Suzhou, China, Jan 14, 2025 -- MediLink Therapeutics (Suzhou) Co., Ltd. ("MediLink"), a clinical-stage biotech company, announced that a clinical collaboration has been established with AstraZeneca to explore the therapeutic potential in solid tumors, of the combination of MediLink's B7-H3-targeting antibody-drug conjugate (ADC) YL201 and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® ( durvalumab).

A multicenter, open-label, phase I/Ib study will be initiated to evaluate the safety, efficacy, and pharmacokinetics of YL201 combined with durvalumab in patients with solid tumors.

Durvalumab has been approved globally for the treatment of several solid tumors, either in monotherapy or with chemotherapy. YL201 is currently under clinical development for a variety of advanced solid tumors. Phase I/II clinical data of YL201 has been presented recently, at the 2024 European Society for Medical Oncology (ESMO) Congress, showing encouraging antitumor activity and safety of YL201 in multiple solid tumor types, including small cell lung cancer, nasopharyngeal carcinoma, and non-small cell lung cancer without actionable genomic alterations. The combinational potential of ADCs and immune checkpoint inhibitors have been demonstrated previously, and preclinical studies have shown the synergy of YL201 combined with durvalumab. This clinical collaboration is expected to explore the opportunity to offer further treatment options for a series of solid tumors.

About YL201

YL201 is an innovative antibody-drug conjugate that specifically targets B7H3. B7H3 is overexpressed on differentiated malignant cells and cancer-initiating cells of various tumor types, but has a restricted expression in normal tissue, indicating its potential as ADC drug. YL201 has been developed by utilizing MediLink's Tumor Microenvironment Activable LINker-payload (TMALIN®) conjugated with a highly specific B7-H3 antibody. YL201 has accumulated clinical data from a sample size of over 300 patients in multi-center phase I/II studies in China and the US.  Currently, Phase III clinical studies for YL201 are being actively prepared.

About MediLink Therapeutics

MediLink Therapeutics, founded in 2020, is a clinical stage biotech company dedicated to developing conjugated drugs with global competitiveness. MediLink has developed its proprietary TMALIN® ADC technology platform, enabling the generation of homogeneous ADC with high drug-antibody ratio and improved therapeutic window for the treatment of solid tumors. MediLink aims to provide improved treatment options for global patients and address unmet medical needs. The company is headquartered in Suzhou, China and has established R&D sites in Shanghai, China and Boston, US.