NEW YORK--(BUSINESS WIRE)--CastleVax, a clinical stage mucosal vaccine platform company, has received an additional Project NextGen award valued at approximately $34 million to support the continued development of the company’s next-generation, mucosal vaccine to protect against symptomatic COVID-19 infection.
The project award was made through the Biomedical Advanced Research and Development Authority’s (BARDA’s) Rapid Response Partnership Vehicle (RRPV) to support CastleVax in planning for and preparing the mucosal vaccine candidate CVAX-01 for Phase 2b clinical efficacy testing. The RRPV is a Consortium funded by BARDA, part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).
Under the award, CastleVax, in collaboration with BARDA’s Clinical Studies Network, will conduct a Phase 2b efficacy study enrolling 10,000 trial participants; half will receive a single intranasal dose of CastleVax’s next-generation NDV-HXP-S vaccine (CVAX-01), and half will receive a single intramuscular dose of a currently licensed COVID-19 vaccine. All study participants will be actively monitored post-vaccination for the occurrence of SARS-CoV-2 breakthrough infection. Based upon pre-clinical and Phase 1 clinical data, it is expected that participants receiving CastleVax’s next-generation, nasally delivered, CVAX-01 COVID-19 vaccine will demonstrate reduced numbers of SARS-CoV-2 breakthrough infections relative to individuals who received the standard systemic vaccine.
“CastleVax is grateful to continue our clinical development efforts under BARDA’s Project NextGen of our innovative, next-generation, mucosal COVID-19 vaccine to protect against breakthrough infection and transmission,” said Michael Egan, PhD, CastleVax’s Chief Executive Officer and Chief Scientific Officer.
The NDV-vectored vaccine platform was developed by Icahn School of Medicine at Mount Sinai scientists Peter Palese, PhD, Horace W. Goldsmith Professor and Chair Emeritus of Microbiology; Adolfo García-Sastre, PhD, Director of the Global Health and Emerging Pathogens Institute, and the Irene and Dr. Arthur M. Fishberg Professor of Microbiology and Medicine (Infectious Diseases); Florian Krammer, PhD, Professor in Vaccinology; and Weina Sun, PhD, Assistant Professor of Microbiology, and was licensed by Mount Sinai to CastleVax Inc. Mount Sinai has a financial interest in this technology and in CastleVax. Drs. Palese, García-Sastre, Krammer, and Sun also have a financial interest in this technology and in CastleVax pursuant to the Mount Sinai Intellectual Property Policy. Mount Sinai is represented on the CastleVax Board of Directors by Dr. Erik Lium; Mr. Matthew Rosamond, Chief Financial Officer, Icahn Mount Sinai; and Mr. Stephen Harvey, MBA, Chief Financial Officer, Mount Sinai Health System.
This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction (OT) number 75A50123D00005.
About CVAX-01: The next-generation, live, attenuated, NDV-vectored COVID-19 vaccine (CVAX-01) expresses a stabilized SARS-CoV-2 spike protein, utilizing HexaPro technology developed in the laboratory of Dr. Jason McLellan at The University of Texas at Austin and licensed to CastleVax. The CVAX-01 vaccine has an attractive safety profile and low reactogenicity in humans as documented in several completed and on-going phase 1, 2 and 3 clinical trials (NCT04871737, NCT05205746, NCT05710783 and NCT05181709). In addition, the live version and an inactivated version of this same vaccine delivered by intramuscular administration has completed two Phase 3 immunobridging studies and has received Emergency Use Authorization in Mexico and Thailand, respectively.
About CastleVax: In August of 2022, the Mount Sinai Health System launched CastleVax, Inc., a clinical-stage vaccine research and development company devoted to the commercial development of the NDV vaccine platform technology with an initial focus on respiratory viruses.
For more information on CastleVax and the NDV vaccine platform, visit https://www.castlevax.com.
