COVID-19 Drug Research Roundup

COVID-19 Vaccine:

Gritstone Oncology is in the process of developing a COVID-19 vaccine using adenovirus and mRNA technology. The company says this technology could be helpful for developing a vaccine that combats future strains of the novel coronavirus. The Bill & Melinda Gates Foundation has provided Gritstone with preclinical funding for the project, and the National Institutes of Health has agreed to partner with the company to launch a phase 1 trial of the vaccine this year.

A recent study found that Pfizer’s and BioNTech’s COVID-19 vaccine likely induces immunity for all 10 known SARS-CoV-2 mutations in the UK. Despite the promising findings from this study, conflicting research suggests that other new variants of the virus may not respond as well to the companies’ vaccine.

Sinopharm’s COVID-19 vaccine candidate was safe in children three to 17 years of age, according to clinical trial findings recently reported by Chinese state media. The company has not said which of the two Sinopharm COVID-19 vaccines were tested in the pediatric trial, but a recently disclosed phase 2 trial from China suggests one of Sinopharm’s vaccine candidates, BBIBP-CorV, may likely be the one tested in patients aged three to 17 years.

The FDA says Sinovac can start clinical trials of its COVID-19 vaccine candidate in the Philippines. Pfizer represents the only pharma company that has received an Emergency Use Authorization from the Philippines for its COVID-19 vaccine. Other companies that have applied for clinical trials of COVID-19 vaccines and received approval to proceed in the Philippines include Janssen and Clover Biopharmaceuticals.

COVID-19 Therapies:

A recent phase 1/2a trial from the University of Miami found that mesenchymal-stem cells from umbilical-cord tissue were helpful for managing acute respiratory distress syndrome (ARDS) in patients with COVID-19. The study found improved survival and reduced inflammatory cytokine levels in 12 patients treated with the therapy vs. 12 patients treated with a control. There were no adverse events associated with the treatment. This research follows previous investigations from Athersys and Orbcel that also explored the use of mesenchymal stem-cell treatments for ARDS.

The UK RECOVERY trial has closed recruitment to the convalescent plasma arm after the trial’s independent data monitoring committee (DMC) found the therapy was unlikely to be effective against severe COVID-19. The DMC said it found no convincing evidence in the interim analysis that convalescent plasma improves survival compared with usual care. The RECOVERY trial will continue to recruit patients into other treatment arms, including those focused on tocilizumab, aspirin, colchicine and an antibody regimen from Regeneron.

Chinese pharmaceutical company Jemincare has launched a phase 1 trial of its anti-SARS-CoV-2 neutralizing antibody candidate JMB2002. Early studies found that the candidate effectively neutralizes live virus infection in cell lines. Additionally, this research demonstrated potent binding and blocking activities to the spike proteins on mutant COVID-19 strains.

Cyxone has announced that it has enrolled its first patient in a phase 2 study examining the use of rabeximod, an investigational rheumatoid arthritis drug, for the treatment of COVID-19. The oral compound may prevent progression of disease in patients hospitalized with COVID-19 by controlling the overactive immune system in patients infected with SARS-CoV-2. The phase 2 clinical trial plans to enroll 300 patients with moderate COVID-19 at sites in Poland, Slovakia and up to three other European countries. Preliminary results from the trial are expected to be announced in the third quarter of 2021.

A phase 2 clinical trial has launched in France to study the efficacy and safety of Debiopharm’s antiviral agent alisporivir for the treatment of hospitalized patients with early-stage COVID-19. The first patient has been dosed in the randomized, open-label trial. Patients in the trial will be randomized to either twice-daily alisporivir with standard of care or standard of care alone for 14 days.

Findings from the phase 3 BLAZE-2 COVID-19 prevention trial show Eli Lilly’s monoclonal antibody bamlanivimab prevented COVID-19 infections in nursing home residents and staff. While the FDA previously authorized bamlanivimab for emergency use in the treatment of patients with COVID-19 at risk for more severe disease, this study suggests the therapy could help prevent disease in certain circumstances. The 1,097-participant study found that treatment with bamlanivimab reduced symptomatic infections by 57 percent. Only four deaths occurred in the study, all of which were reported in the placebo arm.