Lisata Therapeutics & Qilu Pharmaceutical Announce First Patient Treated in Qilu’s Phase 2 Trial 

Lisata Therapeutics, Inc. and Qilu Pharmaceutical Co., Ltd. recently announced 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,” said Xiaoyan Kang, MD, 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,” added Kristen K. Buck, MD, 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.”

Preliminary data from the Qilu Phase 1b/2 trial (CEND1-201) evaluating LSTA1 (formerly known as CEND-1) in combination with nab-paclitaxel and gemcitabine demonstrated a median overall survival (mOS) of 11.1 months (CI 7.89-14.92). These data corroborate the Phase 1 trial (CEND1-001) conducted in Australia which demonstrated a mOS of 12.8 months (CI 9.9-22.8).

LSTA1 is an investigational drug designed to activate a novel uptake pathway that allows co-administered or tethered 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 resulting in tumors which are more susceptible to immunotherapies. We and our collaborators have amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. To date, LSTA1 has also demonstrated favorable safety, tolerability and clinical activity in completed and ongoing clinical trials designed to test its ability to enhance the effectiveness of standard-of-care chemotherapy for pancreatic cancer. Pursuant to the Collaboration and License Agreement, Qilu has exclusive rights to LSTA1 in Greater China, including Taiwan, Hong Kong and Macau. Accordingly, Qilu is responsible for all development and commercialization activities and costs in the licensed territories and Lisata is eligible to receive up to $221 million in remaining milestone payments across multiple indications based on certain development and commercial achievements as well as tiered double-digit royalties on product sales in the region.

Qilu Pharmaceutical is a leading vertically integrated pharmaceutical company focused on discovering, developing, manufacturing and commercializing both generic and innovative medicines. With a diverse pipeline of novel therapeutics, 12 manufacturing sites and more than 36,000 employees worldwide, Qilu is dedicated to transforming scientific innovation by internal R&D across 6 R&D centers based in the US (Seattle WA, Boston MA, San Francisco CA) and China (Shanghai, Jinan and Haikou), and external partnership globally into healthcare solutions to address unmet medical needs. To date, Qilu has launched 300+ products with 60+ products “First to launch” in China and 3 products “D181 launch” in US with approximately US$5.42 billion sales revenue in 2023. For more information, visit http://en.qilu-pharma.com.

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.