- Celldex Therapeutics (NASDAQ:CLDX) is up 5% premarket on light volume in response to its announcement of positive results from a Phase 2 clinical trial assessing antibody-drug conjugate glembatumumab vedotin in advanced treatment-resistant melanoma. The data were presented at the European Society for Medical Oncology 2016 Annual Meeting in Copenhagen.
- The objective response rate (ORR) was 11% (n=7/62) and the median duration of response was 6.0 months (heavily pretreated population). The disease control rate (responders + those with stable disease for at least three months) was 52% (n=32/62) as was the proportion of patients experiencing tumor shrinkage. Median progression-free survival (PFS) was 4.4 months.
- The company has amended the protocol of the study to add a second cohort of patients who will be treated with a combination of glembatumumab vedotin and varlilumab. After enrollment is completed, a new arm will be explored assessing a combination of glembatumumab vedotin and an immune checkpoint inhibitor.
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Glembatumumab vedotin is fully human antibody-drug conjugate that links a glycoprotein NMB (gpNMB)-targeting antibody called CR011 to a potent cytotoxic agent called monomethyl auristatin E. GpNMB is overexpressed in multiple tumor types, including more than 80% of metastatic melanoma cases. It is also being evaluated in triple negative breast cancer and osteosarcoma (bone cancer).
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Varlilumab (CDX-1127) is a fully human monoclonal antibody that targets CD27, a member of the tumor necrosis factor receptor class. It plays a key role in the activation pathway of lymphocytes and can be effectively manipulated with activating antibodies to induce potent anti-tumor effects while being less toxic due to its restricted expression and regulation.