COVID-19 Drug Research Roundup

Below is a roundup of research activity on COVID-19 vaccines and treatments. It is an update of a weekly column that we will be featuring. To see last week’s column, click here.

COVID-19 Vaccines:

GlaxoSmithKline and Vir Biotech announced a partnership to develop a COVID-19 vaccine. The two said that they aim to have a phase 2 trial underway in the next three to four months.

The FDA has approved Inovio’s investigational NDA for a COVID-19 vaccine hopeful, paving the way to begin a phase 1 trial of INO-4800. The study will be comprised of 40 healthy adult patients in Philadelphia and Kansas City, Mo., and initial immune response and safety data are expected by late summer.

Novavax will begin a phase 1 trial of its Matrix-M adjuvant in combination with NVX-CoV2373 in mid-May. The trial will enroll 130 healthy volunteers.

Gene and cell therapy group Oxford Biomedica has joined the COVID-19 vaccine research consortium led by the University of Oxford’s Jenner Institute. The consortium will begin a trial of ChAdOx1 later this month, recruiting patients age 18 to 55 years old from the Thames River Valley area.

Pfizer says it may begin clinical trials of its lead protease inhibitor in the third quarter of 2020, three to four months earlier than it had planned.

Russia’s Vektor State Virology and Biotechnology Centre has proposed phase 1 trials of three vaccine candidates starting in June. Researchers currently are conducting animal testing of several options.

COVID-19 Treatments:

Alexion says it will begin a phase 2 study of its FDA-approved rare blood disease drug Soliris this month. The company reports positive results of an emergency treatment proof-of-concept trial involving 10 COVID-19 patients.

Amgen and Adaptive Biotechnologies are collaborating on efforts to develop antibodies to either prevent COVID-19 or treat infected patients. Adaptive will screen B-cell receptors from recovered patients to identify virus-neutralizing antibodies while Amgen will handle subsequent development and manufacturing.

AstraZeneca reports it will be ready to initiate clinical evaluation of a yet-to-be determined therapy for COVID-19 in three to five months. Using technology designed by the U.S. Defense Advanced Research Projects Agency, the company will examine such data sources as recovered COVID-19 patients and lab testing in mice to identify promising candidates. The U.S. Army Medical Research Institute of Infectious Diseases and the University of Maryland School of Medicine will provide preclinical support.

CSL Behring and human antibody development company SAB Biotherapeutics will begin a trial of SAB’s human antibody agent SAB-185 by early summer.

Canadian biotech CytoDyn is teaming with the North Carolina-based Novant Health network to conduct a phase 2 trial of leronlimab for use in COVID-19 patients with mild to moderate indications.

Emergent BioSolutions has teamed up with the Health and Human Services Department to develop a plasma-derived treatment for COVID-19. The treatment is being researched to potentially treat hospitalized patients with severe symptoms and high-risk, asymptomatic patients to prevent progression to severe symptoms. The Biomedical Advanced Research and Development Authority has granted the biopharma company $14.5 million in funding.

Gilead has vastly increased the size of two of its remdesivir trials, according to an update to its clinicaltrials.gov page: the severe patient study has grown from 400 patients to 2,400, and the moderate patient study is up from 600 to 1,600.

Hope Biosciences has received the go-ahead from the FDA to launch the first stem cell trial for a COVID-19 treatment. The phase 2 trial of HB-adMSCs will enroll 75 patients who are age 50 years and older, have preexisting health conditions or are at high risk of exposure to the virus. The first of three trials Hope has planned will focus on patients who already have stem cells banked with Hope. The other two trials will use another donor source.

Izana Bioscience has begun a two-center compassionate use study of its drug namilumab for treating patients with rapidly worsening COVID-19 infections. The human monoclonal antibody is currently in late-stage clinical development for treating rheumatoid arthritis and ankylosing spondylitis.

Johnson & Johnson has announced its HIV antiviral drug darunavir, which is being tested in two trials, has no effect against COVID-19.

Karyopharm Therapeutics is set to begin a trial of a low dose of its multiple myeloma drug Xpovio. The antiviral has shown efficacy in the treatment of 20 different viruses, including several related to respiratory infection.

Italian biotech Kedrion Biopharma is hopeful it will have a proven plasma-derived therapy available in three to six months.

Neurimmune and Ethris are working together to develop an inhaled, mRNA-based antibody treatment for COVID-19, with clinical testing slated to start in the fourth quarter. The drug would produce therapeutic antibodies in the lungs of affected patients.

Novartis is launching a phase 3 clinical trial of its JAK inhibitor Jakafi (ruxolitinib) to treat cytokine storm, a severe immune reaction experienced by some COVID-19 patients. The trial will assess the drug alongside standard of care in patients with severe pneumonia caused by the virus. The drug is already approved in many countries for treating myelofibrosis and polycythemia vera, a form of blood cancer.

Emory University’s research company Ridgeback Biotherapeutics has received clearance from the FDA to begin human trials of its antiviral compound EIDD-2801. The drug has shown potency against the SARS and MERS viruses in animal models.

Queen’s University in Belfast is ready to test a cell therapy to treat acute respiratory failure. Plans are to enroll at least 60 patients at sites across the UK, including Belfast, Birmingham and London.

Viriom will begin a phase 2 study in May of its HIV drug Elpida (elsulfavirine) in adults with moderate manifestations of COVID-19. The trial will enroll approximately 240 patients in Russia and other countries with high numbers of cases.