Lisata Therapeutics, Inc. announced that a critical milestone has been achieved with the completion of enrollment in the Phase 2b ASCEND study of its novel agent, LSTA1, for the treatment of metastatic pancreatic ductal adenocarcinoma. Lisata expects top-line data from the 95 patients assigned to Cohort A of the study to be reported in the fourth quarter of 2024 and the complete data set of all 155 patients from the study by mid-2025. The ASCEND trial is a 155-patient, double-blind, randomized, placebo-controlled Phase 2b clinical trial evaluating standard-of-care gemcitabine and nab-paclitaxel vs SoC plus LSTA1 in patients with metastatic pancreatic ductal adenocarcinoma.

LSTA1 is Lisata?s lead development candidate designed to augment the targeting to and penetration of anti-cancer drugs in solid tumors expressing a dense stromal barrier without exacerbating any adverse effects normally associated with those anti-cancer drugs. Study participants are randomized 2:1 in favor of study intervention (SoC + LSTA1) vs. SoC plus placebo.

Cohort A, where patients received 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). Cohort A dosing is identical to the dosing used in the previously reported Phase 1b/2a trial in which substantial improvement was shown in both PFS and overall survival in mPDAC patients administered LSTA1 plus SoC.

Cohort B will assess whether a second dose of LSTA1, administered 4 hours after the original dose of LSTA1 plus SoC, will further improve patient outcomes. Both PFS and OS will be assessed in the trial. The trial is being conducted at up to 30 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 approved by the Sydney Local Health District Ethics Review Committee (Royal Prince Alfred Hospital Zone) (2021/ETH00985) and is fully funded by Lisata through an unrestricted research support agreement. 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.