Press Releases
Meissa Vaccines Enters into CGMP Manufacturing Agreement for Pediatric RSV Vaccine Candidate for Phase 2 Clinical Trials
REDWOOD CITY, Calif. and JUMET, Belgium, June 28th, 2023 – Life Science Newswire – Meissa Vaccines (“Meissa”), a clinical-stage biotechnology company developing vaccines to prevent viral respiratory infections, today announced it has entered into a manufacturing agreement with Exothera S.A. (“Exothera”), a Univercells company and full-service Contract Research Development and Manufacturing Organization (CRDMO) delivering customized process development and GMP manufacturing services for vaccines, viral vectors and nucleic acids. Under the agreement, Exothera will manufacture Meissa’s MV-012-968 vaccine candidate under Current Good Manufacturing Practice (CGMP) regulations to supply Phase 2 clinical trials. MV-012-968 is an intranasal live attenuated RSV vaccine in clinical development to protect infants and young children from respiratory syncytial virus (RSV).
Frank Glavin, Chief Executive Officer, Meissa Vaccines, said, “We are excited about our progress in advancing our pediatric RSV vaccine, and we are looking forward to working with Exothera on CGMP manufacturing of MV-012-968 for clinical supply. The clinical data we have generated from both our RSV and COVID-19 vaccine programs demonstrate the enormous potential of Meissa’s AttenuBlockTM platform to develop safe and effective intranasal live attenuated vaccines to protect against serious respiratory viruses, and we look forward to continuing to advance our vaccine candidates in Phase 2 clinical trials.”
Darren Leva, Chief Business Officer, Exothera said, “We are excited to contribute to the development of such a promising pediatric vaccine against RSV and humbled that Meissa recognizes the value of our unique history of viral vector innovation and expertise to help manufacture their live attenuated RSV vaccine candidate for clinical use.”
At Exothera’s GMP state-of-the-art facility located in Jumet, Belgium, Exothera will manufacture Meissa’s MV-012-968 under cGMP regulations using the scale-X™ platform developed by Univercells. The scale-X™ platform is designed for high volume and highest quality production of vaccines with a small footprint.
About RSV
Globally, respiratory syncytial virus (RSV) causes more than 66,000 deaths per year and approximately three million hospitalizations in children less than five years of age. In the United States, RSV is the leading cause of infant hospitalization, with approximately 1% of infants hospitalized each year. For infants, passive protection using monoclonal antibodies or maternal immunization strategies can offer short-term protection. Currently, there is no FDA approved RSV vaccine for pediatrics, and it is considered the “missing” mandatory pediatric vaccine.
About Meissa’s Pediatric RSV Vaccine Candidate
Meissa is developing MV-012-968, an intranasal (needle-free), adjuvant-free, live attenuated vaccine candidate, to protect infants from RSV. Meissa’s clinical data show MV-012-968 is well-tolerated, highly attenuated, and induces a strong systemic and mucosal IgA antibody response in RSV-naïve children. Meissa is currently enrolling participants between the ages of six and 36 months in a Phase 1c clinical study at multiple sites in the U.S. to evaluate the safety and immunogenicity of MV-012-968 (ClinicalTrials.gov Identifier: NCT04909021). MV-012-968 was generated using the company’s proprietary AttenuBlockTM synthetic biology platform with the goal of creating safe, potent, stable, and cost-effective intranasal vaccines.
About Meissa Vaccines
Meissa Vaccines was founded with a mission to protect people everywhere from life-threatening respiratory viruses and a commitment to develop innovative technologies capable of delivering effective vaccines at a global scale. Meissa is advancing intranasal, live attenuated vaccine candidates against respiratory syncytial virus (RSV) and SARS-CoV-2 (COVID-19) in clinical trials. Meissa’s vaccine pipeline also includes a vaccine candidate against human metapneumovirus (hMPV). Meissa’s vaccine candidates, generated on the company’s proprietary AttenuBlock™ platform, are formulated to be delivered as an adjuvant-free, needle-free dose and are designed to generate a strong, durable immune response to prevent infection and disease. Meissa is headquartered in Redwood City, California. For more information, visit www.meissavaccines.com.
About Exothera SA
Exothera is a contract research, development, and manufacturing organization (CRDMO) dedicated to viral vector and nucleic acids production. As a technology-driven company, Exothera provides best-in-class bioprocessing expertise that capitalizes on the best and most innovative manufacturing technologies developed within the Univercells group. The company delivers accelerated discovery services as well as process development/optimization to rapidly reach GMP clinical and commercial production of vaccines, viral vectors, and nucleic acids. At Exothera and Univercells, our mission is to make life-changing therapies available to all. For more information, visit www.exothera.world.
