- Continued progress in METRIC enrollment: Celldex continues to expect that enrollment will be completed by the end of September 2017. METRIC is a Phase 2b randomized study of glembatumumab vedotin in patients with metastatic triple negative breast cancers that overexpress gpNMB.
- Single-agent glembatumumab vedotin Phase 2 study in checkpoint-refractory metastatic melanoma accepted for oral presentation at ASCO: Updated data from the single-agent cohort of the Phase 2 study will be presented in an oral presentation at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in June. Enrollment recently completed in the glembatumumab vedotin and varlilumab arm, with data from this portion of the study expected in the fall of 2017. Enrollment continues in the glembatumumab vedotin plus checkpoint inhibitor (Opdivo ® or Keytruda ®) arm in patients who failed prior checkpoint therapy, a population with limited treatment options.
- Phase 1 varlilumab/Opdivo ® study accepted for oral presentation at ASCO: Updated data from the Phase 1 portion of the varlilumab and Opdivo study will be presented in an oral presentation at the 2017 ASCO Annual Meeting in June. The Phase 2 portion of the combination study includes cohorts in colorectal cancer, ovarian cancer, head and neck squamous cell carcinoma, renal cell carcinoma and glioblastoma, and is currently enrolling patients. The Company plans to complete enrollment across all cohorts in the Phase 2 portion of the study in the first quarter of 2018 and will work with Bristol-Myers Squibb to present data from the study at a future medical meeting. Data from the Phase 1 single-agent study of varlilumab in solid tumors were recently published in the Journal of Clinical Oncology .
- Phase 1 study of CDX-0158 continues to enroll patients: This dose escalation study in patients with advanced refractory gastrointestinal stromal tumors (GIST) and other KIT-positive tumors is designed to determine the maximum tolerated dose, recommend a dose for further study and characterize the safety profile of CDX-0158. Data from the study continue to be expected by year-end 2017.
- CDX-3379 advancing to Phase 2: The Company is currently finalizing plans for advancement into a Phase 2 study in combination with cetuximab in patients with cetuximab-resistant advanced head and neck squamous cell carcinoma.
- Enrollment ongoing in Phase 1 study of CDX-014: The study in advanced renal cell carcinoma (clear cell and papillary) is designed to determine the maximum tolerated dose and to recommend a dose level for further study. Celldex continues to expect the Phase 1 dose-escalation portion of the study will complete enrollment by year-end 2017.
HAMPTON, N.J., May 09, 2017 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported business and financial highlights for the first quarter ended March 31, 2017. "In the first quarter of 2017, Celldex made considerable progress across our pipeline," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "We continue to expect enrollment completion in our ongoing study of glembatumumab vedotin in triple negative breast cancer by the end of September, and we recently completed enrollment in the Phase 2 glembatumumab vedotin plus varlilumab combination cohort in checkpoint-refractory metastatic melanoma. Glemba's target, gpNMB, is highly expressed in melanoma and triple negative breast cancer, among others, and is associated with more aggressive disease. We believe taking an antibody-drug conjugate approach to targeting gpNMB generates a potent cytotoxic effect within the tumor and its environment and may ultimately result in improved outcomes for patients." "We also look forward to presenting data from two programs in oral sessions at ASCO in June—the Phase 2 single-agent study of glembatumumab vedotin in metastatic melanoma and the Phase 1 combination study of varlilumab and Opdivo." Recent Highlights