Medical Device Network

Lisata to use Haystack’s MRD tests for pancreatic cancer therapy trial

Lisata will use Haystack’s minimal residual disease (MRD) test to evaluate the efficacy of certepetide at multiple points during a Phase II trial.

Lisata Therapeutics has partnered with Haystack Oncology, a Quest Diagnostics company, to use the latter’s minimal residual disease (MRD) test in a trial for its solid tumour therapy.

The MRD test will be used to detect circulating tumour DNA (ctDNA) in a clinical study evaluating Lisata’s certepetide in patients with metastatic pancreatic cancer. The serum ctDNA levels will be measured at multiple points and will be used as an exploratory endpoint to assess the therapeutic effect of certepetide.

There has been growing interest in using MRD to evaluate the therapeutic effect of a drug. The Oncologic Drugs Advisory Committee (ODAC) for the US Food and Drug Administration (FDA) have even supported the use of MRD as a surrogate endpoint to enable accelerated approvals of new therapies in multiple myeloma. The MRD endpoints can be read out earlier, compared to conventional endpoints of overall and progression-free survival.

"A significant challenge in the development of anti-cancer therapies for pancreatic tumours is the early measurement of response to treatment,” said Dr Kristen K. Buck, executive vice president of R&D and chief medical officer of Lisata.

“Most clinical trials evaluating pancreatic cancer require waiting for long-term survival outcomes to discern treatment effect. 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."

Certepetide is a bifunctional cyclic peptide. It acts as a tumour-penetrating enhancer via RGD motif interaction with alphav-integrins and via activating neuropilin-1 (NRP-1). It potentially can transform the solid tumour microenvironment into a temporary agent conduit, as per Lisata.

Lisata’s FROTIFIED trial evaluates the certepetide in combination with chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). The company is also evaluating the therapy in other advanced solid tumour indications including colon cancer, colangiocarcoma, and glioblastoma multiforme.