allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq (Orca Bio)

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 . Trademarks or registered trademarks used in this press release are the property of their respective owners. Contacts Corporate Communications Kelsey Grossman media@orcabio.com Investor Relations Joshua Murray ir@orcabio.com

Today, a brief rundown of news from Immunovant and Alto Neuroscience, as well as updates from Oric Pharmaceuticals, Korsana Biosciences and a couple genetic medicine developers you may have missed.Shares for Immunovant, a Roivant spinout, fell Thursday after the company announced its experimental therapy for thyroid eye disease failed two late-stage trials. The company said batoclimab, its drug in development with partner HanAllBiopharma,did not meet the Phase 3 trials key goals, which centered on a reduction in eye swelling for adults with active thyroid disease. Immunovant said safety data was consistent with previous findings, and no new safety signals were identified. The company did not share detailed results. The partners said they will review plans for their candidate and provide updates at a later date. Delilah AlvaradoAn experimental drug from Alto Neuroscience has failed a so-called proof-of-concept study evaluating it as a treatment for the cognitive impairment associated with schizophrenia. The drug, known as ALTO-101, is meant to inhibit the PDE4 enzyme. Altos study found ALTO-101 was not significantly better than a placebo when looking effects on brain activity and cognitive function. The company said has developed a modified-release, once-daily oral formulation of ALTO-101 and plans to explore partnering opportunities for it. Alto shares were subsequently down more than 7% in late morning trading Thursday. Andrew Tsai, an analyst at Jefferies, wrote that Wall Street had low expectations for this trial and is more focused on two Alto drugs for depression that have upcoming readouts. Jacob BellUpdated data published in the New England Journal of Medicine from Beam Therapeutics show that risto-cel, a gene editing treatment that it's studying for sickle cell disease, eliminated severe pain crises among 31 patients enrolled in the trial.The gene therapy company said Wednesday its treatment, which relies on a technology called base editing to change the individual letters in DNA, also helped restore the shape of red blood cells, resolve anemia and reduce the breakdown of red blood cells. Patients were followed anywhere from a little under two weeks to more than 20 months. Beam previously reported a patient death in its study of risto-cel, then known as BEAM-101, that investigators found to be related to busulfan, a chemotherapy drug used to condition patients for stem cell transplants. Late last month, the company also reported positive data from its study of a gene editing treatment for alpha-1 antitrypsin deficiency. Gwendolyn WuCell therapy developer Orca Bio said Wednesday that the Food and Drug Administration has delayed the review of its blood cancer drug Orca-T. Originally slated for this month, federal regulators now have until July 6 to return a decision on its allogeneic T cell therapy. In a Phase 3 study last year, the California biotechnology firm said that its treatment helped three-quarters of trial participants with a variety of hematological cancers avoid a serious side effect called graft-versus-host disease, compared to just 38% of patients given an ordinary stem cell transplant. Orca recently submitted additional information on its manufacturing processes, but has not been asked for additional clinical data, according to the company. The FDA has extended, or missed, deadlines for numerous other drugs over the past year. Gwendolyn WuShares of Oric Pharmaceuticals fell more than 40% Wednesday after the California-based drug developer provided updates on its most advanced research program. Oric has been testing rinzimetostat an experimental medicine meant to block a cancer-linked enzyme called EZH2 in an early-stage clinical trial of patients with metastatic castration-resistant prostate cancer who were previously treated with a median of two prior lines of therapy, including Johnson & Johnsons Zytiga. Oric said based on data from the trial, it has decided to run a larger Phase 3 study to evaluate a 400 milligram dose of its drug in combination with Bayers Nubeqa. Jefferies analyst Maury Raycroft wrote in a client note that some investors believe J&Js Erleada would have been a strategically better combination choice. Raycroft, though, argues that the evidence Oric has gathered so far shows it has a competitive drug. The stock sell off is therefore an overreaction, the analyst wrote. Oric shares rebounded around 10%, to $8.30 apiece, by mid-morning Thursday. Jacob BellKorsana Biosciences on Wednesday announced a reverse merger with Cyclerion Therapeutics. The combined company will trade on Nasdaq under the ticker KRSA and focus on advancing Korsanas potential treatments for neurodegenerative diseases. The most advanced of those treatments, codenamed KRSA-028, is a shuttled monoclonal antibody for Alzheimers disease that targets the protein amyloid beta. Alongside the merger, Korsana secured commitments for an oversubscribed private investment thats expected to total $380 million in gross proceeds. Fairmount and Venrock Healthcare Capital Partners led the investment. Jacob Bell '