Haystack Oncology and Lisata Therapeutics Initiate Research Collaboration to Use the Haystack MRD™ Technology to Evaluate Efficacy of Pancreatic Cancer Therapy
Haystack Oncology, a Quest Diagnostics company, and Lisata Therapeutics (Nasdaq: LSTA) have announced a research collaboration to evaluate the efficacy of a pancreatic cancer therapy. Lisata will use Haystack's MRD™ technology to detect circulating tumor DNA (ctDNA) in a clinical study of certepetide plus chemotherapy for metastatic pancreatic cancer.
The collaboration is part of the FORTIFIDE study, which investigates certepetide's safety, tolerability, and efficacy in combination with standard treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC). Haystack's technology will measure serum ctDNA levels throughout the study as an exploratory endpoint to analyze certepetide's early therapeutic effect.
This collaboration aims to address the challenge of early response measurement in pancreatic cancer treatment development, potentially offering a more sensitive alternative to conventional imaging assessments.
- Collaboration with Haystack Oncology may enhance Lisata's ability to evaluate certepetide's efficacy
- Use of highly sensitive Haystack MRD™ technology could provide early indication of therapeutic response
- Potential for improved assessment of treatment effects in pancreatic cancer clinical trials
- Certepetide is still in clinical trial phase, with efficacy yet to be proven
- Metastatic pancreatic cancer remains a challenging disease with treatment options
The collaboration between Haystack Oncology and Lisata Therapeutics represents a meaningful step forward in the fight against metastatic pancreatic cancer. This area of oncology is particularly challenging due to the aggressive nature of mPDAC and the typical late-stage diagnosis. The use of Haystack's MRD technology to measure circulating tumor DNA (ctDNA) levels is highly relevant. The ctDNA assays provide a more sensitive and earlier indication of therapeutic response compared to traditional imaging, which often lacks sensitivity.
From a clinical perspective, if the early data from ctDNA levels show a positive response, it could accelerate the drug development process by providing early efficacy signals. This is important in pancreatic cancer, where patient survival rates are low and time is of the essence. Monitoring ctDNA as an exploratory endpoint can also help identify which subsets of patients are most likely to benefit from certepetide, thereby personalizing treatment approaches.
Overall, this collaboration could lead to more dynamic and responsive treatment plans, offering hope for quicker and more effective therapeutic strategies. However, it's important to note that this technology and investigational drug are still in the research phase and broader efficacy and safety data will be required.
The incorporation of Haystack's MRD technology in the FORTIFIDE study is a promising development for both companies. From a research standpoint, using ctDNA levels as a biomarker can provide invaluable insights. This method allows for real-time monitoring of tumor dynamics, offering a more flexible and responsive approach to evaluating treatment effectiveness. This can shorten the feedback loop compared to traditional endpoints like imaging and overall survival, which are time-intensive.
For Lisata Therapeutics, this collaboration could significantly enhance the robustness of their clinical data for certepetide. The ability to monitor ctDNA will enable Lisata to make more informed decisions about dosing, timing and patient stratification, potentially increasing the likelihood of clinical success. Moreover, this could lead to faster regulatory approvals if the data convincingly show early therapeutic responses.
In the broader context of cancer research, if successful, this approach could set a new standard for clinical trials in oncology, especially for hard-to-treat cancers like mPDAC. It represents a shift towards more personalized and adaptive treatment methodologies, which could benefit both patients and the healthcare system at large.
BALTIMORE, Md. and BASKING RIDGE, N.J., July 18, 2024 (GLOBE NEWSWIRE) -- 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.
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
"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, 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. 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.
Forward-Looking Statements
This communication contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding the Company’s clinical development programs are forward-looking statements. In addition, when or if used in this communication, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to Lisata or its management, may identify forward-looking statements. Examples of forward-looking statements include, but are not limited to, the potential efficacy of certepetide as a treatment for patients with metastatic pancreatic ductal adenocarcinoma and other solid tumors; statements relating to Lisata’s continued listing on the Nasdaq Capital Market; expectations regarding the capitalization, resources and ownership structure of Lisata; the approach Lisata is taking to discover and develop novel therapeutics; the adequacy of Lisata’s capital to support its future operations and its ability to successfully initiate and complete clinical trials; and the difficulty in predicting the time and cost of development of Lisata’s product candidates. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: results observed from a single patient case study are not necessarily indicative of final results and one or more of the clinical outcomes may materially change following more comprehensive reviews of the data and as more patient data becomes available, including the risk that unconfirmed responses may not ultimately result in confirmed responses to treatment after follow-up evaluations; the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the safety and efficacy of Lisata’s product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in Lisata’s clinical programs, Lisata’s ability to finance its operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of Lisata’s scientific studies, Lisata’s ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in Lisata’s markets, the ability of Lisata to protect its intellectual property rights; and legislative, regulatory, political and economic developments. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in Lisata’s Annual Report on Form 10-K filed with the SEC on February 29, 2024, and in other documents filed by Lisata with the Securities and Exchange Commission. Except as required by applicable law, Lisata undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
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)
FAQ
What is the purpose of the collaboration between Haystack Oncology and Lisata Therapeutics (LSTA)?
How will Haystack's MRD™ technology be used in Lisata's (LSTA) FORTIFIDE study?
What is certepetide and how does it work in Lisata's (LSTA) pancreatic cancer treatment?
What type of pancreatic cancer is Lisata Therapeutics (LSTA) targeting in their FORTIFIDE study?
