Company Overview of PaxVax, Inc.
PaxVax, Inc., a biotechnology company, engages in developing, commercializing, and distributing candidate oral preventative vaccines against various infectious diseases. Its products include an oral vaccine technology platform based on adenovirus, which is a common virus. The company’s platform includes various disposable manufacturing processes and formulations in room temperature stability. It offers its products for influenza, cholera, anthrax, malaria, and HPV infectious diseases. The company was incorporated in 2006 and is based in San Diego, California.
3985A Sorrento Valley Boulevard
San Diego, CA 92121
Founded in 2006
Key Executives for PaxVax, Inc.
Executive Chairman and Chief Executive Officer
Chief Operating Officer and Executive Vice President
Chief Scientific Officer and Executive Vice President
Compensation as of Fiscal Year 2013.
PaxVax, Inc. Key Developments
PaxVax, Inc. Announces Executive Appointments
Mar 3 14
PaxVax Inc. announced the expansion of its commercial leadership team, including appointments of: Linda Rubinstein as Chief Financial Officer, Piers Whitehead as Chief Corporate Development Officer and Thomas Yonker as Vice President of Project Management. Ms. Rubinstein has more than 25 years of operational, financial, and capital markets experience in life science, software, and investment banking. Previously, she served as Senior Vice President and Chief Financial Officer (CFO) of Ingenuity Systems, which was acquired by QIAGEN in 2013, and Vice President and CFO of Solexa, which was acquired by Illumina in 2007. In these roles, she oversaw finance operations, conducted financing and M&A transactions, and contributed to corporate strategy. Mr. Whitehead brings 20 years of experience in the vaccines and biopharmaceutical industries to PaxVax. He joins the company from Paris-based Neovacs, where he was Vice President of Corporate Development. Prior to that, he was Vice President of Corporate and Business Development for vaccine company, VaxGen. At VaxGen, he negotiated several important partnerships and led the company's commercial strategy, resulting in the award of a nearly one billion dollar Project Bioshield Act contract. Mr. Yonker has nearly 30 years of biopharmaceutical experience, with over 25 years in project management for drug development. He joins PaxVax from Kalobios Pharmaceuticals where he managed clinical-stage projects. Prior to that, he held executive project management positions at Entelos, Abgenix, Corgentech, InterMune, Aviron, ALZA, Glaxo, and The Upjohn Company.
PaxVax Announces Interim Data from Phase III Cholera Challenge Study of PXVX0200
Jan 14 14
PaxVax announced interim data from a Phase III cholera challenge study of its single-dose oral cholera vaccine candidate, PXVX0200. The investors compared the rate of diarrhoea in patients vaccinated with PXVX0200 to the rate in participants who had received a placebo. The vaccine appeared well tolerated. In an interim analysis of participants challenged at 10 days post vaccination with wild type, completely pathogenic cholera bacteria, the rate of diarrhoea was decreased in the vaccine group. 20 of 33 participants who received a placebo experienced moderate-to-severe diarrhoea compared to two of 35 participants who received PXVX0200.
PaxVax, Inc. Initiates Phase 3 Clinical Trial Challenge Studies for Single-Dose Oral Cholera Vaccine
Sep 6 13
PaxVax, Inc. announced that it has commenced its Phase 3 clinical trial program for its single-dose oral cholera vaccine candidate, PXVX0200 (also known as CVD 103-HgR). Approximately 3,000 participants will be enrolled in this pivotal program, which is comprised of cholera challenge, safety, and immunogenicity studies. Cholera is an acute intestinal infection caused by toxigenic Vibrio cholerae bacteria generally acquired by ingesting contaminated water or food. According to the World Health Organization, the global disease burden is estimated to be three to five million cases and 100,000 to 130,000 deaths per year. No vaccine for cholera is currently available in the United States (U.S.) for residents who may travel abroad to areas where cholera is common. A cholera vaccine is available in Europe and elsewhere for travelers, but it requires a two-dose regimen, which takes longer to complete. A single-dose, oral vaccine would be more convenient for all travelers to take, particularly for those traveling on short notice. The pivotal efficacy cholera challenge studies will be randomized, double-blind, placebo-controlled, and conducted at three top vaccine testing centers, including the University of Maryland, the University of Vermont Vaccine Testing Center, and Cincinnati Children's Hospital Medical Center. Volunteers enrolled in these studies will first be vaccinated and then challenged, or exposed to the cholera-causing agent (Vibrio cholerae bacterium). At 10 days following vaccination, and again at three months post vaccination, participants will be evaluated to determine the protective ability of PXVX0200. All standard clinical trial safety protocols and guidelines will be followed at each clinical research center. Additional trials will also be conducted at sites in Canada, Australia, and the U.S. to confirm vaccine safety in a larger population, measure immunogenicity, and demonstrate lot-to-lot consistency of different vaccine manufacturing batches required by the U.S. Food and Drug Administration (FDA). In recognition of the lack of any available traveler's vaccine against cholera, and the corresponding unmet medical need, PXVX0200 has been granted Fast Track designation by FDA. Positive results from the Phase 1 trial showed that a single oral dose of PXVX0200 was highly immunogenic; overall, seroconversion to vibriocidal antibody occurred in 89% of vaccinees by day 14. Onset of immune response induced by the vaccine was also rapid, with 80% of subjects demonstrating seroconversion by 10 days after administration. The vaccine was well tolerated; adverse events were infrequent, and generally mild and comparable to placebo. PXVX0200 is the same attenuated vaccine strain (CVD 103-HgR) that was previously approved and marketed in several countries under the brand name "Orochol".
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