Lisata Therapeutics, Inc. announced a positive outcome of the prespecified interim futility analysis for the ASCEND trial, a Phase 2b study evaluating LSTA1, Lisata?s lead investigational product, in combination with standard-of-care gemcitabine/nab-paclitaxel in patients with first-line, metastatic pancreatic ductal adenocarcinoma. Based on the results of the interim futility analysis, which was reviewed by the study?s Independent Data Safety Monitoring Committee, the ASCEND trial will continue as planned without modification. The ASCEND trial is a 155-patient, double-blind, randomized, placebo-controlled Phase 2b clinical trial being conducted at up to 40 sites in Australia and New Zealand, led by the Australasian Gastro-Intestinal Trials Group in collaboration with the University of Sydney and with the National Health and Medical Research Council Clinical Trial Centre at the University of Sydney as the Coordinating Centre.

The trial is fully funded by Lisata through an unrestricted research support agreement. The trial is approved by the Sydney Local Health District Ethics Review Committee (Royal Prince Alfred Hospital Zone) (2021/ETH00985). ASCEND, based upon Cohort A (the group receiving a single dose of LSTA1 plus SOC), has 80% power with 95% confidence to detect a 16% increase in the 6-month progression free survival rate in the experimental arm vs.

the control arm (SOC + placebo). Trial enrollment completion is projected for the first half of 2024; however, current enrollment already exceeds 80% of the target, so earlier enrollment completion may be achieved. 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, 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.