CASI Pharmaceuticals has appointed David Cory as Chief Executive Officer and Board member to lead the company's U.S. operations and focus on advancing its lead drug candidate CID-103, a potential best-in-class anti-CD38 monoclonal antibody. Wei-Wu He, Ph.D. will step down as CEO and remain as Executive Chairman of the Board of Directors.
Leadership Transition Focuses on CID-103 Development
The appointment comes as CASI concentrates its resources on the clinical development of CID-103 for organ transplant rejection and autoimmune diseases. "David's extensive operating background and capital markets experience make him the ideal candidate to lead the CASI U.S. business, focus management and concentrate resources on the advancement of the CID-103 program," said Dr. He.
Cory expressed enthusiasm for the opportunity, stating, "I look forward to joining the team and engaging with the healthcare and investment community to discuss the CASI U.S. operating plan focused on maximizing the broad therapeutic potential of targeting CD38 with the CID-103 program."
Proven Track Record in Biotech Leadership
Cory brings more than 30 years of operational experience across private and public emerging-stage biotech and large pharmaceutical companies. He has an established track record of building high-performing operating teams and has raised over $1 billion in capital markets with multiple successful company exits.
Most recently, Cory served as CEO and Director of LIB Therapeutics, which completed Phase 3 registration-enabling trials for its lead cardiovascular disease program and filed for regulatory approval. Previously, as CEO and Director of Eiger BioPharmaceuticals, he obtained FDA and EMA approval and launched the first therapy to extend survival in Hutchinson-Gilford progeria syndrome, an ultra-rare, ultimately fatal disease.
His biotech career began as a founding member and executive in multiple start-up companies including InterMune, CoTherix, and Prestwick Pharmaceuticals, which resulted in exits by acquisition of approximately $9 billion collectively. Cory also spent over a decade in large global pharma at The Upjohn Company and Glaxo-Smith Kline.
CID-103: Targeting CD38 for Multiple Indications
CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that recognizes a unique epitope and has demonstrated an encouraging pre-clinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies. CASI owns exclusive global rights to the compound.
Peer-reviewed medical literature, including publications in the New England Journal of Medicine, point to the therapeutic promise of targeting CD38 in autoimmune diseases including immune thrombocytopenia (ITP) and organ transplant rejection.
Current Clinical Development Status
The company achieved significant regulatory milestones in 2024. In May 2024, CASI announced FDA clearance of a U.S. IND application for the initiation of a Phase 1/2 study of CID-103 in adults with ITP. This was followed by clearance from the China Center for Drug Evaluation (CDE) within the National Medical Products Administration (NMPA) of China in October 2024.
The Chinese ITP study is part of the global multi-center study that was approved by the U.S. FDA and is currently enrolling and dosing patients. Additionally, a U.S. IND application for renal allograft antibody-mediated rejection (AMR) has been filed with the FDA, and the company plans to initiate a Phase 1/2 study in adults with AMR pursuant to regulatory clearance.
Strategic Focus on Specialized Therapeutics
CASI Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapeutics in China, the U.S., and globally. The company concentrates on acquiring, developing, and commercializing products that augment its focus on hematology oncology therapeutics and therapeutics for organ transplant rejection and autoimmune disease.
The company operates in China through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, and intends to leverage its China-based regulatory and commercial competencies alongside its global drug development expertise.
