CastleVax Inc. Receives BARDA Project NextGen Award Valued at up to $338 Million to Advance Intranasal NDV-based COVID-19 Booster Vaccine into Phase 2b Clinical Efficacy Testing
CastleVax, a clinical stage vaccine platform company, has received a Project NexGen award valued at up to $338 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), to support the development of a next-generation, booster vaccine to protect against COVID-19 for years to come. The initial phase of the award provides approximately $8.5 million to plan a Phase 2b clinical trial that would compare CastleVax’s vaccine to currently authorized comparators. The funding will be used to advance CastleVax’s NDV-HXP-S COVID-19 booster vaccine, a nasally-delivered vaccine that uses technology developed at Icahn School of Medicine at Mount Sinai, into Phase 2b clinical efficacy testing. Project NextGen, a $5 billion initiative led by BARDA in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), coordinates across the federal government and the private sector to advance innovative vaccines and therapeutics into clinical trials, regulatory review, and potential commercial availability.
Under the contract, CastleVax 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 and half will receive a single intramuscular dose of a currently licensed COVID-19 booster 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, NDV-HXP-S COVID-19 booster vaccine will demonstrate reduced numbers of SARS-CoV-2 breakthrough infections relative to individuals who received the standard systemic booster vaccine. Importantly, the manufacture of the NDV-HXP-S vaccine needed for the Phase 2b study was made possible by a $4 million grant to CastleVax from the Empire State Development’s New York Biodefense Commercialization Fund.
“We see the potential of CastleVax’s next-generation, COVID-19 vaccine to protect against breakthrough infection and transmission,” said Michael Egan, PhD, CastleVax CEO and Chief Scientific Officer.
“Currently licensed COVID-19 vaccines have saved countless lives over the last 3 years, but it is widely appreciated that these current vaccines are limited in stopping SARS-CoV-2 infection and transmission. Our NDV-vectored, next-generation, COVID-19 booster vaccine was designed specifically to address this issue. In pre-clinical and early clinical studies, CastleVax’s NDV-vectored COVID-19 booster vaccine, when delivered intranasally, has demonstrated induction of potent mucosal immune responses with the potential to block infection and halt transmission. With BARDA support, CastleVax will formally evaluate the ability of our vaccine to prevent infection and transmission. This award is a continuation of the success we have seen in our other COVID-19 booster vaccine development efforts. CastleVax also has a systemically delivered, NDV-vectored vaccine to address inequity in vaccine access. This vaccine has completed Phase 3 clinical trials and is poised for regulatory approval. Only through the development of new vaccine approaches that are globally accessible and capable of preventing infection and transmission can we hope to put an end to the current global pandemic.”
“Next-generation nasally delivered vaccines that elicit robust mucosal immune responses may be a game changer in our fight against infectious diseases like COVID-19,” said Erik Lium, PhD, Chief Commercial Innovation Officer, Mount Sinai Health System, and President, Mount Sinai Innovation Partners. “This funding enables CastleVax to thoroughly evaluate the ability of its nasally delivered COVID-19 booster vaccine to prevent infection and decrease transmission and will substantially advance our understanding of mucosal immunity, infection and transmission.”
Since SARS-CoV-2 is spread through the air, a vaccine inducing an immune response in the respiratory tract will increase protection against COVID-19 infection and transmission,” said Peter Palese, PhD, Horace W. Goldsmith Professor and Chair Emeritus of Microbiology.
The Mount Sinai NDV-vectored vaccine platform was developed by Icahn Mount Sinai scientists Dr. Palese; Adolfo García-Sastre, PhD, Irene and Dr. Arthur M. Fishberg Professor of Medicine and Director of the Global Health and Emerging Pathogens Institute; Florian Krammer, PhD, Mount Sinai 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. Lium; Mr. Matthew Rosamond, Chief Financial Officer, Icahn Mount Sinai; and Mr. Stephen Harvey, MBA, Chief Financial Officer, Mount Sinai Health System. The phase 1 clinical trial mentioned herein is led by independent faculty investigators (Sean Liu, MD, PhD, Assistant Professor of Medicine (Infectious Diseases and Hospital Medicine) at Icahn Mount Sinai and Judith A. Aberg, MD, Chief of the Division of Infectious Diseases, Mount Sinai Health System) who have no financial interests in either the vaccine or CastleVax.
This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50123C00065.
About NDV-HXP-S: The next-generation, NDV-HXP-S COVID-19 booster vaccine express 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 live NDV-HXP-S 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, clinical development of an inactivated version of the NDV-HXP-S COVID-19 vaccine is underway with partners in Thailand (NCT04764422), Vietnam (NCT04830800), and Brazil (NCT04993209, NCT05354024).
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.
About Project NextGen: Project NextGen, a $5 billion initiative led by ASPR’s Biomedical Advanced Research and Development Authority (BARDA) in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), coordinates across the federal government and the private sector to advance innovative vaccines and therapeutics into clinical trials, regulatory review, and potential commercial availability for the American people. The project builds on a better understanding of COVID-19 – with HHS developing, using, and constantly re-evaluating the strengths and weaknesses of current vaccines and therapeutics for over three years. For more information on CastleVax and the NDV vaccine platform, visit https://www.castlevax.com.
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