“Both CDX-011 and CDX-1307 have demonstrated tremendous potential..."
CLDX is the biotech to own people.
“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.
CDX-011 is an antibody-drug conjugate (ADC) that consists of a fully-human monoclonal antibody, CR011, linked to a potent cell-killing drug, monomethyl-auristatin E (MMAE). The ADC technology, comprised of MMAE and a stable linker system for attaching it to CR011, was licensed from Seattle Genetics, Inc. Following intravenous administration, CDX-011 targets and binds to GPNMB, a specific protein that is predominantly expressed in cancerous tumors, including melanoma, breast cancer and gliomas. Upon internalization into the targeted cell, CDX-011 is designed to release MMAE from CR011 to produce a cell-killing effect. CDX-011 has been shown to be safe and active, with observed objective responses, in two positive trials in breast cancer and advanced melanoma.
CDX-1307 is the first antibody-based cancer vaccine designed to induce robust immune responses against cells containing the beta chain of human chorionic gonadotropin (hCG-beta) which are found in several epithelial tumors. hCG-beta appears to directly facilitate cancer progression and has been shown to correlate with poor prognosis. CDX-1307 consists of a fully human monoclonal antibody with specificity for the mannose receptor on dendritic cells, genetically linked to the hCG-beta tumor antigen and combined with the adjuvants TLR-7/8 agonist (toll-like receptor) and Hiltonol™ (a TLR-3 agonist). It is in development for colorectal, pancreatic, bladder, ovarian and breast cancers. CDX-1307 is derived from Celldex’ APC Targeting Technology™ platform.
About Celldex Therapeutics, Inc.
Celldex Therapeutics is the first antibody-based combination immunotherapy company. Celldex has a pipeline of drug candidates in development for the treatment of cancer and other difficult-to-treat diseases based on its antibody focused Precision Targeted Immunotherapy Platform. The PTI Platform is a complementary portfolio of monoclonal antibodies, antibody-targeted vaccines and immunomodulators used in optimal combinations to create novel disease-specific drug candidates. For more information, please visit http://www.celldextherapeutics.com.