FDA Fast Track Designation for Cesalatamig in NSCLC
“This designation reflects the clinical safety and efficacy signals we have seen in our global Phase 1/2 trials, BiPAVE-001 US and BiPAVE-001 China.” said Dr. Yang Liu, Co-founder, Chief Executive Officer and Chief Scientific Officer of OncoC4. “We are rapidly advancing to registrational phase 3 development in PD-(L)1-refractory or resistant NSCLC and other indications”.
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Akeso, Inc. announced that AK158D1, its investigational next-generation bispecific antibody-drug conjugate (ADC) targeting EGFR and TROP2, has secured Phase I clinical trial clearance from the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA). The trial will assess the candidate in patients with advanced malignant solid tumors.
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