Lisata Therapeutics and Qilu Pharmaceutical Announce First Patient Treated in Qilu’s Phase 2 Trial in China of LSTA1 in Patients with Metastatic Pancreatic Ductal Adenocarcinoma

Results of Phase 1b/2 in China reinforce global clinical development rationale and plans for LSTA1

BASKING RIDGE, N.J. and JINAN, China, April 23, 2024 (GLOBE NEWSWIRE) --  Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, and Qilu Pharmaceutical Co., Ltd. (“Qilu”), one of the leading vertically integrated pharmaceutical companies in China that develops, manufactures, and distributes both finished products and active pharmaceutical ingredients, announced that the first patient has been treated in Qilu’s Phase 2 trial in China evaluating LSTA1 (also known as “CEND-1”), Lisata’s lead product candidate, in combination with standard-of-care (“SoC”) chemotherapy as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (“mPDAC”).

Qilu, the licensee of LSTA1 in Greater China, including Taiwan, Hong Kong and Macau, is enrolling subjects in its Phase 2 120-patient, randomized, double-blind, multi-center, placebo-controlled trial evaluating 3.2 mg/kg of LSTA1 administered as a single IV push in combination with SoC chemotherapy, nab-paclitaxel and gemcitabine, versus SoC alone in patients with mPDAC. The study is planned to take approximately 18 months to complete enrollment accrual and another 13 months for patient follow-up and data analysis and reporting. For more information on this trial, please visit ClinicalTrials.gov (Identifier: NCT06261359).

“In China, both the incidence and prevalence of mPDAC cases are on the rise. Promising data from our completed Phase 1 trial suggest that LSTA1 has the potential to be a safe and effective treatment for mPDAC," stated Xiaoyan Kang, M.D., Chief Medical Officer of Qilu. "We are committed to working with Lisata to bring the potential clinical benefits of LSTA1 to mPDAC patients in China.”

"Despite recent advances in cancer treatment, mPDAC is an aggressive disease that results in poor patient outcomes, highlighting the urgent need for innovative therapies," stated Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Lisata. "The first patient enrolled in Qilu's Phase 2 trial in China represents a significant step forward in our mission to improve and extend the lives of patients with pancreatic cancer globally with LSTA1. We are committed to working with Qilu in this partnership to maximize the potential of LSTA1 to address the unmet medical need in mPDAC.”