Yilian Bio Announces Global Clinical Trial Collaboration and Drug Supply Agreement for YL201 in Combination with Amgen’s IMDELLTRA™

Oct 08, 2024 09:40 CST Updated 09:40

MediLink

Antibody-Drug Conjugates Developer

Amgen

Developer of Treatment Drugs for Serious Diseases

Suzhou, China, October 8, 2024 - MediLink Therapeutics (referred to as "MediLink"), a clinical-stage biotechnology company, today announced a global clinical research and drug supply collaboration agreement with Amgen. Under the collaboration agreement, Amgen will lead a global clinical study to evaluate the potential of MediLink’s B7-H3-targeted antibody-drug conjugate YL201 in combination with Amgen's DLL3 and CD3 bispecific T-cell engager (BiTE®) IMDELLTRA™ for the treatment of extensive-stage small cell lung cancer (ES-SCLC). MediLink will provide the investigational drug YL201 for the combination study.

This global multicenter, open-label Phase Ib clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of YL201 in combination with IMDELLTRA™ in patients with ES-SCLC.

YL201 and IMDELLTRA™ have both demonstrated potential in the ES-SCLC field. In May this year, IMDELLTRA™ received accelerated FDA approval for the treatment of adult patients with ES-SCLC who have progressed during or after platinum-based chemotherapy. The accelerated approval of this indication is based on ORR and DoR data, with full approval contingent upon further verification and clarification of its clinical efficacy in confirmatory trials. Currently, IMDELLTRA™ is commercially available in the U.S. market. YL201 monotherapy has also shown excellent efficacy in ES-SCLC, and MediLink has announced the Phase I/II clinical trial results of YL201 in patients with advanced solid tumors, including SCLC, at the 2024 European Society for Medical Oncology (ESMO). This combination collaboration will explore the potential of the two innovative drugs in ES-SCLC treatment, with the potential synergistic effects of YL201 and IMDELLTRA™ expected to further enhance clinical benefits.

SCLC is an aggressive high-grade neuroendocrine tumor with a very poor prognosis. Each year, there are approximately 2.4 million new cases of lung cancer globally, of which SCLC accounts for about 15%, with around 360,000 new cases.Approximately two-thirds of patients with small cell lung cancer (SCLC) are diagnosed with extensive-stage disease (ES-SCLC), characterized by distant metastases or tumor spread beyond the scope of a single radiation treatment. Compared to patients with limited-stage disease (LS-SCLC), those with ES-SCLC have a poorer prognosis, with a median overall survival of approximately 12 months after initial treatment and a 5-year overall survival rate of about 3%.

YL201 is an antibody-drug conjugate (ADC) targeting B7-H3 developed by MediLink. B7-H3 is overexpressed on the differentiation and initiating cells of various malignant tumors but has limited expression in normal tissues, showing potential for ADC drug development. YL201 leverages MediLink's next-generation proprietary tumor microenvironment-activatable novel toxin linker platform technology (TMALIN®) conjugated with a highly specific B7-H3 antibody. Currently, YL201 is undergoing four Phase I or II studies, including an international multicenter Phase I clinical trial.

IMDELLTRA™ is a first-in-class targeted immunotherapy developed by Amgen. It can simultaneously bind to DLL3 on tumor cells and CD3 on T cells, activating T cells to form cytolytic synapses and kill DLL3-expressing SCLC cells. DLL3 is expressed on the surface of tumor cells in approximately 85-96% of SCLC patients but is rarely expressed on healthy cells. This differential expression makes DLL3 a potential target for the diagnosis and treatment of SCLC.

MediLink, founded in 2020, is a clinical-stage biotechnology company focused on developing innovative conjugate drugs. The company has developed a next-generation proprietary tumor microenvironment-activatable novel toxin linker platform technology (TMALIN®) can achieve stable conjugation with high DAR values and high uniformity, which helps to improve the therapeutic window of ADC drugs for solid tumor indications. The company is committed to targeting unmet clinical needs and bringing better treatment options to cancer patients worldwide. MediLink is located in Suzhou, China, with research and development branches established in Shanghai, China, and Boston, USA.