AIM ImmunoTech Submits IND and Accompanying Fast Track Application for Phase 2 Trial of Ampligen in Patients with Locally Advanced or Metastatic Late-Stage Pancreatic Cancer

OCALA, Fla., Oct. 19, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has submitted an Investigational New Drug application (IND) and an accompanying application for Fast Track status with the U.S. Food and Drug Administration (FDA) for a planned Phase 2 study of the company’s drug Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer.

The planned AMP-270 clinical trial of approximately 250 subjects will be a Phase 2, randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen when added to SOC (standard of care) versus SOC alone for subjects with advanced pancreatic carcinoma recently treated with FOLFIRINOX chemotherapy regimen. Secondary objectives include comparing safety and tolerability.

will manage the AIM-sponsored study. The Buffett Cancer Center at the and in The Netherlands are expected to be the primary study sites, although additional sites are anticipated.

Key support for both the study and the application for Fast Track status includes statistically significant clinical data in an Erasmus MC early-access program of 27 subjects where the overall survival of the Ampligen-treated cohort was 19.2 months from the start of FOLFIRINOX, compared to 12.5 months in the historical control group, for an increase in survival of 6.7 months. Additionally, several subjects are still alive more than three years later.

AIM believes that the clinical significance of these data as a treatment for pancreatic cancer provide Ampligen with a strong case for FDA Fast Track designation, which is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill unmet medical needs. A drug that has been granted FDA Fast Track status is eligible for some or all of the following:

• More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
• More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
• Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
• Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

AIM Chief Scientific Officer David Strayer, MD, commented, “Given the extensive work to date, we are well positioned to move aggressively and launch the Phase 2 trial of Ampligen upon approval of the IND. We could not be more enthusiastic about the outlook for this program given the compelling prior clinical data from Erasmus MC, which demonstrated a significant improvement in median overall survival, compared to a matched historical control group. Ampligen has also demonstrated a strong safety profile in numerous trials. At the same time, we are excited to have submitted our Fast Track application, which would confer a number of important benefits and potentially help accelerate approval.”

AIM CEO Thomas K. Equels further commented, “Submission of our IND and Fast Track application are very significant milestones for the company and I would like to thank our entire team, as well as our clinical and regulatory advisors, for their tremendous efforts in preparing these carefully planned submissions. The rapid progress we have made is especially important given the devastating nature of pancreatic cancer. Further, both the FDA and the EMA have granted Ampligen orphan drug status in pancreatic cancer. This creates the potential for several years of market exclusivity. There is a significant unmet need for a safe and effective therapy for these patients, and we believe Ampligen holds enormous promise.”

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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 disease caused by the SARS-CoV-2 virus.

Cautionary Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. No assurances can be given as to whether the FDA will promptly authorize the Company’s IND or require significant changes or grant Fast Track status. If the IND is authorized, no assurance can be given that any studies will be successful or yield favorable data. Studies and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be an effective therapy for locally advanced or metastatic late-stage pancreatic cancer or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

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