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Meissa Announces IND Clearance for Phase 1 Study of COVID-19 Intranasal Live Attenuated Vaccine

Initial preclinical data shows MV-014-212 induced a SARS-CoV-2-specific mucosal IgA response, generated serum neutralizing antibodies, and provided efficacy against challenge

REDWOOD CITY, Calif., March 16, 2021 – Meissa Vaccines (“Meissa”), a biotechnology company developing vaccines to prevent serious viral respiratory infections, announced today that the company has received clearance from the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical study of MV-014-212, the company’s intranasal live attenuated chimeric vaccine candidate against SARS-CoV-2, the coronavirus that causes COVID-19. MV-014-212 offers significant potential advantages for COVID-19 vaccine global deployment, including needle-free intranasal administration, a single adjuvant-free dose to induce mucosal and systemic immunity, as well as a straightforward, economical, and scalable manufacturing process.

Intranasal vaccines generate both mucosal (IgA) antibodies in the nasal cavity and antibodies that circulate in the blood (serum). In contrast, injected vaccines typically induce circulating but not mucosal antibodies. While circulating antibodies are important for preventing serious lung disease, mucosal antibodies are important for blocking infection and transmission of respiratory viruses.

“Compared to injected vaccines, intranasal vaccines have greater potential to stop the transmission of SARS-CoV-2,” said Martin Moore, Ph.D., CEO and Cofounder of Meissa. “Furthermore, a single intranasal dose of Meissa’s COVID-19 vaccine candidate, MV-014-212, may be sufficient to generate durable immunity against SARS-CoV-2 and its variants. We think Meissa’s intranasal COVID-19 vaccine candidate can be a globally accessible, end-game vaccine.”

Meissa’s initial preclinical data in nonhuman primates shows MV-014-212 induced a SARS-CoV-2 Spike-specific mucosal IgA response, generated serum neutralizing antibodies against Spike-expressing pseudovirus, and was highly protective against SARS-CoV-2 challenge in the upper and lower respiratory tract.

“We are encouraged by the potential of our intranasal COVID-19 vaccine candidate. We have positive preclinical data on the safety and efficacy of MV-014-212. In addition, we have clinical data demonstrating a mucosal immune response from our intranasal RSV vaccine candidate built on the same technology platform. This intranasal RSV vaccine is now in Phase 2 and has been well-tolerated in healthy individuals to date, including young children,” said Roderick Tang, Ph..D., Cofounder and Chief Scientific Officer of Meissa Vaccines. “We hope to quickly confirm clinical tolerability and immunogenicity of MV-014-212, so we can accelerate the development of an intranasal live attenuated vaccine against COVID-19.”

The Phase 1, open-label, dose-escalation study ( identifier: NCT04798001) is designed to evaluate the safety, tolerability, and immunogenicity of a single intranasal dose of MV-014-212 in 130 healthy adult participants between the ages of 18 and 69 years. The company plans to begin enrolling by the end of March 2021 at two sites in the U.S.

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About MV-014-212: A Unique Intranasal Live Attenuated Vaccine Candidate for COVID-19

Because coronaviruses, like SARS-CoV-2, are prone to recombination and genetic instability, MV-014-212 was built on the company’s AttenuBlockTM platform. This platform incorporates 10 years of research and development employing rational and precise codon deoptimization and other genetic strategies to produce hundreds of targeted mutations into the RSV genome, providing exquisite control over viral protein expression. The AttenuBlock platform has also produced the company’s RSV live attenuated vaccine candidate, MV-012-968, which is in Phase 2 clinical studies. For MV-014-212, the RSV surface proteins were replaced with the SARS-CoV-2 Spike protein, thus creating a genetically stable, live attenuated chimeric vaccine candidate for COVID-19.

About Meissa Vaccines

Meissa Vaccines was founded with a mission to protect people everywhere from deadly respiratory viruses and a commitment to develop innovative technologies capable of delivering effective vaccines at a global scale. Meissa is advancing live attenuated vaccine candidates against respiratory syncytial virus (RSV), SARS-CoV-2 (COVID-19), and human metapneumovirus (hMPV). These vaccine candidates have been developed using the company’s proprietary AttenuBlockTM synthetic biology platform, which includes codon deoptimization and technologies exclusively licensed from Emory University and Children’s Healthcare of Atlanta. Meissa’s vaccine candidates are formulated to be delivered as a single, intranasal, adjuvant-free, needle-free dose and are designed to prevent infection and disease and generate a strong, durable immune response.


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