Also known as: CTLA-4 Ig
BioNTech reported a Q1 2026 net loss of $622.3 million as revenue declined to $138.0 million and R&D spending rose to $651.6 million. The company expanded its oncology pipeline with five new pivotal trials for pumitamig and announced manufacturing site exits to save $584.9 million annually by 2029.
A phase 2 trial showed neoadjuvant pembrolizumab achieved a 71% pathological complete response rate in resectable desmoplastic melanoma. A real-world study found ipilimumab monotherapy after anti-PD-1 progression yielded an ORR of 10.8% and median OS of 7.6 months in advanced melanoma.
New clinical data for ANKTIVA immunotherapy in lung cancer, a study on EBV-driven resistance via ADAR1 RNA editing, and research on microbiome metabolites modulating immunotherapy response were presented at major conferences and in recent publications.
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.
The phase 3 RAMPART trial updated results show adjuvant durvalumab monotherapy did not significantly improve disease-free survival in resected renal cell carcinoma, while the durvalumab plus tremelimumab combination showed benefit in high-risk patients. Real-world treatment decisions are also shaped by patient-specific factors.
Dual immunotherapy allowed 70.6% of MSI-H gastric cancer patients to avoid surgery in the INFINITY trial. German off-label immunotherapy shows 20-25% response rates, requiring careful patient selection.
The FDA granted Fast Track designation to COYA 302 for ALS. Phase 1 data showed tolerability and biomarker effects, and the phase 2 ALSTARS trial is underway.
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.
The global cancer monoclonal antibodies market was valued at USD 66.7 billion in 2025 and is expected to reach USD 135.2 billion by 2033. Growth is being driven by targeted therapies, bispecific antibodies, ADCs and checkpoint inhibitors.
Studies on immune checkpoint inhibitor therapy found pretreatment biomarkers strongly predicted checkpoint inhibitor-associated autoimmune diabetes, while hyperglycemia during treatment was common and did not worsen disease progression.
