MediLink Unveils Global Trial and Supply Deal for YL201 Combo Therapy

SUZHOU, China, Oct. 7, 2024 /PRNewswire/ -- MediLink Therapeutics (Suzhou) Co., Ltd. ("MediLink"), a clinical-stage biotech company, has entered into a global clinical trial collaboration and supply agreement with Amgen Inc. The collaboration focuses on a global clinical study to assess the therapeutic potential of combining MediLink's B7-H3-targeting antibody-drug conjugate (ADC) YL201 with Amgen's DLL3- and CD3-targeting bispecific T-cell engager (BiTE®) IMDELLTRA™ in patients with extensive-stage small cell lung cancer (ES-SCLC). MediLink will supply the investigational drug YL201 for this study.

The global, multi-center Phase Ib clinical study is open-label and aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of the YL201 and IMDELLTRA™ combination in ES-SCLC patients.

Both YL201 and IMDELLTRA™ have shown promising results in ES-SCLC. In May 2024, IMDELLTRA™ received accelerated approval from the FDA for treating adult patients with ES-SCLC who have experienced disease progression after platinum-based chemotherapy. This approval is contingent upon continued clinical benefits being demonstrated in confirmatory trials. Meanwhile, YL201 has shown encouraging efficacy as a monotherapy in ES-SCLC. MediLink recently presented data from a Phase I/II clinical trial of YL201 for advanced solid tumors, including SCLC, at the ESMO Congress 2024. This collaboration aims to explore the combined potential of these two innovative drugs for ES-SCLC treatment, introducing a novel and synergistic mechanism of action for clinical benefit.

About ES-SCLC

Small cell lung cancer (SCLC) is an aggressive, high-grade neuroendocrine carcinoma with poor outcomes. SCLC accounts for approximately 15% (around 0.36 million new cases) of the 2.4 million new lung cancer cases worldwide each year. Around two-thirds of SCLC patients are diagnosed with extensive-stage (ES) disease, characterized by tumors with distant metastasis or spread beyond a region treatable by a single radiation field. Compared to limited-stage (LS) SCLC, ES-SCLC has a worse prognosis, with a median overall survival of about 12 months following initial therapy and a five-year overall survival rate of just 3%.

About YL201

YL201 is an advanced ADC that targets B7-H3, a protein overexpressed on various malignant cells and cancer-initiating cells in multiple tumor types but with limited expression in normal tissues. This makes B7-H3 a promising target for ADC drugs. YL201 is developed using MediLink's proprietary Tumor Microenvironment Activable LINker-payload (TMALIN®) technology, conjugated with a highly specific B7-H3 antibody. YL201 is currently being evaluated in four Phase I or II studies, including a global Phase I clinical study.

About IMDELLTRA™

IMDELLTRA™ is a pioneering immunotherapy created by Amgen that binds to both DLL3 on tumor cells and CD3 on T cells, activating T cells to destroy DLL3-expressing SCLC cells. DLL3 is present on the surface of SCLC cells in approximately 85-96% of patients but is minimally expressed on healthy cells, making it an exciting therapeutic target.

About MediLink Therapeutics

Founded in 2020, MediLink Therapeutics is a clinical-stage biotech company committed to developing competitive conjugated drugs. The company has developed the TMALIN® ADC technology platform, which allows the creation of homogeneous ADCs with high drug-antibody ratios and improved therapeutic windows for solid tumor treatments. MediLink, headquartered in Suzhou, China, also has research and development sites in Shanghai, China, and Boston, USA. The company's goal is to provide better treatment options globally and address unmet medical needs in cancer therapy.