Meissa Vaccines signs CGMP manufacturing agreement for phase 2 trial of pediatric RSV vaccine

06-Jul-2023 - Last updated on 06-Jul-2023 at 10:16 GMT

Related tags RSV cGMP phase 2 Manufacturing

Meissa Vaccines, a clinical-stage biotech company developing vaccines to prevent viral respiratory infections, has entered into a manufacturing agreement with contract research development organization (CRDMO) Exothera.

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).

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.

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.

The biotech is currently enrolling participants between the ages of six and 36 months in a phase 1c clinical study at multiple sites in the US to evaluate the safety and immunogenicity of the treatment.

Frank Glavin, CEO at 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 AttenuBlock™ 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 at Exothera, added: "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."

Exothera will manufacture Meissa’s MV-012-968 at its state-of-the-art facility located in Jumet, Belgium.