CastleVax Inc. Gets $34M from BARDA for Phase 2b Testing of Intranasal COVID-19 Vaccine

July 30, 2024, CastleVax, a company specializing in mucosal vaccines, has secured an additional $34 million from Project NextGen to further develop a mucosal vaccine aimed at preventing symptomatic COVID-19 infections. This funding is provided through the Biomedical Advanced Research and Development Authority's (BARDA's) Rapid Response Partnership Vehicle (RRPV). BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) under the U.S. Department of Health and Human Services (HHS).

CastleVax will use this grant in collaboration with BARDA's Clinical Studies Network to conduct a Phase 2b clinical trial involving 10,000 participants. In this trial, half of the participants will receive a single intranasal dose of CastleVax’s NDV-HXP-S vaccine (CVAX-01), while the other half will receive a single intramuscular dose of a currently licensed COVID-19 vaccine. All participants will be closely monitored for any breakthrough SARS-CoV-2 infections following vaccination. Based on prior pre-clinical and Phase 1 clinical data, it is anticipated that the nasal delivery of CVAX-01 will result in fewer breakthrough infections compared to the standard systemic vaccines.

Michael Egan, CEO and Chief Scientific Officer of CastleVax, expressed gratitude for the continued support from BARDA’s Project NextGen, emphasizing the importance of their next-generation mucosal COVID-19 vaccine in protecting against both breakthrough infections and transmission.

The NDV-vectored vaccine platform utilized by CastleVax was developed by scientists at the Icahn School of Medicine at Mount Sinai. Key contributors include Peter Palese, PhD; Adolfo García-Sastre, PhD; Florian Krammer, PhD; and Weina Sun, PhD. The technology was licensed to CastleVax, with Mount Sinai holding a financial interest in both the technology and the company. Drs. Palese, García-Sastre, Krammer, and Sun also have financial interests in this technology and the company, in line with Mount Sinai's Intellectual Property Policy. Additionally, Mount Sinai is represented on CastleVax’s Board of Directors by Dr. Erik Lium, Mr. Matthew Rosamond, and Mr. Stephen Harvey.

The project is supported with federal funds from the U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), and BARDA.

CVAX-01, the next-generation live attenuated NDV-vectored COVID-19 vaccine, incorporates a stabilized SARS-CoV-2 spike protein using HexaPro technology developed at The University of Texas at Austin. This technology, licensed to CastleVax, has demonstrated an appealing safety profile and low reactogenicity in humans, as evidenced by various Phase 1, 2, and 3 clinical trials. Furthermore, both live and inactivated versions of this vaccine, delivered intramuscularly, have completed Phase 3 immunobridging studies and have received Emergency Use Authorization in Mexico and Thailand, respectively.

CastleVax was launched in August 2022 by the Mount Sinai Health System. The company focuses on vaccine research and development, particularly the commercial development of the NDV vaccine platform technology, initially targeting respiratory viruses.

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