SOUTH SAN FRANCISCO, Calif.—Meissa Vaccines, a biotechnology company developing vaccines to prevent viral respiratory infections, announced in late June that it has initiated preclinical studies and manufacturing and completed a pre-IND meeting with the U.S. Food and Drug Administration (FDA) for the development of MV-014-210, a live attenuated vaccine (LAV) to induce immunity and protect against SARS-CoV-2, the novel coronavirus that causes COVID-19.
Meissa also announced interim results from the first-in-human study of MV-012-968, the company’s LAV candidate for respiratory syncytial virus (RSV), showing that the candidate generates an immune response in healthy adults. These initial clinical data support the further development of MV-012-968 for RSV and the application of Meissa’s technology to a COVID-19 vaccine candidate, according to the company
Meissa’s COVID-19 vaccine candidate, MV-014-210, was developed on the company’s codon deoptimized RSV vaccine platform with the goal of creating safe, potent, stable, and cost-effective intranasal vaccines. The company’s platform technology can potentially solve challenging obstacles in modern vaccinology such as suboptimal immune responses, vaccine stability and manufacturing.
The Meissa COVID-19 vaccine candidate MV-014-210 was derived by modifying the RSV MV-012-968 LAV, replacing the RSV glycoproteins with a functioning fusogenic SARS-CoV-2 Spike protein. MV-014-210 is designed to be administered as a single needle-free, adjuvant-free dose to protect against COVID-19. Meissa’s COVID-19 vaccine candidate offers significant potential advantages for global deployment including easy intranasal administration, a single dose to induce systemic and mucosal immunity and a simple, economical and scalable manufacturing process capable of supplying global demands. Clinical trials are expected to begin in early 2021.
“The COVID-19 vaccine pipeline is dominated by non-replicating vaccines, while live attenuated vaccines are known to induce long-lasting immunity after a single adjuvant-free intranasal low dose, presenting an economical and effective solution to this global pandemic,” said Dr. Martin Moore, co-founder and CEO of Meissa. “A single dose of MV-014-210 may be sufficient to generate immunity against SARS-CoV-2.”
In animal models evaluated previously, Meissa’s RSV LAV candidate MV-012-968 induced a strong mucosal IgA response and a serum-neutralizing antibody response against RSV. MV-012-968 has been safe and well-tolerated among healthy RSV sero-low adults assessed through day 56 in an ongoing randomized, open-label, dose-ranging Phase 1a trial (ClinicalTrials.gov Identifier NCT04227210). A 106 PFU dose of MV-012-968 resulted in no detectable shed vaccine virus nasally, indicating heavy attenuation, and yet induced RSV-specific mucosal IgA in the majority of vaccine recipients.
Concluded. Moore: “The promising clinical data from our RSV vaccine candidate showing that it generated an immune response and has been safe and well-tolerated in healthy individuals further supports the application of Meissa’s technology to a COVID-19 vaccine candidate as well as continued development of MV-012-968 for RSV.”