Lisata Therapeutics, Inc. and Qilu Pharmaceutical Co. Ltd. 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. 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.

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.