AIM ImmunoTech Bolsters Intellectual Property Estate for Ampligen® with Issuance of Two Key U.S. Patents

Extends certain exclusive U.S. rights to Ampligen for cancer and ME/CFS through 2039

Management discusses patent issuance and what this means in a brief video: 

OCALA, Fla., Nov. 27, 2023 (GLOBE NEWSWIRE) -- (NYSE American: AIM) (“AIM” or the “Company”) today announced that the U.S. Patent and Trademark Office (USPTO) has issued U.S. patent No. 11,813,279 and 11,813,281 for Ampligen^® titled “Compositions for cancer therapy and methods,” and “Methods for improving exercise tolerance in myalgic encephalomyelitis patients,” respectively.

AIM Chief Executive Officer Thomas K. Equels stated: “Our ongoing effort to expand and solidify AIM’s global intellectual property estate is a foundational component of our development strategy for Ampligen. AIM’s expectation for Ampligen — both as a therapeutic for people suffering from dire diseases and as a valuable asset for our stockholders — is the driving force behind our multiple clinical studies in oncology, ME/CFS and Post-COVID conditions. These two new U.S. patents will serve to further strengthen the potential financial future of our company by extending certain sole rights to Ampligen and for these uses to 2039.”

Click to watch a brief video from the AIM management team discussing the issuance of the U.S. patents and what it means for the pipeline development strategy for Ampligen^®.

Oncology Patent

The new patented methods involve the administration of a unique combination of two compounds to patients suffering from pancreatic cancer, renal cell carcinoma, colorectal cancer and/or melanoma. The first compound is an anti-PD-L1 antibody and the second compound is Ampligen. The combination of these compounds is designed to work synergistically to enhance the effectiveness of the treatment.

The company believes this novel approach promises to revolutionize the treatment landscape for cancers that have historically been challenging to treat. As symptoms appear only in advanced stages and these cancers are extremely difficult to diagnose without deliberate screening, these cancers contribute to high mortality rates and are a significant burden on public health. The advancement, as claimed in the issued patent, is expected to significantly improve treatment outcomes for patients suffering from these cancers in ongoing and upcoming clinical trials.

The granting of U.S. Patent No. 11,813,279 is not only a testament to AIM’s dedication to pioneering cancer treatment, but also opens new avenues for future research and therapy development. AIM, as patent holder, will have the sole rights to exclude other companies from using the claimed method for research or for treatment until August 9, 2039. On the other hand, AIM, either independently or with strategic licensed partners, will be able to continue refining and enhancing this patented treatment method.

ME/CFS Patent

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating condition characterized by extreme fatigue, pain, and cognitive issues. The Centers for Disease Control and Prevention (CDC) estimates that between 836,000 and 2.5 million Americans suffer from ME/CFS. Addressing these severe symptoms has been a complex challenge for healthcare professionals. However, the issuance of U.S. Patent No. 11,813,281 represents a major leap forward, bringing new hope to those impacted by the enduring and debilitating symptoms of ME/CFS.

The novel methods outlined in the new patent claims involve, at least, identifying individuals who have experienced ME/CFS symptoms for 2 to 8 years — a feature identified through extensive research — and treating these symptoms by administering Ampligen. This precision in treatment timing reflects a targeted, cutting-edge approach to personalized medicine in ME/CFS care and is expected to lead to significant improvements and effectiveness in ME/CFS symptoms in this population.

U.S. Patent No. 11,813,281 bestows AIM ImmunoTech Inc. with the sole rights to exclude others from practicing the claimed methods of treating ME/CFS symptoms using Ampligen until January 12, 2040. This exclusivity fortifies AIM's position in the market by enabling development of a distinctive and unparalleled treatment option. Additionally, the patent paves the way for strategic alliances and licensing deals, endowing AIM with the unique opportunity to conduct further research and development of the claimed method, either independently or with licensed partners, to continue refining and enhancing this patented treatment method.

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 and linked video contain 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.