IMMUNEONCO-B (01541): The U.S. Food and Drug Administration has approved the IND application for the Phase Ib/II clinical trial of IMM0306 for the treatment of systemic lupus erythematosus.

IMMUNEONCO-B (01541) announced that the group has obtained approval from the U.S. Food and Drug Administration for the investigational new drug (IND) application for the Ib/II phase clinical trial of IMM0306 for the treatment of systemic lupus erythematosus (SLE). IMM0306, independently developed by the group, is a bispecific molecule targeting cluster of differentiation 47 (CD47) and cluster of differentiation 20 (CD20). It is the world's first CD47 and CD20 dual-targeting bispecific molecule to enter clinical stages. IMM0306 inhibits the CD47-SIRP interaction to block the "don't eat me" signal, enhances the Fc-FcRIIa and Fc-FcRIIIa interactions to activate macrophages and NK cells, and preferentially binds to CD20 rather than CD47, effectively eliminating malignant B cells while minimizing toxicity, thus improving therapeutic efficacy. As of the date of this announcement, the group holds global intellectual property and commercialization rights for IMM0306.