French drugmaker Sanofi and its US partner Translate Bio will kick off human Phase 1/2 clinical trials for MRT5500, its messenger RNA-based vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. Translate Bio shares climbed almost 5% in Friday’s pre-market trading session.
Sanofi (SNYNF) announced that the clinical trial, which is expected to enroll 415 participants, will assess the safety, immune response and reactogenicity, after preclinical data showed “high neutralizing antibody levels.” Interim results from the trial are planned to be released in the third quarter of 2021.
Sanofi Pasteur, the drugmaker’s vaccine global business unit, has been working with Translate Bio (TBIO) on the development of a messenger RNA (mRNA) vaccine against COVID-19. The French drugmaker has said in the past that it has the capacity to produce up to 1 billion doses a year.
In parallel, Sanofi also announced that early-stage studies are underway to assess additional mRNA candidates against emerging SARS-CoV-2 variants.
“Our mRNA vaccine candidate is the result of our expertise in infectious diseases coupled with the innovative technologies of our partner,” said Global Head of Sanofi Pasteur Thomas Triomphe. “Initiating the Phase 1/2 trial represents an important step forward in our goal of bringing another effective vaccine to the ongoing fight against the COVID-19 pandemic.”
Additionally, Sanofi and Translate Bio seek to improve the vaccine’s temperature stability and are targeting a -20°C storage temperature for late-stage clinical trials and for the launch, and refrigerator temperature of 2-8°C.
Shares of Translate Bio have surged a stellar 224% over the past year, while analysts still rate the stock with a Strong Buy consensus backed by 5 unanimous Buy ratings. That’s with a price target of $33.25, which implies that another 38% upside potential lies ahead over the coming 12 months.
H.C. Wainwright analyst Andrew Fein this month reiterated a Buy rating on the stock with a $32 price target (33% upside potential), citing the “ongoing mRNA vaccine development for infectious diseases with Sanofi.”
“With regard to COVID-19, we are encouraged by positive preclinical data that indicated potent neutralizing antibodies against SARS-CoV-2, significantly greater than a panel of COVID-19 patient samples, noting multiple COVID-19 mRNA candidates were assessed for both immunogenicity and neutralizing antibody activity,” Fein wrote in a note to investors. “Furthermore, we remain encouraged by management’s discussion of its strategic plan emphasizing pipeline development that leverages expertise in mRNA therapeutics while pursuing multiple investigational new drug applications during the coming years.” (See Translate Bio stock analysis on TipRanks)
On TipRanks’ Smart Score ranking system, TBIO gets a 7 out of 10, suggesting that the stock is likely to perform in line with market averages.
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