Botensilimab

Brazil emerges as a key hub for oncology clinical trials, with Roche leading in trials for drugs like Atezolizumab and Pertuzumab. NSCLC trials dominate, reflecting high lung cancer rates. Phase III trials prevail, supported by CROs, indicating Brazil's role in late-stage cancer treatment development.

In July 2024, the FDA made significant strides in cancer treatment approvals and designations, including the approval of FoundationOne Liquid CDx for BRCA-mutated mCRPC and Guardant Shield for colorectal cancer detection. Fast track designations were granted to therapies like OBX-115 for melanoma and AIC100 for thyroid cancer. The FDA also accepted BLAs for treatments targeting SR-aGVHD and EBV+ PTLD, and mandated phase assessments for NSCLC perioperative regimens, aiming to improve patient outcomes.

Agenus announced a $100M royalty financing agreement with Ligand Pharmaceuticals to support its BOT/BAL program, aiming for a Phase 3 study in colorectal cancer. The company reported a Q1 2024 net loss of $63.5M, with a cash balance of $52.9M. Agenus is preparing for a BLA submission and anticipates significant developments in its cancer treatment programs.