First participant dosed in a Phase 1 clinical evaluation of a fusion protein vaccine designed to provide ‘serotype-independent’ protection against disease caused by multiple Streptococcus pneumoniae serotypes
BOSTON, MA, USA I March 16, 2023 I Vaccine development company Matrivax announces the start of its Phase 1 clinical study to assess the safety, tolerability, and immunogenicity of its lead pneumococcal disease vaccine candidate, MVX01.
Streptococcus pneumoniae is the primary bacterial cause of community-acquired pneumonia and meningitis, and a significant cause of otitis media, sinusitis, and bacteremia. Pneumococcal disease continues to be a major global public health concern causing greater than 1 million deaths worldwide annually, with a substantial proportion of fatalities among the elderly and immunocompromised, and in children populations less than 5 years old in Asian and African countries.
MVX01 is a fusion protein of two highly conserved protein antigens across Streptococcus pneumoniae bacterial serotypes: a genetically inactivated form of the virulence factor, pneumolysin toxin, and two epitopes from the cell surface protein, choline binding protein A.
“This Phase 1 study is an exciting milestone for Matrivax, and a major step forward in the development of a vaccine that has potential to be a technological breakthrough in vaccination options against pneumococcal disease,” said Enda Moran, Chief Executive Officer of Matrivax. “While there are effective vaccines currently available, they are very expensive to the end-user, and they don’t protect against all the bacterial serotypes that can cause disease. Our low-cost manufacturing platform and the prospect of a single-component, broad-coverage vaccine can translate directly into a much needed low-cost vaccine for pneumococcal disease.”
Kevin Killeen, Chief Scientific Officer of Matrivax, added, “Our preclinical data clearly demonstrate that MVX01 effectively immunizes and protects against a broad range of S. pneumoniae bacterial serotypes, including the serotypes covered by the leading commercial 20-valent conjugate vaccine. We’ve engineered the vaccine to present antigens to the vaccinee that are highly conserved across the >100 wild-type serotypes that cause pneumococcal disease. This vaccine candidate provides the real opportunity of a vaccine that can immunize against the broad spectrum of disease-causing strains. We are delighted to now start clinical development of the vaccine in human subjects with our clinical research partner, FHI Clinical.”
About the MVX01 Phase 1 Study
The Phase 1 study will be executed at two US clinical sites and will evaluate the safety, tolerability, and immunogenicity of the MVX01 vaccine candidate in healthy volunteers aged 18-75 years. Participants will be separated to 5 cohorts with the dose level of MVX01 being sequentially escalated across cohorts ranging from concentrations of 10 μg/dose to 90 μg/dose. Participants within cohorts will receive two doses about a month apart, of either placebo or MVX01 vaccine. Participants will be monitored and assessed throughout the study and for approximately 6.5 months after the booster dose. Immunogenicity will be evaluated by measuring serum antigen-specific IgG antibody titers.
Matrivax is a privately-held biotechnology company funded by Morningside Investments and based in the biotech hub of Boston, MA, USA. The company is developing human vaccine candidates for the prevention and treatment of life-threatening infectious diseases. The pipeline includes two vaccine candidates implementing proprietary protective antigens against Streptococcus pneumoniae (MVX01) and Clostridioides difficile (MVX02). For more information, visit www.matrivax.com/.