Orca Bio Appoints Bijan Nejadnik, M.D., as Chief Medical Officer

MENLO PARK, Calif.--(BUSINESS WIRE)--Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, today announced the appointment of Bijan Nejadnik, M.D., as Chief Medical Officer (CMO). Dr. Nejadnik is a veteran biopharmaceutical executive with over 20 years of experience spearheading global medical and regulatory strategy.

Concurrent with this appointment, J. Scott McClellan, M.D., Ph.D., will transition from his role as CMO to assume the newly created role of Chief Development Officer, where he will lead the strategic expansion of Orca Bio’s robust pipeline and oversee the advancement of next-generation programs into the clinic.

“We are thrilled to welcome Dr. Nejadnik whose rare expertise in bridging complex clinical innovation with successful global regulatory outcomes will be instrumental as we transition into a commercial-stage company,” said Nate Fernhoff, Ph.D., co-founder and Chief Executive Officer of Orca Bio. “His leadership will be vital in building a world-class medical organization, driving our late-stage clinical strategy and partnering closely with the medical community to bring our high-precision therapies to every patient in need.”

Dr. Nejadnik joins Orca Bio from Tanabe Pharma, where he served as CMO and Head of R&D and Regulatory Affairs. His career is marked by a distinguished track record of leading cross-functional organizations to navigate the path from early-stage biologics to global commercialization. He has overseen multiple successful regulatory submissions, securing approvals from the U.S Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA).

Beyond his clinical and regulatory roles, Dr. Nejadnik has served as a Board Director and senior officer for several biotech innovators, where he was a key architect of corporate strategy, capital formation and strategic M&A. His clinical oversight spans early- to late-stage clinical trials across oncology, immunotherapy and cell-based therapies. Earlier in his career, he held academic appointments at Johns Hopkins, Cornell and Stanford. He holds an M.D. with honors from the Catholic University of Louvain in Belgium.

“The team at Orca Bio has made extraordinary strides towards redefining the standard of care for allogeneic stem cell transplant through its high-precision platform,” said Dr. Nejadnik. “I am eager to build on this momentum, furthering our clinical innovation to ensure our pipeline meets the highest bar of scientific excellence while simultaneously building the medical infrastructure necessary to broaden patient access to these potentially life-changing therapies.”

“Our platform has the potential to redefine treatment across a vast array of diseases by replacing diseased blood and immune systems,” Dr. Fernhoff continued. “Realizing that potential requires dedicated strategic oversight to prioritize and advance our next wave of therapies. We are fortunate to have Dr. McClellan’s leadership and expertise focused on shaping and constructing a pipeline that will bring Orca Bio’s approach to even more patients who could benefit.”

“It has been a privilege to lead our clinical efforts through the development of Orca-T, and I am excited to now dedicate my focus to the next chapter of Orca Bio’s growth,” said Dr. McClellan. “I look forward to working closely with Dr. Nejadnik and the rest of the leadership team as we accelerate our broader pipeline and explore the full potential of our high-precision platform to treat blood cancers and autoimmune diseases.”

About Orca Bio

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. The company’s manufacturing platform uses single-cell precision to create proprietary, uniquely defined products designed to replace a patient’s diseased blood and immune system with a healthy one. At Orca Bio, we are on a mission to redefine what’s possible for patients by transforming the field of curative allogeneic cell therapy. For more information, visit www.orcabio.com.

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Kelsey Grossman
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Investor Relations
Joshua Murray
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