Sanofi (NASDAQ:SNY) SNY and partner Translate Bio (NASDAQ:TBIO) TBIO announced the initiation of a phase I/II study on their mRNA-based vaccine candidate, MRT5500.
The phase I/II clinical study on MRT5500 will assess the vaccine’s safety, immune response and reactogenicity. The study is expected to enroll 415 adult participants. Interim data from the study is expected to be presented in the third quarter. Pre-clinical data on MRT5500, announced last year, showed that two doses of MRT5500-induced neutralizing antibody levels significantly higher than those observed in COVID-19 patients.
Sanofi stock has declined 1.2% this year so far compared with a decrease of 0.6% for the industry
Meanwhile, Sanofi is also making an adjuvanted recombinant protein-based COVID-19 vaccine candidate in partnership with Glaxo GSK. The vaccine is being developed by combining Sanofi’s recombinant protein-based technology with Glaxo’s pandemic adjuvant technology.
In December, the companies had announced a delay in the development plans of the vaccine due to insufficient immune response in older adults in early-stage studies. Data from a phase I/II study showed that in adults aged 18 to 49 years, the candidate showed an immune response comparable to patients who recovered from COVID-19. However, in older adults, the candidate demonstrated a low immune response, which the companies believe may be due to an insufficient concentration of the antigen.
To address this problem, last month, they announced the start of a new phase II study on their adjuvanted vaccine candidate with an improved antigen formula.
The new phase II study aims to select the most appropriate antigen dosage for adults of all ages for phase III evaluation. If the data of the phase II study are positive, the companies plan to start a phase III study in the second quarter of 2021 and the vaccine is now expected to be available in the fourth quarter of 2021.
Incidentally, Sanofi is lagging in its COVID-19 vaccine development efforts. Pfizer/BioNTech, Moderna (NASDAQ:MRNA) MRNA, AstraZeneca (NASDAQ:AZN) and J&J have already launched their COVID-19 vaccines in several countries and vaccinations are in full swing.
Sanofi currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In a separate press release, Sanofi announced positive results from a phase III study evaluating its cancer drug, Libtayo (cemiplimab) monotherapy in patients with advanced cervical cancer regardless of PD-L1 status. The Independent Data Monitoring Committee (IDMC) recommended the study be stopped early as the study data demonstrated an overall survival (OS) benefit in these patients. The data showed that patients receiving Libtayo experienced a 31% reduced risk of death (in total patient population) compared to chemotherapy. The company plans to file regulatory applications for the indication in 2021. Libtayo is approved for certain patients with advanced non-small cell lung cancer, basal cell carcinoma and advanced cutaneous squamous cell carcinoma.
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