CASI Pharmaceuticals Announces Submission Of Clinical Trial Application (IND) To Conduct Phase 1 Study For Anti-38 Monoclonal Antibody Program

On June 8, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that it submitted a Clinical Trial Application (CTA) (IND) with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for CID-103, its novel anti-CD38 monoclonal antibody for the treatment of multiple myeloma and other hematological malignancies (Press release, CASI Pharmaceuticals, JUN 8, 2020, View Source [SID1234560911]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Wei-Wu He, Ph.D., CASI’s Chairman and Chief Executive Officer, commented, "Submitting this CTA is an important step in the clinical development of this promising therapy in our hematology oncology franchise. CID-103 demonstrated encouraging efficacy in preclinical models and we believe it has the potential to be best in class and can offer meaningful clinical benefits over the standard of care for patients with CD38 malignancies, including multiple myeloma."

Alexander Zukiwski, M.D., CASI’s Chief Medical Officer commented, "We look forward to launching our study for this novel biological entity as a potential treatment for patients with hematological malignancies. We will continue to monitor the COVID-19 related circumstances in the UK and are working on administrative activities in support of this trial. Based on the current environment and timetable of our clinical sites, we are targeting the study initiation in late 2020 or early 2021."

About CID-103 (Anti-CD38 Mab)

CID-103 (f/k/a TSK011010) is a novel anti-CD38 monoclonal antibody program. CASI licensed the global rights to CID-103, from Tusk Therapeutics, Ltd in April 2019. Preclinical data demonstrate CID-103 possesses enhanced activity against a broad array of malignancies expressing CD38, and potentially enhance safety and efficacy benefits when compared to other CD38 monoclonal antibodies. CASI maintains exclusive global rights to CID-103.