Lisata Therapeutics has secured a significant intellectual property milestone with the issuance of U.S. Patent No. 12,351,653, a composition of matter patent for its lead drug candidate certepetide that extends protection through March 2040. The United States Patent and Trademark Office granted this patent with subsequent opportunity for patent term extension, providing the clinical-stage pharmaceutical company with exclusive rights to manufacture and sell the investigational cancer therapy.
Patent Significance and Commercial Impact
The composition of matter patent represents the strongest form of intellectual property protection available, safeguarding certepetide's unique chemical structure and preventing competitors from manufacturing or selling the drug. The patent encompasses claims to certepetide's chemical structure, pharmacokinetic properties, methods of manufacturing, and applications for treating solid tumor cancers.
"This new patent marks a key milestone, significantly boosting the value of both certepetide and the Company by delaying generic encroachment for essentially the next two decades," stated David J. Mazzo, Ph.D., President and Chief Executive Officer of Lisata. "This extended patent protection aids our commercialization efforts by offering long-term market exclusivity and enhances the potential future development and commercialization of certepetide."
Certepetide's Mechanism and Clinical Development
Certepetide, formerly known as LSTA1, is an internalizing RGD (arginyl-glycyl-aspartic acid or iRGD) cyclic peptide designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. The drug actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in tumors.
The investigational therapy has demonstrated additional benefits beyond enhanced drug delivery. Certepetide has been shown to modify the tumor microenvironment, resulting in tumors that are more susceptible to immunotherapies. Lisata and its collaborators have accumulated significant non-clinical data demonstrating enhanced delivery of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics.
Clinical Progress and Regulatory Recognition
To date, certepetide has demonstrated favorable safety, tolerability, and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. The company is exploring certepetide's potential to enable various treatment modalities for treating a range of solid tumors more effectively.
The drug has received multiple regulatory designations recognizing its therapeutic potential. Certepetide has been awarded Fast Track designation in the United States and Orphan Drug Designation for pancreatic cancer in both the U.S. and European Union. Additionally, it has received Orphan Drug Designation for glioma and osteosarcoma in the United States, along with Rare Pediatric Disease Designation for osteosarcoma.
Strategic Positioning and Future Outlook
The patent strengthens Lisata's negotiating position with potential partners and increases the potential for sustained growth and value creation for shareholders, according to company leadership. Lisata has already established commercial and R&D partnerships based on its CendR Platform® technology.
The company expects to announce numerous milestones over the next 1.5 years and believes its projected capital will fund operations into the fourth quarter of 2026, encompassing anticipated data milestones from ongoing and planned clinical trials. This extended patent protection provides a foundation for maximizing certepetide's full therapeutic potential across multiple solid tumor indications.
