Vical and U of Washington jointly own patents for novel HSV vaccines. Just look up U.S. Patent No. 7,935,352 through Google to see how broad-based the key patent is. Clinical trials under the patented vaccnies could include Vaxfectin or not. Considering the size of the potential market "prize", AND the new FDA approach for speeding time to market for breakthrough drugs, discussions won't be simple with potential big pharma partners probably who would fund HSV-2 drug development using patented vaccine formulas. What's more, Vical and potential partners would need feedback/guidance from the FDA on clinical trial protocol options BEFORE a big joint deal could be signed. And an HSV trial probably would be global, adding complexity to the early clinical trial scope, costs, and deal construct between Vical and Big Pharma X. And YES, this is a BUY just based on HSV assuming Vical is actively moving to advance a deal.
"Vical and potential partners would need feedback/guidance from the FDA on clinical trial protocol options BEFORE a big joint deal could be signed."
I think VICL will want to complete HSV Phase I and possibly Phase I/II trials before entering into a partnership. VJ has been saying that he thinks these trials would be quick and easy to enroll, so we wouldn't have to wait long for these results. If these relatively cheap early stage clinical trials are successful, then the value of any possible partnership would be greatly enhanced.
Also, if the mid-year A-7 news is good, then I expect the stock to move up a lot. This would greatly lower VICL's equity cost of capital and allow it to raise cash with minimal diliution. This cash could be used to commercialize and extend A-7's label, as well as move the early stage pipeline forward, raising its value before partnering it. My view is that if A-7 is successful, then it will affect how VICL chooses to develop the rest of its unpartnered pipeline. If I were VJ and A-7 is a big win, then it makes sense to maximize shareholder value by cheapy increasing the value of the unpartnered pipeline and not prematurely give away too much valuable upside.
This is from the WHO website, didn't see Vical mentioned:
HSV-2 subunit vaccines were developed based on the use of viral envelope glycoproteins.
A two-component gB2 and gD2 recombinant glycoproteins subunit vaccine formulated in MF59 adjuvant was developed by Chiron. The 2-component vaccine induced high antibody titres and showed 26% efficacy in women for a period of six months but protection did not persist and male volunteers were not protected.
GSK developed a single component gD2 vaccine formulated in AS04 adjuvant (alum + monophosphoryl lipid A). The gD2 vaccine induced good Th1 immunity in mice, including high IFN-γ secretion, and provided good protection against vaginal HSV-2 challenge in female guinea pigs. The vaccine was tested in two large, double-blind, controlled Phase III trials on volunteers with a partner with genital herpes disease. In the first study, 847 subjects were selected as seronegative for both HSV-1 and HSV-2, whereas in the second study the 2491 selected subjects were selected only on the basis of HSV-2 seronegativity. The vaccine was 73% efficacious against genital herpes disease in doubly seronegative women. Trends towards protection against infection were also observed, but the figures were not statistically significant (less than 48% efficacy). Most unexpectedly, however, the vaccine was not effective in women previously seropositive for HSV-1 and in men, regardless of their HSV seropositivity status. This suggests that HSV-1 immunity is protective against HSV-2, but no satisfactory explanation is available of why subunit vaccines seem to provide only gender-specific protection. Further Phase III efficacy trials of the gD2 vaccine (Herpevac) are in progress in collaboration with the NIH, involving about 7500 persons from 18 to 30 years of age, double HSV-1/HSV-2 seronegative women. A vaccine that protects women could be expected to decrease the rate of neonatal HSV infection and have an impact on the epidemic spread of genital herpes. Lack of efficacy of vaccines in HSV-1 infected individuals would however render the vaccine of little use in developing countries, where HSV-1 infection is ubiquitous.
A novel, live attenuated HSV-2 candidate vaccine has been developed by Xenova/GSK using a replication-impaired virus mutant that lack the gene of the essential glycoprotein gH (ICP8 gene mutation) as a disabled infectious single cycle (DISC) virus vaccine. The vaccine was tested in Phase II trials in the USA as a therapeutic vaccine in HSV-2 seropositive symptomatic patients. It was well tolerated and induced neutralizing antibodies and CTL in 83% of the vaccinees, but no difference in time to recurrence and no difference in virus shedding were observed as compared with controls. The development of the DISC vaccine has been refocused towards its use as a prophylactic vaccine.
Another live, replication-impaired vaccine is currently under development by Avant Immunotherapeutics. Other viral mutants that are defective for replication and impaired for establishment of latency, such as mutant dl5–29, are at a preclinical stage of development.
A live attenuated vaccine based on a replication-competent ICP10 mutant of HSV-2 developed by AuRix is in Phase II clinical study.
DNA vaccine formulations have shown incomplete efficacy in animal models. Similarly, whole inactivated virus vaccines did not show efficacy and their development has been stopped.