On April 8, 2026, MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company dedicated to innovating antibody-based therapies for cancer treatment, announced a pivotal update regarding its Phase 2 LINNET study. The U.S. Food and Drug Administration (FDA) has officially removed a partial clinical hold that was previously placed on the study of lorigerlimab, an investigational bispecific DART® molecule targeting PD-1 and CTLA-4. This development marks a crucial turning point for the ongoing research and development of lorigerlimab.

2. Details on the LINNET Study

The LINNET study is designed to evaluate the efficacy of single-agent lorigerlimab in approximately 60 eligible participants suffering from platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC). These patients have undergone one or more prior lines of therapy, making them critical candidates for innovative treatment options. The primary endpoint of the study is the objective response rate (ORR), with several secondary endpoints also being evaluated.

As of the latest update, 41 study participants have been dosed in the LINNET study, contributing to a broader data set that includes over 300 participants across all previous Phase 1 and Phase 2 clinical studies involving lorigerlimab.

3. Revised Protocol and Risk Mitigation

During the period of the partial clinical hold, existing study participants were allowed to continue receiving the study drug. Moving forward, the FDA's lifting of the hold permits MacroGenics to enroll new participants under a revised protocol that incorporates additional risk-mitigation measures aimed at addressing potential hematologic and cardiac toxicities associated with lorigerlimab. This proactive approach underscores MacroGenics' commitment to patient safety while advancing its clinical programs.

4. Leadership's Remarks

Eric Risser, President and CEO of MacroGenics, expressed gratitude for the collaborative efforts between the company and the FDA's Office of Oncologic Diseases. He emphasized the importance of the FDA's decision, stating, "We are grateful for the productive interaction with the reviewers at the FDA… With the partial clinical hold lifted, we intend to resume enrollment of new study participants in the ongoing LINNET study and we remain on track to provide a mid-year clinical update on the program."

5. About MacroGenics, Inc.

MacroGenics is at the forefront of biopharmaceutical innovation, focusing on the development of monoclonal antibody-based therapeutics targeting cancer. The company leverages its proprietary suite of next-generation antibody technology platforms, which have broad applications across various therapeutic domains. MacroGenics has successfully generated a robust pipeline of product candidates and established several strategic partnerships with global pharmaceutical and biotechnology companies.

6. Conclusion

The removal of the partial clinical hold on the LINNET study represents a significant advancement in MacroGenics' pursuit of innovative cancer treatments. With plans to enroll new participants and a commitment to safety and efficacy, the company is poised to make meaningful contributions to the oncology landscape. Investors and stakeholders alike will be keenly watching for the forthcoming clinical updates expected mid-year, signaling the next steps in the journey of lorigerlimab and its potential impact on patient outcomes in challenging cancer indications.

Original press release