AIM ImmunoTech Inc. (NYSE: AIM) shares ticked higher on Thursday after the company announced some big developments with the U.S. Food and Drug Administration (FDA) concerning its treatment for cancer patients with COVID-19.
Specifically, the FDA has authorized the first human trial assessing the safety and effectiveness of AIM ImmunoTech’s Ampligen (rintatolimod) in combination with interferon alfa-2b, in cancer patients who have contracted COVID-19.
The new clinical trial will be conducted at Roswell Park Comprehensive Cancer Center under the leadership of Pawel Kalinski, M.D., Ph.D., a pioneer in developing this combination as an investigational treatment for cancer, and Brahm Segal, M.D.
Ultimately, the 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 1/2b study will enroll roughly 40 patients in two stages. Phase 1 will see 12 to 24 patients receiving both Ampligen and interferon alfa-2b at escalating doses.
Once that initial phase is complete, the study participants will be randomized to two arms: one receiving the two-drug combination and a control group who will not receive Ampligen or interferon alfa but will receive the best available care.
Dr. Kalinski commented:
We hope that these two drugs, given together, will limit viral replication in the infected cells, prevent viral transmission to other cells and spur early innate immune response in cancer patients with COVID-19, before the virus spreads and they become seriously ill. While for decades, immuno-oncology drew heavily from virology, this development suggests that recent progress in the immuno-oncology field may allow us to return the favor and to accelerate the development of new treatments of infectious diseases.
AIM ImmunoTech stock traded up about 26% on Thursday to $2.97, in a 52-week range of $0.38 to $7.50. The consensus price target is $5.83.