A clinical trial investigating a two-drug immunotherapy combination will soon be available to patients with cancer infected with COVID-19 at Roswell Park Comprehensive Cancer Center in Buffalo. The U.S. Food and Drug Administration (FDA) has authorized clinical researchers at the center to conduct a study assessing the safety and effectiveness of administering rintatolimod in combination with interferon alfa to patients with cancer and COVID-19. The investigational agent rintatolimod is a form of double-stranded RNA that mimics viral RNA.
Pawel Kalinski, MD, PhD, Vice Chair for Translational Research at Roswell Park was the first researcher to propose giving these two immune-modulating drugs in combination as treatment for cancer. He is scientific lead on five clinical studies in progress or in development assessing the combination in patients with solid-tumor cancers including breast and colorectal cancer. Dr. Kalinski and clinical principal investigator Brahm Segal, MD, will lead the team investigating whether the two drugs may function effectively together as antiviral agents that could benefit patients with COVID-19.
Pawel Kalinski, MD, PhD
Brahm Segal, MD
“There are similarities between cancer and COVID-19, which both manage to avoid activating the interferon pathway,” says Dr. Kalinski, who is also Director of Cancer Vaccine and Dendritic Cell Therapies, Rustum Family Professor for Molecular Therapeutics and Translational Research and Professor of Oncology at Roswell Park, and will be scientific lead on the study. “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.… We believe that the two agents to be tested in our trial, given together, can activate the missing interferon response in COVID-19-infected cells,” he said.
Phase I/II Study
The new clinical trial will test the safety of this combination regimen in patients with cancer and mild to moderate COVID-19, and the extent to which this therapy will promote clearance of the SARS-CoV-2 virus from the upper airway. The phase I/II study will enroll approximately 40 patients in two stages—first to a dose-escalating phase and then to a randomized comparison between patients receiving the combination and a control group.
For additional information visit RoswellPark.org.