Lisata Therapeutics Announces First Patient Treated in the Phase 2a Trial of LSTA1 in Patients With Glioblastoma Multiforme

Lisata Therapeutics, Inc. recently announced treatment of the first patient in a Phase 2a trial evaluating LSTA1 in patients with newly diagnosed glioblastoma multiforme (GBM). The trial is an investigator-initiated study by Lenne-Triin Kõrgvee, MD, PhD, principal investigator of the study. The first patient was enrolled at Tartu University Hospital in Tartu, Estonia.

The study is a Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating LSTA1 when added to standard of care (SoC), temozolomide, versus SoC and placebo in subjects with newly diagnosed GBM. The study is being conducted across multiple sites in Estonia and Latvia and is targeted to enroll 30 patients with a randomization of 2:1 in favor of the LSTA1 treatment group. In addition to provisioning LSTA1, Lisata will also provide funding for this study. As previously announced by the company, LSTA1 has been granted orphan drug designation by the US FDA for malignant glioma.

“We are very pleased to announce the first patient treated in this Phase 2a study evaluating LSTA1 in patients with newly diagnosed GBM, a very aggressive brain tumor that is often fatal. We hold great hopes for the benefits of LSTA1 in this indication based on preclinical evidence that demonstrates LSTA1 enhances penetration through the limited permeability of the blood-brain barrier,” said Kristen K. Buck, MD, Executive Vice President of R&D and Chief Medical Officer of Lisata. “We appreciate the efforts of Dr. Kõrgvee and her team at Tartu University Hospital as well as those patients participating. We look forward to monitoring the results closely. We are excited by the opportunity to work with Lisata and study LSTA1’s tumor targeting and penetrating technology in GBM. GBM has, historically, been very difficult to successfully treat and we believe LSTA1 may be an important tool in improving those outcomes for patients.”

LSTA1 is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered (ie, covalently bound) anti-cancer drugs to penetrate solid tumors more effectively. LSTA1 actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor. LSTA1 also has the potential to modify the tumor microenvironment, with the objective of making tumors more susceptible to immunotherapies. Lisata and its collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of existing and emerging anti-cancer therapies, including chemotherapeutics, immunotherapies and RNA-based therapeutics. Additionally, LSTA1 has demonstrated favorable safety, tolerability, and activity in clinical trials to enhance delivery of SoC chemotherapy for pancreatic cancer. Lisata is exploring the potential of LSTA1 to enable a variety of treatment modalities to treat a range of solid tumors more effectively.

Lisata Therapeutics is a clinical-stage pharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for the treatment of advanced solid tumors and other major diseases. Lisata’s lead product candidate, LSTA1, is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more effectively. Based on Lisata’s CendR Platform Technology, Lisata has already established noteworthy commercial and R&D partnerships. The company expects to announce numerous clinical study and business milestones over the next 2 years and has projected that its current business and development plan is funded with available capital through these milestones and into early 2026. For more information, visit www.lisata.com.