China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy and safety of its drug candidate BL-B01D1 as a treatment for solid tumors. The study will evaluate the drug both in combination with chemotherapy and in combination with SI-B003, with or without chemotherapy.
BL-B01D1: An Innovative EGFR/HER3 ADC
BL-B01D1 is an in-house developed antibody-drug conjugate (ADC) targeting EGFR and HER3. It is currently subject to five Phase Ia/Ib clinical studies covering 16 solid tumors. Over 200 subjects with 12 solid tumors have been enrolled in studies for BL-B01D1 as a monotherapy. Data from these studies show that BL-B01D1 alone had a strong signal of efficacy in all 12 tumors, with a good safety profile at the Phase II recommended dose (RP2D). The drug has the potential to advance to pivotal regulatory clinical trials in patients with non-small cell lung cancer and end-line nasopharyngeal carcinoma.
SI-B003: A Bispecific Antibody with Promising Efficacy
SI-B003 is a bispecific antibody (BsAb) targeting PD-1 and CTLA-4. It has demonstrated clear efficacy signals in multiple solid tumors in Phase I studies as a monotherapy, along with a good safety profile. A Phase Ib/II study for SI-B003 combined with EGFR/HER3 BsAb SI-B001 in first-line squamous cell carcinoma of the head and neck is currently underway.-Fineline Info & Tech
