Orca Bio announced significant leadership changes as the late-stage biotechnology company prepares for a critical regulatory milestone with its lead allogeneic T-cell immunotherapy. Co-founder and Chief Scientific Officer Nate Fernhoff, Ph.D., has been appointed Chief Executive Officer, succeeding Ivan Dimov, Ph.D., while co-founder Jeroen Bekaert, Ph.D., transitions from Chief Operating Officer to President.
Strategic Leadership Transition
The leadership restructuring positions Orca Bio for its planned 2025 Biologics License Application (BLA) submission to the U.S. FDA for Orca-T, following positive Phase 3 clinical results. Dr. Fernhoff, who has been instrumental in advancing the company's high-precision cell therapy platform from early development through clinical translation, will now lead the organization through this pivotal commercial phase.
"I am honored and humbled to serve as CEO as we progress toward our vision of transforming the treatment landscape for patients living with blood cancer," said Dr. Fernhoff. "Following the positive Phase 3 results for Orca-T, we remain focused on a 2025 BLA submission and ensuring commercial readiness."
Manufacturing and Commercial Expansion
The company is simultaneously scaling its U.S. manufacturing infrastructure to support the anticipated commercial launch of Orca-T. This expansion includes activating new production lines in its state-of-the-art commercial manufacturing facility to increase capacity and meet future demand for its allogeneic T-cell immunotherapy products.
Orca Bio is also strengthening its commercial organization by recruiting leaders with proven cell therapy launch experience across commercial operations, market access, and stakeholder engagement. This strategic buildup reflects the company's confidence in Orca-T's regulatory prospects and market potential.
Pipeline Development
Beyond Orca-T, the company continues advancing its broader pipeline of high-precision cell therapies. Dr. Fernhoff, who serves as one of the inventors of Orca-Q, the company's second-generation investigational allogeneic T-cell immunotherapy for hematologic malignancies, emphasized the platform's potential to benefit additional patient populations.
"We are advancing our pipeline of groundbreaking cell therapies that leverage the same high-precision platform to potentially offer new and innovative treatments to more patients who could benefit," Dr. Fernhoff noted.
Leadership Backgrounds
Dr. Fernhoff brings extensive scientific expertise to his new role, having previously served as a Ruth L. Kirchstein National Research Service Award Postdoctoral Scholar in the Irving Weissman laboratory at Stanford University. He holds a Ph.D. in molecular and cell biology from UC Berkeley and bachelor's degrees in biological sciences and mathematics from Stanford University.
Dr. Bekaert, in his expanded role as President, will oversee operations across all company functions. His background includes leadership positions at Merck KGaA's Silicon Valley innovation center and Johnson & Johnson's Supply Chain group, along with research experience at Los Alamos National Laboratory. He holds a Ph.D. in computer science engineering from Ghent University and a master's degree in management from Stanford Graduate School of Business.
The leadership transition reflects Orca Bio's evolution from a research-focused organization to a commercial-stage company preparing to deliver its high-precision cell therapy platform to patients with blood cancers and autoimmune diseases.
