On July 18, 2024 Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company, and Lisata Therapeutics, Inc. (Nasdaq: LSTA), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, reported a research collaboration (Press release, Lisata Therapeutics, JUL 18, 2024, View Source [SID1234645015]). Lisata will deploy the highly sensitive Haystack MRD technology for the detection of circulating tumor DNA (ctDNA) in a clinical study evaluating certepetide plus chemotherapy as an investigational treatment for metastatic pancreatic cancer.

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In the FORTIFIDE study, Lisata is investigating the safety, tolerability, and efficacy of its lead product candidate, certepetide, when given as a 4-hour continuous infusion in combination with standard-of-care treatment in subjects with metastatic pancreatic ductal adenocarcinoma (mPDAC) who have progressed on FOLFIRINOX, a treatment for pancreatic cancer. As part of this research, Lisata has engaged Haystack to use its MRD technology to measure serum ctDNA levels at multiple timepoints in patients throughout the study as an exploratory endpoint for analyzing the early therapeutic effect of certepetide. Certepetide 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.

"Our collaboration with Lisata underscores the value of our Haystack MRD technology in helping to drive forward the development of novel treatments for solid tumor cancers," said Dan Edelstein, Vice President and General Manager of Haystack Oncology. "Haystack’s technology was engineered to detect ctDNA with exceptional sensitivity, and we aim to continue to gain insights into ctDNA kinetics via serial measurements as an important and early indication of therapeutic response."

The American Cancer Society estimates more than 66,000 individuals nationwide will be diagnosed with pancreatic cancer in 2024. mPDAC accounts for more than 90% of pancreatic cancer cases and is a highly aggressive form of the disease. Typically, mPDAC advances to this stage because of a lack of early diagnosis or limited patient response to treatments.1

"A significant challenge in the development of anti-cancer therapies for pancreatic tumors is the early measurement of response to treatment. Most clinical trials evaluating pancreatic cancer require waiting for long-term survival outcomes to discern treatment effect," said Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Lisata. "Conventional response assessment via imaging may lack sensitivity in certain situations, and highly sensitive ctDNA assays offer the potential to quickly identify clinically meaningful biologic activity in difficult to treat cancers. The Haystack MRD test has the level of sensitivity required for us to better identify the selective tumor penetrating effect of certepetide, our lead candidate, for the treatment of solid tumors."