into trash. I heard Vijay describe where his (and apparently your) optimism come from, but it still has the aura of a roll of the dice imo; though apparently leaning north of 50-50.
Just a note to newcomers - VICL watchers have already discounted the relevance to flu stuff. As Vijay Samant (CEO) said they will probably not be used this season UNLESS something drastic happens in which case FDA would relax conditions. He emphasized the recurrence of H5N1 (bird flu) as more of a worry - as that is more dangerous (though less infectious right now). But if it mixes with the more infectious H1N1 or mutates to be faster spreading then he saw H5N1 as bigger threat.
Meanwhile they don't want to spend their own money on flu stuff - mainly also because they have the Navy working that out for them - negotiating money from government for clinical trials etc. The H1N1 trial is set to start Sept 2009. Money was the main problem with government, but once that is available things move fast with the Navy (according to the CEO).
This will establish human data for VICL's H1N1 vaccine.
Even though VICL may not be used this season (NVAX also likely would not), because of the faster process for VICL's stuff (faster than NVAX, and thus faster than conventional egg culture), it would seem that the Navy would want VICL flu stuff quickly tested. Because a fast way to produce vaccines is a STRATEGIC asset - and the Navy probably recognizes it as that.
In addition VICL has a non-squalene based adjuvant (other manufacturers use squalene etc.). No adjuvants are currently approved within the U.S. (though they are in Europe). VICL's adjuvant works with it's own as well as conventional vaccines.
However flu is a small part of what VICL does - one of many applications of "DNA Vaccines". VICL (and Univ. Wisconsin) basically DISCOVERED DNA vaccines.
To respond to some of the comments about this posting.
The rule of thumb is that it takes 5 to 7 years to go from a Phase I trial of a new drug to FDA approval. I just checked Vical's Web site. It doesn't claim to have even started Phase I testing of its H1N1 vaccine. Vical did put its Avian flu vaccine into Phase I trials in 2005, but that is as far as it has gotten with that vaccine. The Web site says 100 volunteers have received the vaccine. So it seems to me pretty pie-in-the-sky to say that Vical will have an H1N1 vaccine on the market in the 2010-2011 flu season, given the fact that 1) it hasn't started Phase I testing yet and 2) its other plasmid vaccine for avian flu has been in Phase I for four years.
About fifteen years ago, I got interested in the nasal spray for flu and invested in what ultimately was Medimmune. Like Vical, nasal vaccine used a novel approach to triggering immune reactions in the body. Medimmune was desperate to get its product on the market and enrolled over 30,000 children in its Phase II tests. Even that wasn't good enough. An FDA panel picked through the results and ordered further testing, thus delaying approval for another year. And there is a much higher standard of safety demanded for a vaccine against regular flu because conventional flu is simply not that dangerous. Health officials don't want to get in a situation where more people die from the vaccine than the flu. The reality is that Vical is still years away from having an H1N1 flu vaccine approved. Vical's Avian flu vaccine is a different matter. That's a very deadly virus, and so the government would be more willing to take a risk with Vical's vaccine against that should a pandemic break out.
Your "rule of thumb" does not apply to flu vaccines. Flu vaccines do not go through III Phases of clinical trials - why, because a new flu vaccine is required every year to mutations and shifts in the virus. Conventional flu vaccines are only tested on a small patient population each year to ensure they generate a sufficient immune response before they distributed to the general population. VICL is in a little different position because they have an "unconventional" flu vaccine, so the FDA will require some level of safety testing, regardless of immune response. This is what the Navy trial is intended to provide - they already know it generates a strong immune response - they just need to verify safety in a decent sized population in order for it to become eligible. It may not be blessed with complete approval based on the Navy trial (children, seniors, pregnant women may be excluded), but if the situation gets desperate enough and there is a shortage of conventional vaccines, the FDA is not going to dismiss other sources of vaccines so easily.
I agree with your assessment, but a $4 share price does not reflect that assumption. Granted, the H1N1 scare is helping the stock price, but I don't think the price is irrational at this stage. The news is saying that H1N1 will probably worse than people thought this flu season and there is a chance for it to present severe problems for the health industry. If that is the case and VICL's vaccine goes through a succesful Navy trial this year, then there is a reasonable chance it becomes part of next year's FDA-approved arsenal (or some foreign govt places an order). A $4 price for the chance to be a player in the 2010 flu season is reasonable, especially in light of the rest of VICL's pipeline, which could take the price into double digits over the next year, regardless of what happens with the flu program.
Ok I have been reading this and agree and disagree. Take a look at Nvax they came out and said they are not ready for this pandemic of 2009 but will be on track for 2010 if necessary. And their stock keeps going up. Nobody from Vicl has come out and said they have nothing for 2009's pandemic, so in my opinion "game on" Vicl still has a chance to run many more dollars in fact, good argument though....
"they have never been used in humans other than in trials"
This is true of every drug until it goes to market, isn't it? How else are they supposed to do it?
Yes, I would use Vical's vaccine for my family if I had the option to do so.
Vical's technology will be validated this year in many different applications.