The U.S. FDA has approved Beigene Co. Ltd.’s Tevimbra (tislelizumab-jsgr) as a monotherapy for treating adults with unresectable or metastatic esophageal squamous cell carcinoma following prior chemotherapy that did not include a PD-1 inhibitor. A humanized IgG4 anti-PD-1 monoclonal antibody, tislelizumab is designed to minimize binding to Fc-gamma receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
The U.S. FDA has approved Beigene Co. Ltd.’s Tevimbra (tislelizumab-jsgr) as a monotherapy for treating adults with unresectable or metastatic esophageal squamous cell carcinoma following prior chemotherapy that did not include a PD-1 inhibitor. A humanized IgG4 anti-PD-1 monoclonal antibody, tislelizumab is designed to minimize binding to Fc-gamma receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group Ltd., has received approval from the FDA and China’s National Medical Products Administration (NMPA) to conduct clinical trials with SIM-0500 in patients with relapsed or refractory multiple myeloma.
A first-quarter 2024 launch for Alzheimer’s drug donanemab appears to be off the table as Eli Lilly and Co. disclosed a last-minute decision by the U.S. FDA to convene an advisory committee to review data from the phase III Trailblazer-ALZ 2 trial.
Merus NV added Gilead Sciences Inc. to its collaboration roster, entering a deal potentially worth more than $1.5 billion. While its previous agreements have focused primarily on bispecific antibodies, the Gilead alliance takes aim at trispecifics, antibodies capable of binding three targets at once. In other news, shares of Biomx Inc. (NYSE:PHGE) jumped 194% March 6, ending the day at 68 cents, up 45 cents, on news that it was merging with fellow phage-focused company Adaptive Phage Therapeutics Inc. and raised $50 million in a concurrent private placement.
Apogee Therapeutics Inc.’s phase I home run put IL-13-targeting antibody APG-777 on an accelerated development path in atopic dermatitis, and the company touted its similarity to further-along IL-13 competitor lebrikizumab, from Eli Lilly and Co., as a likely indicator of further success.
Tumors in the stomach and pancreas are known to express claudin 18.2 (CLDN18.2) and the absence of expression in normal tissues makes it an attractive therapeutic target.
T-cell-engaging antibodies (TCEs) are synthetic molecules that redirect T cells to bind to the antigens on the surface of cancer cells to promote tumor elimination. In the case of multiple myeloma (MM), the approvals of anti-CD38 monoclonal antibodies (MAbs), chimeric antigen receptor T-cell therapies (CAR T) targeting B-cell maturation antigen (BCMA) or, more recently, bispecific TCEs represent great advances, but some patients still relapse after treatment.
Preventing the interaction between the cellular adhesion integrin α4β7 and endothelial ligand mucosal addressin cell-adhesion molecule-1 (MAdCAM-1) is a validated strategy for Crohn’s disease and ulcerative colitis treatment. Paragon Therapeutics Inc. and Spyre Therapeutics Inc. have reported preclinical efficacy data on SPY-001, a long-acting monoclonal antibody targeting integrin α4β7.
Researchers from Paragon Therapeutics Inc. and Spyre Therapeutics Inc. have reported preclinical data for SPY-002, a novel extended half-life, fully human IgG1 monoclonal antibody (MAb) targeting tumor necrosis factor (TNF)-like ligand 1A (TL1A), being developed for the treatment of inflammatory bowel disease (IBD).
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