Artiva Biotherapeutics (NASDAQ:ARTV) Chief Executive Officer Dr. Fred Aslan said the company is preparing to move its lead autoimmune program into a pivotal rheumatoid arthritis study after reporting data in refractory patients and reaching alignment with the U.S. Food and Drug Administration on a single registrational trial.
Speaking at the Jefferies Global Healthcare Conference in a fireside chat with Jefferies’ Fiona Jia, Aslan said Artiva has treated more than 70 patients with autoimmune disease to date and recently shared data from 37 patients across rheumatoid arthritis, Sjögren’s disease and scleroderma. He described the results as consistent with “auto CAR-T-like efficacy” while emphasizing that the company’s therapy is designed for easier use in community settings.
Focus on Refractory Rheumatoid Arthritis
“There are around 14 different approved drugs in rheumatoid arthritis covering six different mechanisms,” Aslan said. However, he added that about 25% of patients who go on a biologic or JAK inhibitor become refractory to two mechanisms.
According to Aslan, approximately $20 billion is spent annually on biologics and JAK inhibitors in RA, with about $5 billion of that in patients already refractory to two mechanisms. He said the chance of achieving an ACR50 response in that late-line population is generally in the 10% to 20% range, based on sources including academic studies and the CorEvitas registry.
Data Highlights and Durability
Aslan said Artiva’s RA data included highly refractory patients, some of whom had lived with the disease for decades and had been treated with multiple mechanisms. He highlighted three main points from the dataset: the refractory nature of the enrolled patients, the high response rate and the durability observed so far.
In the company’s basket study, Aslan said seven RA patients had reached six months of follow-up, all had an ACR response, and five of the seven had an ACR50 response. He said the company has not yet had a patient relapse after losing response in a way that would allow retreatment, but expects relapses may occur over time, as they do with auto CAR-T approaches.
Aslan framed Artiva’s approach as potentially differentiated from chronic therapies because it is intended as a one-time treatment that could allow patients to remain off immunocompromising drugs for extended periods, with the possibility of redosing later.
Pivotal Trial Planned for Second Half of Year
Artiva plans to begin its pivotal RA trial in the second half of this year, with a readout expected in the second half of 2028, Aslan said. The trial is expected to enroll 150 patients randomized 2:1 between Artiva’s therapy and rituximab alone, with ACR50 at six months as the primary endpoint.
Aslan said rituximab was selected as the active comparator because it is used in late-line RA and is also part of Artiva’s mechanism. He described the therapy as a non-genetically modified NK cell that uses rituximab as the targeting agent: rituximab binds to B cells, activates the NK cell and leads to B-cell killing.
Patients in the rituximab arm who do not achieve an ACR50 response are expected to roll over into the AlloNK arm, according to Aslan. He said this design could allow the company to compare its therapy directly with “one of the best agents today in that same population.”
Aslan said there were no major gating items to highlight before trial initiation beyond protocol submission, institutional review board review and site activation. He said Artiva already has more than 40 sites, with additional sites opened in Europe and Latin America to prepare for the randomized controlled trial. The company expects to use about 80 sites to enroll the 150-patient study.
Safety, Lymphodepletion and EULAR Updates
Jia asked Aslan about concerns around the cyclophosphamide and fludarabine lymphodepletion regimen. Aslan said Artiva uses doses consistent with those used in cell therapy and argued that the question should be data-driven. He said the company has not yet seen evidence that cell therapy without lymphodepletion achieves the same level of B-cell depletion.
Aslan said most side effects in Artiva’s regimen come from rituximab and cyclophosphamide/fludarabine rather than AlloNK itself. He said patients are typically cytopenic for about one to two weeks and receive prophylactic antibacterial, antifungal and antiviral medications during that period. He added that the company has not seen high rates of grade 3 infections in the data presented to date.
Artiva is also presenting data at EULAR, including additional detail on RA and Sjögren’s disease. Aslan said the Sjögren’s data provide more information on clinical endpoints, patient-reported outcomes and objective measures such as salivary flow. He said Artiva has not yet selected its second indication but views Sjögren’s as attractive because it is a large indication treated by many of the same community physicians who treat RA.
Financing Extends Runway Into 2029
Aslan said Artiva recently raised $300 million, extending its cash runway into 2029. He said the financing is sufficient to fund the RA randomized controlled trial through its expected 2028 readout, continue enrollment across open-label autoimmune studies and potentially initiate a second randomized or pivotal study.
Asked about pricing, Aslan said it is too early to make a determination but suggested the therapy would likely be priced between autoimmune biologics and CAR-T therapies. He said response rate and durability would be key factors in any pricing strategy.
About Artiva Biotherapeutics (NASDAQ:ARTV)
Artiva Biotherapeutics, Inc is a clinical-stage biotechnology company focused on the development of allogeneic “off-the-shelf” cell therapies for cancer. The company’s proprietary platform leverages natural killer (NK) cells engineered to express chimeric antigen receptors (CARs) or other targeting modalities, with the goal of delivering potent anti-tumor activity while minimizing the safety and supply limitations associated with patient-derived (autologous) approaches.
Artiva’s pipeline includes multiple lead product candidates designed to address both hematologic malignancies and solid tumors.
