CPO301 granted the fast track designation by U.S. FDA for the treatment of adult patients with NSCLC
“CPO301 (also known as SYS6010 in China), a first-in-class epidermal growth factor receptor (‘‘EGFR’’) antibody drug conjugate (ADC), has been granted the third Fast Track designation by the U.S. Food and Drug Administration (‘‘FDA’’) for the treatment of adult patients with advanced or metastatic non-squamous non-small cell lung cancer (Nsq-NSCLC) without EGFR mutations or other actional genomic alterations (AGA), with prior disease progression on platinum-based chemotherapy and an anti-PD-(L)1 antibody.”
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“Antengene announced it has entered into a global clinical collaboration with MSD to evaluate the combination of ATG-022, a CLDN18.2-targeting antibody-drug conjugate (ADC), and MSD’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors. At the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2025), Antengene
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“EMA approval of the MIRACLE trial protocol is a huge milestone for us. Although we’re already seeing recruitment in our first non-EU country, we believe that this expansion into the EU really supercharges our recruitment potential,” said Walter Klemp, Chairman and CEO of Moleculin. “Importantly, when combined with the sites
