CastleVax Inc. Receives $34 Million from BARDA to Continue Advancing Intranasal NDV-based COVID-19 Vaccine into Phase 2b Clinical Efficacy Testing
2024年7月31日 - 3:10AM
ビジネスワイヤ(英語)
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240730713002/en/
Media: Rebecca Byers connect@castlevax.com