AIM also intends to pursue Japanese Orphan Drug Designation for Ampligen in treatment of pancreatic cancer
March 18, 2026 08:36 ET | Source: AIM ImmunoTech Inc.
OCALA, Fla., March 18, 2026 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the Japan Patent Office has fully approved a Japanese 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. The patent was granted in September 2025, but had to then pass a 6-month opposition period. Japan is one of the largest health markets in the world, with Japan and the United States expected to experience the greatest increase in global pancreatic cancer burden by 2030. The Japan patent expires December 20, 2039.
The allowed claims in Japan cover an agent for treating cancer consisting of Ampligen in combination with a checkpoint inhibitor. The claims are broad and encompass multiple cancer types – including pancreatic cancer. AIM also holds a U.S. patent (expires August 9, 2039) for methods involving the 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).
AIM CEO Thomas K. Equels stated: “AIM is committed to developing Ampligen for the treatment of late-stage pancreatic cancer, which is an extremely lethal and unmet global health problem. Securing this critical patent in a key global market is just the latest step in AIM’s robust development and commercialization strategy.”
AIM also intends to expand its intellectual property portfolio by pursuing orphan drug designation in Japan for Ampligen in the treatment of pancreatic cancer. The Company already holds Orphan Drug designations for pancreatic cancer in the United States and the European Union. While the details of the designations vary by region, the purpose is to incentivize the development of therapies for unmet health needs, by providing various benefits and market exclusivity after a drug receives market approval.
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of its lead product, Ampligen® (rintatolimod), for the treatment of late-stage pancreatic cancer, a lethal and unmet global health problem. Ampligen is a dsRNA and highly selective TLR3 agonist immuno-modulator that has shown broad-spectrum activity in clinical trials.
Forward-Looking Statements
Some of the statements included in this press release may be forward-looking statements that 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 Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in the press release speak only as of the date of the press release. 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 Company is in various stages of seeking to determine whether Ampligen® will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders and disclosures in the Company’s reports filed with the SEC on its website and in its press releases set forth its current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen® will be effective in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen® will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data and the 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. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Among the studies are clinical trials that provide only preliminary data with a small number of subjects, and no assurance can be given that the findings in these studies will prove true or that the study or studies will yield favorable results. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced in the Company’s reports filed with the SEC, on the Company’s website and in its press releases. No assurance can be given that intention to seek Orphan Drug Designation will result in the granting of that status, nor that the possession of Orphan Drug Designations or any patents means that a drug will receive market approval. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its potential foreign operations will not be adversely affected by these risks.
Please review the “Risk Factors” section in the Company’s latest annual report on Form 10-K and subsequent quarterly reports on Form 10-Q and the Registration Statement. Its filings are available at www.aimimmuno.com. The information found on the Company’s website is not incorporated by reference herein and is included for reference purposes only.
