AlloNK cell therapy wins FDA fast track status for lupus nephritis
Experimental treatment is made to be given with antibody-based therapies
The U.S. Food and Drug Administration (FDA) has granted fast track status to AlloNK, an experimental natural killer (NK) cell therapy, for treating lupus nephritis, when given in combination with rituximab or obinutuzumab.
Fast track status is designed to aid the development and accelerate the review of investigational treatments that have the potential to treat serious conditions and fulfill an unmet medical need, helping them reach patients sooner. Lupus nephritis is a common complication of systemic lupus erythematosus (SLE).
The designation grants Artiva Biotherapeutics, the therapy’s developer, access to earlier and more frequent communication with the FDA throughout the regulatory review process. Therapies receiving this designation may also be eligible for accelerated approval and priority review if other criteria are met.
“The FDA Fast Track designation gives us an opportunity to accelerate our efforts to bring our AlloNK cell therapy to autoimmunity patients,” Fred Aslan, MD, Artiva’s CEO, said in a company press release.
In SLE, the most common form of lupus, B-cells produce autoantibodies that target and attack healthy tissue, causing inflammation in several organs and leading to a wide array of symptoms. Lupus nephritis, which occurs in about 40% of adults with SLE, is marked by kidney damage and inflammation. Many patients don’t respond to standard therapies and develop kidney failure.
Rituximab (sold as Rituxan, among other brands) and obinutuzumab (sold as Gazyva) are antibody-based therapies approved for certain types of blood cancers involving B-cells. They work by targeting CD20, a protein on B-cells’ surfaces, ultimately killing them.
What is AlloNK?
AlloNK, or AB-101, is a non-genetically modified cell therapy designed to be administered with these antibody-based therapies to enhance antibody-dependent cellular cytotoxicity (ADCC). ADCC is mainly mediated by NK cells, which recognize and destroy cells harboring molecules recognized by certain antibodies.
Unlike other immune cells, NK cells are less likely to drive unwanted immune reactions and don’t need to be matched to a specific patient. This, together with their fast and cheap production, makes them the ideal cell type in off-the-shelf cell therapies.
AlloNK cells are collected from the umbilical cord blood of healthy donors and cryopreserved. They don’t require genetic manipulation to recognize a specific protein and are immediately ready for use in outpatient settings.
With its cell therapy manufacturing platform, Artiva can generate thousands of doses of infusion-ready AlloNK cells from a single umbilical cord unit of blood, while maintaining production of activating NK receptors.
“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,” Aslan said.
CAR T-cell therapies use a patient’s own immune T-cells, which are engineered to be equipped with a chimeric antigen receptor that lets them recognize a specific disease-associated protein.
A Phase 1 trial (NCT06265220), which is recruiting participants at a site in the U.S., will evaluate the safety, tolerability, and preliminary activity of AlloNK, when given alone or with rituximab. The trial is estimated to enroll around 18 patients with lupus nephritis, who’ve relapsed or didn’t respond to previous standard of care treatments.
AlloNK has shown promising safety and activity in a Phase 1/2 trial (NCT04673617) enrolling patients with hard to treat B-cell non-Hodgkin lymphoma when given with rituximab, according to Artiva.
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