FDA Clears IND Application for CID-103 in Immune Thrombocytopenia

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Announced on May 15, 2024, the IND application supports a phase 1/2 study of CID among adults with chronic ITP.

FDA Clears IND Application for CID-103 in Immune Thrombocytopenia | Image Credit: US Food and Drug Administration

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for CID-103 for the treatment of adults with chronic immune thrombocytopenia (ITP).1

Announced by CASI Pharmaceuticals on May 15, 2024, the IND application was initially submitted to the FDA in April to support a phase ½ study of CID-103 in adults with ITP. On May 13, the company received a letter from the FDA stating the study may move forward.

“ITP is a serious autoimmune blood disorder characterized by autoantibody-mediated platelet destruction and impaired platelet production, leading to thrombocytopenia and an increased risk of life-threatening bleeding episodes,” Wei-Wu He, PhD, chief executive officer of CASI Pharmaceuticals, said in a statement. “We are excited to advance this program into clinical development as CID-103 has the potential to represent a new therapeutic option to help alleviate the disease burden in this patient community."

The therapy, CID-103, is a fully human IgG1 monoclonal antibody (Mab) directed against the cell glycoprotein ADP-ribosyl cyclase 1 (CD83), with potential antineoplastic activity. At administration, CID-103 specifically targets and binds to CD38 expressions. CD83 is a type II glycoprotein present on various immune cells and hematologic malignancies.

Early preclinical data of CID-103 have suggested enhanced activity against malignancies and a better preclinical safety profile, compared with other anti-CD38 monoclonal antibodies, according to CASI Pharmaceuticals. The company is also evaluating CID-103 in a phase 1 dose escalation and expansion trial for relapsed or refractory multiple myeloma.

“CID-103 has previously shown encouraging preclinical efficacy, a favorable safety profile and greater antibody-dependence cellular cytotoxicity activity over other anti-CD38 mAbs, and we are hopeful this will translate into patient benefit,” He previously stated. "This Phase 1 trial will generate valuable information and has the potential to provide early evidence of clinical activity in the treatment of multiple myeloma.”

References

  1. Pharmaceuticals C. Casi Pharmaceuticals receives FDA clearance on the Investigational New Drug (IND) application for CID-103 in immune thrombocytopenia (ITP). PR Newswire: press release distribution, targeting, monitoring and marketing. May 15, 2024. Accessed May 15, 2024. https://www.prnewswire.com/news-releases/casi-pharmaceuticals-receives-fda-clearance-on-the-investigational-new-drug-ind-application-for-cid-103-in-immune-thrombocytopenia-itp-302145848.html.
  2. CASI Pharmaceuticals Announces Dosing Of First Patient Of CID-103 In Phase 1 Clinical Trial For Relapsed Or Refractory Multiple Myeloma. June 2021. Accessed May 15, 2024. https://www.casipharmaceuticals.com/mediapress/19.153.html.
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