Artiva has received FDA clearance for their investigational new drug application for lupus nephritis treatment AlloNK plus rituximab, marking the first IND clearance for an allogeneic, off-the-shelf natural killer (NK) cell therapy in the field of autoimmune diseases. AlloNK is a non-genetically modified, cryopreserved therapy designed to enhance the effectiveness of B-cell-targeting monoclonal antibodies, hence promoting B-cell depletion.
The manufacturing process of AlloNK does not require integrating vectors, thus eliminating the need for extensive patient follow-up or the risk of secondary malignancy warnings usually associated with some autologous chimeric antigen receptor (CAR)-T therapies.
Currently, AlloNK’s clinical activity and safety are being assessed in a multicentre, open-label clinical trial. This trial focuses on lupus nephritis treatment patients who have not responded or relapsed following standard care and are treated with the therapy in conjunction with anti-CD20 antibodies.
Artiva’s AlloNK Cell Therapy Secures FDA Fast Track Following Clinical Success
The safety and activity of AlloNK have previously been demonstrated in a multicentre Phase I/II clinical trial with rituximab involving patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL).
Artiva’s cell therapy manufacturing platform is capable of producing thousands of doses of AlloNK cells ready for infusion from a single umbilical cord blood unit. This FDA Fast Track designation, according to Artiva CEO Fred Aslan, provides an opportunity to accelerate efforts to bring AlloNK cell therapy to autoimmunity patients.
Artiva’s Lupus Nephritis Treatment AlloNK Plus Rituximab Shows Deep Depletion Potential
Findings from the Phase I/II multicentre clinical trial in non-Hodgkin lymphoma have been encouraging, with AlloNK combined with rituximab showing potential to drive deep B-cell depletion in patients with late-line B-cell cancers. AlloNK operates in a way very similar to B-cell targeted autologous CAR-T therapies but with a superior safety profile and is believed to be free from the risk of secondary malignancy associated with genetically engineered cell therapies.
FDA clearance for Artiva’s investigational new drug application for AlloNK plus rituximab for lupus nephritis treatment marks a significant step in the field of autoimmune diseases. The therapy, which enhances the effectiveness of B-cell-targeting monoclonal antibodies, is currently being assessed for safety and clinical activity in a multicentre, open-label clinical trial. The encouraging results from earlier trials, coupled with the potential of AlloNK to drive deep B-cell depletion in patients with late-line B-cell cancers, signal a promising future for this novel therapy.
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