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Deciphera Pharmaceuticals Begins ULK Kinase Inhibitor Study in RAS-, RAF-Mutated Cancers

NEW YORK – Deciphera Pharmaceuticals said on Wednesday that it has dosed its first patient in a Phase I trial of the investigational ULK kinase inhibitor DCC-3116.

The trial is designed to evaluate safety, tolerability, and objective response rates among patients with RAS- or RAF-mutated advanced solid cancers and treated with DCC-3116. In the dose escalation portion of the trial, one cohort of patients will receive DCC-3116 as a monotherapy, and another will receive the agent combined with the MEK inhibitor trametinib (Novartis' Mekinist).

Contingent on study results, Waltham, Massachusetts-based Deciphera plans to evaluate the agent plus trametinib in expansion cohorts, respectively, consisting of patients with advanced or metastatic KRAS- or BRAF-mutated pancreatic cancer; KRAS-, NRAS-, or BRAF-mutated non-small cell lung cancer; KRAS-, NRAS-, or BRAF-colorectal cancer; and NRAS- or BRAF-mutated melanoma.

According to Deciphera, preclinical studies have shown that, in RAS- and RAF-mutated cancer cell lines, DCC-3116 inhibits a process called autophagy, in which cancer cells generate energy through recycled components. The agent is designed to accomplish this by inhibiting the ULK kinase, which plays a key role in the autophagy pathway. The studies also suggested the agent could block increased autophagy that can arise as a resistance mechanism following treatment with MAPK pathway inhibitors.

DCC-3116 "may offer a novel approach to targeting a broad array of cancers," Matthew Sherman, Deciphera's executive VP and chief medical officer, said in a statement. "We look forward to … further evaluating the role of the ULK kinase inhibition and its potential to represent a new treatment paradigm for cancers caused by RAS or RAF mutations."