Home PipelineMGC018 (B7-H3)

Background

MGC018 is an investigational antibody-drug conjugate (ADC) comprised of a humanized B7-H3 monoclonal antibody (mAb) conjugated via a cleavable linker to the prodrug seco-DUocarmycin hydroxyBenzamide Azaindole (DUBA; licensed from Byondis, B.V.), with an average drug-to-antibody ratio (DAR) of ~2.7. DUBA is an alkylating agent that can damage DNA in both dividing and non-dividing cells, causing cell death. MGC018 is designed to target solid tumors expressing B7-H3.

Clinical Development

MGC018 is currently being evaluated in a Phase 1/2 dose expansion study in patients with metastatic castrate-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN) and melanoma. Preliminary results from the dose escalation phase of this study were presented at the 2020 American Society for Clinical Oncology (ASCO) Scientific Program. Preliminary results from the dose expansion phase of this study were presented at the 2021 ASCO Annual Meeting and the 2021 European Society for Medical Oncology (ESMO) Annual Meeting.

The Company is planning to initiate a Phase 2/3 study in patients with mCRPC who have had prior exposure to a taxane and at least one androgen receptor axis-targeted, or ARAT, agent (including abiraterone, enzalutamide or apalutimide), and a PARP (poly adenosine diphosphate-ribose polymerase) inhibitor, if appropriate.

MacroGenics is also evaluating the activity of MGC018 plus lorigerlimab (an investigational PD-1 × CTLA-4 bispecific DART® molecule) in a Phase 1 study in patients with advanced solid tumors.

Our Rights

MacroGenics retains global rights to MGC018.

Clinical Trials

Presentations & Publications

Relevant Publications and Presentations can be found at https://www.macrogenics.com/publications/.

The safety and efficacy of investigational agents and/or investigational uses of approved products have not been established.

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