• Company’s priority oncology clinical programs continue to advance toward key milestones
  
• Additional clinical trial site now open at University of Nebraska for Phase 2 study of Ampligen® for the treatment of pancreatic cancer (AMP-270)
• Ongoing progress toward Phase 1 data in clinical development program of Ampligen for the treatment of early-stage triple negative breast cancer
• Significant findings from a new analysis support the potential to identify patients with LAPC that could respond better to Ampligen
• Company bolsters patent portfolio for Ampligen as a potential therapy against Ebola virus disease

OCALA, Fla., June 12, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, today provided an update on its ongoing clinical development programs evaluating Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immune-modulator with broad spectrum activity.

AIM Chief Executive Officer Thomas K. Equels commented, “We have made promising progress across multiple clinical fronts, and I am proud of the dedication of our team and their evident operational execution. Ampligen continues to demonstrate significant potential across multiple types of cancers, immune disorders and viral diseases. We are committed to advancing Ampligen’s development and are poised to achieve multiple key milestones in 2023.”

Ampligen Phase 2 Study as a Therapy for Locally Advanced Pancreatic Cancer ("LAPC”) (AMP-270)

The AMP-270 clinical trial is the Company’s randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability. AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the United States and Europe.

The Company is recruiting patients for its AMP-270 Phase 2 study of Ampligen as a therapy for LAPC. The lead site at the University of Nebraska Medical Center is now open and actively working to enroll patients. The Gabrail Cancer & Research Center in Canton, Ohio is also recruiting patients.

Kelsey Klute, MD, Medical Director of the Pancreatic Diseases Specialty Clinic at Nebraska Medicine, commented, “We are pleased to join into what we believe is an important Phase 2 study that has the potential to address a much-needed treatment option for LAPC. Our team is actively working to enroll and treat patients on the study in a joint effort with all other clinical trial sites. We are encouraged by the potential of Ampligen and look forward to further exploring its potential in the treatment of LAPC.”

AIM continues its efforts to open additional clinical sites at premier cancer centers across the United States and Europe. The Company remains optimistic for first patient enrollment in the second quarter of this year.

For more information about the AMP-270 please visit ClinicalTrials.gov and reference identifier NCT05494697.

Ampligen Phase 1 Study for the Treatment of Early-Stage Triple Negative Breast Cancer (“TNBC”)

Ampligen is currently being evaluated in a Phase 1 study for TNBC by Roswell Park Comprehensive Cancer Center. The study is designed to evaluate the safety and tolerability of a combination of Ampligen and celecoxib with or without Intron A, when given along with chemotherapy. The primary endpoint was safety and tolerability. Secondary endpoints included pCR rate. Tumor and blood biomarkers were analyzed in exploratory studies. The goal of this approach is to increase survival. In November 2022, Roswell presented positive data at the SITC 37^th Annual Meeting demonstrating the chemokine-modulating regimen including Ampligen was well tolerated, with promising clinical activity of pathologic complete response (pCR) + microinvasive residual disease (ypTmic).

Roswell has now completed the study and is currently analyzing data. Based on current timelines, the Company anticipates Roswell will release — via publications — full study results before the end of the year.

For more information about the Phase 1 study of Ampligen for the treatment of TNBC, visit ClinicalTrials.gov and reference identified NCT04081389.

Ampligen Analysis Demonstrating Potential as a Maintenance Therapy After Systemic Chemotherapy in Patients with Metastatic and LAPC

A new analysis was recently presented in an abstract titled, “Immune Response in Stable Pancreatic Cancer after Rintatolimod Treatment,” by Professor C.H.J. van Eijck, MD, PhD of Erasmus Medical Center at the 2023 Annual Pancreas Club Meeting held in Chicago, Illinois. Findings from the analysis demonstrated that treatment of patients with LAPC after FOLFIRINOX with Ampligen (rintatolimod) may induce markers of dendritic cells and T cells in a subgroup of patients. The absence of these markers may predict tumor progression after FOLFIRINOX, providing the future possibility of identifying pancreatic cancer patients who could potentially respond to Ampligen.

The results from the new analysis build on the previously reported peer-reviewed article “Rintatolimod (Ampligen®) Enhances Numbers of Peripheral B Cells and Is Associated with Longer Survival in Patients with Locally Advanced and Metastasized Pancreatic Cancer Pre-Treated with FOLFIRINOX: A Single-Center Named Patient Program,” published in March 2022 in the journal Cancers.

Ampligen as a Potential Therapy Against Ebola Virus Disease (“EVD”)

The South African Patent and Trademark Office (CIPC) has granted patent No. 2022/01079, titled “Compositions and Methods Useful for Ebola Virus Infection.” This pioneering patent recognizes the efficacy of AIM’s tdsRNA drug family, of which Ampligen is a member, as a potential solution to combat the devastating impact of Ebola outbreaks. Under the newly granted patent, a composition comprising tdsRNA may be used in a method that involves administering the composition to a subject to prevent, treat, inhibit, or attenuate an Ebola virus infection in that subject. Significantly, the composition may be used as a treatment for individuals already infected with the Ebola virus, or the composition may be used to prevent an Ebola infection.

About Ampligen

Ampligen is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen has demonstrated in the clinic the potential for standalone efficacy in a number of solid tumors. Additionally, Ampligen has shown success in increasing survival rates and efficacy in the treatment of animal tumors when used in combination with checkpoint blockade therapies.

Ampligen is currently being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the country. Ampligen is being used to treat pancreatic cancer patients in an Early Access Program approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center. Additionally, Ampligen is also approved in Argentina for the treatment of severe chronic fatigue syndrome and is currently being evaluated in SARS-CoV-2/COVID-19, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Post COVID Conditions.

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.

For more information, please visit aimimmuno.com and connect with the Company on Twitter, LinkedIn, and Facebook.

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. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.