Kyverna Therapeutics, Inc.

Georg Schett presented data on CD19-directed CAR-T therapies in refractory autoimmune and rheumatic diseases at ACR Convergence 2024, highlighting low relapse rates and faster manufacturing processes.

Biogen and UCB detailed Phase III PHOENYCS GO trial results for dapirolizumab pegol, showing a 49.5% response rate vs. 34.6% with standard care, significant in lupus. DZP hit key secondary endpoints, improved disease activity scores, and corticosteroid tapering, with a well-tolerated side effect profile. A second Phase III trial is planned.

The European Medicines Agency granted orphan drug status to Kyverna Therapeutics' KYV-101, a CAR T-cell therapy for myasthenia gravis (MG). The therapy targets CD19 on B-cells to reduce autoantibodies, and is being tested in a Phase 2 trial. KYV-101 has also received orphan drug designation from the FDA and fast track and RMAT designations.

DelveInsight's 'Multiple Sclerosis Pipeline Insight 2024' report highlights 75+ companies developing 80+ therapies, including promising candidates like GA Depot, Remibrutinib, and IMU 838. Key events include Immunic's positive Phase 3 ENSURE trial interim analysis, Roche's FDA approval for Ocrevus injectable, and Sanofi's mixed results for tolebrutinib in Phase III trials. The report covers global pipeline stages, product types, molecule types, mechanisms of action, and routes of administration.

TRex Bio raises $84M in Series B to advance immune drug research, including pushing TRB-061 into Phase 1 trials for atopic dermatitis and ulcerative colitis. The company's technology focuses on activating regulatory T cells to treat autoimmune conditions, with partnerships including Eli Lilly and Johnson & Johnson.

Multiple sclerosis (MS) is a chronic CNS disease with varied symptoms, caused by immune system attacks on myelin. Biotech companies like Biogen, Immunic Therapeutics, Kyverna Therapeutics, Progentos Therapeutics, TG Therapeutics, and Zenas BioPharma are developing new treatments, including BTK inhibitors, CAR-T therapies, and bispecific antibodies. The global MS drug market is expected to grow significantly, offering hope for more effective treatments for different forms of MS.

The gene therapy market is rapidly expanding, with over 180 companies developing more than 200 gene therapies. Key players include Ultragenyx Pharmaceutical Inc, Rocket Pharmaceuticals, and Adverum Biotechnologies. Prominent therapies in the pipeline include DTX401, RP-L102, and ADVM-022. Gene therapy aims to treat diseases by modifying genes, offering potential long-lasting effects with fewer side effects. Challenges include immune reactions, long-term effects, and high costs.

Gene therapy clinical trials gain momentum with over 180 companies advancing treatments, leveraging technologies like CRISPR/Cas9 for precision. Key therapies include ZOLGENSMA for spinal muscular atrophy and LUXTURNA for inherited retinal diseases. Challenges include immune reactions, long-term effects, and high costs, necessitating ethical oversight and equitable access.

Kyverna Therapeutics appoints biotechnology executive Mert Aktar as an independent director to its Board of Directors, enhancing expertise in corporate strategy and cell therapy.