GlaxoSmithKline plc GSK and privately-held Medicago announced promising interim data from a phase II/III study evaluating their COVID-19 vaccine candidate.

Data from the study showed that people vaccinated with the candidate achieved 10-fold neutralizing antibody responses compared to a panel of sera from people who are recovering naturally from COVID-19 infection. Moreover, antibody responses were similar in both adults and in the elderly.

Please note that Glaxo and Medicago had collaborated last year to develop Medicago’s recombinant Coronavirus Virus-Like Particles (CoVLP) in combination with Glaxo’s pandemic adjuvant system.

The companies seem to be progressing well with the development of their COVID-19 vaccine candidate. The safety and immunogenicity demonstrated in an early-stage study was sustained into the phase II/III study.

The phase II/III study is multi-portion study where the phase II portion is evaluating two doses (3.75 µg each) of a refrigerator-stable formulation of CoVLP combined with Glaxo’s pandemic adjuvant administered 21 days apart for an acceptable immunogenicity and safety profile in adults (18-64 years), elderly (65 years and above) and adults with comorbidities. A very strong immune response and well-tolerated profile of the candidate as observed during the interim analysis of the study reinforces its potential benefits.

The study will continue to assess safety and durability of the immune responses of the vaccine candidate for 12 months after the second-dose in all participants.

Meanwhile, the companies initiated the phase III portion of the study in March that will evaluate the efficacy and safety of the candidate plus pandemic adjuvant in up to 30,000 subjects across several countries.

The companies anticipate to manufacture approximately 100 million doses of the COVID-19 vaccine candidate by the end of 2021, if approved. They expect to deliver up to 1 billion doses annually by the end of 2023. They may extend their collaboration to develop a post-pandemic COVID-19 vaccine candidate as well as vaccine candidates for other infectious diseases.

So far this year, Glaxo’s shares have gained 7.6% compared with the industry’s 6.5% increase.

Glaxo has formed several collaborations to make its pandemic adjuvant technology available to partners, including its scientific partners in North America, Europe and China, who are making adjuvanted COVID-19 vaccine candidates. The company is developing another adjuvanted COVID-19 vaccine in collaboration with Sanofi SNY. Glaxo has also collaborated with CureVac CVAC to jointly develop multi-valent mRNA vaccines for COVID-19.

Apart from COVID-19 vaccines, Glaxo is also engaged in developing antibody therapeutic for COVID-19 infection in collaboration with Vir Biotechnology VIR.

GlaxoSmithKline plc Price

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Zacks Rank

Glaxo currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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