Haystack Oncology and Lisata Therapeutics Initiate Research Collaboration to Use the Haystack MRD™ Technology to Evaluate Efficacy of Pancreatic Cancer Therapy

BALTIMORE, MD and BASKING RIDGE, NJ – 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, today announced a research collaboration. 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.

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.”

About Haystack Oncology

Haystack Oncology represents the culmination of over 20 years of collaboration to advance technical and clinical development in liquid biopsy technologies by cancer genomics pioneers at Johns Hopkins School of Medicine. The company, a wholly owned subsidiary of Quest Diagnostics, developed Haystack MRD™, a next generation tumor-informed approach for the measurement of minimal residual disease. Haystack MRD uses an error-corrected ctDNA technology to detect down to one ctDNA molecule in a million normal DNA molecules. Haystack Oncology works with biopharmaceutical companies to accelerate and better inform clinical development programs and advance important therapeutics to global markets, from early phase clinical development to companion diagnostics.

Haystack MRD was developed and validated in a CLIA-certified laboratory and is available for testing in laboratories located in Baltimore, Maryland; Hamburg, Germany; and Helsinki, Finland. Learn more at haystackmrd.com

About Quest Diagnostics

Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world’s largest databases of deidentified clinical lab results, Quest’s diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world. www.QuestDiagnostics.com.

About Lisata Therapeutics, Inc

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 product candidate, LSTA1, 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. Based on Lisata’s CendR Platform® Technology, Lisata has already established noteworthy commercial and R&D partnerships. The Company expects to announce numerous clinical study and business milestones over the next two years and has projected that its current business and development plan is funded with available capital through these milestones and into early 2026. For more information on the Company, please visit www.lisata.com.

SOURCE Quest Diagnostics

For further information on Quest Diagnostics or Haystack Oncology: Jennifer Petrella, Quest Diagnostics (Media): 973-520-2800 or mediacontact@QuestDiagnostics.com; Shawn Bevec, Quest Diagnostics (Investors): 973-520-2900

For further information on Lisata Therapeutics: John Menditto, Lisata Therapeutics,
(Investors): 908-842-0084 or jmenditto@lisata.com; Elizabeth Coleman, ICR Westwicke (Media): 203-682-4783 or elizabeth.coleman@westwicke.com


[1] Metastatic Pancreatic Ductal Adenocarcinoma Symptoms | Pancreatic Cancer Signs (lisata.com)

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