NEW YORK – Strata Oncology said on Wednesday that it has entered into a partnership with Kansas City, Missouri-based BioMed Valley Discoveries to identify and enroll for a Phase II study of BioMed's investigational agent ulixertinib.
The Phase II clinical trial will evaluate the efficacy of ulixertinib, a first-in-class small-molecule ERK1/2 inhibitor, in patients with advanced cancers harboring mutations that result in aberrant MAPK pathway signaling.
Under the terms of the collaboration, Ann Arbor, Michigan-based Strata Oncology will employ its next-generation sequencing technology, StrataNGS, which is designed to work with exceedingly small tumor samples, to identify patients with BRAF gene mutations or alterations, MEK mutations or alterations, or MAP2K1 or MAP2K2 gene mutations or alterations. The pool of patients who undergo sequencing for potential enrollment into the ulixertinib study will come from the large, multi-center observational Strata Trial, in which patients with advanced cancer undergo molecular profiling with StrataNGS in order to match with a biomarker-driven clinical trial within a portfolio available across over 25 different select health centers.
The Phase II trial, for which the estimated enrollment is 528 patients, comes in the wake of positive safety and tolerability results that BioMed Valley reported from ulixertinib's Phase I trial. The drug also showed promising early evidence of clinical activity during the earlier study.
"We are delighted to collaborate with Strata to develop our first-in-class ERK inhibitor," BioMed Valley Discoveries' CEO and President David Chao said in a statement. "Strata's ability to rapidly identify patients with specific tumor mutations has the potential to dramatically accelerate the recruitment of patients for our trial."