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Enoblituzumab is an investigational monoclonal antibody that targets B7-H3 and has been enhanced using MacroGenics’ Fc Optimization platform. B7-H3 is a protein in the B7 family of immune regulator proteins. B7-H3 is widely expressed by a number of different tumor types and may play a key role in regulating the immune response to various types of cancer.
Enoblituzumab was evaluated in a Phase 1 clinical study in combination with an anti-PD-1 monoclonal antibody in patients with B7-H3-expressing melanoma, squamous cell carcinoma of the head and neck (SCCHN), non-small cell lung cancer (NSCLC) and urothelial cancer. Data were presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in November 2018.
MacroGenics evaluated the activity of enoblituzumab plus retifanlimab (an anti-PD-1 monoclonal antibody) in PD-L1 positive patients and enoblituzumab plus tebotelimab (a PD-1 × LAG-3 bispecific DART® molecule) in PD-L1 negative patients as chemotherapy‐free regimens in front‐line recurrent and metastatic SCCHN. As of July 8, 2022, this study was closed for safety reasons. Please see press release.
At ASCO in June 2022, investigators from Johns Hopkins presented a poster with encouraging clinical activity from an ongoing investigator-sponsored, single-center, single-arm, open-label Phase 2 study of enoblituzumab in patients with localized prostate cancer in the neoadjuvant setting.
MacroGenics has been collaborating on the development and commercialization of enoblituzumab with I-Mab Biopharma in Greater China. In August 2022, I-Mab notified MacroGenics of its intention to terminate its enoblituzumab license effective February 25, 2023. Thereafter, MacroGenics will retain full development and commercialization rights in all territories.
Relevant Publications and Presentations can be found at https://macrogenics.com/publications/.
The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established.