IMMUNEONCO-B (01541) announced that the company has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the Phase III clinical study protocol of IMM0306 combined with lenalidomide in treating relapsed/refractory follicular lymphoma. This marks an acceleration in the development of innovative therapies for this condition.
IMM0306, independently developed by the group, is a bispecific molecule targeting both CD47 and CD20, making it the first globally to enter clinical-stage development as a dual-targeting bispecific molecule for these markers. IMM0306 works by inhibiting the CD47-SIRPα interaction to block the "don't eat me" signal, while enhancing Fc-FcγRIIa and Fc-FcγRIIIa interactions to activate macrophages and NK cells. It preferentially binds to CD20 over CD47, effectively eliminating malignant B cells while minimizing toxicity, thereby improving therapeutic outcomes.
As of the announcement date, the group holds global intellectual property and commercialization rights for IMM0306.
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