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Haystack Oncology, TriSalus Partner on Liver, Pancreatic Cancer Clinical Studies

NEW YORK – Haystack Oncology on Monday said it signed a collaboration agreement with TriSalus Life Sciences to use its minimal residual disease (MRD) platform to evaluate patient responses in clinical studies of TriSalus' TLR9 agonist SD-101 as a treatment for liver, bile duct, and pancreatic cancer.

Under the terms of the agreement, Baltimore-based Haystack will evaluate therapeutic response and provide molecular insights within TriSalus' clinical trials. According to the company, its sequencing-based technology, Haystack MRD, is designed to detect circulating tumor DNA with high sensitivity in patients with low tumor burden and in clinically challenging cancer types.

"A significant challenge in the development of immunotherapies for liver and pancreatic tumors is early measurement of response to treatment," Steven Katz, TriSalus' chief medical officer, said in a statement. "Conventional imaging response assessment methods may be misleading in certain situations, and accurate ctDNA assays offer the potential to identify meaningful biologic activity in difficult-to-treat cancers."

TriSalus has multiple Phase I trials of SD-101 with checkpoint inhibitors underway in hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and pancreatic adenocarcinoma.

In one Phase Ib/II study, TriSalus is examining escalating doses of SD-101 alone, with Merck's Keytruda (pembrolizumab), or with both Bristol Myers Squibb's Opdivo (nivolumab) and BMS's Yervoy (ipilimumab) in about 89 patients with advanced hepatocellular carcinoma and intrahepatic cholangiocarcinoma. In Phase II, patients will receive SD-101 at the optimal dose with either single- or dual-agent checkpoint blockade, as determined in the previous phase. In Phase II, investigators will assess the overall response rate, and, as a secondary outcome measure, overall survival.

In a separate Phase I/Ib trial, the Westminster, Colorado-based TriSalus is evaluating SD-101 with immune checkpoint blockade in patients with locally advanced pancreatic cancer. Once the optimal and recommended doses are determined in Phase I, patients in Phase Ib will receive SD-101 with Keytruda for two cycles, one month apart. The endpoints of the trial will include overall response rate, progression-free survival, and overall survival.

SD-101 is delivered via TriSalus' pressure-enabled drug delivery technology, which is designed to overcome intratumoral pressure to allow it to be delivered via the peripheral vascular system.

Haystack, a Johns Hopkins School of Medicine spinout acquired by Quest Diagnostics last year, inked similar deals recently with the research organization Alliance Foundation Trials and with Rutgers Cancer Institute of New Jersey. Earlier this month, Haystack partnered with Alliance Foundation Trials to apply its platform within a Phase II trial of Genentech's cancer drug Tecentriq (atezolizumab) in patients with unresectable stage III non-small cell lung cancer. And in December, it signed an agreement with Rutgers Cancer Institute to evaluate responses in a study of liposomal doxorubicin and carboplatin in patients with early-stage triple-negative breast cancer.