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.
The Company’s lead product, Ampligen® (rintatolimod), is an immuno-modulator with broad spectrum activity being developed for globally important cancers, viral diseases and disorders of the immune system.
In particular, we are developing Ampligen as part of a combination therapy with our lead program in pancreatic cancer.
We’ve also seen exciting data in two ongoing Phase 2 studies of Ampligen and AstraZeneca’s Durvalumab for pancreatic cancer and Merck’s Keytruda.
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AIM has multiple active clinical trials across areas of unmet medical need and in high value indications — bringing us closer to helping patients and unlocking the Company's intrinsic value for shareholders.
Metastatic Pancreatic Ductal Adenocarcinoma
• Commenced enrollment and dosing in DURIPANC Phase 1b/2 study combining Ampligen® with AstraZeneca’santi-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) for the treatment of late-stage pancreatic cancer;
• Announced that the first dose level is generally well-tolerated in the DURIPANC Phase1b/2 study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer; and
• Reported positive preliminary data from Phase 1b/2 Study of Ampligen and Imfinzi as a combination therapy for late-stage pancreatic cancer demonstrating a preliminary finding of stable disease in two out of three patients at 6 months in the first subject cohort.
Locally Advanced Pancreatic Adenocarcinoma
• Received authorization from the Erasmus Medical Center Ethics Committee to open a European site for the ongoing Phase 2 study ("AMP-270") of Ampligen as a therapy for locally advanced pancreatic cancer; and
• Announced the publication of new data analysis from a long-term Early Access Program studying Ampligen for the treatment of advanced pancreatic ductal adenocarcinoma.
Recurrent Ovarian Cancer
• Reported positive top-line, protocol-planned interim report data from the study of Ampligen combined with pembrolizumab for the treatment of recurring ovarian cancer.
Post-COVID Conditions
• Reported positive top-line results from the Company's Phase 2 study evaluating the efficacy and safety of Ampligen as a potential therapeutic for people with the post-COVID condition of fatigue ("AMP-518"); and
• Reported an analysis of the AMP-518 clinical trial which supported the Company's belief in Ampligen as a potential therapeutic for people with the moderate-to-severe post-COVID condition of fatigue, and that this would be the likely subject population for AIM's planned follow-up clinical trial.
Additional Key Accomplishments
• Successfully completed cGMP manufacturing of 9,042 clinical vials of Ampligen;
• Announced the publication of new pre-clinical data of Ampligen as part of a combinational therapy in the treatment of melanoma; and
• Granted a patent for Ampligen for the treatment of endometriosis.
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