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.
Biotheus Inc. out-licensed Chinese rights to its preclinical EGFR/MET bispecific antibody, PM-1080, to Hansoh Pharmaceutical Group Co. Ltd. for ¥50 million (US$359,150) up front and up to ¥1.42 billion in future development, regulatory and commercialization milestones, plus tiered sales-based royalties.
Conditionally active antibody specialist Cytomx Therapeutics Inc. has agreed to work with Regeneron Pharmaceuticals Inc. to discover and develop new bispecific antibodies with what the partners said is the potential to "widen the therapeutic window and help minimize off-target effects."
Biotheus Inc. out-licensed Chinese rights to its preclinical EGFR/MET bispecific antibody, PM-1080, to Hansoh Pharmaceutical Group Co. Ltd. for ¥50 million (US$359,150) up front and up to ¥1.42 billion in future development, regulatory and commercialization milestones, plus tiered sales-based royalties.
The U.S. FDA cleared teclistamab from Janssen Pharmaceutical Cos. as the first bispecific antibody for treating patients with relapsed or refractory multiple myeloma (MM), joining other BCMA-targeted drugs, including an antibody-drug conjugate and CAR T therapies.
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