Artiva Therapeutics is looking to dose the first patient in a Phase I/II trial assessing its cell therapy AlloNK in lupus nephritis (LN).
CEO Fred Aslan told the Clinical Trials Arena that the company is currently enrolling patients on the trial with hopes to dose the first patient within H1 2024.
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The Phase I/II trial (NCT06265220) will be a multi-centre, open-label study to assess the safety and clinical activity of AlloNK, also known as AB-101, in combination with anti-CD20 monoclonal antibodies in patients with LN who have relapsed or did not respond to standard of care (SoC).
The trial will not be controlled, with different arms exploring the candidate at varying doses with different monoclonal antibodies.
On 22 February, Artiva received fast track designation from the US Food and Drug Administration (FDA) for AlloNK in LN after receiving an investigational new drug (IND) application for the candidate approved in LN and systemic lupus erythematosus (SLE) in August 2023.
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AlloNK is a non-genetically modified, allogeneic, cryopreserved natural killer (NK) cell therapy candidate that enhances the activity of B-cell-targeting monoclonal antibodies to drive B-cell depletion.
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By GlobalDataAslan said: “Part of the reason why we think monoclonal antibodies do not work as well is because we give them antibodies and they don’t have the NK cell. We think if we give high doses of allogeneic NK cells with monoclonals, can we drive a more significant effect than alone.”
If the Phase I/II trial is successful, the company plans to initiate a Phase III trial of the candidate in LN to push for approval.
The San Diego-based biotech has also investigated the candidate and established safety and activity in a Phase I/II trial of relapsed/refractory B-cell non-Hodgkin lymphoma (NCT04673617).
Aslan said if approved, the candidate could be preferable to B-cell CAR-T cell therapies in some indications as AlloNK is an off-the-shelf outpatient procedure while a common toxicity of CAR-T cell therapy, cytokine release syndrome (CRS) requires every patient to be monitored and potential hospitalisation.
The company said that the candidate could also show promise in other autoimmune diseases including myositis, scleroderma, myasthenia gravis and rheumatoid arthritis, with Aslan adding that after analysis, the company will pick a subset of these to run further trials with the candidate.
Lupus landscape
The market for LN and SLE is predicted to grow significantly over the next few years, reaching sales of $3.5bn in 2031 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan). The US is anticipated to account for 81.2% of that market and a market value of $2.8bn.
Much of the drive in growth is predicted to come from the launch of pipeline products, including Roche’s Gazyvaro (obinutuzumab), Novartis’s ianalumab and Biogen’s litifilimab, which are all monoclonal antibodies.
Biologics have been identified as major drivers for growth, however, there are concerns about the high annual cost of candidates, which is likely to represent a major barrier, meaning there is a desire for alternative mechanisms of action.
GlobalData is the parent company of the Clinical Trials Arena.
