US-based biotechnology company Meissa Vaccines has started preclinical studies and manufacturing of its intranasal, live attenuated vaccine (LAV) candidate MV-014-210 against Covid-19.
MV-014-210, formulated for a single adjuvant-free dose, will be assessed for its ability to trigger immunity and protect against SARS-CoV-2, the coronavirus that causes Covid-19.
Based on the company’s codon deoptimized RSV vaccine platform, the Covid-19 vaccine candidate is obtained by altering RSV LAV candidate MV-012-968. The company replaced RSV glycoproteins with a functioning SARS-CoV-2 Spike protein.
Meissa completed a pre-investigational new drug (IND) meeting with the US Food and Drug Administration (FDA) for the development of MV-014-210 against Covid-19, with clinical trials anticipated to commence early next year.
Meissa Vaccines cofounder and CEO Martin Moore said: “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 dose, presenting an economical and effective solution to this global pandemic.
“A single dose of MV-014-210 may be sufficient to generate immunity against SARS-CoV-2. Furthermore, building our Covid-19 vaccine candidate on our RSV vaccine platform provides safety advantages compared to a live attenuated coronavirus approach.”
The company also reported interim data from the first-in-human study of MV-012-968. Results showed that the RSV vaccine produced an immune response in healthy adults.
Moore added: “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.”
Previously, MV-012-968 was found to induce a strong mucosal IgA response, as well as a serum-neutralising antibody response against RSV in animal models.
In an ongoing randomised, open-label, dose-ranging Phase Ia trial, MV-012-968 was safe and well-tolerated in healthy RSV sero-low adults monitored through day 56.