Rockville vaccine maker Novavax continues to make progress on its virus-like particle vaccines for both seasonal and H1N1 influenza and now has more funding to move the initiative forward.
The company reported completing enrollment for a phase 2a study of its seasonal flu vaccine in older adults, comparing it with the currently marketed conventional flu vaccine Fluzone. The study has enrolled 467 adults, 60 and older, at six sites in the U.S.
Novavax also reported that it closed its previously announced public offering of 6,800,000 shares of its common stock at $3.30 per share. Novavax received net proceeds from the sale of the shares, after underwriting discounts, commissions and estimated offering expenses, of about $21 million, which will be used for preclinical studies and clinical trials of VLP-based vaccines, internal research and development programs, working capital, capital expenditures and other general corporate purposes.
Meanwhile, Novavax reported favorable initial results from the first stage of a two-stage phase 2 study of its H1N1 flu vaccine in Mexico involving 1,000 healthy volunteers ages 18 to 64. The vaccine was well tolerated at all three dose levels, with no systemic side effects.
Based on these findings, the H1N1 vaccine will next be tested in 3,000 subjects.
"With the rapid completion of enrollment in this [seasonal flu] clinical trial as well as the first part of our H1N1 vaccine study in Mexico ... we are on track to report results from our two most advanced clinical programs during the first quarter of next year," CEO Rahul Singhvi said in a statement. "If results from the seasonal flu vaccine study are positive, we will be able to advance this program into phase 3 clinical testing as early as 2010."
Unlike conventional vaccines, Novavax's use virus-like particles that mimic the external structure of viruses but lack the live genetic material that causes viral replication and infection, according to company information. The particles can be designed quickly to match individual viral strains and be produced more efficiently using portable cell-culture technology. The vaccines can also be manufactured more quickly than conventional egg-based vaccines.
In other Maryland bioscience industry news:
Human Genome Sciences of Rockville announced the closing of its public offering of 17,825,000 newly issued shares of its common stock at $26.75 per share, which includes 2,325,000 shares sold upon exercise by the underwriters of their option to purchase additional shares. The net proceeds to the company from the offering are about $456.3 million, after deducting the underwriting discount and estimated offering expenses.
The company plans to spend a portion of the proceeds on acquiring more manufacturing capacity and developing new indications for Benlysta, its lupus drug candidate, according to HGS information.
Now that a federally imposed waiting period has expired, Vanda Pharmaceuticals can pocket its $200 million upfront payment from Novartis for licensing the Rockville biotech's schizophrenia treatment, Fanapt.
The deal, struck in October, gives Novartis exclusive commercialization rights to Fanapt in the U.S. and Canada, according to a Vanda statement. Novartis will also be responsible for further clinical development activities there. Vanda retains commercialize rights elsewhere.
Akonni Biosystems has won a $3.2 million, phase 2 Small Business Innovation Research grant from the National Institutes of Health to develop tests to detect influenza, including antiviral resistant types.
"The development of highly extensible, low-cost diagnostics for use in near-point-of-care settings is critical for mitigating the spread of disease and improving global health," said Charles Daitch, CEO of the Frederick company, in a statement.
Partnering with Akonni Biosystems on this program are Wadsworth Center, Columbia University, Little Company of Mary Hospital, and the federal Centers for Disease Control and Prevention.
Akonni's products are for research use only, not diagnostic procedures.
Annapolis biodefense company PharmAthene reported that its anthrax vaccine candidate SparVax is structurally stable and potent after 16 months at temperatures as high as 131 degrees.
"These new data are very encouraging as they demonstrate that PharmAthene's lyophilized rPA could be used to provide a stable cold-chain-free vaccine, enabling us to develop a formulation which could be stored and distributed at room temperature, an important attribute for deployment in the civilian Strategic National Stockpile," CEO David P. Wright said in a statement.
Both PharmAthene and Emergent BioSolutions of Rockville are developing next-generation anthrax vaccines for the federal government.
PharmAthene also reported that an anthrax treatment it is developing, Valortim, showed positive results in a study involving New Zealand white rabbits.
"We are very excited about these new data, which showed Valortim to be an effective treatment at very low doses in the NZW rabbit model for inhalation anthrax," Wright said. "The impressive survival rates in these studies further demonstrate the potential for Valortim to provide treatment for individuals displaying signs or symptoms following lethal inhalation exposure to anthrax."