Lisata Therapeutics & Warpnine Announce First Patient Treated in Locally Advanced Non-Resectable Pancreatic Ductal Adenocarcinoma Trial

Lisata Therapeutics, Inc. and Warpnine Incorporated recently announced the treatment of the first patient in the iLSTA Trial of Lisata’s LSTA1 in combination with standard-of-care chemotherapy and immunotherapy as a first-line treatment in locally advanced non-resectable pancreatic ductal adenocarcinoma (PDAC).

The iLSTA Trial is a 30-patient, randomized, single-blind, single-center, safety and pharmacodynamic Phase 1b/2a study evaluating LSTA1 in combination with the checkpoint inhibitor, durvalumab, plus standard-of-care chemotherapy, nab-paclitaxel, and gemcitabine, versus standard-of-care alone in patients with locally advanced non-resectable PDAC. As the study sponsor, Warpnine will provide all funding and manage all recruitment activities for the study while Lisata will provide the study drug, LSTA1, as well as regulatory support. WARPNINE and Lisata will share use of the data with the goal of advancing development of LSTA1 toward registration to the benefit of patients in need.

“The iLSTA Trial is potentially the first major opportunity that we have to enable immunotherapy to fully engage against pancreatic cancer as, to date, pancreatic cancer has been resistant to the effects of immunotherapy due to both the hostile tumor microenvironment and the protective layer of tissue surrounding the tumor (called the stroma). The use of LSTA1 in combination with standard-of-care chemotherapy and immunotherapy is intended to both augment chemotherapy delivery into the tumor and facilitate the effects of tumor infiltrating lymphocytes and immunotherapy compounds to optimize therapy against cancer of the pancreas,” said Dr. Andrew Dean, MBChB, MRCP (UK), FRACP, Medical Oncologist, Principal Investigator.

“Warpnine exists to fund research into pancreatic, gastro-intestinal, and rare cancers. We are committed to transform these cancers into curable diseases and addressing the inequity in outcomes for patients and families impacted by these devastating malignancies. The extraordinary support of the Warpnine community has enabled us to sponsor this innovative and potentially game-changing trial. Community is power, and together we are charging at ‘warp speed’ to find the cancer treatments of the future, today,” said Meg Croucher, Chief Executive Officer of Warpnine, iLSTA Trial sponsor.

“Dosing the first patient in our iLSTA Trial of LSTA1 in patients with pancreatic cancer in Australia is an important step in our mission to create new hope for patients by providing meaningful treatments to those with few remaining alternatives. We believe that LSTA1 represents a new treatment option for these patients who haven’t been fully served by standard-of-care alone,” added Kristen K. Buck, MD, Executive Vice President of R&D and Chief Medical Officer of Lisata. “We are thrilled by the progress being made to help advance LSTA1 through the clinical trial process and are grateful to Warpnine for their financial and operational support.”

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. 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.

Warpnine is Western Australia’s research into pancreatic, gastro-intestinal, and rare cancers. Established by a group of leading cancer specialists, Warpnine seeks to address the inequity in cancer outcomes for what are essentially underfunded and under-researched malignancies. We are committed to providing real and meaningful benefit to patients, while building on Western Australia’s best-in-the-world outcomes for these cancers. For more information, visit www.warpnine.org.au.

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 investigational product candidate, 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, while normal tissues are not affected. LSTA1 also has the potential to modify the tumor microenvironment, with the objective of making tumors more susceptible to immunotherapies. LSTA1 has demonstrated favorable safety, tolerability, and activity in clinical trials to enhance delivery of standard-of-care chemotherapy for pancreatic cancer. Lisata and its collaborators have also amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anti-cancer therapies, including immunotherapies and RNA-based therapeutics. Lisata is exploring the potential of LSTA1 to enable a variety of treatment modalities to treat a range of solid tumors more effectively. For more information, visit www.lisata.com.