— This Phase 2 study will evaluate the safety, tolerability and systemic/mucosal immunogenicity of CastleVax’s next generation COVID-19 vaccine compared to an approved mRNA vaccine comparator —

CastleVax, a clinical-stage biotechnology company developing intranasal vaccines using its attenuated Newcastle Disease Virus (NDV)-based vaccine platform, announced today that the first participant has been dosed in a Phase 2 clinical study of CVAX-01, its intranasal, next-generation, COVID-19 vaccine candidate. The study is designed to evaluate the safety, tolerability and both systemic and mucosal immunogenicity of CVAX-01 against a U.S. Food and Drug Administration (FDA)-approved injectable mRNA-based COVID-19 vaccine (NCT07215520).

“This Phase 2 study represents a major step forward towards our goal to develop a next-generation COVID-19 booster vaccine capable of eliciting mucosal immunity and protecting against SARS-CoV-2 breakthrough infection and transmission,” said Michael A. Egan, Ph.D., Chief Executive Officer and Chief Scientific Officer of CastleVax. “Importantly, we expect this Phase 2 trial to validate the potential of our NDV-based vaccine platform to elicit infection blocking mucosal immune responses, allowing for the development of next generation vaccines targeting a wide variety of diseases.”

The NDV-vectored vaccine platform was developed by the Icahn School of Medicine at Mount Sinai by 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. 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.

In previous preclinical studies, intranasal delivery of CastleVax’s next-generation, NDV-vectored COVID-19 vaccine (CVAX-01) efficiently induced mucosal immune responses which protected animals from SARS-CoV-2 infection and blocked virus transmission. More recently, a Phase 1 clinical study (NCT05181709) was completed in which intranasal delivery of CVX-01 was shown to be safe, well tolerated, and induced SARS-CoV-2 spike-specific mucosal immune responses in healthy adult volunteers.

The Phase 2 study aims to enroll approximately 200 adults representative of the U.S. population, including individuals at high risk for severe COVID-19 and those aged 65 and older, all of whom have previously received an FDA-authorized COVID-19 vaccine. Participants will be followed for 6 months after vaccination. This study is designed to evaluate the safety, tolerability, and effectiveness of intranasal delivery in enhancing systemic immune responses and stimulating mucosal immunity, which are believed to play a key role in reducing SARS-CoV-2 infection and/or transmission.

This project has been supported in whole or in part with funding from the New York State Biodefense Commercialization Fund.

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 full regulatory approval in Thailand and Emergency Use Authorization in Mexico.

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 its intranasal NDV vaccine platform, visit https://www.castlevax.com.

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‼️CastleVax announces first participant dosed in Phase 2 trial evaluating CVAX-01, a next-gen intranasal COVID-19 vaccine designed to elicit mucosal immunity that may block infection and transmission⚕️ #Vaccines #COVID19 #CastleVax