Equillium, Inc., a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced that it has acquired Bioniz Therapeutics, Inc., a privately held clinical-stage biotechnology company. Bioniz developed its novel structured-domain peptides, including BNZ-1 and BNZ-2, entirely in-house from its proprietary product discovery platform. The Bioniz lead product candidates are multi-specific inhibitors of key disease-driving, clinically validated cytokine targets aimed at addressing unmet needs across a range of immuno-inflammatory indications.
Through the acquisition, Equillium significantly expands its immunology pipeline with a diversified portfolio of first-in-class immuno-inflammatory drug candidates across a range of development stages, consisting of:
BNZ-1: a first-in-class, tri-specific inhibitor of IL-2, IL-9 and IL-15, three inflammatory cytokines implicated in multiple diseases. BNZ-1 has demonstrated clinical proof-of-concept as a novel cytokine inhibitor through a completed Phase 1/2 study in cutaneous T cell lymphoma (CTCL), a dermato-oncology indication, achieving its primary objective of safety and tolerability where the compound was shown to be well tolerated with a favorable safety profile and showed clinically meaningful improvements in mSWAT scores (modified severity-weighted assessment tool). BNZ-1 is Phase 2 ready in alopecia areata, a dermatological autoimmune disorder, and is Phase 2/3 ready in CTCL with open U.S. INDs for each indication and has orphan designation for CTCL in the U.S. and Europe. BNZ-1 is currently formulated for intravenous administration, with subcutaneous formulation development underway. Equillium plans to initially focus further development of BNZ-1 in patients suffering from alopecia areata, where currently no drugs are approved.
BNZ-2: a first-in-class, selective inhibitor of IL-15 and IL-21. BNZ-2 has undergone substantial translational work supporting its potential use as a treatment for various gastrointestinal diseases and is Phase 1 ready for a study planned to include a proof-of-concept evaluation in patients with celiac disease, an immune disorder related to gluten exposure. The high degree of selectivity for IL-15 and IL-21 inhibition aligns well with the demonstrated key involvement of these two cytokines that work synergistically in driving the pathology in celiac disease and other inflammatory gut and hepatic disorders. BNZ-2 is currently formulated for subcutaneous administration where it is positioned to address an unmet need in patients experiencing symptoms despite attempts to maintain a gluten-free diet.
Discovery Platform: Proprietary and patented technology with origins from the National Institute of Health where seminal discoveries in cytokine biology were made. The flexible, structure-based platform is paired with deep in-house knowledge of cytokine pathways and computational modeling to create a discovery capability generating highly differentiated immunology products. The discovery pipeline includes BNZ-3, an advanced pre-clinical candidate that is a stabilized peptide designed to be orally administered and locally acting in the gut to treat GI inflammation.
This robust pipeline, combined with Equillium
