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CASI Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients with organ transplant rejection and autoimmune diseases, announced FDA clearance of an IND application for CID-103, an anti-CD38 monoclonal antibody in adults with active and chronic active renal allograft antibody mediated rejection (AMR). The phase 1 clinical trial is a dose-ranging and safety study evaluating the tolerability and efficacy of CID-103 in patients with AMR.
"Antibody-mediated rejection remains a significant challenge in kidney transplantation, with limited safe and effective treatment options currently available for those patients whose disease that has progressed," said Alex Zukiwski, M.D., chief medical officer of CASI. "New therapeutic treatment options are urgently needed for patients with resistant AMR."
"This IND for CID-103 is a significant milestone in our mission at CASI to develop innovative therapies for patients with organ transplant rejection and autoimmune diseases," said David Cory, CEO of CASI. "We look forward to providing guidance in the future regarding the CID-103 development programme."
CID-103 is a fully human IgG1, potentially best-in-class, anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated an encouraging pre-clinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies, and for which CASI owns exclusive global rights. A body of evidence demonstrates the therapeutic promise of targeting CD38 in autoimmune diseases and organ transplant rejection. The CID-103 IND/CTA for immune thrombocytopenic purpura (ITP) has been approved by FDA and Chinese Health Authority and is actively recruiting and dosing patients. FDA has approved the IND application for renal allograft antibody-mediated rejection (AMR). The company plans to initiate a phase 1 study in adults with active and chronic active renal allograft AMR.
CASI Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the US, and throughout the world.
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