Artiva had previously secured FDA clearance for an investigational new drug application for AlloNK plus rituximab for LN.
This marked the first IND clearance for an allogeneic, off-the-shelf natural killer (NK) cell therapy in the realm of autoimmune diseases.
A non-genetically modified and cryopreserved therapy, AlloNK is designed to boost the efficacy of B-cell-targeting monoclonal antibodies, promoting B-cell depletion.
It is manufactured without needing integrating vectors permitting AlloNK not requiring extensive follow-up in patients or carry the secondary malignancy warnings risk associated with some autologous chimeric antigen receptor (CAR)-T therapies.
Currently, AlloNK is being analysed in a multicentre, open-label clinical trial. The study is designed to assess the clinical activity and safety of this therapy in combination with anti-CD20 antibodies in LN patients who have not responded to or have relapsed following standard care.
The safety and activity of AlloNK was demonstrated in a multicentre Phase I/II clinical trial with rituximab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL).
The cell therapy manufacturing platform of Artiva can produce thousands of doses of infusion-ready AlloNK cells from a single umbilical cord blood unit.
Artiva CEO Fred Aslan said: “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 I/II multicentre 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.”