The FDA has cleared CStone Pharmaceuticals' investigational new drug application to begin a Phase II trial of its trispecific antibody CS2009 in advanced solid tumors. The multicenter trial will evaluate monotherapy and combination regimens across nine cancer types in Australia, China, and the U.S. Initial Phase I data showed a favorable safety profile and encouraging antitumor activity.
Two new interchangeable Lucentis biosimilars — Lupin's Ranluspec and Formycon/Bioeq's Nufymco — have received FDA approval, while Xbrane's Lucamzi is under review with an October target date. The Lucentis global market was valued at $630 million in 2024.
European biotechs are exploring new immunotherapy targets beyond PD-1/PD-L1, including BTLA, TIGIT, and SLAMF6. Lund University researchers discovered a SLAMF6-mediated immune evasion mechanism. BioNTech and GenMab are advancing next-generation ICIs and bispecific antibodies through strategic partnerships.
Compass Therapeutics reported mixed Phase 2/3 data for tovecimig in biliary tract cancer and plans to meet with the FDA for a BLA discussion. The study met its primary ORR endpoint (17% vs 5%), while PFS and OS data are due late this quarter.
Samsung Bioepis reached settlement agreements with Regeneron and Bayer for its aflibercept biosimilar OPUVIZ, enabling U.S. launch in January 2027 and staged international rollout beginning early 2026.
The FDA has approved an expanded label for Sandoz's aflibercept biosimilar Enzeevu to include multiple retinal indications beyond its original approval for neovascular age-related macular degeneration. The product is expected to launch in the US in Q4 2026.
CStone Pharmaceuticals has received FDA clearance for its IND application to initiate a Phase II trial of CS2009, a trispecific antibody targeting PD-1, VEGFA, and CTLA-4, in patients with advanced solid tumors across nine cancer indications.
DNA methylation-derived Protein EpiScores significantly improved prognostic accuracy for colorectal cancer survival when added to traditional clinical risk factors, raising concordance indices from 0.64 to 0.70 for disease-free survival and 0.70 to 0.75 for overall survival.
CStone Pharmaceuticals received FDA IND clearance to initiate a Phase II trial of CS2009, a PD-1/VEGF/CTLA-4 trispecific antibody, in patients with advanced solid tumors across nine cancer indications.
CStone Pharmaceuticals received FDA IND clearance to begin a Phase II trial of CS2009, a trispecific antibody targeting PD-1, VEGF, and CTLA-4, in advanced solid tumors across nine cancer indications.
