MediLink Therapeutics has announced early data with a HER3 antibody drug conjugate (ADC) that the biotech is codeveloping with BioNTech, showcasing its safety profile and early efficacy signals.

YL202/BNT326 is being jointly developed by the Suzhou, China-based biotech and BioNTech under a licencing agreement signed in October 2023.

Results for this Phase I study (NCT05653752) will be shared at the upcoming American Society of Clinical Oncology (ASCO) 2024 conference, which will see pharma, healthcare providers, and experts congregate to discuss the latest trends in oncology and share new data from clinical studies. The conference will be held on 31 May – 4 June in Chicago.

YL202/BNT326 is an ADC designed to target cells expressing HER3 and inhibit topoisomerase 1 by delivering a cytotoxic payload to the cell, which results in the blocking of DNA replication and transcription, and ultimately, cell apoptosis.

The Phase I study is actively recruiting patients with EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior treatments with a third-generation TKI and platinum-based chemotherapy, in addition to patients with HR-positive and HER2-negative breast cancer.

According to the ASCO abstract, YL202/BNT326 demonstrated “encouraging” efficacy in patients with pretreated locally advanced and metastatic NSCLC and breast cancer. Among 46 evaluable patients, there was one reported complete response, 16 partial responses, and 26 patients with stable disease.

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The drug candidate also demonstrated an adequate safety and tolerability profile. Of the 52 participants enrolled in the dose escalation and backfilled cohorts for certain doses, the trial recorded one Grade 3 dose limiting toxicity event of febrile neutropenia which occurred in the highest dose group in the dose escalation stage. In the DL3 to DL5 dose range, overall response rate was 41% across all tumour types.

Other treatment related adverse events (TRAEs) such as anemia, nausea, vomiting, dry mouth, fatigue, stomatitis, alopecia, as well as decreased white blood cell, neutrophil counts, appetite, lymphocyte counts, and platelet counts, were also observed.

The study’s primary completion is expected in December 2024, as per

MediLink joins the growing list of companies presenting clinical results with their ADCs at the ASCO conference. Merck & Co will present data from its Phase III study (NCT06312176) of sacituzumab tirumotecan, an ADC being evaluated in patients with previously treated locally recurrent or metastatic triple-negative breast cancer.

Pfizer also plans to present data from the Phase III ECHELON-3 study (NCT04404283) of its ADC Adcetris (brentuximab vedotin), an asset gained through the $43bn acquisition of Seagen. The drug was evaluated in combination with lenalidomide and rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).