Lupus Therapeutics, Artiva team up on AlloNK Phase 1 trial

18 adults with lupus nephritis to test natural killer cell therapy candidate

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by Margarida Maia |

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Lupus Therapeutics is collaborating with Artiva Biotherapeutics on a Phase 1 clinical trial testing AlloNK, a natural killer (NK) cell therapy candidate, in patients with lupus nephritis, which is one of the most common and severe complications of lupus that affects the kidneys.

With a single clinical site open at the University of California in San Diego, the Phase 1 trial (NCT06265220) seeks to recruit as many as 18 adults whose lupus nephritis has returned or didn’t respond to standard of care treatment approaches.

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Phase 1 trial to test AlloNK alone or in combination with rituximab

The trial will test the safety of AlloNK, also known as AB-101, for up to two years and its efficacy for lupus nephritis when given alone or in combination with rituximab, a B-cell-depleting antibody-based therapy. Patients may receive up to two cycles of treatment spaced apart by about six months.

“As the clinical affiliate of the Lupus Research Alliance, Lupus Therapeutics strives to progress innovative approaches to new therapies for the benefit of individuals living with lupus,” Stacie Bell, PhD, executive vice president of Lupus Therapeutics, said in an emailed statement to Lupus News Today.

“With the explosion of cell therapy as a potential treatment paradigm for lupus, we are very fortunate to collaborate with organizations such as Artiva to support the evaluation of these possible treatment options,” she added. “The novel NK cell-based therapy, in combination with monoclonal antibodies, is being evaluated for active lupus nephritis, an area of continued unmet need.”

Autoimmune attacks in lupus are caused by antibodies that B-cells, a type of immune cell, mistakenly produce against the body’s own tissues. They also play a role in lupus nephritis, which occurs when the self-reactive antibodies attack the kidneys, causing inflammation and damage.

As many as an estimated two out of three lupus patients in the U.S. will develop lupus nephritis, but current treatments are limited. Because not all patients experience lupus the same way, more treatment options are needed.

Cell therapies are gaining attention in this field where Artiva is charting a course for AlloNK, a cell therapy that contains NK cells derived from the umbilical cord blood of healthy donors. AlloNK is designed to enhance the effectiveness of antibody-based therapies that deplete disease-causing B-cells.

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NK cells contain enzymes that can kill diseased cells

NK cells, thought to be present in lower numbers in lupus patients, contain enzymes that can kill diseased cells. Unlike other immune cells used in cell therapies, NK cells are less likely to drive unwanted immune reactions and don’t require genetic manipulation to recognize a specific protein on B-cells.

By leveraging its manufacturing platform, Artiva can grow enough active NK cells from healthy donors to treat hundreds to thousands of patients, according to the company. NK cells can be frozen and stored for ready, off-the-shelf use, offering the opportunity for repeat dosing in outpatient settings.

Rituximab, sold as Rituxan among other brand names, works by targeting a protein called CD20 on the surface of B-cells. NK cells in AlloNK are rich in CD16, a protein that can bind strongly to anti-CD20 antibodies. This interaction activates and directs NK cells to attack B-cells containing CD20 on their surface, thereby boosting the effects of anti-CD20 antibodies.

“These cell therapies are an exciting area of research in lupus with rapidly growing commitment among all the stakeholders comprising the lupus community, including industry and the research centers that are part of the Lupus Clinical Investigators Network,” Bell said in a press release. This network of research centers across North America is overseen by Lupus Therapeutics.

Together, Lupus Therapeutics and the Lupus Research Alliance have a strong interest in advancing cell therapies and have previously advised and supported research that laid the groundwork for moving AlloNK into clinical development.

The U.S. Food and Drug Administration granted fast track status to AlloNK earlier this year for its potential to treat lupus nephritis, which may hasten the development and regulatory review of the cell therapy candidate.