Nkarta, Inc. is a biopharmaceutical company, which engages in the discovery, development, and commercialization of natural killer cell therapies for the treatment of cancer. The firm’s product include NKX101, which is in Phase I clinical trials for the treatment of relapsed/refractory acute myeloid leukemia or higher risk myelodysplastic syndromes, and NKX019, a pre-clinical product, which is based on the ability to treat various B cell malignancies by targeting the CD19 antigen found on these types of cancerous cells. The company was founded by Dario Campana in 2005 and is headquartered in South San Francisco, CA.
Clinical Trials
4
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2015
Active, not recruiting
2
50.0%
Recruiting
2
50.0%
No approval data available
- Biotech industry leaders are calling for the FDA to ensure drug reviews remain grounded in scientific expertise rather than political influence following significant leadership turnover. - The FDA has lost more than 3,000 employees under the Trump administration, with the main drug-review arm cycling through six different leaders since January 2025. - Former FDA Commissioner Scott Gottlieb urged reinstating the standard that medical product centers be led by experienced scientific and clinical experts in a JAMA editorial. - The agency has announced plans to fill 2,200 open positions and accelerate clinical trial timelines, with a particular focus on maintaining U.S. leadership in cell therapy.
- Nkarta received FDA agreement to administer NKX019 CAR-NK cell therapy in outpatient settings, reducing patient monitoring from 24 hours to 2 hours and eliminating overnight hospital stays. - The protocol amendments enable community rheumatology centers to participate in trials and allow patient redosing options in both Ntrust-1 and Ntrust-2 studies. - Rheumatoid arthritis will be added as a new indication to the Ntrust-2 trial, expanding the therapeutic scope of the investigational CD19-targeted NK cell therapy. - Current dosing continues at 4 billion cells per dose for a total of 12 billion cells across three doses, with initial clinical data expected at a medical conference in 2026.
- Nkarta has appointed Shawn Rose, M.D. Ph.D., as Chief Medical Officer and Head of R&D, effective June 23, 2025, replacing David R. Shook who is returning to oncology. - Dr. Rose brings extensive immunology expertise, having advanced over a dozen programs from discovery to clinical development and contributed to approved medicines including Sotyktu, Stelara, and Tremfya. - The leadership change supports Nkarta's strategic focus on developing allogeneic NK cell therapies for autoimmune diseases, with lead candidate NKX019 targeting CD19-positive B cells. - NKX019 is an off-the-shelf CAR-NK cell therapy engineered with IL-15 for enhanced persistence and is being evaluated across multiple autoimmune conditions.
- The global lupus nephritis market is projected to grow significantly by 2034, with the United States accounting for over 80% of the current $1.12 billion market share across major regions. - Several innovative therapies are advancing through clinical trials, including CAR-T cell treatments from companies like Allogene Therapeutics, Adicet Bio, and Caribou Biosciences, which received FDA Fast Track designations. - Key pharmaceutical players including Aurinia Pharmaceuticals, AstraZeneca, and Roche are developing treatments such as voclosporin, anifrolumab, and obinutuzumab to address the significant unmet needs in lupus nephritis management.
• Nkarta has initiated enrollment for the Ntrust-2 clinical trial to evaluate NKX019 cell therapy in patients with ANCA-associated vasculitis (AAV) and other autoimmune disorders. • The Ntrust-2 trial will assess the safety and efficacy of NKX019 in promoting long-term disease remission in up to 12 participants with AAV, systemic sclerosis, or idiopathic inflammatory myopathy. • NKX019 is engineered to target and eliminate B-cells, which produce self-reactive antibodies that drive autoimmune diseases like AAV, offering a potential new treatment approach. • Preliminary results from the Ntrust-1 and Ntrust-2 trials, evaluating NKX019 in autoimmune diseases, are anticipated next year, marking a key milestone for Nkarta's cell therapy program.
• The NK cell therapy field is experiencing significant growth, driven by its potential to address unmet needs in cancer treatment with safer, more targeted options. • Over 140 companies are actively involved in developing more than 160 NK cell therapies, indicating robust R&D investment and confidence in this therapeutic area. • Clinical trials are progressing for various NK cell therapies, including CAR-NK cell therapies and those targeting autoimmune disorders, showcasing versatility. • Regulatory support, such as FDA orphan drug designation and fast track designation, is facilitating the development and potential approval of NK cell therapies.
• Nkarta has dosed the first patient in both the Ntrust-1 trial (lupus nephritis) and the investigator-sponsored trial (systemic lupus erythematosus) of NKX019, with enrollment ongoing. • The company plans to initiate enrollment in the Ntrust-2 trial for systemic sclerosis, myositis, and vasculitis by the end of 2024 and expects preliminary clinical data from Ntrust-1 and Ntrust-2 in 2025. • Nkarta will discontinue NKX019 development in non-Hodgkin lymphoma to focus on autoimmune diseases, where it believes NKX019 has greater potential. • With a cash balance of $405.3 million as of September 30, 2024, Nkarta anticipates funding operations into late 2027.
