Phase 2 Trial of BVD-523 (ulixertinib) for Patients with Advanced Solid Tumors Harboring MEK or Atypical BRAF Alterations

 Strata Oncology, Inc., a precision oncology company advancing molecular indications for cancer therapies, today announced it has signed an agreement with BioMed Valley Discoveries, Inc. to accelerate patient identification and enrollment for BioMed Valley’s Phase 2 study of BVD-523 (ulixertinib) for patients with advanced malignancies harboring MEK or atypical BRAF alterations (non-BRAF V600E mutations).

Ulixertinib is a first-in-class potent and selective small molecule inhibitor of ERK1/2. BioMed Valley reported positive preliminary Phase I data for ulixertinib in patients harboring MAPK alterations, including atypical BRAF alterations.

Under the terms of the agreement and through the Strata Trial, Strata Oncology will identify patients with advanced solid tumors that harbor mutations in the MAPK signaling pathway and meet other eligibility criteria, for consideration of enrollment into BioMed Valley’s Phase 2 study. The Strata Trial, an ongoing observational study providing tumor molecular profiling for patients with advanced cancer paired with a portfolio of biomarker-guided clinical trials, is available across a network of 25+ select health systems nationwide. Through the Strata Trial, patients with advanced cancer are profiled using StrataNGS™, a comprehensive molecular profiling test optimized for performance on tissue samples as small as 0.5mm² surface area.

“This partnership with BioMed Valley Discoveries supports our commitment to improving the lives of patients with cancer by providing local access to promising investigational therapies,” said Dan Rhodes, Ph.D., CEO of Strata Oncology. “We are confident our network of health system partners, standardized on the Strata Trial, will help drive rapid enrollment of this important study.”

David Chao, President & CEO of BioMed Valley Discoveries, commented, “We are delighted to collaborate with Strata to develop our first-in-class ERK inhibitor. Strata’s ability to rapidly identify patients with specific tumor mutations has the potential to dramatically accelerate the recruitment of patients for our trial.”

For more information about BioMed Valley’s BVD-523 study (NCT04488003) please visit clinicaltrials.gov.