Shooting for further proof of durable, drug-free, disease-free remission with a single dose of KYV-101 in generalized myasthenia gravis, Kyverna Therapeutics Inc. plans to start phase III work by the end of this year. The Emeryville, Calif.-based firm rolled out positive interim results from the phase II portion of the registrational Kysa-6 clinical trial testing the drug, a fully human, autologous, CD19 CAR T-cell therapy with CD28 costimulation.
Astrazeneca plc seems on the way to expanding its presence in myasthenia gravis (MG) with positive “high-level” results from a global, randomized, double-blind, placebo-controlled phase III trial with once-weekly, self-administered gefurulimab in adults with anti-acetylcholine receptor antibody-positive, generalized disease.
At the 11th Congress of the European Academy of Neurology, which was held in Helsinki June 21 to June 24, researchers presented new data on using CAR T cells in autoimmune neurological conditions.
At the 11th Congress of the European Academy of Neurology, which was held in Helsinki June 21 to June 24, researchers presented new data on using CAR T cells in autoimmune neurological conditions.
At the 11th Congress European Academy of Neurology, which was held in Helsinki June 21 to June 24, researchers presented new data on using CAR T cells in autoimmune neurological conditions.
Ahead Therapeutics SL has received positive feedback from the EMA on its way toward initiating regulatory toxicology studies for its lead program in myasthenia gravis. The feedback supports the company’s scientific approach.
Watchers of the percolating myasthenia gravis space are waiting eagerly for data from Dianthus Therapeutics Inc.’s phase II Magic study testing DNTH-103, an active C1s inhibitor, compared to placebo in patients with anti-AChR-positive generalized disease.
Cartesian Therapeutics Inc. followed up December’s phase IIb data with more good news regarding Descartes-08, offering 12-month efficacy and safety results that whetted Wall Street’s appetite for the phase III Aurora effort ahead. Milos Miljkovic, chief medical officer, told BioWorld that minimum symptom expression – among the areas where Descartes-08 shone, providing relief for “months and months after the last dose of treatment” – is especially important to patients.
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.
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.
