Sanofi and Translate Bio mRNA COVID-19 Vaccine Candidate Induced High Antibody Levels in Preclinical Studies
-- mRNA-based vaccine candidate MRT5500 induced potent neutralizing antibodies against SARS-CoV-2 in preclinical studies --
-- Two doses of MRT5500 induced neutralizing antibody levels significantly higher than those observed in COVID-19 patients --
-- Phase 1/2 clinical trial anticipated to begin in the fourth quarter of 2020 --
Preclinical evaluation of MRT5500, importantly, demonstrated a favorable immune response profile against SARS-CoV-2. These data support the selection of MRT5500 for clinical development. A Phase 1/2 clinical trial is anticipated to begin in the fourth quarter of 2020. Full results are available here. MRT5500 is being developed under a collaboration agreement between
“To tackle this global pandemic, we must look to both the strong knowledge we have from years of infectious disease expertise and the promise of new, innovative technologies,” said
“The rapid development of effective vaccines to address the COVID-19 pandemic continues to be an urgent global public health need and I am encouraged by the progress we’ve made to date with our partner
Key preclinical findings
The main findings of the preclinical studies demonstrate the potential of MRT5500 to elicit neutralizing antibodies against SARS-CoV-2.
In mice, four dose levels were assessed at 0.2, 1, 5 and 10 µg per dose using a two-dose vaccination schedule, administered three weeks apart. MRT5500 induced dose-dependent levels of binding antibodies and neutralizing antibodies specific to the SARS-CoV-2 spike protein. 100% seroconversion was observed at all dose levels after one administration, and a further increase in titers was observed following a second administration. Neutralizing antibody titers were observed across all dose levels after receiving the two-dose-administration regimen. In the higher dose groups (5 µg, 10 µg), titers were detected after one administration of MRT5500 and were more pronounced after the second administration.
In non-human primates (NHPs), three dose levels were assessed at 15, 45 and 135 µg per dose using a two-administration vaccination schedule, three weeks apart. The potency of MRT5500 was assessed by two types of neutralization assays: pseudovirus neutralization and micro-neutralization. After the first administration, the majority of NHPs developed neutralizing antibodies reactive to the SARS-CoV-2 spike protein and those antibody titers were further enhanced after a second administration with 100% of NHPs reaching levels significantly higher than those from human convalescent sera by day 35.
It was also demonstrated that MRT5500-immunized mice and non-human primates exhibited a Th1-biased T cell response against SARS-CoV-2.
The preprint publication, “Immunogenicity of novel mRNA COVID-19 vaccine MRT5500 in mice and non-human primates,” is available here.
About mRNA vaccines
Vaccines work by mimicking disease agents to stimulate the immune system, building up a defense mechanism that remains active in the body to fight future infections. mRNA vaccines offer an innovative approach by delivering a nucleotide sequence encoding the antigen or antigens selected for their high potential to induce a protective immune response. mRNA vaccines also represent a potentially innovative alternative to conventional vaccine approaches for several reasons - their high potency, ability to initiate protein production without the need for nuclear entry, capacity for rapid development and potential for low-cost manufacture and safe administration using non-viral delivery. This approach potentially enables the development of vaccines for disease areas where vaccination is not a viable option today. Additionally, a desired antigen or multiple antigens can be expressed from mRNA without the need to adjust the production process, offering maximum flexibility and efficiency in development.
This collaboration brings together Sanofi Pasteur’s leadership in vaccines and Translate Bio’s mRNA research and development expertise. Under the agreement, the companies are jointly conducting research and development activities to advance mRNA vaccines and mRNA vaccine platform development during a research term of at least four years after the original signing in 2018.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
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Translate Bio Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the goal to initiate a Phase 1/2 clinical trial of MRT5500 in the fourth quarter of 2020; the potential for MRT5500 to be a promising candidate for clinical development; the development of an mRNA vaccine candidate; the potential for MRT5500 to elicit a robust immune response; Translate Bio’s beliefs regarding the broad applicability of its MRT platform; and Translate Bio’s plans, strategies and prospects for its business, including its lead development programs and continued development of mRNA vaccines for the treatment of infectious diseases. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forward,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from current expectations and beliefs, including but not limited to: the current and potential future impacts of the COVID-19 pandemic on Translate Bio’s business, financial condition, operations and liquidity; Translate Bio’s ability to advance the development of its platform and programs, including without limitation its vaccine development program generally and MRT5500 specifically, under the timelines it projects, demonstrate the requisite safety and efficacy of its product candidates and replicate in clinical trials any positive findings from preclinical studies; the successful advancement of the collaboration agreement between
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Source: Translate Bio, Inc.