MacroGenics, Inc. Announces FDA Lifts Partial Clinical Hold On Phase 2 LINNET Study, Allowing Enrollment To Resume Under Updated Safety Protocol

MacroGenics, Inc., a clinical-stage biopharmaceutical company listed on NASDAQ under the ticker MGNX, announced that the partial clinical hold placed by the U.S. Food and Drug Administration on its Phase 2 LINNET study has now been lifted. The study evaluates lorigerlimab, an investigational bispecific DART® molecule designed to simultaneously target PD-1 and CTLA-4—two important immune checkpoints involved in cancer progression.

The FDA’s partial clinical hold did not interrupt treatment for individuals already participating in the trial, who continued receiving the investigational therapy. However, enrollment of new participants was paused while the company addressed regulatory concerns. With the hold now removed, new patient enrollment will resume under an updated study protocol. This revised protocol includes additional safety measures intended to mitigate the risks of potential hematologic and cardiac toxicities, reflecting the FDA’s request for enhanced safeguards.

Eric Risser, President and CEO of MacroGenics, expressed appreciation for the constructive dialogue with the FDA’s Office of Oncologic Diseases and acknowledged the team’s rapid effort to provide the necessary information and analyses. He stated that the company remains committed to advancing lorigerlimab and expects to deliver a clinical update on the program around mid-year.

The LINNET study is designed to evaluate lorigerlimab as a single agent in approximately 60 eligible patients. These participants include individuals with platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC), all of whom have received one or more previous treatment regimens. The primary objective of the study is to measure the objective response rate (ORR), supported by several secondary endpoints that assess additional aspects of clinical activity and safety.

Up to this point, 41 patients have already been dosed in the LINNET study. Across all earlier Phase 1 and Phase 2 studies involving lorigerlimab, more than 300 participants have received the investigational treatment. This growing dataset continues to support the molecule’s clinical development as MacroGenics moves forward with renewed momentum following the FDA’s decision.