Core Insights - Nkarta, Inc. has announced the initiation of an investigator-sponsored trial (IST) for NKX019, a CAR NK-cell therapy targeting CD19, in patients with systemic lupus erythematosus (SLE) [1][2] - The IST aims to expand the clinical evaluation of NKX019, following the initiation of the Phase 1 clinical trial Ntrust-1 for lupus nephritis [1][2] Company Overview - Nkarta is a clinical-stage biotechnology company focused on developing allogeneic, off-the-shelf NK cell therapies [5] - The company utilizes a combination of cell expansion, cryopreservation, and proprietary cell engineering technologies to create a pipeline of NK cell therapies [5] Clinical Trial Details - The Phase 1 IST is being conducted at Columbia University Irving Medical Center and will enroll up to 6 patients with SLE [2] - The trial will assess safety and clinical outcomes, including translational and biomarker studies [2] - Patients will receive NKX019 on Days 0, 7, and 14 after lymphodepletion with cyclophosphamide [2] NKX019 Characteristics - NKX019 is an allogeneic, cryopreserved immunotherapy candidate engineered with a humanized CD19-directed CAR and a membrane-bound form of interleukin-15 (IL-15) [4] - The therapy aims to provide enhanced cell targeting and greater persistence without the need for exogenous cytokine support [4]

"This new leadership structure enables Nkarta to meet this transformative moment for cell therapy as we embark on groundbreaking clinical trials and expand our footprint in multiple autoimmune disease settings. These executive changes are expected to significantly enhance our ability to accelerate the development and ultimate commercialization of pioneering NK cell therapies for patients that need them," said Paul J. Hastings, CEO of Nkarta. "I am thrilled to have Nadir, a trusted thought partner of many ye ...

Core Insights - Nkarta, Inc. has announced a new leadership structure aimed at enhancing its capabilities in developing and commercializing NK cell therapies for autoimmune diseases [1][7][8] - The company has initiated clinical trials for its NKX019 therapy, targeting conditions such as lupus nephritis and systemic sclerosis [3][15] Leadership Changes - Nadir Mahmood, Ph.D., has been appointed as President, sharing executive responsibilities with CEO Paul J. Hastings [7][13] - David R. Shook, M.D., has been promoted to Chief Medical Officer, Head of Research & Development, reflecting his expanded role in overseeing the R&D organization [14] Clinical Development - Nkarta has launched the Ntrust-1 clinical trial for NKX019 in lupus nephritis and received FDA clearance for its second IND application for NKX019 in autoimmune diseases [3][15] - The company plans to announce preliminary data from the Ntrust-1 and Ntrust-2 trials in 2025 [15] Technology and Innovation - NKX019 is an engineered therapy utilizing NK cells derived from healthy adult donors, designed for enhanced targeting and persistence in treating autoimmune diseases [4][10] - The company combines cell expansion, cryopreservation, and CRISPR-based genome engineering to develop its NK cell therapies [11]

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Core Insights - Nkarta, Inc. has initiated Ntrust-1, the first U.S.-based clinical trial of NKX019 for lupus nephritis, with patient screening currently underway [21] - The company has received FDA clearance for its second IND application for NKX019, allowing the initiation of Ntrust-2 for systemic sclerosis, idiopathic inflammatory myopathy, and ANCA-associated vasculitis [21][11] - NKX019 is an engineered allogeneic CAR NK-cell therapy designed to target CD19-positive cells, offering potential advantages such as reduced toxicity and on-demand dosing [1][17] Company Developments - Ntrust-1 and Ntrust-2 are multi-center, open-label, dose escalation clinical trials aimed at assessing the safety and efficacy of NKX019 in autoimmune diseases [12] - The trials will evaluate NKX019's ability to induce long-term remissions by eliminating pathogenic B cells, with each trial initially enrolling up to 12 patients [4][12] - Nkarta aims to improve the accessibility and safety of cell therapy, particularly for underserved populations with lupus and other autoimmune diseases [11] Industry Context - Systemic lupus erythematosus (SLE) affects approximately 200,000 patients in the U.S., with about 40% developing lupus nephritis, a severe manifestation of the disease [23] - Systemic sclerosis (SSc) has around 100,000 patients in the U.S., with no available treatments to halt or reverse the disease process [6] - Idiopathic inflammatory myopathy (IIM) affects an estimated 50,000 people in the U.S., with many patients experiencing refractory disease despite existing therapies [7]

Patient screening underway in Ntrust-1, the first U.S.-based clinical trial of an engineered NK cell therapy for the treatment of lupus nephritis SOUTH SAN FRANCISCO, Calif., June 27, 2024 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies, today announced the initiation of Ntrust-1, a multi-center clinical trial of NKX019 in lupus nephritis, with the first patient in screening. The company also announced the clearance by the ...

Company Overview - Nkarta, Inc. is a clinical-stage biopharmaceutical company focused on developing engineered natural killer (NK) cell therapies [3][16] - The company is advancing NKX019, an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate designed to treat autoimmune diseases, particularly lupus nephritis [12][15] Leadership and Expertise - George Vratsanos, M.D., a translational immunology expert, has joined Nkarta's board of directors, bringing extensive R&D leadership experience in autoimmune diseases [3][7] - Vratsanos expressed enthusiasm for supporting Nkarta's clinical work and emphasized the potential of NK cell therapy to treat autoimmune diseases without the safety concerns associated with other cell therapies [4][7] Product Development - NKX019 utilizes NK cells derived from healthy adult donors, engineered with a humanized CD19-directed CAR and a proprietary form of interleukin-15 (IL-15) to enhance cell targeting and persistence [12] - The therapy aims to provide a safe, well-tolerated, and accessible treatment option for patients suffering from autoimmune diseases [15][16]

luismmolina I have a strong affinity for cell technology tickers attempting to push limits in order to provide cutting-edge therapies to the market to address some of the worst diseases known to man. It wasn't that long ago the FDA approved the first CAR-T therapy, which was Novartis's (NVS) Kymriah (tisagenlecleucel) for acute lymphoblastic leukemia (ALL). Since then there have been a few more CAR-T therapies approved targeting lymphomas and myelomas. However, the development of cell therapies is just gett ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Former name, former address and former fiscal year, if changed since last report) Securities registered pursuant to Section 12(b) of the Act: For the transition period from to Commission Fil ...