Immunotherapy combination could help patients with cancer fight COVID-19
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A clinical trial is underway to assess the safety of a novel immunotherapy combination for the treatment of mild to moderate COVID-19 infection among patients with cancer.
The FDA authorized Pawel Kalinski, MD, PhD, vice chair for translational research at Roswell Park Comprehensive Cancer Center, and colleagues to conduct a study evaluating the safety and efficacy of rintatolimod (Ampligen, AIM ImmunoTech) plus interferon alfa-2b, also known as interferon A, for this patient population.
“There are similarities between cancer and COVID-19, which both manage to avoid activating the interferon pathway,” Kalinski, who also serves as director of cancer vaccine and dendritic cell therapies at Roswell Park Cancer Institute, as well as scientic lead on the study, said in a press release. “This helps them to go undetected and spread in patients’ bodies and differentiates them from viruses that cause the common cold, which cause rapid symptoms and are rapidly cleared by the immune system.”
Kalinski spoke with Healio about what prompted this research, the timeline for results and potential implications of the findings.
Question: What prompted this study?
Answer: This combination of immunostimulatory factors — a viral mimic and mediator of cellular response to cell damage and viral infection — has shown synergistic activity in our preclinical models of cancer immunotherapy and is being evaluated in phase 1 and phase 1/phase 2 trials in breast, colon, ovarian and prostate cancers. We knew that the same type of immunity is needed to eliminate both cancer cells and virally infected cells. In addition, our preclinical data have shown that these two factors induce a panel of actors that mediate intracellular, intrinsic/innate resistance of cells to viral infections.
Because both COVID-19 and cancer remain silent in patients’ bodies and spread by avoiding the induction of type 1 immunity, we felt the paradigms from our cancer trials can be useful to treat the coronavirus.
Q: How will you conduct the study?
A: This is a phase 1/phase 2a study with a standard dose-escalation component and a randomized component comparing the best available treatment alone or combined with experimental treatment. The primary endpoint of efficacy is the ability of patients to clear the infection, as measured by molecular marker (viral RNA). We will assess the safety of this combination regimen in patients with cancer and mild to moderate COVID-19 infection and the extent to which this therapy will promote clearance of the SARS-CoV-2 virus from the upper airway. In phase 1, patients will receive both rintatolimod and interferon alfa-2b at escalating doses. In phase 2, one group will receive the two-drug combination and the control group will receive best available care. About 40 patients will be enrolled in total, and we hope to complete the study within 6 months.
Q: What are the potential implications of the results?
A: The results may allow us to offer a new treatment option to patients with COVID-19. In addition, the same treatment may be used to address additional infections, particularly infections caused by RNA viruses. We believe the two agents can activate the missing interferon response in COVID-19-infected cells. This would induce protective interferons and other antiviral factors in adjacent cells, stopping the virus from spreading and generating a synergistic effect that could help patients with cancer and mild or moderate COVID-19 to ght the virus before it causes serious damage to the lungs or other organs.
Q: Is there anything else that you would like to mention?
A: This is one of those rare examples when drugs and experience from the immuno-oncology field are being used to advance the field of infectious diseases. This new direction reflects massive progress in the area of immuno-oncology over the past 10 years.
For more information:
Pawel Kalinski, MD, PhD, can be reached at Roswell Park Comprehensive Cancer Center, Elm and Carlton streets, Buffalo, NY 14263.
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