ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced the completion of patient enrollment for Phase I dosage escalation studies for both IMM2510 and IMM27M, with the recommended Phase II dosage (RP2D) determined for each.
IMM2510: A PD-L1/VEGF Bispecific Antibody for Solid Tumors
IMM2510, a PD-L1/VEGF bispecific antibody (BsAb) based on ImmuneOnco’s mAb-Trap technology platform, is in development for the treatment of multiple solid tumors. Pre-clinical studies have confirmed IMM2510’s significant therapeutic efficacy in various tumor models, demonstrating superiority over single or combination drugs targeting the same pathways, with added safety benefits. The Phase I dosage escalation study has yielded positive preliminary efficacy data, with responses observed across three dosage groups (3mg/kg, 10mg/kg, 20mg/kg). Notably, one partial remission (PR) was observed in lung squamous cell carcinoma patients who had previously failed PD-1 monoclonal antibody treatment in the 3mg/kg and 10mg/kg dose groups, and one thymic adenosquamous cell carcinoma PR was observed in the 20mg/kg dose group. The 20mg/kg Q2W dosage will be used as the single drug RP2D dose for IMM2510’s Phase II clinical study.
IMM27M: An ADCC Enhanced CTLA-4 Antibody Targeting Treg Cells
IMM27M, an in-house developed antibody, can comprehensively eliminate Treg cells in the tumor microenvironment. The Phase I dose escalation study for IMM27M in solid tumors is progressing smoothly, with the first patient dosed in June 2022. The overall data shows that IMM27M is well tolerated, and no dose limiting toxicity (DLT) was observed in the seven dose groups ranging from 0.1mg/kg to 7.5mg/kg. Among the participants, two patients with multiline recurrent breast cancer achieved PR after receiving 3mg/kg and 5mg/kg, respectively, and one patient with late recurrent melanoma achieved disease stability (SD) after receiving 2mg/kg. The 5mg/kg Q3W dosage will be used as the single drug RP2D dose for IMM27M’s Phase II study.
Combination Therapy and Regulatory Progress
Additionally, a Phase II clinical filing for the combination of IMM27M and IMM2510 has been accepted for review by the National Medical Products Administration (NMPA), indicating the potential for synergistic effects in treatment and the advancement towards regulatory approval.-Fineline Info & Tech
