Covid-19 roundup: GSK and Vir reach sotrovimab supply agreement in Singapore; J&J vaccine shows varied success against variants

30 Jun 2021
endpts.com
VaccineCollaborateAntibodyEmergency Use AuthorizationmRNA
GSK Singapore and Vir Biotechnology have reached an agreement with the Singapore government to supply it with a single-dose monoclonal antibody for Covid-19. GSK has submitted an application for regulatory review in the country. Phase III data showed the drug spurred an 85% reduction in hospitalization or death compared to the placebo. The study included 583 patients, and preclinical data suggested that the drug maintains activity against the Alpha, Beta, Gamma and Delta variants. “This is another example of Singapore’s role in the global innovation ecosystem and their commitment to invest in innovation,” said GSK SVP Mike Crichton in a press release. “As variants continue to arise, vaccines together with the availability of safe and effective monoclonal antibody treatments have the potential to increase the chance of ending the pandemic. The FDA granted emergency use authorization to sotrovimab on May 26. Last week, both Pfizer and Moderna came out and announced that their respective mRNA vaccines provided effective protection against Covid-19 variants. Tuesday, J&J’s jab joined that list, though with significantly less success against the Beta and Gamma variants. Clinical trial data from the National Institute of Health showed that J&J’s vaccine protected patients in Brazil and South Africa from serious infection but was also associated with a 3-fold reduction in antibodies that could recognize and bind to the gamma variant, and a 5-fold reduction in the beta variant. “Although the mechanistic correlates of protection for COVID-19 are not yet known, the vaccine’s robust protective efficacy in these regions raises the possibility that non-neutralizing antibodies and/or T cell responses may also contribute to protection,” Dan Barouch, the doctor who led the study, said in a press release. “Alternatively, it is possible that low levels of neutralizing antibodies are sufficient for protection against COVID-19.” Newer variants , such as the delta variant, will be tested in future trials. A lesser-known Chinese vaccine developer inked an agreement with Gavi, the Vaccine Alliance on Wednesday to provide up to 414 million doses of its prospective vaccine to COVAX. Clover Biopharmaceuticals will make 64 million doses of its jab available in 2021, and an additional 350 million in 2022. Clover expects the vaccine to be available in Q4, pending emergency use authorization. “The pandemic continues to evolve, and in order to be best prepared, COVAX’s actively managed, diverse portfolio will be critical to meeting countries’ needs, and protecting against risks such as regulatory delays, variants, and supply constraints,” Gavi CEO Seth Berkley said in a press release. “Today’s agreement with Clover Biopharmaceuticals is yet another important step in that direction.” Just two months after launching into a Phase III trial in Covid-19 patients who have not been hospitalized, Boston-based company Atea Pharmaceuticals announced results from a Phase II study of its lead antiviral AT-527 that reduced viral loads in hospitalized patients. Patients who received AT-527 experienced an 80% reduction from the baseline viral load through eight days, analysis showed. The drug was safe, and no serious side effects were reported, the company said. The drug is an oral antiviral treatment and works by blocking the viral RNA polymerase enzyme that is needed for viral replication. The company is from Jean-Pierre Sommadossi, the founder of Idenix and a co-founder of Pharmasset. Last February, Sommadossi and his team put all of their eggs into the Covid-19 basket, then raised $215 million to launch the Phase II trial in May. “Such potent activity may lead to faster recovery time for patients with COVID-19 while minimizing the transmission of infection,” Sommadossi said in a press release. “As COVID-19 continues to evolve worldwide, we need a multi-pronged approach to control this disease. AT-527, an oral, potent, target-specific DAA, may offer a convenient treatment to prevent disease progression and allow people to resume daily life more quickly, especially in areas where vaccines and antibody therapies are not readily available.” In October, Roche put down $350 million for ex-US rights to the candidate. For a look at all Endpoints News coronavirus stories, check out our special news channel .
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