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Cartesian Therapeutics Announces the Appointment of Adrian Bot to Board of Directors
Globenewswire· 2025-12-18 21:05
Core Insights - Cartesian Therapeutics, Inc. has appointed Dr. Adrian Bot to its Board of Directors, bringing extensive experience in biopharma and a focus on immune and cell therapies [1][2] - Dr. Bot's expertise includes pioneering CAR T cell therapies and RNA-based precision medicines, which will be valuable as the company advances its pipeline and explores new opportunities [2] - The company is at the forefront of cell therapy for autoimmune diseases, with its lead asset, Descartes-08, in Phase 3 clinical development for generalized myasthenia gravis and plans for a Phase 2 trial in myositis [3] Company Overview - Cartesian Therapeutics is a clinical-stage biotechnology company specializing in cell therapy for autoimmune diseases [3] - The lead product, Descartes-08, is currently undergoing Phase 3 trials for myasthenia gravis, with future plans for trials in myositis [3]
Kyverna Therapeutics Announces Pricing of $100 Million Public Offering of Common Stock
Globenewswire· 2025-12-17 14:24
Core Viewpoint - Kyverna Therapeutics, Inc. has announced a public offering of 13,333,333 shares at a price of $7.50 per share, aiming to raise approximately $100 million before expenses [1][2]. Company Overview - Kyverna Therapeutics is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases, with its lead candidate being miv-cel, an autologous CD19-targeting CAR T-cell therapy [5][6]. Offering Details - The public offering is expected to close on or about December 18, 2025, pending customary closing conditions [1]. - The underwriters have a 30-day option to purchase up to 1,999,999 additional shares at the public offering price [1]. Management and Underwriters - J.P. Morgan, Leerink Partners, Morgan Stanley, and Wells Fargo Securities are acting as joint book-running managers for the offering [2].
Kyverna Therapeutics Announces Proposed Public Offering of Common Stock
Globenewswire· 2025-12-15 21:01
Core Viewpoint - Kyverna Therapeutics, Inc. has initiated an underwritten public offering of $100 million in common stock, with an option for underwriters to purchase an additional $15 million [1] Group 1: Offering Details - The public offering consists of $100 million in shares, with a 30-day option for underwriters to buy up to an additional $15 million [1] - J.P. Morgan, Leerink Partners, Morgan Stanley, and Wells Fargo Securities are acting as joint book-running managers for the offering [1] - The offering is subject to market conditions, and there is no assurance regarding its completion or terms [1] Group 2: Company Overview - Kyverna Therapeutics is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases [4] - The company's lead therapy candidate is miv-cel, an autologous CD19-targeting CAR T-cell therapy [4] - Kyverna is advancing its neuroimmunology franchise with completed and ongoing registrational trials for conditions such as stiff person syndrome and generalized myasthenia gravis [4]
Kyverna Therapeutics Highlights Potential of KYV-101 in Rheumatoid Arthritis with Phase 1 Data from Investigator-Initiated Trial Presented at ACR Convergence 2025
Globenewswire· 2025-10-25 15:00
Core Insights - KYV-101 shows significant reduction in disease-associated autoantibodies and improvement in disease activity for patients with difficult-to-treat rheumatoid arthritis (RA) [1][5] - The treatment has a well-tolerated profile, consistent with previous observations from 100 patients [1][2] - Emerging data from investigator-initiated trials (IIT) in RA suggest broad potential for KYV-101 in rheumatology indications [1][2] Company Overview - Kyverna Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases [10] - The lead candidate, KYV-101, is advancing through late-stage clinical development with ongoing trials for various autoimmune conditions [10] Clinical Trial Details - The COMPARE trial is a Phase 1/2 study comparing KYV-101 to rituximab in ACPA-positive, treatment-refractory RA patients [3] - Six patients in the Phase 1 portion had a mean of 5.8 prior failed biologic therapies