Celldex Therapeutics, Inc. (Nasdaq: CLDX) announced today it will regain full worldwide rights to develop and commercialize rindopepimut (CDX-110), effective November 1, 2010. Celldex and Pfizer Vaccines LLC entered into a global development and commercialization agreement in April 2008 for rindopepimut, an experimental therapeutic cancer vaccine that targets the tumor-specific molecule epidermal growth factor receptor variant III (EGFRvIII) in patients with Glioblastoma Multiforme (GBM). Pfizer has informed Celldex that the rindopepimut program is no longer a strategic priority of Pfizer and has terminated the agreement. As previously disclosed, across three clinical studies, rindopepimut has met or exceeded all pre-determined safety and efficacy objectives.
"There is a significant need for new therapies for GBM and we are fully committed to developing rindopepimut for the patients who suffer from this fatal disease," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "Importantly, the program has advanced significantly, including the completion of a multi-center Phase 2 study, the development of a diagnostic companion product, the manufacture of drug supply for clinical studies, and the execution of discussions with regulatory agencies on the design of a global controlled study. We believe the program is very well-positioned to advance into pivotal clinical studies and that the GBM market remains extremely attractive."
"Rindopepimut is widely perceived by clinicians as one of the most promising non-toxic drug candidates for a patient population that has very limited treatment options," commented Tom Davis, M.D., Chief Medical Officer of Celldex Therapeutics. "Moving forward, we remain committed to the brain cancer patient and physician community and to the continued development of rindopepimut."
Rindopepimut has been studied in three open-label Phase 2 clinical studies in more than 110 patients with GBM confirmed positive for EGFRvIII expression. These studies consistently demonstrated significant improvements in median-time-to-disease progression, progression free survival and overall survival, when compared to historical controls receiving the standard of care. Celldex expects that new data from the ACT III study will be presented at the 2010 Society for Neuro-Oncology Scientific Annual Meeting, November 18-21, 2010 in Montreal, Canada. Between today and November 1, 2010, Celldex and Pfizer will work together to transition rindopepimut and related data, intellectual property and materials from Pfizer Vaccines to Celldex.
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