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Very favorable safety profile; no evidence of immune related toxicities
Three patients with significant tumor shrinkage, including an ongoing CR in Hodgkin diseaseEight patients with stable disease or better; PFS range of 3.0 to 14+ monthsImmune monitoring data in patients confirms CDX-1127 mechanism of action
PHILLIPSBURG, N.J., Nov. 7, 2013 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported data from its ongoing Phase 1 dose-escalation study of the fully human monoclonal antibody CDX-1127. The results suggest an excellent safety profile and demonstrate clear biologic activity and promising signs of clinical activity in an advanced, refractory patient population. No maximum tolerated dose has been reached to date. The data will be presented in two poster sessions (poster #144 and 146) at the 2013 Society for Immunotherapy of Cancer (SITC) Annual Meeting, November 7 – 10, 2013. In addition, a third poster (#85) will be presented on preclinical combination studies of CDX-1127 with chemotherapies and checkpoint inhibitors. The Company will host a webcast/conference call at 8:30 am ET today to discuss the results (details provided below).
"CDX-1127 has exceeded our expectations thus far in this ongoing Phase 1 dose-escalation study," said Thomas Davis, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics. "Our primary goal was to establish a favorable safety profile, a challenge that other agonist antibodies in this class have not been able to meet. To date, CDX-1127 has demonstrated minimal toxicity and, importantly, no evidence of worrisome overlap with toxicities seen with other immunotherapies—a critical hurdle for combination therapy. We were also very pleased to see clear evidence of biologic and anti-cancer activity in a heavily pretreated patient population. While future data from the expansion cohorts will be important to understanding single-agent activity, we are confident based on the dose-escalation data we have seen to date that we are well positioned to initiate combination studies of CDX-1127, with a particular interest in immune modulators."