Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced the presentation of promising clinical data on CDX-011 in metastatic melanoma at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois. The Phase 2 study has met its primary endpoint and the results support additional studies in this indication. CDX-011 is an antibody-drug conjugate (ADC) in Phase 2 development for the treatment of melanoma and advanced breast cancer. In addition, in a separate presentation today at ASCO, the Company presented the study design for its recently initiated Phase 2 trial of CDX-1307 in bladder cancer. CDX-1307 is an antibody-based cancer vaccine candidate and is being evaluated as a treatment for bladder cancer.
“Further development is warranted for both candidates and we look forward to reporting additional clinical data in the near future.”
"Both CDX-011 and CDX-1307 have demonstrated tremendous potential for the treatment of the most difficult to treat cancers," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "Further development is warranted for both candidates and we look forward to reporting additional clinical data in the near future."
CDX-011 Phase 2 Melanoma Study Results
In the poster entitled Frequent Dosing and GPNMB Expression with CDX-011 (CRO11-vcMMAE), an Antibody-Drug Conjugate (ADC), in Patients with Advanced Melanoma, Celldex described updated results from the Phase 2 portion of the multicenter, open-label Phase 1/2 study of CDX-011 in patients with unresectable Stage III/IV melanoma. A total of 34 patients were enrolled in the Phase 2 expansion and the primary activity endpoint of overall response rate (ORR) in the cohort was achieved with an ORR of 15%. Median progression free survival (PFS) was 3.9 months. CDX-011 was found to be active in advanced melanoma patients in the study.
In the Phase 2 expansion study, CDX-011 was administered at the pre-defined maximum tolerated dose (MTD) once every three weeks. A more frequent dosing schedule at MTD was evaluated in two additional, parallel dose-escalation arms in which patients received CDX-011 weekly>