Pfizer’s (PFE) anti-4-1BB antibody PF-05082566 reached a safe dose in Phase 1 without undue toxicity signals (ASCO 2014, Abstract #3007). Pfizer disclosed combination trials with rituximab in Non-Hodgkin Lymphoma (NHL) and pembrolizumab (anti-PD-1). The BMY antibody urelumab was tolerated through its’ dose escalation cohorts, and ex vivo analysis showed activation of CD8+ T cells and NK cells (ASCO 2014, Abstract #3017). The Celldex anti-CD27 mAb also has demonstrated safe dose escalation, although to date without signs of clinical activity (ASCO 2014, Abstracts #3024 and #3027). Celldex (CLDX) claims planned studies in combination with nivolumab, ipilimumab, and the targeted therapeutics darafenib and trametinib.
As per SEC fillings CDX-011 ReACT study in recurrent GBM to produce interim data anticipated by year-end 2014, and a potential Hampton, N.J.-based Celldex could file for faster approval of CDX-011, which the company has developed without a partner, if positive results come to pass in either of the co-primary endpoints of the trial, objective response rate or PFS. In short CLDX catching up with PBYI before their NDA filling in Mid 2015.