Artiva's NK cell therapy takes FDA RMAT status for rheumatoid arthritis. June 11, 2026 San Diego-based Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) announced receipt of US FDA Regenerative Medicine Advanced Therapy (RMAT) designation for AlloNK (AB-101) in combination with rituximab for refractory rheumatoid arthritis treatment, coinciding with five data presentations at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress in London. AlloNK is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved natural killer (NK) cell therapy designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of anti-CD20 monoclonal antibodies to drive deep B-cell depletion. RMAT designation, established under the 21st Century Cures Act, applies to cell therapies, gene therapies, and tissue-engineered products intended to treat serious conditions, and confers early and frequent FDA interactions, rolling review eligibility, and potential qualification for accelerated and priority review. Artiva has not previously disclosed any other expedited designation for AlloNK. The designation is grounded in Phase II data from two basket trials - a company-sponsored Phase IIa study and an investigator-initiated trial - enrolling patients with long-standing, highly active RA who had failed multiple prior biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs). As of the April 3, 2026 data cutoff, in the company-sponsored Phase IIa trial, 71% of patients with six months of follow-up achieved an ACR50 response (5 of 7 patients). In the investigator-initiated trial, 5 of 6 patients with six months of follow-up achieved an ACR50 or modified ACR50 response. Across the pooled RA dataset of 21 patients with at least 12 weeks of follow-up, clinical responses emerged as early as three months and deepened at six months. As of the data cutoff, no patient had experienced loss of response, required high-dose steroids, or initiated a new b/tsDMARD following treatment. No p-values have been reported; all data derive from single-arm, non-randomized studies. Baseline patient characteristics reported in a May 8, 2026 data release - which contains more granular detail than the EULAR announcement - indicated a mean age of 52.5 years, 100% female, mean disease duration of 14.8 years, mean baseline Clinical Disease Activity Index (CDAI) of 50.7, mean baseline DAS28-ESR of 7.3, and 81% of patients having failed two or more prior b/tsDMARDs. Translational data from 51 evaluable autoimmune patients demonstrated uniform B-cell depletion by Day 13 following treatment with the conditioning regimen of cyclophosphamide and fludarabine, AlloNK, and rituximab. Complete B-cell depletion, confirmed by high-sensitivity assay, was observed in all 28 evaluable RA patients. B-cell reconstitution was characterized by a predominance of naïve and transitional B cells, consistent with the proposed immune reset hypothesis. Safety data from 55 autoimmune patients treated with AlloNK plus rituximab showed no cytokine release syndrome (CRS), no immune effector cell-associated neurotoxicity syndrome (ICANS), no AlloNK-related serious adverse events, and no treatment discontinuations due to adverse events. The rate of Grade 3 or higher infections was 2%. Two of 55 patients were hospitalized for treatment-emergent adverse events during the initial 28-day post-treatment period, neither deemed related to AlloNK. EULAR 2026 presentations also included initial data in Sjögren disease (SjD) and systemic sclerosis (SSc). In SjD, mean stimulated salivary flow increased from 0.65 mL/min at baseline to 1.23 mL/min at six months, with high baseline disease activity (mean ClinESSDAI 16.1, mean ESSPRI 8.0). In SSc, mean modified Rodnan skin score improved by 9.5 points at six months, all patients achieved rCRISS25, and 50% achieved rCRISS50. These indications are not covered by the RMAT designation. Artiva plans to initiate a Phase III registrational trial evaluating AlloNK plus rituximab versus rituximab alone in refractory RA in 2026, with ACR50 at six months as the primary endpoint and approximately 150 patients enrolled. The company has cited FDA alignment on this registrational strategy and stated that capital from a recent financing is expected to extend runway into 2029. Research context. Refractory RA represents a population with limited options after failure of multiple b/tsDMARDs. The current treatment landscape includes TNF inhibitors, IL-6 receptor antagonists, JAK inhibitors, and rituximab, none of which reliably produce deep, durable responses in multiply-refractory patients. The most directly competitive approach is CD19-directed CAR-T cell therapy. Early investigator-initiated data with autologous CD19 CAR-T, including work from groups at Erlangen and elsewhere, have reported sustained drug-free remissions in small numbers of RA patients, generating substantial interest in B-cell depletion as a disease-modifying strategy. However, autologous CAR-T requires patient-specific manufacturing, inpatient administration, and access to specialized centers, constraints that limit scalability. Artiva has positioned AlloNK as delivering comparable depth of B-cell depletion to CD19 CAR-T - a claim supported by the 100% complete depletion rate in evaluable patients - while using an allogeneic, off-the-shelf product that the company contends is compatible with outpatient, community rheumatology settings. Unlike autologous CAR-T, AlloNK is not genetically modified and does not carry a CD19-targeting construct; instead, it relies on enhancing the ADCC activity of co-administered rituximab to achieve B-cell killing. This distinction has implications for manufacturing scalability and the absence of CRS and ICANS in the current dataset, though the dataset remains small and non-randomized. Whether the depth and durability of B-cell depletion observed with AlloNK plus rituximab will replicate in a randomized Phase III setting, and how it will compare against the emerging autologous CAR-T data in RA, remains to be established. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/

