Lisata Therapeutics Announces First Patient Treated in BOLSTER Trial Novel Tumor-Targeting & Penetrating Peptide in Patients With Advanced Solid Tumors

Lisata Therapeutics, Inc. recently announced treatment of the first patient in the head and neck squamous cell carcinoma cohort of the BOLSTER trial, by Dr. Alexander N. Starodub, a principal investigator of the study, at The Christ Hospital in Cincinnati, Ohio.

The BOLSTER trial is a Phase 2a, double-blind, placebo-controlled, multi-center, randomized study evaluating LSTA1 when added to standard-of-care (SOC) versus SOC alone in patients with either advanced second-line head and neck squamous cell carcinoma, second-line esophageal squamous cell carcinoma, or first-line cholangiocarcinoma. The BOLSTER trial is a basket trial being conducted at approximately 40 sites in North America, Europe, and Asia-Pacific. Total trial enrollment of 120 patients is expected to be completed in the second half of 2024. A “basket” trial is a trial in which a product (eg, LSTA1) is tested in multiple indications sharing a similar trait or challenge (eg, dense stroma in solid tumors) in separate arms of the study. The individual arms are enrolled and analyzed independently but share operational synergies such that the study is more efficient to execute than would be for conducting independent studies for each indication. Each arm of BOLSTER will enroll 40 patients: 20 randomized to LSTA1 in combination with SOC, 20 randomized to placebo in combination with SOC.

“We are excited to announce treatment of the first patient in the second-line head and neck squamous cell carcinoma cohort of the BOLSTER trial. Head and neck squamous cell carcinoma, which usually begins in the mucosal surfaces of the mouth, throat or voice box, is a rare and aggressive form of solid tumor cancer that is diagnosed in roughly 67,000 patients a year in the US. Most head and neck cancers eventually spread to the lymph nodes nearest to the affected area and can become incurable or uncontrollable resulting in advanced or terminal stage disease. The BOLSTER trial gives us the opportunity to evaluate the potential of LSTA1 in a variety of solid tumor settings in combination with corresponding standards-of-care and will provide direction on potential next steps in development,” said Kristen K. Buck, MD, Executive Vice President of R&D and Chief Medical Officer of Lisata. “Now that the first patient in BOLSTER has been treated, we expect an uptake in enrollment in the coming quarters. We remain committed to developing groundbreaking therapies that can transform the outcomes of individuals facing these life-threatening conditions.”

For more information on the BOLSTER Trial, please visit https://clinicaltrials.gov/study/NCT05712356.

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 two 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.