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Phase Ib/IIa clinical study of ImmuneOnco IMM01 combined with bortezomib and dexamethasone in the treatment of multiple myeloma has been approved by the National Medical Products Administration (NMPA)
2023-01-18
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On January 18, 2023, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (hereinafter referred to as "ImmuneOnco") announced that the Phase Ib/IIa clinical study of the first domestic SIRPαFc fusion protein drug targeting human CD47 (project number: IMM01) combined with boron tezomib and dexamethasone in the treatment of multiple myeloma has been approved by the National Medical Products Administration (NMPA), further establishing ImmuneOnco's position as a leader in the research and development of CD47-targeted drugs.

IMM01 has entered phase II clinical development for multiple indications, covering hematological tumors and solid tumors, involving different drug combinations (including AZA, PD1 antibody and other drugs), and the clinical development of multiple indications fully reflects the differentiation layout.

Dr. Tian Wenzhi, Founder and Chairman of ImmuneOnco, said,

"I am very pleased to know that the phase Ib/IIa clinical study of IMM01 combined with bortezomib and dexamethasone in the treatment of multiple myeloma has been approved by NMPA. Due to the differential design of our drug molecules, IMM01 has shown no interaction with red blood cells in vitro Combined, it will not cause severe anemia events. At the same time, due to the glycosylation modification, the immunogenicity of the drug is greatly reduced, the pharmacokinetic parameters are improved, and the bioavailability of the drug is significantly improved, so that the dose can be climbed in the single-drug clinical phase I. The slope stage showed good safety and efficacy. During the single-drug dose escalation process, 2 cases of complete remission (CR) and 1 case of partial remission (PR) appeared in patients with relapsed and refractory lymphoma who had undergone repeated treatment. One of the patients has been in long-term remission for more than 2 years. In addition, it is particularly important that complete remission has been observed in the previously enrolled CMML, MDS and AML patients, which is expected to bring long-term survival opportunities to patients We will work closely with clinical experts and subjects to accelerate the clinical trial research of IMM01 and benefit cancer patients as soon as possible."