Artiva raises $300M. BIOTECH: Stock Sale to Fund Phase 3 Trial for RA Cell Therapy May 26, 2026 SAN DIEGO - With $300 million in the bank, Artiva Biotherapeutics (Nasdaq: ARTV) is set to launch a pivotal clinical trial later this year for its potential treatment for rheumatoid arthritis. The cell therapy company announced positive initial clinical data in early May for its AlloNK cell therapy candidate when administered along with the monoclonal antibody medication rituximab. That dataset, which included treatment of 21 patients with refractory rheumatoid arthritis, formed the basis of Artiva's alignment with federal regulators about launching a Phase 3 trial later this year as well as investor interest in a common stock offering that produced $300 million in financing for the company. "It probably is the largest financing for an allogeneic cell therapy company in the last five years," Artiva President and CEO Dr. Fred Aslan said. "Which speaks to how impressed investors were with the efficacy, with the tolerability profile and with this possibility that we could be first to market in such a meaningful indication." According to Aslan, Artiva plans to initiate its Phase 3 randomized control trial for refractory rheumatoid arthritis in the second half of 2026 with the goal of reporting results by the second half of 2028. - Advertisement - The company also plans to continue enrolling patients in its current and ongoing basket trial, in which one drug candidate is studied across multiple different disease types simultaneously. Artiva's basket study is analyzing the efficacy of AlloNK among rheumatoid arthritis patients as well as the autoimmune disorders known as Sjogren's syndrome and scleroderma. Artiva is likely to choose between Sjogren's syndrome, scleroderma and myositis as a second indication for further clinical study, according to Aslan. "I think we're at the point where the field is maturing, where specific companies are choosing the one place where they hope to be first to market," Aslan said of the cell therapy industry. "And I'm really proud of our team for actually making all this progress and positioning us in place to be the first in refractory RA." The body's natural killers. Roughly 1.5 million people in the U.S. have rheumatoid arthritis, an autoimmune disorder that causes joint pain, swelling and inflammation. Between 10% and 15% of those rheumatoid arthritis patients are deemed refractory, as their bodies are resistant to multiple existing treatments. Emerging forms of medicine like chimeric antigen receptor (CAR) T-cell therapies have been effective in treating cancer and autoimmune diseases by training the body's immune system to recognize and attack unhealthy cells, though CAR T-cell therapies are expensive and cumbersome for patients. "When you're using (autologous) CAR T, you have to do that in a CAR T center, in academic centers," Aslan said. "We are able to have patients receive our therapy in the infusion chair of a community rheumatologist." Artiva's cell therapies leverage NK cells, or natural killer cells, which are white blood cells that destroy cancer cells and other unhealthy cells in the body. The company initially developed AlloNK as a cancer therapeutic, but opted to make rheumatoid arthritis its primary indication. AlloNK works by killing overactive B cells, vital aspects of the immune system that normally produce antibodies to fight disease but can cause autoimmune disorders by mistakenly setting off an immune response that destroys healthy cells. "There are different ways to deplete B cells, and the more you deplete them effectively, the more likely you are to experience the durable clinical results that (have) been seen in (autologous) CAR T studies," Aslan said. "We knew from our experience in oncology that our ability to get rid of B cells... was actually really strong." Cost effective method. While effective for certain kinds of cancers and autoimmune diseases, CAR T-cell therapies are also highly expensive to develop and require complex manufacturing processes. That's especially true for CAR T-cell therapies that are autologous, meaning they're developed from a patient's own cells rather than a healthy donor. Artiva sources NK cells from umbilical cord samples, according to Aslan, and can develop enough stock of AlloNK from one sample to treat more than 500 patients. The company also conducts all of its manufacturing in its San Diego headquarters and laboratory facility. According to Aslan, the $300 million financing should carry the company into 2029 as it seeks to ultimately commercialize AlloNK for rheumatoid arthritis. "I think that this deep B-cell-depleting mechanism is probably the most potent mechanism that we have seen today working in autoimmune disease," he said. "It's just really exciting for us to be the first out of any of these agents to go into the largest autoimmune market." Artiva Biotherapeutics FOUNDED: 2019 CEO: Fred Aslan HEADQUARTERS: San Diego BUSINESS: Cell therapy development for patients with autoimmune diseases EMPLOYEES: About 100-110 CASH ON HAND: $86.8 million (Q1 2026) STOCK: ARTV (Nasdaq) WEBSITE: artivabio.com CONTACT: [email protected] NOTABLE: Artiva conducts all of its manufacturing in its San Diego headquarters and laboratory facility. Eli is an award-winning reporter primarily covering the tech and life sciences industries. He previously worked as the San Diego City Hall reporter for the regional wire City News Service. He has also covered public health, transportation and state and local politics in the San Francisco Bay Area for Local News Matters, the nonprofit arm of the regional wire Bay City News Service, where he also oversaw the development and daily content management of the outlet's public health and COVID-19 news and resource webpage. He is also a contributing writer covering Minor League Baseball for the analysis and commentary website Baseball Prospectus. Eli is a graduate of San Francisco State University and a native of Northern California. -Advertisement-