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Lisata Therapeutics Granted FDA Orphan Drug Designation for LSTA1 in Malignant Glioma Therapy

Wednesday, August 09, 2023

Lisata Therapeutics, Inc. (Nasdaq: LSTA), a clinical-stage pharmaceutical company specializing in innovative therapies for advanced solid tumors and other critical diseases, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to their primary product candidate, LSTA1. This designation is for the purpose of treating malignant glioma.

Dr. Kristen K. Buck, who serves as the Executive Vice President of Research and Development as well as the Chief Medical Officer of Lisata, highlighted the severity of malignant glioma. She noted that it is a highly aggressive and often fatal form of cancer. Dr. Buck expressed how this Orphan Drug Designation underscores the urgent requirement for effective treatments within this patient group and underscores the potential efficacy of LSTA1.

Orphan Drug Designation, conferred by the FDA, offers a unique status to drugs or biologics created to tackle rare diseases affecting fewer than 200,000 individuals in the United States. This designation provides financial incentives to support clinical development and also guarantees seven years of exclusive marketing rights within the U.S. if the drug successfully attains FDA approval for the designated use.

Presently, LSTA1 is involved in various Phase 1b/2a and 2b clinical studies across multiple global locations. It is being explored in combination with a range of anti-cancer regimens for different types of solid tumors. Lisata intends to collaborate with the University of Tartu in Estonia to initiate a clinical study. This study will assess LSTA1 in the treatment of newly diagnosed glioblastoma multiforme (GBM), a type of brain cancer. The study's design involves a Phase 2a double-blind, randomized, placebo-controlled approach, with a focus on evaluating LSTA1's impact when administered alongside the standard-of-care temozolomide. This trial is slated to enroll 30 GBM patients and is expected to commence in the fourth quarter of 2023. The study will take place at multiple locations in Estonia and Latvia.

LSTA1, the investigational drug, is engineered to enhance the delivery of co-administered or tethered anti-cancer drugs specifically to solid tumors. This mechanism activates a distinct uptake pathway that facilitates improved penetration of anti-cancer drugs into tumors. LSTA1 also exhibits potential in altering the tumor microenvironment, rendering tumors more receptive to immunotherapies. Clinical trials have indicated favorable safety, tolerability, and effectiveness, particularly in augmenting the delivery of standard-of-care chemotherapy for pancreatic cancer. Lisata aims to further explore LSTA1's potential in enhancing the efficacy of various treatment modalities for an array of solid tumors.

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