AIM ImmunoTech Announces Positive Top-Line Data from the Study of Ampligen Combined with Keytruda in the Treatment of Recurrent Ovarian Cancer

OCALA, Fla. — AIM ImmunoTech Inc. (NYSE: AIM) today announced top-line interim data indicating that combining Ampligen (rintatolimod) with Keytruda (pembrolizumab) in the treatment of recurrent ovarian cancer may have a powerful synergistic effect, leading the investigator to conclude that the combination therapy could be far more effective than pembrolizumab alone as a therapy for the disease.

See further details on the study “Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer” at NCT03734692. Additionally, the immunological signature supporting this synergistic enhancement has been seen in other clinical trials, including with pancreatic cancer, metastatic triple-negative breast cancer and colorectal cancer metastatic to the liver.

Ampligen is a dsRNA product candidate that acts via the TLR-3 receptor present on several immune cells, epithelial cells and most solid tumors. In the ongoing, investigator-initiated Phase 2, single-arm efficacy/safety trial, University of Pittsburgh Medical Center researchers saw an Objective Response Rate (“ORR”) of 45% when combining Ampligen, pembrolizumab and cisplatin in platinum-sensitive subjects with recurrent ovarian cancer. ORR includes complete response (“CR”) and partial response (“PR”) to treatment. There was a total Clinical Benefit Rate (“CBR”) of 55% when including patients who experienced stable disease (“SD”). Researchers also reported a median Progression-Free Survival (“PFS”) of 7.8 months.

Robert Edwards, MD, Chair of the Department of Obstetrics, Gynecology & Reproductive Sciences and Co-Director of Gynecologic Oncology Research at Magee-Womens Hospital of UPMC, stated: “These results are incredibly favorable when compared to data from the hallmark Phase 2 study Keynote-100, which looked at the use of pembrolizumab alone in the treatment of recurrent ovarian cancer in both platinum-resistant and platinum-sensitive subjects. Keynote-100 reported an ORR of approximately 8% in these subjects – meaning that the new data analysis showed that combining pembrolizumab treatment with Ampligen created a greater than 500% increase in ORR over the Keynote-100 findings. Additionally, Keynote-100’s median PFS was 2.1 months, or significantly less than that seen in the ongoing Ampligen study. Additionally, the new ovarian cancer data analysis revealed an acute increase in anti-tumor immunity — specifically in biomarkers CXCL9, CXCL10, CXCL11 — which is consistent with the immune-stimulatory effects of Ampligen that researchers have seen in clinical studies of other solid tumors, including triple-negative breast cancer, pancreatic cancer and colorectal cancer. We look forward to publishing a more detailed analysis of these data in a peer-reviewed clinical journal this summer.”

AIM Chief Executive Officer Thomas K. Equels stated: “These interim data clearly suggest that there may be a massive positive impact on efficacy when Ampligen is combined with pembrolizumab for the treatment of recurrent ovarian cancer. Other research suggests a similar effect in other solid tumor types. We therefore see an Ampligen combination therapy as having potential across multiple types of cancers. We look forward to the additional clinical studies underway and planned in many of these types of tumors to further confirm these effects.”


About AIM ImmunoTech Inc.

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 a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.


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