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Artiva Biotherapeutics' AlloNK® Receives FDA Fast Track Designation for Lupus Nephritis

Friday, February 23, 2024

Artiva Biotherapeutics, Inc., a clinical-stage biotech firm committed to advancing highly effective, off-the-shelf allogeneic natural killer (NK) cell-based therapies, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its leading program, AlloNK® (also known as AB-101), for treating lupus nephritis (LN) alongside rituximab or obinutuzumab. This signifies a significant achievement as Artiva becomes the first to secure FDA clearance for an Investigational New Drug (IND) application for an allogeneic, off-the-shelf NK cell therapy in autoimmune disease, particularly in LN. AlloNK collaborates with B-cell-targeting monoclonal antibodies to enhance B-cell depletion, offering a promising therapeutic avenue.

Artiva, expressed optimism about the FDA Fast Track designation, stating, “This designation accelerates our journey to provide AlloNK cell therapy to autoimmune patients. Encouraging results from our Phase 1/2 multicenter clinical trial in non-Hodgkin lymphoma highlight AlloNK's potential to drive deep B-cell depletion in late-line B-cell cancers, akin to autologous CAR-T therapies, but with distinct advantages such as off-the-shelf availability and a presumably safer profile without the risks associated with genetically engineered cell therapies.”

AlloNK is currently under investigation in a multi-center, open-label clinical trial evaluating its safety and clinical activity in combination with anti-CD20 antibodies for LN patients who have relapsed or failed previous standard treatments. Furthermore, its safety and efficacy have been demonstrated in combination with rituximab in a Phase 1/2 multicenter clinical trial for patients with relapsed or refractory B-cell-non-Hodgkin lymphoma.

AlloNK® (AB-101) is an allogeneic NK cell therapy designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of monoclonal antibodies or NK cell engagers. Offering the potential for community-based administration, AlloNK is cryopreserved and produced without integrating vectors, thereby avoiding extensive patient follow-up or concerns about secondary malignancies linked with approved autologous CAR-T therapies. Utilizing Artiva's cell therapy manufacturing platform, thousands of doses of infusion-ready AlloNK cells can be generated from a single umbilical cord blood unit while maintaining consistent CD16 expression and activating NK receptors. The FDA has granted Fast Track designations for AlloNK in combination with rituximab or obinutuzumab for treating lupus nephritis and for treating relapsed/refractory non-Hodgkin lymphoma of B-cell origin.

Fast Track Designation expedites the development and review of drugs targeting serious conditions with unmet medical needs, potentially enabling earlier access for patients. Clinical programs with Fast Track designation may benefit from enhanced communication with the FDA and eligibility for Accelerated Approval and Priority Review under relevant criteria.



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