AIM ImmunoTech Inc. has secured a significant patent from the Japan Patent Office covering the company's proprietary use of Ampligen (rintatolimod) in combination with checkpoint inhibitors for cancer treatment. The patent, which does not expire until December 20, 2039, strengthens the company's intellectual property portfolio in one of the world's largest oncology markets.
Broad Patent Coverage Across Multiple Cancer Types
The Japanese patent covers an agent for treating cancer consisting of Ampligen in combination with checkpoint inhibitors, specifically anti-PD-1 or anti-PD-L1 antibodies. The claims encompass 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.
According to AIM ImmunoTech CEO Thomas K. Equels, "This Japan patent 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." The patent also captures specific dosing regimens, administration routes, and synergistic therapeutic effects observed when Ampligen is combined with checkpoint inhibitors.
Global Patent Strategy
AIM's Japanese patent adds to an expanding international portfolio. The company also holds a U.S. patent expiring August 9, 2039, for methods involving use of Ampligen as part of a combination oncology therapy when paired with an anti-PD-L1 antibody. Additionally, AIM holds a patent in the Netherlands expiring December 19, 2039, for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors, including Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab).
Clinical Development Progress
The combination of Ampligen with checkpoint inhibitors is designed to work synergistically to enhance treatment effectiveness. 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 collaboration with AstraZeneca, Ampligen is currently in a Phase 2 clinical trial combined with AstraZeneca's durvalumab (an anti-PD-L1) for the treatment of metastatic pancreatic cancer. AIM recently released a DURIPANC Mid-Year Interim Clinical Progress Update showing promising signs of superior Progression-Free Survival and Overall Survival, as well as no significant toxicity.
Similarly, a Phase 2 study in collaboration with Merck Sharp & Dohme LLC in advanced recurrent ovarian cancer combining Ampligen with Keytruda has been completed, with final data expected within the next two months.
Strategic Market Position
Japan represents the third-largest pharmaceutical market globally, with oncology as the fastest-growing therapeutic area. The patent supports AIM's strategy to expand international market protection, providing opportunities for licensing, collaborations, and long-term revenue growth.
Equels emphasized that "the scope of this patent enhances the value for any future strategic oncology transactions" and "further reinforces our ability to advance our clinical pipeline, secure strategic collaborations, and capture value in the growing global immuno-oncology sector."
About Ampligen
Ampligen (rintatolimod) is AIM ImmunoTech's lead product, described as a first-in-class investigational drug that functions as a dsRNA and highly selective TLR3 agonist immuno-modulator. The compound demonstrates broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.
