RARE Daily

FDA Grants Fast Track Designation for Artiva’s AlloNK in Lupus Nephritis

February 22, 2024

Rare Daily Staff

The U.S. Food and Drug Administration has granted Fast Track designation to Artiva Biotherapeutics’ lead program AlloNK for the treatment of lupus nephritis in combination with rituximab or obinutuzumab.

Artiva previously received FDA clearance of an Investigational New Drug application for AlloNK in combination with rituximab in lupus nephritis, marking the first IND clearance of an allogeneic, off-the-shelf NK cell therapy in autoimmune disease. AlloNK is a non-genetically modified, allogeneic, cryopreserved natural killer cell therapy candidate that enhances the activity of B-cell-targeting monoclonal antibodies to drive B-cell depletion.

“The FDA Fast Track designation gives us an opportunity to accelerate our efforts to bring our AlloNK cell therapy to autoimmunity patients,” said Fred Aslan, CEO of Artiva. “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.”

Artiva says its NK allogeneic cell therapy has a mechanism very similar to B-cell targeted autologous CAR-T therapies, but with the benefits of being an off-the-shelf therapy with a better safety profile, that it believes will not be subject to the secondary malignancy risk associated with genetically engineered cell therapies.

Lupus nephritis is a rare type of kidney disease caused by systemic lupus erythematosus. Lupus is an autoimmune disease—a disorder in which the body’s immune system attacks the body’s own cells and organs. Kidney disease caused by lupus may get worse over time and lead to kidney failure.

AlloNK is being investigated in a multi-center, open-label clinical trial to assess the safety and clinical activity of AlloNK in combination with anti-CD20 antibodies in patients with LN who have relapsed or did not respond to previous standard of care treatment approaches.

Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need, enabling drugs to potentially reach patients earlier. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

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