Lorigerlimab - (LINNET)

April 8, 2026: MacroGenics, Inc. (NASDAQ: MGNX) said the FDA removed the partial clinical hold on its Phase 2 LINNET study of lorigerlimab, an investigational bispecific DART molecule targeting PD-1 and CTLA-4, in gynecologic cancers. Previously enrolled participants were allowed to continue dosing during the hold; the company plans to resume enrollment of new participants under a revised protocol that adds risk-mitigation measures for potential hematologic and cardiac toxicities.

LINNET is evaluating single-agent lorigerlimab in up to ~60 patients with platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC) who have received one or more prior lines of therapy. The primary endpoint is objective response rate (ORR), with multiple secondary endpoints. To date, 41 participants have been dosed in LINNET, and over 300 participants have been dosed across prior lorigerlimab Phase 1 and Phase 2 studies.

The company stated it remains on track to provide a mid-2026 (mid-year) clinical update on the program.