OR WAIT null SECS
The designation will grant Lisata EU marketing exclusivity for 10 years after approval and protocol assistance from EMA.
On Oct. 17, 2023, Lisata Therapeutics announced that the European Medicines Agency (EMA) granted orphan drug designation to LSTA1, Lisata’s lead product candidate for pancreatic cancer treatment. As of the publication of this article, LSTA1 has several ongoing and planned clinical studies conducted globally. These studies use a variety of solid tumor types, including pancreatic cancer, with a range of anti-cancer regimens.
LSTA1 is an investigational drug intended to aid co-administered or tethered anti-cancer drugs to more effectively penetrate solid tumors by activating a novel uptake pathway. LSTA1 activates the pathway in a tumor-specific way, potentially modifying the tumor microenvironment and making tumors more venerable to immunotherapies. There is significant non-clinical data showing LSTA1 enhancing delivery of a variety of existing and emerging anti-cancer therapies, including immunotherapies, chemotherapeutics, and RNA-based therapeutics.
The orphan drug designation is given to drugs and biologics that treat rare disease, which affect no greater than five in 10,000 people in the European Union. The designation is based on a positive opinion from the EMA Committee for Orphan Medicinal Products. The companies of eligible products receive EU marketing exclusivity for 10 years after approval, possible fee reductions, and protocol assistance from EMA.
“To date, LSTA1 has demonstrated favorable safety, tolerability, and activity to enhance delivery of standard-of-care chemotherapy for patients with metastatic pancreatic cancer,” said Kristen K. Buck, M.D., executive vice president of R&D and Chief Medical Officer of Lisata, in a press release. “Obtaining orphan drug designation from the EMA reinforces our belief that LSTA1 offers major improvement in treating patients with this terrible disease. We are excited by the promise of LSTA1 for the treatment of pancreatic cancer and other solid tumors and are committed to advancing our development programs with the goal of providing a benefit to patients.”
Source: Lisata Therapeutics