AIM ImmunoTech Secures Patent in Japan Through 2039 for Novel Cancer Therapy Combining Ampligen® (Rintatolimod) with Checkpoint Inhibitors

Patent supports AIM’s strategy to expand international market protection, providing opportunities for licensing, collaborations, and long-term revenue growth

Japan is the third-largest pharmaceutical market globally, with oncology as the fastest-growing therapeutic area

OCALA, Fla., Sept. 25, 2025 (GLOBE NEWSWIRE) -- (NYSE American: AIM) (“AIM” or the “Company”) today announced that the Japan Patent Office has issued a patent covering the Company’s proprietary use of Ampligen^® (Rintatolimod) in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer.

“We remain committed to strengthening our global intellectual property protection for Ampligen as we continue to advance its clinical development. This Japan patent – which does not expire until December 20, 2039 – further strengthens our intellectual property portfolio in one of the world’s largest oncology markets and enhances exclusivity around combination therapies that address high-need cancer indications. Importantly, this patent further reinforces our ability to advance our clinical pipeline, secure strategic collaborations, and capture value in the growing global immuno-oncology sector. The scope of this patent enhances the value for any future strategic oncology transactions,” AIM ImmunoTech CEO Thomas K. Equels stated.

The allowed claims in Japan cover an agent for treating cancer consisting of Ampligen in combination with a checkpoint inhibitor. The claims are broad, encompassing multiple cancer types, including pancreatic cancer, skin cancer, colorectal cancer, ovarian cancer, melanoma, breast cancer/triple negative breast cancer, head and neck tumors, bladder cancer, renal cell carcinoma, and lung cancer. The claims also capture specific dosing regimens, administration routes, and synergistic therapeutic effects observed when Ampligen is combined with checkpoint inhibitors.

AIM also holds a U.S. patent (expires August 9, 2039) for methods involving use of Ampligen as part of a combination oncology therapy when paired with an anti-PD-L1 antibody and a patent in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors, such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab).

The combination of these compounds is designed to work synergistically to enhance the effectiveness of the treatment. AIM believes this novel approach could revolutionize the treatment landscape for cancers that have historically been challenging to treat, such as pancreatic cancer and advanced recurrent ovarian cancer. In fact, in collaboration with AstraZeneca, Ampligen is in  combined with AstraZeneca’s durvalumab (an anti-PD-L1) for the treatment of metastatic pancreatic cancer. AIM recently released a showing promising signs of superior Progression-Free Survival and Overall Survival, as well as no significant toxicity.

Similarly, in collaboration with Merck Sharp & Dohme LLC in advanced recurrent ovarian cancer combing Ampligen with Keytruda has been completed and we expect the final data report within the next two months.

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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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,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon 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. Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a therapy for any indication. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the 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.