Chemotherapy Regimen 1

Chemotherapy Regimen 1 is a trial-specific designation for a combination chemotherapy backbone used in clinical studies sponsored by Biotheus Inc. (a subsidiary of BioNTech), most notably the Phase II trial NCT07133750. This regimen is evaluated as a first-line treatment for patients with metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS) or mismatch repair proficient (pMMR), administered in combination with the bispecific antibody Pumitamig (PM8002/BNT327). Chemotherapy Regimen 1 is defined as an entirely intravenous (IV) treatment administered every two weeks (Q2W). It typically consists of standard-of-care cytotoxic combinations such as FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or FOLFIRI (fluorouracil, leucovorin, and irinotecan), with the specific choice of agents determined by the investigator. The regimen provides a cytotoxic foundation that works in tandem with PM8002's dual inhibition of PD-L1 and VEGF-A to enhance anti-tumor activity.