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FDA Grants Fast Track Designation to NK Cell Therapy AlloNK® for Lupus Nephritis


22 February 2024

Artiva Biotherapeutics' AlloNK® has received FDA Fast Track designation for the treatment of lupus nephritis in combination with rituximab or obinutuzumab. AlloNK® signifies a major step forward in the development of advanced treatments for autoimmunity and oncology.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Artiva Biotherapeutics, Inc.'s flagship program, AlloNK® (also known as AB-101), for the treatment of lupus nephritis. As a pioneer in the development of allogeneic natural killer (NK) cell-based therapies, this marks a significant breakthrough. AlloNK®, the first off-the-shelf NK cell therapy for autoimmune diseases, not only promises to accelerate the availability of treatment for patients but also offers a safer, more convenient alternative that minimizes the risk of secondary malignancies.

AlloNK®, a non-genetically modified, cryopreserved allogeneic NK cell therapy candidate, has emerged as a significant advancement for treating lupus nephritis, an autoimmune disease primarily affecting the kidneys. By enhancing the activity of B-cell-targeting monoclonal antibodies like rituximab or obinutuzumab, AlloNK® drives B-cell depletion, offering new hope to patients who have had limited therapeutic options for this debilitating condition.

Dr. Fred Aslan, CEO of Artiva, expressed optimism about the designation, stating, “The FDA Fast Track designation gives us an opportunity to accelerate our efforts to bring our AlloNK cell therapy to autoimmunity patients. We are encouraged by clinical data from our Phase 1/2 multicenter clinical trial in non-Hodgkin lymphoma, where we observed that AlloNK in combination with rituximab can drive deep B-cell depletion in patients with late-line B-cell cancers. Our therapy has a mechanism very similar to the B-cell targeted autologous CAR-T therapies, but with the benefits of being an off-the-shelf therapy with a better safety profile, and that we believe will not be subject to the secondary malignancy risk associated with genetically engineered cell therapies.”

AlloNK®'s journey continues as it undergoes rigorous testing in a multi-center, open-label clinical trial, aimed at assessing its safety and effectiveness in lupus nephritis patients who have not responded to or have relapsed following standard treatments. The trial identifier on is NCT06265220. Additionally, the therapy has shown promise in a Phase 1/2 trial ( Identifier: NCT04673617) in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma, highlighting its potential in treating autoimmune diseases beyond cancer.

With the FDA's Fast Track designation for the treatment of lupus nephritis and relapsed/refractory non-Hodgkin lymphoma of B-cell origin, AlloNK® is poised to make significant contributions to the field of autoimmunity and oncology, offering new hope to patients in need of innovative treatment options.

About AlloNK®

AlloNK® represents a new frontier in cell therapy, designed to enhance the efficacy of monoclonal antibodies through antibody-dependent cellular cytotoxicity (ADCC). This cryopreserved, off-the-shelf therapy could revolutionize treatment approaches, offering a convenient option for administration in community settings. AlloNK®'s manufacturing process, which avoids the use of integrating vectors, aims to sidestep the complications associated with autologous CAR-T therapies, including extensive patient follow-up and the risk of secondary cancers. Artiva's platform enables the production of thousands of AlloNK® doses from a single umbilical cord blood unit, maintaining high levels of CD16 and activating NK receptors.


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