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Meissa Vaccines Receives FDA Clearance of IND Application, Phase 1 Clinical Trial of MV-012-968

SOUTH SAN FRANCISCO, Calif., July 12, 2017 -- Meissa Vaccines, a biotechnology company developing vaccines to prevent viral respiratory infections, announced that it has been awarded a Fast Track SBIR grant by the National Institutes of Health entitled, "Development of live attenuated respiratory syncytial virus vaccines with novel thermal stable fusion protein" with a total value of $1.56m. It will fund activities needed to file an investigational new drug (IND) application with the FDA for Meissa's lead product candidate, a vaccine to prevent RSV disease in infants. INDs are required to initiate clinical trials. Activities covered by the grant include pharmacology studies and the generation of virus seed stocks to support production of clinical trial material. 

This is the second recent NIH grant award to Meissa: in May 2017, the Company announced a SBIR award supporting development of its rhinovirus vaccine candidate.

Meissa's live attenuated RSV vaccine MV-012-968 is attenuated by down regulation of RSV virulence genes using codon-deoptimization, and this vaccine strain also expresses a propriety fusion protein with enhanced pre-fusion meta-stability. These unique characteristics are specifically designed to make a safe and highly immunogenic live RSV vaccine suitable for immunizing RSV naïve infants, the population most vulnerable to severe RSV disease and in need of a vaccine. Dr. Roderick Tang, Meissa's CSO and Principal Investigator on the grant said, "Advancing this promising RSV vaccine candidate towards the clinic is a priority for Meissa. We are very grateful to NIH/NIAID for this award, which will accelerate entry of MV-012-968 into human trials."

"A safe and effective pediatric RSV vaccine is a top WHO vaccine priority," added Dr. Martin Moore, Meissa's Chief Executive Officer. "Worldwide, RSV is a major cause of infant mortality and hospitalizes up to 1% of US infants every year. In addition to a novel approach to attenuation and immunogenicity, our recombinant live attenuated RSV vaccine MV-012-968 has enhanced thermal stability compared to the natural virus."

About Meissa

Meissa Vaccines is focused on the advancement of vaccines for respiratory syncytial virus (RSV, the largest unmet respiratory medical need in pediatrics) and rhinovirus (the leading cause of infectious disease worldwide). The technology is sourced from Dr. Martin Moore's laboratory at Emory University. Dr. Moore, together with Dr. Roderick Tang, a leading developer of viral vaccines, are co-founders of Meissa. They are supported by a team with extensive experience in conducting vaccine clinical trials. Meissa Vaccines is a resident company of Johnson & Johnson Innovation, JLABS in South San Francisco (JLABS @SS


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