Onco-Summaries: Daily Oncology Updates at a Glance

05/09/2025

CERo Therapeutics' CER-1236 received the FDA Fast Track Designation for AML (Ref)

The US FDA granted the Fast Track Designation to CERo Therapeutics' CER-1236 (TIM-4 ligand targeting CER-T therapy) for the treatment of Acute Myeloid Leukemia (AML).

• Chris Ehrlich, CEO, CERo Therapeutics: “These FDA designations are important additional validation with regard to the urgency of the condition as well as the potential that the agency sees in the existing data as submitted. Further, these designations help to decrease the potential time to market and provide additional benefits across the FDA process that are expected to prove both medically and financially valuable. We continue to believe that CER-1236 represents a truly novel approach to cancer immunotherapy and are gratified by this regulatory milestone.”

Phase 3 Dynasty-Breast01 trial of trastuzumab pamirtecan met its primary endpoint of PFS in HER2+ve breast cancer (Ref)

The pivotal Phase 3 Dynasty-Breast01/NCT06265428 trial of BioNTech and Duality Biologics' trastuzumab pamirtecan (BNT323/DB-1303; HER-2 ADC) vs trastuzumab emtansine met its primary endpoint of PFS at a pre-specified interim analysis in patients with HER2+ve, unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane-based chemotherapy.

• DualityBio plans to discuss the next steps with the CDE of China's NMPA regarding the submission of a BLA of trastuzumab pamirtecan

  
  

• To note, BioNTech holds global commercial rights to trastuzumab pamirtecan (excluding Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region), while DualityBio has commercial rights for Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region.