AlloNK plus rituximab is intended to treat systemic lupus erythematosus in patients with active lupus nephritis. Credit: mi_viri / Shutterstock.com.

The US Food and Drug Administration (FDA) has approved Artiva Biotherapeutics’ investigational new drug (IND) application for the combination of AlloNK (AB-101) and rituximab to treat systemic lupus erythematosus (SLE) in active lupus nephritis (LN) patients.

Designed to improve antibody-dependent cellular cytotoxicity (ADCC), AlloNK is a non-genetically modified, allogeneic, cord blood-derived, cryopreserved NK cell therapy candidate.

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AlloNK is currently under assessment in two cancer trials, where it is being studied alongside antibody or NK-engager biologics.

In May 2022 the company revealed preliminary results from the dose-escalation stage of its Phase I/II clinical trial involving AB-101.

The trial, which focused on patients with relapsed/refractory B-cell non-Hodgkin’s lymphoma (B-NHL), showed AlloNK’s therapeutic potential and favourable safety profile when used in conjunction with rituximab.

Artiva CEO Fred Aslan stated: “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 I study by enhancing the activity of rituximab.

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“Our hypothesis is that AlloNK plus rituximab also has the potential to drive deep B-cell depletion in LN patients with an off-the-shelf therapy that could be administered and managed in an outpatient setting.”

SLE is a severe autoimmune condition characterised by faulty B-cell activity and production of autoantibodies. Its clinical symptoms include end-organ damage and increased risk of death.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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