1 July 2020 - - US-based biotechnology company Meissa Vaccines has initiated preclinical studies and manufacturing and completed a pre-IND meeting with the US Food and Drug Administration for the development of MV-014-210, a live attenuated vaccine candidate to induce immunity and protect against SARS-CoV-2, the novel coronavirus that causes COVID-19, the company said.

Meissa also announced TODAY interim results from the first-in-human study of MV-012-968, the company's LAV candidate for respiratory syncytial virus, showing MV-012-968 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.

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.

Meissa's COVID-19 vaccine candidate, MV-014-210, was derived by modifying the company's RSV LAV candidate, MV-012-968, replacing the RSV glycoproteins with a functioning SARS-CoV-2 Spike protein.

Meissa's COVID-19 vaccine candidate offers significant potential advantages for global deployment, including needle-free intranasal administration, a single adjuvant-free dose to induce systemic and mucosal immunity, and a straightforward, economical, and scalable manufacturing process capable of supplying global demands. Clinical trials are expected to begin in early 2021.

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 randomised, 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, despite pre-existing immunity to RSV.

Meissa is a private biotechnology company focused on the advancement of vaccines for respiratory viruses. Meissa was founded on proprietary technologies employing reverse genetics for rational design of more effective live attenuated vaccines.

The technology is exclusively licensed from Emory University and Children's Healthcare of Atlanta. Dr. Moore, together with Dr. Roderick Tang, a vaccine biotech expert, cofounded Meissa.

Meissa is currently a resident company at Johnson and Johnson Innovation JLABS in South San Francisco.