Rare Pediatric Disease Designation for Lisata’s Osteosarcoma Candidate

Lisata Therapeutics (Nasdaq: LSTA) has been granted Rare Pediatric Disease Designation by the FDA for LSTA1, the company’s lead product candidate, for the treatment of osteosarcoma, a rare cancer that can develop in children, adolescents and young adults. LSTA1 has demonstrated favorable safety, tolerability, and activity in clinical trials. The company’s share price settled up +8.41% on Thursday following the news.

“LSTA1 has already demonstrated promise in preclinical and clinical settings for the treatment of several advanced solid tumors, and we believe that potential extends to a beneficial impact in osteosarcoma, a rare cancer that usually develops in the osteoblast cells that form bone,” stated Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Lisata. “Receiving RPDD from the FDA is an important milestone as we plan future clinical expansion for LSTA1, and, more importantly, it underscores the high unmet medical need of this patient population.” 

Highlights

LSTA1 is an investigational drug designed to activate a novel uptake pathway that allows co-administered or covalently bound anti-cancer drugs to penetrate solid tumors more effectively.

LSTA1 also has the potential to modify the tumor microenvironment, with the objective of making tumors more susceptible to immunotherapies.

The FDA defines rare pediatric diseases as rare diseases, those with fewer than 200,000 cases in the United States, that are serious or life threatening and primarily affect individuals under 18 years of age. 

About Lisata Therapeutics

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 on the Company, please visit www.lisata.com.

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Rare Pediatric Disease Designation for Lisata’s Osteosarcoma Candidate

Catie Corcoran

Biotech Editor