$8M grant supports Phase1b/2 trial of IMPT-514 for active, resistant SLE

One-time CAR T-cell therapy to be tested in about 30 patients at US sites

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by Andrea Lobo, PhD |

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Immpact Bio has received an $8 million grant from the California Institute for Regenerative Medicine (CIRM) for its ongoing Phase 1b/2 study evaluating the safety and efficacy of IMPT-514 in people with active and treatment-resistant systemic lupus erythematosus (SLE), including those with active lupus nephritis.

The open-label clinical trial (NCT06153095), which is currently recruiting patients at one center in Los Angeles — with four other U.S. sites set to open — expects to enroll 30 eligible adults who previously used at least two standard-of-care disease treatments.

The Phase 1 part of the trial will evaluate multiple ascending doses of IMPT-514, a one-time CAR T-cell therapy, in people with active, refractory SLE and lupus nephritis, a serious complication characterized by kidney inflammation and damage. Its Phase 2 part will enroll additional patients, with or without active lupus nephritis.

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IMPT-514 is a bispecific CAR T-cell therapy, targeting 2 proteins

“We expect initial efficacy and safety data from our Phase 1b/2 dose escalation trial in the second half of 2024,” Jonathan Benjamin, MD, PhD, Immpact Bio’s chief medical officer, said in a company press release. “We are extremely grateful that CIRM has recognized the scientific merit and technical feasibility of our clinical trial evaluating IMPT-514 for the treatment of both [lupus nephritis] and SLE.”

Lupus is caused by the immune system mistakenly attacking the body’s healthy tissues. B-cells, the immune cells mainly responsible for producing antibodies, play a central role in this autoimmune attack. Lupus symptoms depend on which organs and body tissues are affected, and they can vary widely.

“No ‘one size fits all’ treatment exists for complex individuals like me,” said Kathleen A. Arntsen, president and CEO of the Lupus and Allied Diseases Association, a patient advocacy group. “What works in one person may not work in another. Therefore, our physicians need an arsenal of therapies to treat lupus and lupus nephritis.”

IMPT-514, as a CAR-T cell therapy, uses T-cells, another type of immune cell that’s capable of killing other cells. T-cells are collected from a patient and genetically modified in the lab to have a chimeric antigen receptor, or CAR — a specialized receptor that directs T-cells to attack and kill cells harboring specific molecular targets.

In the case of IMPT-514, T-cells are engineered specifically to target CD19 and CD20, two proteins common to B-cells. The modified T-cells then are infused back to the patient, where they are expected to destroy B-cells, helping to reduce disease activity.

Aim is to replace need for ‘chronic immune suppression’ with active lupus

A goal, the company stated, is to offer “a one-time treatment option with potential to replace the need for chronic immune suppression.”

Data from a previous Phase 1 trial in lymphoma patients showed that IMPT-514 had a favorable safety profile, with no reports of serious adverse events.

“CAR T-cell therapies have transformed the treatment of blood cancers, but their therapeutic potential in autoimmune diseases is a promising opportunity,” said Abla Creasey, PhD, vice president of therapeutics development at CIRM. “We believe the ImmPACT Bio approach with IMPT-514 as a one-time treatment holds significant potential to change the treatment paradigm and clinical care of severe, refractory lupus.”

IMPT-514 was placed on a fast track by the U.S. Food and Drug Administration last year. The designation is given to therapies with the potential to treat serious conditions, and it allows the therapy’s developer earlier and more frequent communication with the regulatory agency to accelerate the development process.

Patients will be followed closely for about one year after treatment with IMPT-514, and continue to be checked for the therapy’s safety and efficacy for about 15 years.