AIM ImmunoTech Secures U.S. Patent For Manufacturing Methods Of Therapeutic dsRNA, Including Ampligen®

AIM ImmunoTech Inc. announced that the United States Patent and Trademark Office has granted the company a new U.S. patent (No. 12312376), titled “Therapeutic Double Stranded RNA and Methods for Producing the Same.” This patent, which is set to expire on January 25, 2041, covers methods related to the manufacturing of a variety of therapeutic double-stranded RNA (dsRNA) products, including AIM’s flagship investigational drug, Ampligen.

The addition of this manufacturing patent strengthens AIM’s overall intellectual property protection around Ampligen by securing exclusive rights not only for the drug’s compositions and uses but also for its production processes. This broader patent coverage gives the company extended control over the synthesis and future development of Ampligen, which is a first-in-class dsRNA drug. With this protection in place until 2041, AIM has a longer window to advance its drug development efforts and continue its pursuit of regulatory approvals.

Thomas K. Equels, CEO of AIM, said in a statement, “This patent is a significant milestone for AIM as it represents the final step in a multi-year project to strengthen and secure our global patent portfolio surrounding Ampligen. AIM now has extended patent protection for the manufacture of Ampligen, the composition of Ampligen and the way in which Ampligen can be utilized as a therapeutic for a diverse collection of unmet medical needs, from deadly cancers to Post-COVID conditions to endometriosis.”

Ampligen has shown broad therapeutic potential in various clinical trials, demonstrating activity across several high-priority disease areas, including cancers, viral infections, and immune-related conditions. The company is actively working toward gaining U.S. Food and Drug Administration (FDA) approval for Ampligen across a range of indications. In addition to the new manufacturing patent, AIM holds other important patents involving Ampligen, including those covering its use in the treatment of cancer (U.S. patent 11,813,279, expiring August 9, 2039), post-COVID fatigue (Netherlands patent 2032813, expiring August 21, 2042), and endometriosis (U.S. patent 12,102,649, expiring October 22, 2040).

Beyond its patent portfolio, Ampligen is also supported by several Orphan Drug Designations (ODD) from both the FDA and the European Medicines Agency (EMA). These designations offer additional layers of market exclusivity seven years in the U.S. and ten years in the EU following approval. The ODDs cover a number of serious conditions, including metastatic melanoma, renal cell carcinoma, pancreatic adenocarcinoma (both U.S. and EU), Ebola virus disease (U.S. and EU), chronic fatigue syndrome/myalgic encephalomyelitis (U.S.), and HIV (U.S.). Taken together, AIM’s comprehensive intellectual property protections and regulatory designations provide a strong foundation for the ongoing development and future commercialization of Ampligen.