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Celldex Reports Fiscal 2013 Business/Financial Results And Outlines 2014 Strategy

Stocks in this article: CLDX

HAMPTON, N.J., March 3, 2014 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) today reported business and financial highlights for the fourth quarter and year ended December 31, 2013 and outlined the Company's major clinical development goals for 2014.

"This past year was transformational for Celldex as we continued to make strides in cultivating one of the most robust, well-staged pipelines in immuno-oncology," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics. "We enter 2014 with five candidates in the clinic, including rindopepimut and glembatumumab vedotin in registration studies. By year-end, we anticipate the initiation of four new Celldex-sponsored clinical trials and several investigator-sponsored studies, including multiple combination regimens. These combination studies are designed to address what we believe is the next great opportunity for the immuno-oncology field—further unlocking the power of the immune system to deliver the greatest benefit to the largest population of patients possible. With last year's successful financing of the Company and current cash projected to fund our planned activities through 2016, we look forward to what we believe will be an exceptionally productive year."

2013 Program Updates:

Rindopepimut ("rindo"; CDX-110) in EGFR v III(v3)-Positive Glioblastoma (GBM):

  • Celldex continues to actively enroll newly diagnosed patients with GBM in ACT IV, the Phase 3 registration study. More than 200 sites are currently open to enrollment across 24 countries. The Company continues to anticipate completion of enrollment in mid-2014.  
  • Celldex announced the presentation of four- and five-year survival data from the Phase 2 rindopepimut clinical program in frontline GBM (3 studies; pooled n=105) in November. Survival data suggests a substantial and continuing survival benefit in comparison to a matched historical control dataset, at the median and at all other time points evaluated. Eighteen percent (18%) of patients from the Phase 2 frontline rindopepimut program were alive at four years and 14% were alive at five years. No patients in the matched historical control dataset survived beyond three years.  
  • In November, positive interim data from the ReACT study in recurrent GBM were presented in an oral session at the Annual Meeting of the Society for Neuro-Oncology. The data demonstrated promising signs of clinical activity in advanced patient populations, including patients both naive and refractory to Avastin ®. Enrollment in ReACT is expected to be completed in late 2014 with data anticipated by year-end 2014.

Glembatumumab vedotin ("glemba"; CDX-011) targeting gpNMB in multiple cancers:

In December, Celldex initiated a randomized, accelerated approval study (METRIC) of glembatumumab vedotin in patients with metastatic triple negative breast cancer that overexpresses the tumor associated marker gpNMB. The METRIC study is expected to include up to 100 sites in the United States, Canada and Australia. The glembatumumab vedotin program will expand into additional indications in 2014 (outlined below).

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