Oncolytics Biotech has lost its CMO shortly before it is due to start a pivotal metastatic breast cancer trial. Andres Gutierrez, M.D., Ph.D., is leaving to pursue other opportunities after spending 18 months as CMO of the Canadian microcap.
Gutierrez arrived at Oncolytics shortly after it parted company with its CEO, Brad Thomson. Together with Thomson’s replacement, Matt Coffey, Ph.D., Gutierrez formed part of a new-look executive team tasked with guiding the immuno-oncolytic virus specialist back from setbacks that caused its stock to fall by more than 90% in the years preceding their appointments.
That effort remains unfinished. But Coffey framed the timing of Gutierrez’s departure as falling at a natural cutoff point, stating that he arrived with “a mandate to position and prepare the company for a phase 3 study.” That part of Oncolytics’ attempt to bounce back is done.
“Having played a pivotal role in developing a comprehensive clinical development plan and the design of our phase 3 study in HR-positive, HER2-negative metastatic breast cancer required for approval, his work culminated in the submission to receive a special protocol assessment from the FDA,” Coffey said in a statement.
The task of running the phase 3 still awaits Oncolytics, though. Gutierrez is leaving effective April 23, and Oncolytics is now searching for a replacement to work out of its San Diego office. In the interim, the clinical and regulatory teams Gutierrez leaves behind will guide Oncolytics toward first patient in.
Oncolytics is looking to the trial for evidence its type 3 reovirus pelareorep improves outcomes in patients with HR-positive, HER2-negative metastatic breast cancer. The candidate is designed to take out tumors by causing the disintegration of cells, which, in turn, triggers innate and adaptive immune responses.