FDA lifts partial clinical hold on MacroGenics' cancer drug study
MacroGenics Inc. (NASDAQ: MGNX) announced the U.S. Food and Drug Administration has removed the partial clinical hold on the company's Phase 2 LINNET study of lorigerlimab, an investigational drug targeting gynecologic cancers.
The biopharmaceutical company said it plans to resume enrollment of new participants under a revised protocol that includes additional risk-mitigation measures for potential blood and heart-related side effects. Previously enrolled study participants were allowed to continue receiving the experimental drug during the hold period.
The LINNET study evaluates lorigerlimab as a single treatment in up to 60 patients with either platinum-resistant ovarian cancer or clear cell gynecologic cancer who have received one or more prior therapies. The drug is a bispecific molecule that targets PD-1 and CTLA-4 proteins.
To date, 41 study participants have received the drug in the LINNET study, and over 300 participants have been dosed across all previous lorigerlimab Phase 1 and Phase 2 clinical studies, according to the company.
MacroGenics said it remains on track to provide a mid-2026 program update on the clinical trial. The study's primary endpoint measures objective response rate, with multiple secondary endpoints.
"We are grateful for the productive interaction with the reviewers at the FDA's Office of Oncologic Diseases," said Eric Risser, president and chief executive officer of MacroGenics.
The Rockville, Maryland-based company focuses on developing antibody-based cancer treatments using its proprietary technology platforms.
