• Originator Biotheus
• Developer BioNTech; Biotheus; Bristol-Myers Squibb; Duality Biologics; Genmab
• Class Antineoplastics; Bispecific antibodies; Immunotherapies
• Mechanism of Action Antibody-dependent cell cytotoxicity; Programmed cell death-1 ligand-1 inhibitors; T lymphocyte stimulants; Vascular endothelial growth factor A inhibitors

• Orphan Drug Status

  Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  Yes - Small cell lung cancer
• New Molecular Entity Yes

Highest Development Phases

• Phase III Small cell lung cancer; Triple negative breast cancer
• Phase II/III Colorectal cancer; Non-small cell lung cancer
• Phase II Liver cancer; Malignant-mesothelioma; Neuroendocrine tumours; Solid tumours
• Phase I/II HER2 positive breast cancer; Lung cancer

Most Recent Events

• 29 Dec 2025 BioNTech plans a phase II trial in Glioblastoma (Recurrent, Second-line therapy or greater, Monotherapy, Combination therapy) (IV, Infusion), in January 2026 (NCT07297212)
• 22 Dec 2025 Bristol-Myers Squibb and BioNTech SE plan the phase I/II ROSETTA HCC-206 trial for Liver cancer (Combination therapy, First-line therapy, Inoperable/Unresectable, Late-stage disease, Monotherapy) in USA, Australia, Chile, China, France, Germany, Italy, Poland, Singapore, South Korea, Spain, Taiwan, United Kingdom (IV), in February 2026 (CTIS2025-523602-33), (NCT07291076)
• 19 Dec 2025 Bristol-Myers Squibb plans a phase I/II ROSETTA RCC-208 trial for Renal cell carcinoma (Monotherapy, Combination therapy, Late-stage disease, Inoperable/unresectable, Metastatic disease) in the UK, Switzerland, Spain, South Korea, Romania, Mexico, Japan, Italy, Ireland, Germany, France, Finland, Colombia, Czech Republic, Chile, Canada, Brazil, Australia, Argentina and US in March 2026 (Parenteral) (NCT07293351)