MacroGenics, Inc. (NASDAQ: MGNX) rose Wednesday, after reporting positive results from pivotal Phase 3 SOPHIA study of margetuximab.
MacroGenics, the clinical-stage biopharmaceutical company out of Rockville, Maryland, is focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer.
Wednesday, it announced positive results from SOPHIA, the Company’s Phase 3 clinical study of margetuximab in HER2-positive metastatic breast cancer patients. Margetuximab is an investigational immune-enhancing monoclonal antibody derived from the Company’s proprietary Fc Optimization technology platform.
The SOPHIA study enrolled more than 500 patients at trial sites across North America, Europe and Asia. Patients were treated with either margetuximab or trastuzumab in combination with one of four chemotherapy agents (capecitabine, eribulin, gemcitabine or vinorelbine).
All study patients had previously received trastuzumab and pertuzumab, and approximately 90% had previously received ado-trastuzumab emtansine. The combination of margetuximab and chemotherapy demonstrated acceptable safety and tolerability, comparable overall to that of trastuzumab and chemotherapy.
Said CEO Scott Koenig, "We are pleased with the SOPHIA clinical results and are especially grateful to the patients, their caregivers, trial investigators and site personnel who participated in the study.
"I would also like to thank the entire MacroGenics team and our business partners who worked diligently to bring margetuximab to the clinic and execute the SOPHIA study."
Shares in MacroGenics were propelled higher by $18.29, or 164.6%, to $29.40.
