Doer Biologics Announces First Patient Dosed in Phase Ib Clinical Trial of DR30206 for Non-Small Cell Lung Cancer

DR30206 for Injection is a Class 1 therapeutic biologic independently developed by Doer Biologics with global intellectual property rights. DR30206 is an antibody fusion protein targeting PD-L1, VEGF, and TGF-β. By blocking the PD-1/PD-L1 signaling pathway, it restores the proliferation of exhausted CD8+T cells; by specifically binding to free VEGF and TGF-β, it reduces the formation of tumor neovascularization while relieving immunosuppression, thereby achieving the purpose of killing tumors.

On June 28, 2023, Doer Biologics received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration (NMPA), approving the clinical trial application for injectable DR30206, and agreeing to conduct clinical trials of DR30206 for the treatment of patients with advanced solid tumors. On April 3, 2025, Doer Biologics received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration (NMPA), agreeing to conduct clinical trials of DR30206 in combination with standard chemotherapy for the treatment of patients with advanced or metastatic gastrointestinal tumors.

Completed non-clinical studies have demonstrated that DR30206 has a clear mechanism of action and activity in inhibiting tumor growth. The ongoing Phase I clinical trial has observed good safety and preliminary signals of anti-tumor efficacy for DR30206.

The Phase Ib clinical study plan for DR30206 in the treatment of non-small cell lung cancer aims to enroll first-line advanced or metastatic non-small cell lung cancer patients with histologically confirmed absence of EGFR-sensitive mutations and ALK gene fusions (with centrally confirmed tumor PD-L1 tumor proportion score [TPS] ≥50%). The Phase Ib study aims to evaluate the safety and preliminary anti-tumor activity of injectable DR30206 at the RDE/RP2D dose in non-small cell lung cancer and determine the recommended Phase 2 dose (RP2D) of injectable DR30206. The initial dosing of DR30206 in the Phase Ib study is 30 mg/kg, administered once every three weeks. During the study, subsequent dosing regimens and frequencies will be comprehensively assessed based on subjects' safety, tolerability, and efficacy data.