Studies Forge On as Omicron Surges and More COVID-19 News
In the last two years, the sheer volume of scientific research focused on COVID-19 has been astounding—thousands of clinical studies, dozens of vaccines and new compounds, and hundreds of approved drugs tested for efficacy against COVID-19. More studies are still being run, especially in light of the Omicron surge and the virus’s ability to evolve. Here’s a look.
Moderna Doses First Participant in Phase II Trial of Omicron-Specific Vaccine
Moderna launched the Phase II trial of its Omicron-specific booster vaccine candidate, dosing the first patient. The study will focus on adults 18 years and older and have two cohorts, people who previously received the two-dose Moderna series at least six months ago and people who received the two-dose primary series plus a 50-microgram booster dose of the original vaccine at least three months ago. They expect to enroll about 300 people in each cohort.
The company also published data in The New England Journal of Medicine about antibody results against the Omicron variant six months after its initial vaccine booster dose. Neutralization against the Omicron variant dropped 6.3-fold from peak titers at day 29 post-boost but was still detectable in all participants. They also dropped faster against Omicron than against the original wildtype Wuhan (ancestral) strain.
“We are reassured by the antibody persistence against Omicron at six months after the currently authorized 50-microgram booster of mRNA-1273,” stated Stéphane Bancel, chief executive officer of Moderna. “Nonetheless, given the long-term threat demonstrated by Omicron’s immune escape, we are advancing our Omicron-specific variant vaccine booster candidate and we are pleased to begin this part of our Phase II study.”
Mix-and-Match Vaccine Trial Finds Booster Dose Safe and Immunogenic
A National Institutes of Health-sponsored study of booster doses of the Moderna, Pfizer-BioNTech and Johnson & Johnson vaccines, regardless of the initial vaccine, showed few side effects and all increased neutralizing antibody levels ranging from 4.2- to 76-fold higher than those detected before the booster. The study included 458 adults who had been fully vaccinated with any of the 3 vaccines at least 12 weeks before enrollment and had no reported history of COVID-19 infection. A single booster shot was administered—150 received Johnson & Johnson, 154 received Moderna, 154 received Pfizer-BioNTech boosters. Some participants received the same shot they received initially; others received something new. More than half reported headache, pain at the injection site, muscle aches and malaise, but no serious side effects were reported. Additional data is expected in the coming months.
Aridis Wins Funds from Gates Foundation to Study Inhaled Antibody Therapy
Los Gatos, Calif.-based Aridis Pharmaceuticals received a grant for $1.9 million from the Bill and Melinda Gates Foundation to study the company’s inhaled formulation technology for cost-effective monoclonal antibodies against COVID-19 and influenza in low- and middle-income countries. The monoclonal antibodies will be generated using a novel, spirulina-based technology developed by Lumen Bioscience. Aridis’ technology allows self-administration of prophylactic and therapeutic antibodies into the upper or lower airways. Inhaled, local delivery significantly decreases the needed dose, which should cut the cost of treatment.
“The combination of dose sparing achieved by inhaled delivery and algae sourced mAbs has the potential to dramatically reduce the cost of antiviral treatment and expand the access of mAbs worldwide,” said Vu Truong, Ph.D., chief executive oficer of Aridis.
NRx Pharma Publishes BriLife Vaccine Effectiveness Data Against Omicron
NRx Pharmaceuticals, with the Israel Institute for Biological Research, published data demonstrating that the BriLife vaccine may be effective against the Omicron variant. In addition, many of the mutations in the spike protein of Omicron have been identified in the spike protein of the BriLife vaccine. The BriLife vaccine is a live, viral vector vaccine where the spike protein of the SARS-CoV-2 virus has been added to a benign virus dubbed VSV. A similar viral vector was leveraged for the FDA-approved Ebola virus vaccine.
The IIBR report stated, “Taken together, our data indicate that BriLife-induced antibodies maintain neutralizing potential against all tested variants, and most importantly against Delta, and the recently emerged Omicron VOCs.”
Galecto’s Inhaled COVID-19 Drug Shows Promise
Boston-based Galecto Biotech published full results of a trial of its inhaled galectin-3 inhibitor, GB0139, in hospitalized patients with COVID-19 who required oxygen but not mechanical ventilation. It was compared to patients who received only standard of care. The drug hit the primary endpoint of safety with no treatment-related adverse events. The mean age of patients was 65 years, with a mean BMI of 32, multiple comorbidities, and breathlessness, but they were all able to effectively inhale the drug and hit pharmacologically relevant plasma levels. Galectin-3 plays a central role in COVID-19-related acute lung injury, cytokine storm, T-cell exhaustion and organ micro-thrombosis. The drug also appeared to rapidly decrease markers of inflammation associated with cytokine storm, micro-thrombosis and short- or long-term fibrosis.
BerGenBio to Launch Study of Bemcentinib in Hospitalized COVID-19 Patients
BerGenBio and Oslo University Hospital will initiate a study of BerGenBio’s bemcentinib in hospitalized COVID-19 patients. The EU-SolidAct trial— European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial—is part of EU-RESPONSE, a pan-European research project to identify drugs against COVID-19. Bemcentinib, an AXL inhibitor, will be evaluated in up to 500 hospitalized COVID-19 patients. The first drug to be studied under the EU-SolidAct platform was Eli Lilly’s baricitinib, which now has a market authorization evaluation by the European Medicines Agency for use in hospitalized COVID-19 patients. Bemcentinib is the second drug to be evaluated under the program.
Martin Olin, chief executive officer of BerGenBio, noted, “As the COVID-19 pandemic continues to evolve, it is even more important to identify new therapies for hospitalized patients that have a mechanism of action effective across disease variants. The EU-SolidAct platform provides BerGenBio with a unique opportunity to rapidly study the effectiveness of bemcentinib and to evaluate the promising signals of efficacy that were observed in the hospitalized patients requiring oxygen in earlier studies.”