OCALA, Fla. — May 7, 2026 — Leads & Copy — AIM ImmunoTech Inc. (NYSE American: AIM) has announced the Final Primary Endpoint Report on Objective Response Rate data from a Phase 2 clinical trial, signaling a potential advancement in overcoming immunotherapy resistance in recurrent ovarian cancer.
The University of Pittsburgh Medical Center (“UPMC”) trial, in which AIM and Merck Sharp & Dohme (“Merck”) are collaborators, evaluated Ampligen® (rintatolimod) in combination with checkpoint inhibition and chemotherapy. The study sought to improve clinical outcomes by addressing the immunosuppressive tumor microenvironment of ovarian cancer through immune activation strategies.
The clinical trial was financially supported by a Merck grant. Topline results showed a 50% Objective Response Rate (ORR), including 21% complete responses, a 79% Clinical Benefit Rate, and a Median Overall Survival of 32.5 months. Durable responses exceeding 70+ months were observed in select patients. No Grade 4 or 5 toxicities were reported.
Additional secondary endpoint data, including progression-free survival, time to disease progression, and overall survival, is expected to be completed in January 2027. The study can be found at ClinicalTrials.gov: NCT03734692.
Dr. Robert P. Edwards, MD, McCall Chair of Obstetrics, Gynecology, and Reproductive Science at the University of Pittsburgh School of Medicine, noted the trial is the third in a series evaluating IP chemotherapy or chemoimmunotherapy using this analytical approach. He stated that the addition of IP Ampligen and systemic PD-1 checkpoint inhibition to IP cisplatin chemotherapy resulted in a significant improvement in both clinical response rates and immune activation across highly comparable patient cohorts in the 3 trials.
AIM Chief Executive Officer Thomas K. Equels expressed optimism, stating that the results represent a strong step forward in enhancing the treatment of recurrent ovarian cancer, pending further studies. Equels noted that data suggests that Ampligen may unlock the full potential of checkpoint immunotherapies.
He also highlighted the durability of the observed responses, supporting the proposition that Ampligen has the potential to play a major role in solid tumor immuno-oncology. This includes expanding the number of patients who benefit from checkpoint inhibitors across multiple cancer types, including ovarian cancer and pancreatic cancer.
Equels added that with intellectual property protection extending into 2039 and a growing body of positive clinical evidence, AIM is well positioned to advance Ampligen into later-stage development and strategic partnerships.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for cancers, viral diseases and disorders of the immune system.
Source: AIM ImmunoTech Inc.
