Immutep MS therapy IMP761 found safe in initial Phase 1 trial data
Company says no treatment-related side effects seen in healthy volunteers
IMP761, an experimental immunotherapy Immutep is developing for multiple sclerosis (MS) and other autoimmune conditions, has shown a promising safety profile in an ongoing Phase 1 clinical trial in healthy volunteers, with no treatment-related side effects reported to date, the company said.
The first-in-human Phase 1 trial (NCT06637865) is expected to enroll 49 healthy adults at a single site in the Netherlands to investigate the treatment’s safety and pharmacological properties.
A series of doses, given once or multiple times over a given period of time, are being tested in the trial. The recently shared safety data pertains to the first three of five groups of participants who received a single ascending dose of IMP761.
Additional safety and pharmacological data — including how the therapy moves into, through, and out of the body, as well as its effects on the body — are expected in the first half of next year.
“We are very encouraged by the safety data generated to date for IMP761, the world’s first LAG-3 agonist antibody, in this Phase I setting,” Frédéric Triebel, MD, PhD, Immutep’s chief scientific officer, said in a company press release.
Putting the brakes on cells
MS is an autoimmune disease that occurs when the immune system mistakenly attacks healthy parts of the brain and spinal cord. Several types of immune cells, including T-cells, have been implicated in this process.
IMP761 is an antibody-based therapy to be administered directly into the bloodstream. It’s designed to activate LAG-3, a receptor protein found at the surface of immune T-cells. This protein normally functions as a brake on T-cells and other immune cells, preventing them from becoming overactive and attacking healthy tissues in the body.
By boosting LAG-3’s function, the therapy is expected to suppress the activity of these self-reactive cells and restore immune balance, the immune system’s ability to accurately distinguish the body’s own cells from foreign microbes, in people with autoimmune diseases.
In preclinical studies, IMP761 effectively inhibited T-cell growth and activation, and reduced the levels of inflammatory molecules produced by cells derived from people with an autoimmune condition called oligoarticular juvenile idiopathic arthritis.
The Phase 1 trial, which dosed its first participant in August, is now testing IMP761 in healthy volunteers before moving to disease-specific clinical trials.
In the single-dose part, participants receive a dose of either IMP761 at increasing doses or a placebo. In the multiple ascending portion, participants are given three infusions of the therapy at increasing doses or a placebo every 28 days.
“Derisking this promising asset in this proof-of-concept study in healthy subjects assessing its safety and immunosuppressive efficacy … is an important step for this exciting program in autoimmune diseases,” Triebel said. “Given that IMP761 is potentially addressing the root cause of many different autoimmune diseases, we are eager to see this study generating more data,” he added.
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