BND-22
BND-22 is a novel anti-ILT2 (LILRB1) antagonist antibody developed for the treatment of solid tumors.
BND-22 (formerly SAR44481) is currently being evaluated in a Phase 2 Biomarker Study of BND-22 in Combination with Cemiplimab in Solid Tumors at M.D. Anderson Cancer Center (Huston, TX, USA) (NCT06651593).
BND-22-001 study (NCT04717375) was the first-in-human clinical trial of BND-22 conducted by Sanofi. This Phase 1/2 multicenter, open label, dose escalation and expansion study enrolled advanced cancer patients with select solid tumor types. The study evaluated the safety and tolerability, maximum tolerated dose/recommended Phase 2 dose (MTD/RP2D), pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of BND-22, administered alone and in combination with an anti-Programmed Cell Death Protein-1 (PD-1) pemrolizumab or with an anti-Epidermal Growth Factor Receptor (EGFR) antibody cetuximab. Following determination of BND-22 (SAR44481) recommended Phase 2 dose, the study was expanded to evaluate the anti-tumor activity of BND-22 (SAR44481) in specific tumor types. The study enrolled 125 patients, of which 50 were treated with BND-22 monotherapy, 22 received combination therapy with pembrolizumab and 52 received combination therapy with cetuximab. BND-22 was safe and well tolerated and has led to objective response as monotherapy and in combination with pembrolizumab and cetuximab.
BND-22 (SAR44481) is an investigational drug, and it has not been approved for the treatment of any cancer types. Patients should contact their physician for information regarding any aspect of their treatment or involvement in clinical trials.
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ESMO 2024 Phase 1 Dose Escalation Study