Vir and GSK Dose First Patient in COVID-19 Monoclonal Antibody Study and Other Pandemic Updates

COVID 19 Glimmer of Hope

Vir Biotechnology and GlaxoSmithKline dosed the first patient in a new sub-trial of a Phase III study assessing the monoclonal antibody VIR-7831 as a potential treatment of hospitalized adults diagnosed with COVID-19.

The ACTIV-3 trial will assess the safety and efficacy of VIR-7831 in those patients. The study is part of the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program. ACTIV-3 has been designed as a “master protocol” that allows for the simultaneous evaluation of multiple investigational therapeutics as they become available, but within the same clinical trial structure, across multiple trial sites, Vir said. VIR-7831 is an investigational monoclonal antibody that was selected based on its potential to neutralize the virus, as well as provide a high barrier to resistance and achieve high concentrations in the lungs. The two companies initially paired up on the monoclonal antibody in April.

George Scangos, chief executive officer of Vir, said recent data suggests the neutralizing activity of antibodies may be insufficient to protect hospitalized adults from the most severe consequences of COVID-19.

“We are hopeful that the differentiating factors and broad anti-coronavirus activity of VIR-7831 may allow it to help those patients and add to our preparedness for related coronaviruses that could emerge in the future,” Scangos said in a statement.

VIR-7831 is also being evaluated in the Phase II/III COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial for the early treatment of COVID-19 in adults at high risk of hospitalization.

In other COVID-19 news:

Vaccine Development – The vaccine candidate developed by Oxford University and AstraZeneca induces broad antibody and T cell functions following a two-dose treatment, as opposed to the dose-and-a-half treatment. On Thursday, Oxford University released new details from Phase I and II studies that pointed to the efficacy of a two-dose regimen.

The university’s release did not mention the data from ongoing Phase III studies that accidentally included a half-dose following a full dose. However, the university said it had explored different types of dosing regimens in early trials as part of a dose sparing strategy.

“The booster doses of the vaccine are both shown to induce stronger antibody responses than a single dose, with the standard dose/standard dose inducing the best response,” the university said.

These findings are reported in two papers, both released in the peer-reviewed journal Nature Medicine.

AstraZeneca’s efficacy is at 70.4%. During Phase III trials, one of the cohorts was administered one and a half doses, as opposed to two full doses. Vaccine efficacy in that cohort was up to 90%. The disparity is under investigation by the researchers. 

In other vaccine development news, Johnson & Johnson has fully enrolled its 45,000 patient Phase III study. Interim data from the ENSEMBLE trial is currently anticipated to be available by the end of January, the life sciences giant said Thursday. J&J initially intended to enroll 60,000 patients in the study, but earlier this month reduced that number due to the worsening nature of the COVID-19 pandemic. The company said 45,000 patients should be enough to generate the necessary data.

If the data shows the vaccine candidate is safe and effective, J&J said it expects to seek Emergency Use Authorization from the U.S. Food and Drug Administration in February. It will also seek approval from other regulatory bodies.

Unlike AstraZeneca’s candidate, or the two mRNA vaccines developed by the collaboration of Pfizer and BioNTech, as well as Moderna, J&J’s vaccine candidate is a single-dose treatment. J&J is conducting a separate Phase III clinical trial of a two-dose regimen of the vaccine candidate.

Another vaccine candidate, one developed by India’s Bharat Biotech, has been deemed safe following a Phase I study. The company is rapidly moving into Phase III studies and is expected to involve about 26,000 patients in India.

Clearing Safety Review – California-based CalciMedica announced its ongoing clinical study evaluating Auxora in patients with severe COVID-19 pneumonia received a recommendation to continue, following a pre-scheduled safety review by an Independent Data Monitoring Committee (IDMC).

Auxora is a small molecule CRAC channel inhibitor designed to block inflammation and protects lung cells from damage associated with the virus. Recently published data showed that Auxora reduced ventilator use by more than 50% and more than doubled the rate of recovery compared to patients receiving standard of care alone. The company is on track to complete its COVID-19 pneumonia in April.

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