West Coast Editor
As reports surfaced that the avian flu has been found in a German cat, fears mounted that the germ might soon pounce on humans, and two more biotech firms joined the race to develop a strong vaccine.
DelSite Biotechnologies Inc., a subsidiary of Carrington Laboratories Inc., tapped Invitrogen Corp. for the latter’s cell-based avian H5 whole virion flu antigen, which will become part of DelSite’s GelVac nasal powder vaccine.
Carrington’s stock (NASDAQ:CARN) jumped $1.05 on the news, or 23 percent, to close Wednesday at $5.60. Invitrogen (NASDAQ:IVGN) ended the day at $74.66, up $3.73, or 5.3 percent.
"Our target is to be in the clinic in 2007," said Bill Yates, president of DelSite, adding that there are "different thoughts" as to how long development of the vaccine might take.
"The FDA has not come out with final guidance regarding pandemic strains, but they will be doing that soon," he said, but noted that in projects such as biodefense, only early trials often are required before vaccine makers can ask for approval.
"The key is manufacturing capability," Yates said, and that’s what the Invitrogen deal provides for DelSite.
Preclinical studies with the vaccine started in late 2004 under a $6 million, three-year biodefense grant, and formulation development has been ongoing since then, using antigen produced at laboratory scale. The agreement with Invitrogen allows DelSite to transition from the current lab-scale procedures to a scalable manufacturing process, before revving up cGMP production for clinical trials.
Specifically, Carlsbad, Calif.-based Invitrogen brings its PD-Direct services team, the latest member of which is called Revolution, an approach said to combine advanced cell engineering technology for speed with high-throughput screening to optimize production cell lines for expression levels, growth performance, or product characteristics. Other terms were not disclosed.
DelSite last year showed in a Phase I trial with the GelVac system, minus antigen, that the approach was safe and well tolerated, with doses consistently and reproducibly delivered to the nasal cavity.
The system is based on GelSite polymer, a high-molecular-weight anionic polysaccharide. Water based, the polymer changes from a solid or liquid into a gel upon contact with body fluids, allowing for a sustained release of active biomolecules. It also adheres to mucus membranes, which makes it particularly suitable to delivery via that route.
"You have a first line of defense," Yates said. "The vaccine stimulates a generalized immune response in that area as well."
Another advantage, along with ease of administration, is the vaccine’s powder form.
"It lends itself to room temperature storage, and that’s a big factor when you have to start moving vaccines around quickly to different areas, especially remote areas," Yates said.
The cell-based (rather than egg-based) approach is important, too.
"Several companies are working in that area, but we’re using the whole virion," he said. "So it’s a killed vaccine, but we’re using the whole virus particle, which has been demonstrated literature-wise to have the broadest opportunity for protection, in case there is strain drift, a mutation in the virus," Yates said.
Last month, DelSite formed a research collaboration to evaluate the feasibility of using a GelSite nasal powder formulation to deliver a peptide for Alzheimer’s disease from Nippon Chemiphar Co. Ltd., of Tokyo.
But the bird flu has world health leaders more on edge, given word of H5N1 in a dead cat in Germany that apparently had eaten an infected bird on Ruegen, an island in the Baltic Sea.
DelSite, in December at the American Society for Microbiology’s 45th Interscience Conference on Antimicrobial Agents and Chemotherapy in Washington, offered encouraging preclinical data with the avian flu vaccine delivered by way of GelVac.
Invitrogen had other news, as well. Fourth-quarter earnings disclosed Tuesday, showed an income jump of 63 percent to $49.6 million, or 87 cents per share, on revenue that rose 24 percent to $325.3 million. Pro forma net income of 90 cents per share beat the Thomson Financial consensus by 2 cents.
Leerink Swann & Co. in Boston upgraded Invitrogen from "market perform" to "outperform," with a price target of $80 to $84, and UBS Securities LLC in New York held its "buy" rating on Invitrogen but raised the price target from $83 to $85.
Others to make bird-flu news in recent weeks include Alnylam Pharmaceuticals Inc., the RNAi firm based in Cambridge, Mass., and Novartis AG, of Basel, Switzerland, which formed a research partnership and hope to file an investigational new drug application by the end of this year. Terms of the deal were not disclosed. (See BioWorld Today, Feb. 22, 2006.)
Novavax Inc., of Malvern, Pa., raised $20 million in a direct offering of 4.6 million shares to two institutional investors, with proceeds to fund ongoing clinical development of the company’s virus-like particle avian and seasonal flu vaccines. This week, the company formed a strategic alliance with San Diego-based PacificGMP Inc. to collaborate on a commercial-scale production process for Novavax’s avian flu vaccine and other products.
A major vaccine player with Fluvirin is Chiron Corp., of Emeryville, Calif., which entered a supply contract with the UK government for pre-pandemic influenza vaccine for a stockpile based on the H5N1 strain. Chiron earlier agreed to deliver H5N1 vaccine for the U.S. government’s stockpile.
"Our technology and approach is new, and so it’s going through a stepwise progression," Yates said. "All the major manufacturers are moving as quickly as they can."