Doer Biologics Announces First-in-Human Dosing of DR30206 in Phase I Clinical Trial for Advanced Solid Tumors in China
Doer Biologics
Biological Drug Developer
Hangzhou, China, December 5, 2023 — Zhejiang Doer Biologics Co., Ltd. ("Doer Biologics"), a clinical-stage biopharmaceutical company developing innovative biotherapeutics for metabolic diseases and cancer, today announced the development of its...Three-Target Multi-Specific Innovative Drug DR30206The Phase I clinical trial for the treatment of advanced solid tumors has successfully enrolled the first participant (First-Patient-In, FPI) at Shanghai Pulmonary Hospital affiliated with Tongji University, and completed the first human dosing (First-In-Human, FIH).
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 goal of killing tumors. To date, there are no antibody fusion protein drugs targeting PD-L1, VEGF, and TGF-β simultaneously available on the market worldwide.
Doer Biologics received the "Clinical Trial Approval Notice" issued by the National Medical Products Administration (NMPA) on June 28, 2023. The clinical trial application for injectable DR30206 was approved, allowing the product to proceed with clinical trials for advanced solid tumors. The Phase I clinical study of DR30206 in China is divided into two parts (Part A and Part B). Part A is the dose escalation phase, which aims to evaluate the safety and tolerability of injectable DR30206 in subjects with advanced solid tumors, exploring the maximum tolerated dose (MTD) and the recommended expansion dose (RDE). Part B is the dose expansion phase, which aims to assess the preliminary anti-tumor activity of injectable DR30206 at the RDE/RP2D dose in specific tumor types; evaluate the safety of injectable DR30206; and determine the recommended Phase 2 dose (RP2D) for injectable DR30206.
Dr. Huang Yanshan
Founder & CEO of Doer Biologics
Dr. Huang Yanshan, founder and CEO of Doer Biologics, stated: "DR30206 is an innovative trispecific biologic drug designed, modified, and developed using Doer Biologics' proprietary SMART-VHHBody and MultipleBody® platform technologies. It exhibits high affinity and excellent specificity for the three targets: PD-L1, VEGF, and TGF-β. In preclinical experiments, DR30206 demonstrated strong anti-tumor activity across multiple different solid tumor models."
Dr. Yongliang Fang
Chief Operating Officer of Doer Biologics
Dr. Yongliang Fang, Chief Operating Officer of Doer Biologics, commented: "We are encouraged by the progress of the Phase I clinical study of DR30206 currently underway in China. The enrollment and dosing of the first subject at Shanghai Pulmonary Hospital affiliated with Tongji University marks an important advancement in the clinical development of DR30206 in China. We look forward to DR30206 providing a new treatment option for patients with solid tumors in the future."
More information about the Phase I clinical trial of DR30206 in China can be found on the Drug Clinical Trial Registry and Information Disclosure Platform (Registration No.: CTR20233502).
About Doer Biologics
Zhejiang Doer Biologics Co., Ltd. ("Doer Biologics") is a clinical-stage biopharmaceutical company focused on the discovery and development of multi-specific biotherapeutics based on multi-domain structures to address unmet medical needs in the fields of metabolic diseases and cancer.
Doer Biologics has developed a variety of proprietary platform technologies, including xLONGylation®, MultiBody®, AccuBody®, and SMART-VHHBody.
For more information about Doer Biologics, please visit www.doerbio.com.