Will Stem Cell Therapies Aid in Fight Against Coronavirus?
Ekta Bagri
As the coronavirus pandemic deepens, resulting in more and more fatalities with each passing day, pharma/biotech companies are fighting a race against time to develop treatments to combat this contagious disease.
Desperate times call for desperate measures and the pharma/biotech companies are currently evaluating every possible weapon in their arsenal to contain and fight this outbreak. While some are developing vaccines to prevent the spread, others are working to develop antibodies to cure the infected. Meanwhile, innovative therapies like stem cell therapy are also being evaluated to treat the infection and companies developing cell therapies for the treatment of COVID-19 are currently in the spotlight.
Athersys, Inc. ATHX is evaluating its MultiStem cell therapy product in subjects with moderate to severe acute respiratory distress syndrome (ARDS), induced by the novel coronavirus disease. The MultiStem treatment modulates patients’ hyperinflammatory response to highly pathogenic respiratory viruses, including SARS-CoV-2, which causes COVID-19, and represents a promising approach to improving outcomes in these patients. The FDA recently authorized the company to initiate a phase II/III pivotal study to assess the safety and efficacy of MultiStem therapy in these patients. Shares were up on the news. Athersys recently completed a phase I/II study, evaluating the administration of MultiStem to patients with ARDS. Based on the promising data from the study, the program was recently granted a Fast Track designation by the FDA.
Israel-based PluristemTherapeutics Inc. PSTI recently announced that it has treated its first patient suffering from COVID-19 complications in the United States under the FDA’s Single Patient Expanded Access Program. The patient was treated with PLX cell therapy in New Jersey. The patient was critically ill with respiratory failure due to ARDS and under mechanical ventilation in an intensive care unit (ICU) for three weeks. Pluristem’s main aim is to initiate a multinational clinical study as soon as possible for PLX cells in the treatment of patients suffering from complications associated with COVID-19.
Last week, Mesoblast Limited MESO obtained clearance from the FDA for an Investigational New Drug (IND) application to treat patients with ARDS caused by COVID-19 with intravenous infusions of its allogeneic mesenchymal stem cell (MSC) product candidate, remestemcel-L. The candidate will be evaluated in a randomized, placebo-controlled trial in 240 patients with ARDS caused by the coronavirus infection.
While these therapies will need some time to be tested, investors will keep an eye on these companies as the pandemic is unlikely to die out soon.
Pluristem currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Efforts to Develop Treatments Accelerate
Currently, there are no FDA-approved treatments for the severe illness caused by SARS-CoV-2. Given the alarming levels of spread and severity, some approved drugs or pipeline candidates are being tested to see if they are effective in treating the infected patients.
Gilead Sciences, Inc. GILD is pioneering the race for developing a potential cure for COVID-19. The company recently announced promising results on experimental antiviral, remdesivir, in patients hospitalized with severe complications of COVID-19.
Pharma giant Johnson & Johnson JNJ recently announced that it has selected a lead vaccine candidate for COVID-19.
Pfizer PFE too is developing an mRNA-based vaccine, antiviral compounds and a JAK inhibitor to fight COVID-19. The company signed a deal with BioNTech to jointly develop the latter’s mRNA-based vaccine candidate, BNT162, to prevent the COVID-19 infection. Pfizer is also screening antiviral compounds and has confirmed a lead compound based on the results of initial screening assays. The company plans to start a potential clinical study of the lead molecule in the third quarter of 2020. It is also evaluating azithromycin for its antiviral properties. Moreover, an independent, investigator-initiated phase II study is being planned to evaluate Pfizer’s JAK inhibitor, tofacitinib, in patients with SARS-CoV-2 interstitial pneumonia in Italy later this week.
However, the drugs and vaccines will need some time to be tested and a cure is not imminent.
Meanwhile, many companies are repurposing their drugs for other indications to see if they prove effective in treating these patients. Regeneron REGN and partner Sanofi are evaluating their rheumatoid arthritis (RA) drug, Kevzara, to treat patients hospitalized with severe infection due to COVID-19. Roche is evaluating Actemra for the same.
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