before receiving KYV-101 [4] - The primary endpoint of the Phase 1 study was safety and tolerability, with additional evaluations for efficacy and biomarkers [4] Safety and Efficacy Results - KYV-101 was well-tolerated with no high-grade Cytokine Release Syndrome (CRS) or Immune Cell Associated Neurotoxicity Syndrome (ICANS) reported [7] - CAR T-cells expanded rapidly, with B-cell depletion observed in all patients, and significant reductions in pathogenic autoantibodies [7] - Four out of six patients met the ACR20 response criteria, with two achieving ACR50 response [7] Future Directions - The results support the initiation of the randomized Phase 2 portion of the study, which is currently ongoing with completed patient enrollment [5]
Nkarta Announces Poster Presentation at Upcoming American College of Rheumatology (ACR) Convergence Meeting
Globenewswire· 2025-10-22 14:07
Core Insights - Nkarta, Inc. is set to present clinical data on its investigational therapy NKX019 at the ACR Convergence 2025 meeting, highlighting its potential in treating autoimmune diseases driven by pathogenic B cells [1][2]. Group 1: Clinical Data Presentation - NKX019 demonstrated robust pathogenic B-cell depletion and reconstitution of the B cell compartment in participants with non-Hodgkin lymphoma, indicating an immune reset [2]. - Preclinical studies showed NKX019 effectively depletes pathogenic B cells in both in vivo lymphoma models and in vitro autoimmune disease models, with the ability to traffic to lymphoid organs and disseminate across multiple tissues [2]. Group 2: Market Need and Therapeutic Potential - Millions of patients in the U.S. suffer from autoimmune diseases driven by pathological B cells, with current treatments often inadequate or toxic, leaving limited options [4]. - Nkarta's engineered allogeneic NK cells aim to selectively deplete disease-driving B cells without inducing limiting toxicities, presenting a novel therapeutic approach for B-cell driven autoimmune diseases [4]. Group 3: Presentation Details - The poster presentation titled "NKX019, an allogeneic off-the-shelf CD19 targeting CAR-NK cell therapy, induces deep CD19+ B cell depletion in hematological malignancy and models of autoimmune disease" will take place on October 26 from 10:30 AM to 12:30 PM CT [4]. - Nkarta will also exhibit at booth 1801 during the conference, providing opportunities for attendees to discuss the company's clinical programs [4]. Group 4: Company Overview - Nkarta is a clinical-stage biotechnology company focused on developing allogeneic, off-the-shelf NK cell therapies for autoimmune diseases, utilizing a cell expansion and cryopreservation platform combined with proprietary cell engineering technologies [5].
Cartesian Therapeutics Announces First Participant Enrolled in the Phase 3 AURORA Trial of Descartes-08 in Patients with Myasthenia Gravis
GlobeNewswire News Room· 2025-05-30 11:00
Core Insights - Cartesian Therapeutics has enrolled the first participant in its Phase 3 AURORA trial for Descartes-08, a cell therapy for myasthenia gravis (MG) [1][3] - Descartes-08 is an autologous engineered CAR-T therapy targeting B-cell maturation antigen (BCMA), designed for outpatient administration without preconditioning chemotherapy [2][5] - The Phase 3 trial aims to compare Descartes-08 to a placebo in approximately 100 participants, focusing on improvements in MG Activities of Daily Living (MG-ADL) scores [3][4] Company Overview - Cartesian Therapeutics is a clinical-stage biotechnology company focused on cell therapy for autoimmune diseases, with Descartes-08 as its lead asset in Phase 3 development for generalized MG [5] - The company is also developing Descartes-15, a next-generation CAR-T therapy currently in Phase 1 trials for multiple myeloma [5] Clinical Trial Details - The Phase 3 AURORA trial will randomize participants 1:1 to receive either Descartes-08 or placebo, with the primary endpoint being a three-point improvement in MG-ADL scores at Month 4 [3][4] - Previous Phase 2b trial results showed a significant average reduction of 4.8 points in MG-ADL scores at Month 12, with even greater reductions in patients without prior biologic therapy [4]