COVID-19 Drug Research Roundup

Below is a roundup of research activity on COVID-19 vaccines and treatments for the past week. To see last week’s column, click here.

COVID-19 Vaccines:

Pfizer and BioNTech have begun a U.S. trial of COVID-19 vaccine candidates at the NYU Grossman School of Medicine and the University of Maryland School of Medicine. The phase 1/2 study will assess four mRNA vaccine hopefuls in one continuous trial that will involve 360 healthy subjects between 18 to 55 and 65 to 85 years of age.

Predictive Oncology is developing a COVID-19 vaccine using a novel nanoparticle vaccine platform. The company said its next move is to seek quotes for a phase 1 trial from CROs approved by the HHS’s Biomedical Advanced Research and Development Authority (BARDA).

Moderna is planning to begin phase 3 trials of its coronavirus vaccine by early summer, speeding up its original timeline that had the trials starting in the fall. The agency recently cleared a phase 2 trial for the vaccine candidate, mRNA-1273, which involves approximately 600 participants.

COVID-19 Treatments:

Montefiore Health System, Albert Einstein College of Medicine and NYU Langone have launched a clinical trial studying the effectiveness of convalescent plasma in COVID-19 patients. The trial will enroll 300 people that have COVID-19 respiratory symptoms, with half of them receiving a placebo.

CTI BioPharma has begun a phase 3 trial to evaluate its oral multikinase inhibitor pacritinib in patients hospitalized with severe COVID-19. The trial, which is expected to enroll patients in both the U.S. and Europe in May, will compare pacritinib plus the standard of care to placebo plus standard of care in 358 hospitalized patients.

London’s Guy’s and St. Thomas’ Hospital will run a trial of convalescent plasma for treating COVID-19. The treatment uses donated blood plasma from patients that have recovered from the virus and transfuses it into COVID-19 patients whose bodies are not making enough antibodies to fight the virus.

Glenmark Pharmaceuticals has received approval from the Indian government to conduct COVID-19 trials of the antiviral favipiravir, which is approved for treating influenza in Japan. The randomized study will have 150 mild-to-severe coronavirus patients.

Massachusetts General Hospital will conduct a trial of Mallinckrodt’s INOmax (nitric oxide) for treating low blood-oxygen levels in patients with severe COVID-19 lung complications. Mallinckrodt previously received Canadian approval for a trial of high-dose inhaled nitric oxide therapy to treat COVID-19 infections and associated lung complications.

Eli Lilly and Junshi Biosciences have teamed up to develop antibodies that can potentially prevent and/or treat COVID-19. Eli Lilly and Junshi plan to begin clinically testing the lead antibody, JS016, in the second quarter of this year.

Vir Biotechnology and Alnylam Pharmaceuticals have identified an investigational therapeutic, VIR-2703, as a possible COVID-19 treatment. The inhaled SARS-CoV-2-targeting small-interfering RNA (siRNA) blocks production of specific proteins and could prevent or treat a coronavirus infection.

Anixa Biosciences and OntoChem have identified a potential COVID-19 therapeutic agent and have advanced it to testing. The drug is designed to disrupt interaction of the virus’ endoribonuclease with a protein necessary for its replication.

Amgen said it has plans to test its blockbuster psoriasis drug Otezla (apremilast) as a possible coronavirus treatment. The company expects to begin trials of the drug in the coming weeks and is looking to study the drug in multiple scenarios. Amgen CEO Robert Bradway said the drug could help prevent respiratory stress in late-stage patients.

Incyte and Novartis plan to initiate another phase 3 COVID-19 trial of their JAK inhibitor Jakafi (ruxolitinib). The study will evaluate the drug in coronavirus patients on mechanical ventilation and ones who have acute respiratory distress syndrome. The two have already launched a trial of the drug on COVID-19 patients with cytokine storm.

Researchers at Royal Oak, Mich.’s Beaumont Hospital are enrolling patients in a phase 2 trial to evaluate a combination of naltrexone and ketamine as a COVID-19 treatment. The study is trying to determine if the combination can lessen the severity of symptoms by reducing inflammation.

CSL Behring Australia said it is currently developing an anti-coronavirus plasma product for potential use in Australia. The treatment, known as COVID-19 Immunoglobulin, is being designed for severely ill patients, particularly ones that are progressing toward being put on ventilation. It is being developed at the company’s advanced manufacturing site in Broadmeadows, Victoria.