Trex Bio Inc. has disclosed that its development candidate TRB-071, currently in IND-enabling studies, is a CD30 agonist antibody. The approach could have therapeutic potential in inflammatory bowel disease and other autoimmune and inflammatory diseases.
Samsung Bioepis Co. Ltd. announced positive top-line phase I and phase III data for SB-27, a proposed biosimilar to Merck & Co. Inc.’s blockbuster immunotherapy Keytruda (pembrolizumab). Preliminary analysis of parallel-run global phase I and phase III studies demonstrated SB-27’s clinical and pharmacokinetic (PK) equivalence to the reference product, according to a company announcement.
Samsung Bioepis Co. Ltd. announced positive top-line phase I and phase III data for SB-27, a proposed biosimilar to Merck & Co. Inc.’s blockbuster immunotherapy Keytruda (pembrolizumab). Preliminary analysis of parallel-run global phase I and phase III studies demonstrated SB-27’s clinical and pharmacokinetic (PK) equivalence to the reference product, according to a company announcement.
Graves’ disease is a form of autoimmune hyperthyroidism where the main extrathyroidal feature is thyroid eye disease. Autoantibodies that stimulate thyroid-stimulating hormone receptor (TSHR) are released and orchestrate hormone production in the thyroid tissue and the orbit. Regeneron Pharmaceuticals Inc. has developed REGN-24493, a monoclonal antibody (MAb) that binds TSHR and blocks its activation by those autoantibodies.
Lys Therapeutics SAS is advancing LYS-241 toward the clinic with the support of more than €25 million (US$33 million) in funding raised since the company’s inception in 2021. The financing includes a grant of more than $5 million from The Michael J. Fox Foundation.
Bionyra Pharma has emerged with a $165 million oversubscribed series A and a portfolio of three antibodies with extended half-lives that are designed to offer improvements over existing classes of monoclonal antibodies for treating chronic inflammatory diseases.
In a deal viewed as a big win for both companies, Abbvie Inc. is buying Apogee Therapeutics Inc. for $10.9 billion. The transaction calls for shareholders of Apogee to receive $135.11 per share in cash, marking a nearly 50% premium over Friday’s closing stock price, and puts lead candidate zumilokibart, a late-stage, half-life extended monoclonal antibody targeting IL-13 that has shown competitive phase II data in atopic dermatitis, in the hands of a pharma giant with a well-established immunology franchise.
Avalo Therapeutics Inc. is advancing AVTX-010, a long-acting next-generation anti-IL-1β monoclonal antibody with potential for hidradenitis suppurativa and additional inflammatory disorders
Despite some back-and-forth with the U.S. FDA regarding inclusion in the somewhat controversial Commissioner’s National Priority Voucher (CNPV) program, Sanofi SA’s Tzield (teplizumab) gained FDA clearance, expanding use of the CD3-directed monoclonal antibody as a disease-modifying therapy for patients with recently diagnosed stage 3 type 1 diabetes (T1D).
Ethyreal Bio Inc. has come out of stealth mode in order to disclose preclinical data for ETHY-001, its monoclonal antibody targeting thyroid stimulating hormone receptor, at the Endocrine Society’s 2026 annual meeting on June 15.