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. 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".
PaxVax, Inc. Announces Positive Results for Oral Ad4 Vaccine Technology
Jan 31 13
PaxVax, Inc. announced positive results in a Phase 1 clinical trial for its oral, replicating adenovirus serotype 4 (Ad4) vector vaccine for H5N1 (avian flu). The study was funded by The Wellcome Trust. The goals of this Phase 1 study were to evaluate the safety and immunogenicity of the Ad4-H5-Vtn candidate vaccine, and, more generally, to evaluate the replication-competent Ad4 as an orally administered vector vaccine platform. The authors found the Ad4-H5-Vtn vector vaccine was well tolerated and induced cellular immune responses to the H5 HA. Subsequent boosting with a single dose of a licensed inactivated H5N1 vaccine led to high rates of seroprotection (HAI >= 40), significantly higher than in placebo recipients receiving a single dose of H5N1 vaccine (p<0.001). PaxVax's vaccine vector technology such as the Ad4-H5-Vtn vaccine is based on the existing licensed Adenovirus serotypes 4 and 7 (Ad4 and Ad7) vaccines, currently used by the U.S. Military. These Ad4 and Ad7 vaccines have a substantial safety experience having been administered to more than 10 million recruits without significant adverse experience. To date, PaxVax has bioengineered dozens of vaccine candidates using the Ad4 and Ad7 vector technology. Under NIH supported programs, a number of different Ad4 vector vaccine candidates for HIV and for anthrax have advanced into additional pre-clinical development and animal studies, and are scheduled for Phase 1 clinical trials in 2013. Other vectors that have been constructed and are potential vaccine candidates for further development include Ad4 vectors expressing immunogens for herpes, influenza and rabies viruses. The company has filed for patents to protect the IP involved in developing these replication competent, oral vector vaccines.
PaxVax, Inc. Announces Phase 1 Clinical Trial Data for Single-Dose Cholera Vaccine
Nov 14 12
PaxVax, Inc. announced results from a Phase 1 clinical trial of PaxVax's single-dose oral cholera vaccine candidate at the 2012 American Society of Tropical Medicine and Hygiene (ASTMH) Annual Meeting in Atlanta. The results were presented by the company's collaborator, Dr. Wilbur Chen of the University of Maryland, Baltimore. The vaccine candidate, PXVX0200 (also known as CVD 103-HgR), was found to be well tolerated and immunogenic. 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 3--5 million cases and 100,000--130,000 deaths per year. PaxVax's vaccine candidate PXVX0200 is a single-dose, oral, live, attenuated cholera vaccine. This single-dose vaccine is the same attenuated vaccine strain, CVD 103-HgR, that was previously approved and marketed in six countries under the brand name "Orochol or Mutacol." No vaccine for cholera is currently available in the United States and cholera vaccines available outside the U.S. require a two-dose regimen. A single-dose vaccine regimen would be more convenient for travellers, especially for those traveling on short notice, and can help improve compliance and reduce number of physician visits. In the Phase 1 trial, 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. These data are in line with expectations based on historical clinical trial results with previous formulations of CVD 103-HgR.
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