Suzhou-based biotech MediLink Therapeutics (Suzhou) Co., Ltd has announced a partnership with US pharmaceutical giant Amgen Inc. (NASDAQ: AMGN). The collaboration will see the two companies conduct a global clinical trial combining MediLink’s B7-H3-targeting antibody-drug conjugate (ADC) YL201 with Amgen’s DLL3- and CD3-targeting bispecific T-cell engager (BiTE) IMDELLTRA for the treatment of extensive-stage small cell lung cancer (ES-SCLC).
The open-label, global, multi-center Phase Ib clinical study, led by Amgen, aims to evaluate the safety, tolerability, pharmacokinetics, and efficacy of the combined regimen in patients with ES-SCLC. Both YL201 and IMDELLTRA have demonstrated potential in this indication. IMDELLTRA received accelerated approval from the US FDA in May for use as a monotherapy for ES-SCLC patients who have failed chemotherapy. YL201, on the other hand, has shown positive results in Phase I/II trials for the treatment of SCLC patients.Limertinib is an orally administered, novel third-generation EGFR TKI, with two New Drug Applications (NDAs) filed in China. The first NDA targets adult patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed after prior EGFR TKI therapy. The second NDA is for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations.- Flcube.com
