The advent of bispecific antibodies bridging two different cell types has enabled a new level of cell specificity in cancer biology that has only recently begun to be realized in the clinic.
Researchers at GM Biosciences Inc. have reported developed a novel CD38xCD3 bispecific IgM T-cell engager IGM-2644 with 10 binding sites for human CD38 (Kd=0.27nM; measured by biolayer interferometry) and one anti-CD3 site (Kd=2.1nM) designed to reduce safety concerns.
Aptevo Therapeutics Inc. has filed a provisional patent with the U.S. Patent and Trademark Office (USPTO) pertaining to an anti-PD-L1 x anti-CD40 bispecific antibody, APVO-711, with the potential to treat a range of solid malignancies such as head and neck squamous cell carcinoma, melanoma and carcinomas of the lung, gastrointestinal tract and colon.
Simcere Pharmaceutical Group Ltd. has received IND approval from China's National Medical Products Administration (NMPA) for two immuno-oncology bispecific antibodies, SIM-0348 and SIM-0237.
Two weeks ahead of its Jan. 6, 2023, PDUFA date, the U.S. FDA has approved the bispecific Lunsumio (mosunetuzumab) to treat adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. It’s the first bispecific antibody approved for treating any type of non-Hodgkin lymphoma (NHL). FL is the most common slow-growing form of NHL.
Elpiscience Biopharmaceuticals Inc. has announced Center of Drug Evaluation (CDE) clearance of its IND application for ES-014 for a phase I study in patients with advanced solid tumors.
CD40-targeting therapies have been proposed as an interesting alternative to overcome resistance to immune checkpoint inhibitors. In particular, bispecific CD40 antibodies can target CD40 more efficiently and safely than monospecific therapies. In a recent publication, researchers at Alligator Bioscience AB and collaborators demonstrate that bispecific antibodies targeting CD40 and tumor-associated antigens (TAA) can enhance priming of tumor-specific T cells in vivo.
Context Therapeutics Inc. has selected CTIM-76, a T cell-engaging bispecific antibody, as its lead clinical development candidate to target Claudin-6 (CLDN6)-positive cancers. Resulting from a research collaboration and licensing agreement with Integral Molecular Inc., CTIM-76 is a CLDN6 x CD3 bispecific antibody that incorporates a highly selective CLDN6 binding arm and a CD3 binding single-chain Fv domain in an IgG format with a silenced Fc that is designed to be functionally monovalent to avoid aberrant T-cell activation and to enhance the safety profile.
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