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Enoblituzumab, a first-in-class monoclonal antibody created using our Fc-Optimization platform, is the leading product candidate in our B7-H3 franchise. B7-H3 is a member of the B7 family of molecules involved in immune regulation and is over-expressed on a wide variety of solid tumor types. Inhibition of certain members of the B7 family has been shown to have powerful anti-tumor effects in several solid tumor types. We designed enoblituzumab to have increased ADCC by using the same Fc Optimization that we used to create margetuximab, and to target B7-H3 that is over-expressed on tumor cells and cancer stem-like cells, as well as on the supporting tumor vasculature and underlying tissues, or stroma. Enoblituzumab is designed to target all these components of the cancer environment.
In addition to enoblituzumab, MacroGenics’ comprehensive B7-H3 franchise includes: MGD009, a DART® molecule targeting B7-H3 and CD3 that is in Phase 1 clinical development; and MGC018, a pre-clinical B7-H3 antibody-drug conjugate, or ADC, for which the Company anticipates submitting an Investigation New Drug (IND) application in 2018. (Learn More – MGD009, MGC018)
Data from a Phase 1 study was presented in a late-breaking abstract presentation at the 2015 Society for Immunotherapy of Cancer (SITC) Annual Meeting. Enoblituzumab was shown to be well tolerated at all dose levels tested in the Phase 1 study (up to 15 mg/kg), with Grade 3/Grade 4 drug-related adverse events (AEs) in only 4% of patients, no severe immune-related adverse events, and no drug-related treatment discontinuations. In this Phase 1 study, initial monotherapy anti-tumor activity was observed across several tumor types, including patients with prostate and bladder cancer as well as melanoma. Overall, this patient population had been heavily pre-treated (median number of prior therapies = 3), and in the patients with melanoma, all had been treated previously with one or more checkpoint inhibitors (anti-CTLA-4, anti-PD-1 and/or anti-PD-L1 antibodies).
In addition to the presentation of initial safety and activity data, findings were presented showing that increases in T-cell repertoire (TCR) clonality in the peripheral blood of tumor patients following treatment with enoblituzumab, demonstrating that enoblituzumab can modulate T cells in these patients. (Learn More – 2015 SITC Presentation)
Enoblituzumab is currently being evaluated in the neoadjuvant prostate cancer setting and the Company plans to provide an update on this study in 2018.
We are leveraging the potential power of immunotherapy via the investigation of enoblituzumab in combination with pembrolizumab (anti-PD-1), a checkpoint inhibitor, in patients with B7-H3 positive melanoma, non-small cell lung carcinoma, bladder and head and neck cancers and expect to report this data in 2018. (Learn More: Enoblituzumab Combination with Pembrolizumab)
MacroGenics retains full worldwide rights to the B7-H3 franchise (including enoblituzumab).