AIM ImmunoTech Extends IP Protection for Ampligen Through 2039 with Broad US Patent

Editor’s Take: Patents are crucial to protecting intellectual property, particularly in cancer immunotherapy.

AIM ImmunoTech was granted a patent from the United States Patent and Trademark Office for Ampligen (rintatolimod) until December 2039. The office issued the patent specific to Ampligen’s use in combination with the PD-1 checkpoint inhibitor pembrolizumab. Widely known as Keytruda (by Merck, or MSD outside the U.S. and Canada), pembrolizumab is an established cancer treatment.

Meanwhile, Ampligen, a wide-spectrum Toll-like receptor 3 (TLR3) agonist, has been investigated for treatment of various cancers and other conditions. AIM describes Ampligen as its lead product primarily for treatment of late-stage pancreatic cancer.

AIM ImmunoTech Patent Pursuit

This is not AIM’s first patent for the use of Ampligen as a cancer treatment, and additional applications are pending. One U.S. patent, expiring August 2039, covers Ampligen as a combination oncology therapy with an anti-programmed death-ligand 1 (PD-L1) antibody.

Patents combining Ampligen with PD-1 or PD-L1-related treatments additionally exist in the Netherlands and Japan.

Ampligen Indications May Expand

Despite AIM identifying Ampligen firstly as a pancreatic cancer treatment, the drug’s patent application—combined with pembrolizumab—expands vastly. Other patent claims: skin, colorectal, ovarian, breast, bladder, and lung cancers; melanoma; renal cell carcinoma; and head and neck tumors.

AIM ImmunoTech CEO Thomas Equels discussed the importance of patents in protecting intellectual property (IP) in cancer immunotherapy.

“[This] marks another significant step in building a broad and durable IP patent estate around Ampligen’s potential role,” Equels said. “This patent protects Ampligen’s use in combination therapy with the leading PD-1 checkpoint therapy across a broad range of cancers. It specifically encompasses pancreatic cancer, the central focus of our late-stage oncology strategy. We believe this growing patent estate strengthens both the scientific and strategic foundation supporting Ampligen’s long-term oncology opportunity.”