FDA clears IND application for ‘allogenic, off-the-shelf’ cell therapy for lupus nephritis
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The FDA has cleared an investigational new drug application for AlloNK in combination with rituximab to treat systemic lupus erythematosus in patients with active lupus nephritis, according to a press release from Artiva Biotherapeutics.
The therapy, AlloNK, also recognized as AB-101, is a “non-genetically modified, cord blood-derived, allogeneic, cryopreserved [natural killer (NK)] cell therapy candidate designed to enhance antibody-dependent cellular cytotoxicity,” read the release. The company further noted that this clearance is the first time an “allogenic, off-the-shelf” NK or CAR T cell therapy has received an IND clearance.
“Seminal clinical data has been generated using autologous CAR T cells suggesting that a deeper B cell depletion can induce complete and long-lasting responses in patients with lupus nephritis,” Fred Aslan, MD, CEO of Artiva, said in the release. “AlloNK given in combination with rituximab, an anti-CD20 antibody that targets B cells, is already driving complete responses in late line B-NHL patients in an ongoing phase 1 study by enhancing the activity of rituximab [Rituxan, Genentech].”
To support the new clearance, the company also assembled a board of experts in lupus and lupus nephritis, including Kenneth Kalunian, MD, Jill Buyon, MD, Maureen McMahon, MD, and Brad Rovin, MD.
“Although rituximab has been used off-label in the treatment of SLE, rituximab alone has been shown to give incomplete B-cell depletion,” Kalunian said in the release. “The addition of allogeneic NK cells as an [antibody-dependent cellular cytotoxicity]-enhancing therapy could significantly enhance rituximab’s ability to drive deeper levels of B-cell depletion.
“SLE patients may have lower levels of NK cells than healthy subjects, and these cells may be functionally impaired,” he added. “An effective off-the-shelf cell therapy that can be administered and managed in the community setting could be well received by lupus patients and physicians.”
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