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PHV CBO Michael McGinnis stated, "This program represents a major step toward addressing a significant public health and biodefense threat, and we are grateful to BARDA for the opportunity..."
CAMBRIDGE, MA, March 06, 2019 /24-7PressRelease/ -- Public Health Vaccines, LLC (PHV), a biotechnology company out of Cambridge, MA, has been awarded a contract for the advanced development of its vaccine candidate designed to prevent Marburg virus infections. PHV will leverage the proven recombinant vesicular stomatitis virus (rVSV) vector platform originally developed by the Public Health Agency of Canada (PHAC).
Marburg virus is a hemorrhagic fever virus closely related to Ebola and is responsible for sporadic outbreaks, most often in Africa. In addition to being a naturally occurring public health threat, it has been identified as a potential bioterrorism threat by the U.S. Department of Homeland Security.
The base contract is a 2-year, $10 million contract by The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response. Under this agreement with BARDA, PHV will establish materials, methods, characterizations and processes which enable GMP manufacturing of the vaccine candidate. If the initial development succeeds, BARDA has the option to provide additional funding for a total of up to $72 million. This would advance the Marburg virus vaccine through nonclinical testing in animal models enabling the potential for regulatory acceptance under the FDA's Animal Rule and completion of a Phase 2 clinical trial. In addition, the contract would include initial stages of development of a vaccine against Sudan virus, a closely related hemorrhagic fever virus.
PHV Chief Business Officer Michael McGinnis stated, "This program represents a major step toward addressing a significant public health and biodefense threat, and we are grateful to BARDA for the opportunity to advance this promising candidate vaccine through this collaboration."
PHV has strategically partnered with Crozet BioPharma, LLC and Latham BioPharm Group, Inc., to compile a team of industry veterans with years of vaccine development and program management experience. This includes the exact functional expertise, and in many cases the same personnel, that successfully managed and executed the development of the rVSV Ebola vaccine. "The rVSV Ebola vaccine leveraged the same core platform technology as the rVSV Marburg vaccine candidate being developed under this award from BARDA," noted Dr. Thomas P. Monath, co-founder and Board member of PHV, adding "This relevant and specific experience should significantly advance and de-risk Marburg vaccine development efforts."
About Public Health Vaccines, LLC
Public Health Vaccines, LLC. (PHV), headquartered in Cambridge, Massachusetts, is a privately-held biotechnology company developing vaccines for the prevention and control of emerging infectious diseases. The company's initial focus is to develop vaccines against Marburg virus and Sudan ebolavirus (MARV and SUDV) utilizing the rVSV platform. PHV entered into a license agreement with the Public Health Agency of Canada (PHAC) to leverage the advanced recombinant vesicular stomatitis virus (rVSV) vector platform that PHAC discovered in 2005, to develop vaccines against Marburg virus and Sudan ebolavirus.
About Crozet BioPharma, LLC
Crozet BioPharma (Crozet) is a Contract Product Development Organization specializing in strategies to streamline and accelerate advanced development of biological products for prevention and treatment of infectious diseases, cancer and allergies. Crozet's unique, industry-experienced, multi-disciplinary development team with 10 successful product launches offers a turnkey solution to public and private biotechnology and pharmaceutical enterprises allowing flexibility in resource allocation and enhanced return on investment. For more information please visit www.crozetbiopharma.com.
About Latham BioPharm Group, Inc
Latham BioPharm Group (LBG) is an experienced life science consulting firm that helps clients identify, evaluate, fund, manage, and monetize opportunities in a wide variety of business segments. LBG's offering includes program management, technical product development, and strategic consulting services, with specific expertise in securing and managing government-funded programs for new product development. For more information please visit www.lathambiopharm.com.
About HHS, ASPR and BARDA
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of the Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats.
For more information, please visit www.phvaccines.com or email firstname.lastname@example.org.
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