Seriously what is up here
Why the tight lips?
We are developing a Universal Flu vaccine designed specifically to overcome the limitations of standard seasonal and pandemic vaccines. Our approach combines a proprietary second-generation TLR9 agonist with two conserved influenza antigens – nucleoprotein (NP) and the extracellular domain of matrix protein 2 (M2e)– and a trivalent influenza vaccine. Our vaccine is designed to be differentiated from other influenza vaccines by providing both an adjuvant effect to enhance the immunogenicity of the seasonal vaccine and cross-strain protection via conserved influenza antigens.
In July 2008, we announced an agreement with Novartis for the supply and development, and possible commercialization, of our Universal Flu vaccine in collaboration with Novartis. Under the agreement, Novartis agreed to provide us with a supply of trivalent influenza vaccine, an essential component of our Universal Flu vaccine, for both clinical trial use and vaccine sales. Novartis received an exclusive option to negotiate a Joint Development and Commercialization Agreement with Dynavax. We agreed to conduct early-stage development through a defined proof-of-concept. If Novartis exercises the right to negotiate a further agreement for development and commercialization, we would retain co-commercialization rights in the U.S. and receive product royalties outside of the U.S. Should the option not be exercised, Novartis remains committed to providing commercial supply of trivalent influenza vaccine with pre-agreed commercial terms and we retain the right to independently continue with late-stage development and commercialization.
-- (MARKET WIRE) -- 12/07/10 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported safety and immunogenicity data from its Phase 1a clinical trial of N8295, one of two key components of its Universal Flu Vaccine candidate. N8295 is a fusion protein comprised of NP and M2e, two highly conserved influenza antigens covalently linked to Dynavax's proprietary second-generation TLR9 agonist. The trial assessed three dose levels of N8295 in a total study population of 39 subjects. The Phase 1a data showed:
All doses were very safe and generally well tolerated;
No dose limiting toxicities;
Positive antibody responses to M2e; and
Positive T-cell mediated responses to NP
MARKET WIRE) -- 02/22/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) reported last Friday, February 18 in Geneva, Switzerland at the World Health Organization 7th Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials new Phase 1a and Phase 1b safety and immunogenicity data for its universal flu candidate vaccine. In an oral presentation, Dynavax's Robert Janssen, M.D., Senior Director, Clinical Research, described new findings for N8295, a fusion protein comprised of NP and M2e, two highly conserved influenza antigens covalently linked to Dynavax's proprietary second-generation TLR9 agonist, in combination with an investigational H5N1 avian influenza vaccine. The study evaluated 54 subjects, including 39 from the Phase 1a dose escalation study of N8295 and 15 from the Phase 1b dose escalation study of H5N1/N8295.
Data from the Phase 1a and the Phase 1b study, initiated in September 2010, showed:
N8295 alone or combined with H5N1 vaccine was very safe and generally well tolerated;
The most common adverse events were mild, self-limited injection site reactions;
There were no SAEs;
All N8295 dose groups had an antibody response to M2e, and the placebo group did not;
All N8295 dose groups had an antibody response to NP, and the placebo group did not;
All N8295 dose groups had a cellular immune response to NP, and the placebo group did not;
The addition of N8295 to a non-immunogenic dose of H5N1 vaccine resulted in H1 responses in all N8295 dose groups.(1)
Novartis has a huge complex barely a dozen city blocks south of where Dynavax is located (i.e., the north side of Emeryville and south side of Berkeley are contiguous). The proximity in of itself is not sufficient to warrant M&A or cross-licensing activity, but it might be attractive at least and necessary at most. IMHO only a fool would rule out the Novartis vaccine group making some play for an alliance or even an outright acquisition. Not saying it's going to happen - just saying it could easily...
Novartis Prize for Basic Immunology
"The fundamental discovery by Drs. Mossman and Coffman of the specific types of T cells that helped either cellular or humoral (antibody-mediated) immunity revolutionized our understanding of how the immune system works, and led to major advances in designing therapies for infectious, inflammatory and allergic diseases and in vaccine design," said Dhaval Patel, Head, Novartis Institutes for Biological Research Europe and Global Head of Autoimmunity, Transplantation and Immunology.
yes, the question is; how would that play out with GSK (a huge competitor to Novartis) as they already have some level of partnership with DVAX. Imo if any buy out to happen that'd be by GSK. What do you think?
So far, 2 times into the breach against the FDA and 2 times repelled back.
If it were a company of soldiers being sent in to take some town, hill or position, it would be pretty costly at this point; possibly prohibitively so. It should at least make any leader stop and think before ordering a 3rd assault (unless of course, the leader was sent there to kill or waste his own resources, or to make sure that any attempts were never to be successful).
There are other costs (than lives) at stake here as well. Trials aren't cheap affairs or arranged, planned and run simply either.
For Dynavax to use their heads (and Heplisav) as some battering ram and attempt to ram it down the FDA's throat is a pretty sorry approach
The FDA (controlled by GSK or not) is a thinking group; it's full of doctors and run by doctors with thei backing of the US government. .
Dynavax is supposed to be "medical-degree heavy " as well; and it surely ain't run by the Marine Corps.
All those doctors and other smarty pants in the company need to use those brains for more than a hat rack (or a battering ram) and come up with and employ some flanking manuever around GSK and the FDA.
If it all hangs on Heplisav, then it may never get there; because, like I wrote, 2 times into the breach and 2 times thrown back.
Zero for 2 (0 for 2) aren't good odds OR a hitting percentage OR a ball / strike count.
If Dynavax is this far behind in the strike count in their present at-bat, then they 'd better change their hitting strategy quickly, because it looks like they're down to their last strike.
No longer listed in the pipeline; the "disappearance without a peep" discussed a while back; given recent events, perhaps we should have taken that "disappearance without a peep" more seriously; i.e. taken it as a substantial negative indicator.