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Celldex Therapeutics Announces Positive Three-Year Survival Data For Rindopepimut Phase 2 Clinical Program

Celldex Therapeutics, Inc. (NASDAQ: CLDX) announced today the presentation of three-year survival data from the Phase 2 rindopepimut clinical program in EGFRvIII-positive glioblastoma—a more aggressive form of glioblastoma typically associated with reduced long-term survival in comparison to the glioblastoma population as a whole. Across three Phase 2 studies of rindopepimut, survival data remains consistent and suggests a substantial and continuing survival benefit in comparison to independent control datasets (see chart below) at the median and at three years. In the multi-center Phase 2 ACT III study, the median overall survival is 24.6 months from diagnosis (21.8 months from study entry) and overall survival is 26% at three years. In the Phase 2 ACT II study, the median overall survival is 24.4 months from diagnosis (20.5 months from study entry) and overall survival is 23% at three years. In the Phase 2 ACTIVATE study, the median overall survival is 24.6 months from diagnosis (20.4 months from study entry) and overall survival is 33% at three years.
Rindopepimut Overall Survival (OS) Across Three Phase 2 Studies in EGFRvIII-Positive Glioblastoma vs Independent Control Datasets
Rindopepimut Phase 2 Studies (all data from study entry)

    OS 3 years
ACT III (n=65)     21.8     26%
ACT II (n=22)     20.5     23%
ACTIVATE (n=18)     20.4     33%
Independent Control Datasets (all data from study entry)
MD Anderson EGFRvIII-positive patients matched 1 to ACTIVATE patient population (n=17)

(contemporary with ACTIVATE)
    12.2 2     6%
Radiation Therapy Oncology Group (RTOG) 0525 study - all EGFRvIII-positive patients (n=142)

(contemporary with ACT III)
    15.1     18%
RTOG 0525 study - all EGFRvIII-positive patients treated with standard dose temozolomide (n=62)

(contemporary with ACT III)
    14.2     7%
RTOG 0525 study - EGFRvIII-positive patients matched 1 to ACT III/IV patient population (n=29)

(contemporary with ACT III)
    16     13%

1 Controls are closely matched to rindopepimut patient criteria including gross total resection of patient tumor and ~3 months without disease progression at time of study entry; 2 In order to provide comparable timeframes across datasets, data have been estimated assuming study entry at three months from diagnosis.

“The long-term survival data across all three rindopepimut Phase 2 clinical trials are consistent and suggest that rindopepimut is providing long-term survival beyond what is historically seen in this subset of EGFRvIII-expressing glioblastoma patients—a group that typically has more aggressive disease associated with a worse prognosis than the general glioblastoma patient population,” said John Sampson, MD, PhD, Dr. Robert H. Wilkins and Gloria Wilkins Professor of Neurosurgery & Associate Deputy Director, The Preston Robert Tisch Brain Tumor Center Duke University Medical Center, Durham, NC and lead investigator of the ACT II and ACTIVATE studies. “Based on the results to date, I am hopeful that with continued success in the clinic, rindopepimut has the potential to be a much needed treatment option for patients with EGFRvIII-positive glioblastoma.”

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