Roivant Sciences Ltd. CEO Matt Cline said the firm’s unit Immunovant Inc. with FcRn blocker batoclimab has established “frankly a new bar” in myasthenia gravis (MG) as the New York-based firm reported top-line results from its phase III study and first data from period 1 of the phase IIb study with the same drug in chronic inflammatory demyelinating polyneuropathy. The data look promising, and Immunovant intends to use the findings to help advance second-generation FcRn prospect IMVT-1402 in both indications. Potentially registrational trials are planned. The U.S. FDA has granted IND clearance.
China’s National Medical Products Administration (NMPA) approved the country’s first injectable teprotumumab biosimilar from Innovent Biologics Inc. under the brand name of Sycume (teprotumumab N-01) to treat thyroid eye disease on March 14. The NMPA on March 15 accepted Simcere Pharmaceutical Group Ltd.’s NDA of deunoxavir marboxil (ADC-189) tablets, a product originally developed by Jiaxing Andicon Biotech Co. Ltd. to treat influenza A and B.
APG-777 is an anti-IL-13 humanized monoclonal antibody (mAb) designed to block Th2 inflammatory signaling mediated by the IL-13Rα1/IL-4Rα complex, while APG-990 is a fully human anti-OX40L mAb that that blocks type 1/2/3 inflammatory signaling. Apogee Therapeutics Inc. is studying the combination effects of APG-777 and APG-990 as potential therapy for atopic dermatitis (AD).
Leyden Laboratories BV added a fresh $70 million in financing to advance Panflu, its phase II-ready intranasal pan-influenza prophylactic medicine, while acquiring Cov Biotechnology Pte. Ltd. (Covbio) and its zoonotic virus-targeting portfolio to prepare for the next pandemic.
Yesterday’s first part of this two-part series surveyed bispecific antibodies for immunological and inflammatory (I&I) disease. Apart from bispecifics, Leerink analyst Thomas Smith lately has proven interested in I&I overall, unveiling his “five for 2025” in a January report that listed five indications with “potential for disruption” in the year ahead.
Analysts were pleasantly surprised by the positive phase III data reported for Kyowa Kirin Co. Ltd./Amgen Inc.’s rocatinlimab, a T-cell rebalancing therapy, in moderate to severe atopic dermatitis.
Atopic dermatitis (AD) is a chronic, inflammatory skin condition driven by complex immune mechanisms involving T cells. In the context of AD, OX40, a costimulatory receptor present on activated T cells, supports the function of inflammatory T cells, exacerbating skin dysfunction. Researchers from Astria Therapeutics Inc. presented the preclinical characterization of STAR-0310, a humanized monoclonal IgG1 antibody targeting OX40.
Researchers from Vicero Inc. have developed a Vincobody platform, which allows for design of novel proprietary VHH antibody fragments that possess the efficacy of dual checkpoint blockade while mitigating the toxicity limitations of current monoclonal antibody therapies.
Researchers from Apogee Therapeutics Inc. and Paragon Therapeutics Inc. have reported the preclinical characterization of APG-333, a half-life extended monoclonal antibody targeting thymic stromal lymphopoietin (TSLP), a cytokine secreted by epithelial cells that acts as an alarmin in response to environmental insults.
Antibody-drug conjugate (ADC)-focused Callio Therapeutics debuted on March 3 with the closing of a $187 million series A financing round based on cancer drug technology and assets in-licensed from Hummingbird Bioscience Pte Ltd.
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