Profile

Orca Bio is a late-stage biotechnology company developing high-precision cell therapies for the treatment of blood cancer and autoimmune diseases. Headquartered in Menlo Park, California, with a state-of-the-art cGMP manufacturing facility in Sacramento, California, Orca Bio’s platform uses single-cell precision to create proprietary, uniquely-defined allogeneic T-cell immunotherapies designed to fully replace patients’ diseased blood and immune system with healthy ones. Its team of leading scientists, engineers, clinicians and industry professionals are committed to developing treatments for patients with the goal of providing better outcomes with fewer risks than the standard of care.

Visit www.orcabio.com

Key Products

Orca-T

• Orca-T is their lead investigational allogeneic T-cell immunotherapy designed to treat hematological malignancies like acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndrome (MDS).


• Orca-T is being tested under their Precision-T study, a pivotal, randomized Phase 3 clinical study comparing Orca-T to the current standard of care, an allogeneic hematopoietic stem cell transplant.

Orca-Q

• Orca-Q is their next generation investigational allogeneic T-cell immunotherapy candidate. Orca-Q is designed to deliver therapeutic benefits without the need for a fully matched donor.

Key Executives

Ivan Dimov, PhD, CEO and Co-Founder

Ivan launched Orca Bio in 2016 and is Chief Executive Officer of Orca Bio. He is also co-founder and former Chief Technology Officer of Lucira Health, a molecular diagnostics company that received the first FDA authorization for a COVID-19 at-home self-testing kit. Prior to Orca Bio, Ivan was Siebel Fellow and visiting Instructor in Irv Weissman’s laboratory and Senior Scientist at Stanford University. He was also a visiting research scholar at the BioPOETS Lab at the University of California, Berkeley, where he developed innovative microfluidic platforms for stem cell research and low-cost molecular diagnostics. Earlier in his career, Ivan founded BlobCode Technologies, a startup that incorporates 2D barcode reading capabilities using the standard camera within a mobile phone. Ivan has a PhD in applied biophysics from Dublin City University and bachelor’s and master’s degrees in electronics, telecommunications, and computer science from Universidad Técnica Federico Santa María, Chile. He has established 2 research centers in Chile in the robotics and hospital technologies arena that provide clinical engineering and technology innovation to the largest hospitals in the country. Ivan has published more than 40 articles in peer-reviewed journals and has more than 40 patents or patent applications.

Nate Fernhoff, PhD, Chief Scientific Officer and Co-Founder

Nate is a co-founder of Orca Bio and oversees research and development, clinical science and manufacturing, and regulatory affairs. He is one of the inventors of Orca-Q, a high-precision cell therapy for patients with high-risk blood disease. Prior to Orca Bio, Nathaniel was a Ruth L. Kirchstein National Research Service Award (NRSA) Postdoctoral Scholar in the Irving Weissman laboratory at Stanford University. He holds a PhD in molecular and cell biology from the University of California, Berkeley, and bachelor’s degrees in biological sciences and mathematics from Stanford University. Nate has several publications in peer-reviewed journals, as well as patents and patent applications. He currently serves on the board of the ML4 Foundation.

Jeroen Bekeart, PhD, Chief Operating Officer and co-founder

Jeroen is a co-founder of Orca Bio and leads the company’s clinical and corporate operations as well as its supply and manufacturing operations. Before joining Orca Bio, Jeroen was the head of Merck KGaA’s innovation center in Silicon Valley, where he was responsible for shaping and onboarding science and technology opportunities from universities and emerging biotech companies across Merck KGaA’s pharma and life science sectors. Prior to this, Jeroen held a variety of positions of increasing responsibility in Johnson & Johnson’s Supply Chain group, most recently as director, worldwide engineering and technical operations, overseeing the EMEA portfolio. Jeroen started his career as a researcher at the Los Alamos National Laboratory in New Mexico. He holds a master’s and Ph.D. in computer science engineering from Ghent University. He was a Gustave Boël-Sofina Fellow and also holds a master’s degree in management from Stanford Graduate School of Business.

Dan Kirby, Chief Commercial Officer

Dan leads Orca Bio’s commercial strategy for their cell therapy platform products. His areas of focus include market engagement, reimbursement landscape evaluation, value story creation, key opinion leader outreach, and communications. Previously, Dan was Chief Commercial Officer at Omeros Corporation where he oversaw the market access, medical affairs, advocacy, marketing, sales and operation functions. This includes overseeing all launch preparations for the company’s lectin pathway inhibitor, narsoplimab for HSCT-TMA. Prior to joining Omeros, Dan was Vice President of US Commercial Cell and Gene Therapy at Celgene, overseeing all market access, reimbursement and marketing efforts for their CAR T products. Dan joined Celgene as part of the Juno Therapeutics acquisition where he was Vice President of Marketing and Market Access, responsible for building these functions for Juno. Prior to Juno, Dan was Head of Marketing for Medivation, and spent more than 14 years at Amgen in various commercial roles.

Scott McClellan, MD, Chief Medical Officer

Scott joined Orca Bio in 2018 and leads clinical development for the company. Scott has 13 years of research and development in the fields of oncology and malignant hematology. Prior to joining Orca, Scott was a Medical Director at Genentech in early clinical development (oncology) where he led numerous clinical programs evaluating T cell-directing bispecific antibodies and antibody-drug conjugates for lymphoma and multiple myeloma. Prior to that, Scott was a Resident and Fellow in hematology and oncology at Stanford University School of Medicine. He later served as an Adjunct Clinical Assistant Professor of Medicine at Stanford, treating patients in the hematology clinic at the Palo Alto VA Hospital and performing research on acute lymphoblastic leukemia. Scott received a bachelor’s degree in biology from Birmingham-Southern College followed by an MD and a PhD in immunology from Washington University in St. Louis School of Medicine.

Josh Murray, Chief Financial Officer

Josh Murray leads finance, strategy and investor relations at Orca Bio. Prior to joining Orca Bio, Josh spent 15 years at Goldman Sachs, most recently as a Managing Director in the Investment Banking Division, where he advised a wide array of biotechnology and life sciences companies. Josh currently serves on the board of Corcept Therapeutics. He received an AB in History and Economics from Harvard College.

Lauren Smith, Chief Quality Officer

Lauren leads quality for Orca Bio. Lauren has been in the biotech industry for over 18 years with experience in small molecule, large molecule therapies including cell and gene therapies. Most recently, Lauren worked with Catalent where she was the Vice President of Quality for Cell and Gene Therapy and Biologics and supported the development and launch of numerous therapies. Lauren has a master’s degree and a B.S. in Biology with a focus on Microbiology from the University of Akron. Lauren currently sits on the board (compliance chair) for Axess Pointe-HRSA regulated community health centers.

Investors

Orca Bio is solidly backed by a strong syndicate of leading private investors.