CastleVax, a clinical-stage mucosal vaccine platform company, announced it has received an additional Project NextGen award valued at approximately $34 million to support the continued development of its next-generation mucosal vaccine to protect against symptomatic COVID-19 infection.
This 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. And 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 the 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.
This 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. And 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.
KEY QUOTE:
“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
