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Sanofi/Glaxo Initiate Pivotal Global COVID-19 Vaccine Study
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Sanofi (SNY - Free Report) and GlaxoSmithKline plc (GSK - Free Report) announced that they have initiated enrollment in their global, pivotal phase III study to evaluate their adjuvanted recombinant-protein COVID-19 vaccine candidate. The study will assess safety, efficacy, and immunogenicity of the candidate as its primary endpoints in more than 35,000 volunteers aged 18 and older. The study will be conducted across several countries, including sites in the United States, Asia, Africa, and Latin America.
The study has a two-stage approach where initially a vaccine formulation targeting the original D.614 virus (the Wuhan virus) will be evaluated for efficacy, followed by evaluation of a second formulation targeting the B.1.351 (South African) variant.
Please note that recent scientific studies have observed that antibodies created against the B.1.351 variant are likely to provide broad cross-protection against other more transmissible variants. Moreover, Sanofi/Glaxo’s pivotal study will be conducted across several geographies, which will allow evaluation of the efficacy of the candidate against a variety of circulating variants. The companies are developing two dosing regimens of the candidate, developed using Sanofi’s recombinant antigen and Glaxo’s pandemic adjuvant, administered 21 days apart.
The phase III study follows the encouraging interim data announced from a phase II study on the vaccine candidate earlier this month. The data demonstrated 95% to 100% seroconversion generating neutralizing antibodies following vaccination comparable to those generated by natural infection. Moreover, high neutralizing antibody levels were elicited in participants with evidence of prior SARS-CoV-2 infection, after a single dose of the vaccine. Based on these study data, the companies are also planning to start a booster study program to evaluate the ability of the vaccine candidate to generate a strong booster response irrespective of COVID-19 vaccine used for initial immunization.
The companies anticipate that their adjuvanted COVID-19 vaccine candidate may receive an approval/authorization in the fourth quarter of 2021, subject to the late-stage study data readout and regulatory review.
So far this year, Sanofi’s shares have gained 11% compared with the industry’s 6.6% increase.
Apart from its recombinant COVID-19 vaccine candidate, Sanofi is also developing a mRNA-based vaccine candidate, MRT5500, for COVID-19 in partnership with Translate Bio (TBIO - Free Report) . A phase I/II study is currently evaluating MRT5500.
Moreover, Sanofi is also providing manufacturing support for authorized COVID-19 vaccines including Pfizer/BioNTech’s BNT162b, Moderna’s (MRNA - Free Report) mRNA-1273 and J&J’s single-shot COVID-19 vaccine.
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Sanofi/Glaxo Initiate Pivotal Global COVID-19 Vaccine Study
Sanofi (SNY - Free Report) and GlaxoSmithKline plc (GSK - Free Report) announced that they have initiated enrollment in their global, pivotal phase III study to evaluate their adjuvanted recombinant-protein COVID-19 vaccine candidate. The study will assess safety, efficacy, and immunogenicity of the candidate as its primary endpoints in more than 35,000 volunteers aged 18 and older. The study will be conducted across several countries, including sites in the United States, Asia, Africa, and Latin America.
The study has a two-stage approach where initially a vaccine formulation targeting the original D.614 virus (the Wuhan virus) will be evaluated for efficacy, followed by evaluation of a second formulation targeting the B.1.351 (South African) variant.
Please note that recent scientific studies have observed that antibodies created against the B.1.351 variant are likely to provide broad cross-protection against other more transmissible variants. Moreover, Sanofi/Glaxo’s pivotal study will be conducted across several geographies, which will allow evaluation of the efficacy of the candidate against a variety of circulating variants. The companies are developing two dosing regimens of the candidate, developed using Sanofi’s recombinant antigen and Glaxo’s pandemic adjuvant, administered 21 days apart.
The phase III study follows the encouraging interim data announced from a phase II study on the vaccine candidate earlier this month. The data demonstrated 95% to 100% seroconversion generating neutralizing antibodies following vaccination comparable to those generated by natural infection. Moreover, high neutralizing antibody levels were elicited in participants with evidence of prior SARS-CoV-2 infection, after a single dose of the vaccine. Based on these study data, the companies are also planning to start a booster study program to evaluate the ability of the vaccine candidate to generate a strong booster response irrespective of COVID-19 vaccine used for initial immunization.
The companies anticipate that their adjuvanted COVID-19 vaccine candidate may receive an approval/authorization in the fourth quarter of 2021, subject to the late-stage study data readout and regulatory review.
So far this year, Sanofi’s shares have gained 11% compared with the industry’s 6.6% increase.
Apart from its recombinant COVID-19 vaccine candidate, Sanofi is also developing a mRNA-based vaccine candidate, MRT5500, for COVID-19 in partnership with Translate Bio (TBIO - Free Report) . A phase I/II study is currently evaluating MRT5500.
Moreover, Sanofi is also providing manufacturing support for authorized COVID-19 vaccines including Pfizer/BioNTech’s BNT162b, Moderna’s (MRNA - Free Report) mRNA-1273 and J&J’s single-shot COVID-19 vaccine.
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Sanofi currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Bitcoin, Like the Internet Itself, Could Change Everything
Blockchain and cryptocurrency have sparked one of the most exciting discussion topics of a generation. Some call it the “Internet of Money” and predict it could change the way money works forever. If true, it could do to banks what Netflix did to Blockbuster and Amazon did to Sears. Experts agree we’re still in the early stages of this technology, and as it grows, it will create several investing opportunities.
Zacks has just revealed 3 companies that can help investors capitalize on the explosive profit potential of Bitcoin and the other cryptocurrencies with significantly less volatility than buying them directly.
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