HAMPTON, NJ, USA I April 7, 2014 I Celldex Therapeutics, Inc. (CLDX) today reported results of preclinical studies evaluating the anti-tumor activity of CDX-014 against a variety of cell lines. Based on the results, CDX-014 will enter clinical development. CDX-014 is an antibody drug conjugate (ADC) that targets the protein TIM-1 (T cell immunoglobulin and mucin domain). TIM-1 expression is upregulated in several cancers, including renal cell and ovarian carcinomas. It is associated with kidney injury and the shedding of its ectodomain is a predictive biomarker for tumor progression. TIM-1 has very restricted expression in healthy tissues, making it a promising target for antibody mediated therapy. The data were presented in a poster presentation at the American Association of Cancer Research (AACR) Annual Meeting 2014.
“We believe CDX-014 will be another exciting addition to our clinical pipeline,” said Tibor Keler, PhD, Senior Vice President and Chief Scientific Officer of Celldex. “The data presented today confirm that CDX-014 effectively targets the tumor marker TIM-1 in vitro and elicits significant anti-tumor activity in key models. We are currently completing manufacturing and IND-enabling studies and anticipate that CDX-014 will enter Phase 1 clinical studies in renal cell carcinoma and potentially other TIM-1 expressing tumors in 2015.”
CDX-014 was developed internally by Celldex. A fully human monoclonal antibody specific for extracellular domain of TIM-1 was selected to bind to TIM-1 expressed on a variety of transformed cell lines, including human renal cell and ovarian carcinoma. Internalization studies demonstrated that the antibody was rapidly internalized by cells in vitro and the internalization was confirmed by quantitative imaging flow symmetry. The ADC CDX-014 was produced by the covalent linkage of the anti-TIM-1 antibodies to monomethyl auristatin E (MMAE), a potent cytotoxin. CDX-014 demonstrated in vitro cytostatic or cytotoxic activity against a variety of TIM-1 expressing cell lines, but did not impact TIM-1 negative cell lines. Significant anti-tumor activity was observed in predictive preclinical xenograft models of human renal clear cell carcinoma, human ovarian adenocarcinoma and human lung carcinoma. The results were presented in a poster entitled “Development of an Antibody-drug Conjugate Targeting TIM-1 for the Treatment of Ovarian and Renal Cell Carcinoma” by Lawrence J. Thomas, PhD, DABT, ATS, Senior Director Preclinical Research and Development at Celldex Therapeutics.
About Celldex Therapeutics, Inc.
Celldex is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Our pipeline is built from a proprietary portfolio of antibodies and immunomodulators used alone and in strategic combinations to create novel, disease-specific therapies that induce, enhance or suppress the body’s immune response. Visit www.celldex.com.
SOURCE: Celldex Therapeutics
Post Views: 160
HAMPTON, NJ, USA I April 7, 2014 I Celldex Therapeutics, Inc. (CLDX) today reported results of preclinical studies evaluating the anti-tumor activity of CDX-014 against a variety of cell lines. Based on the results, CDX-014 will enter clinical development. CDX-014 is an antibody drug conjugate (ADC) that targets the protein TIM-1 (T cell immunoglobulin and mucin domain). TIM-1 expression is upregulated in several cancers, including renal cell and ovarian carcinomas. It is associated with kidney injury and the shedding of its ectodomain is a predictive biomarker for tumor progression. TIM-1 has very restricted expression in healthy tissues, making it a promising target for antibody mediated therapy. The data were presented in a poster presentation at the American Association of Cancer Research (AACR) Annual Meeting 2014.
“We believe CDX-014 will be another exciting addition to our clinical pipeline,” said Tibor Keler, PhD, Senior Vice President and Chief Scientific Officer of Celldex. “The data presented today confirm that CDX-014 effectively targets the tumor marker TIM-1 in vitro and elicits significant anti-tumor activity in key models. We are currently completing manufacturing and IND-enabling studies and anticipate that CDX-014 will enter Phase 1 clinical studies in renal cell carcinoma and potentially other TIM-1 expressing tumors in 2015.”
CDX-014 was developed internally by Celldex. A fully human monoclonal antibody specific for extracellular domain of TIM-1 was selected to bind to TIM-1 expressed on a variety of transformed cell lines, including human renal cell and ovarian carcinoma. Internalization studies demonstrated that the antibody was rapidly internalized by cells in vitro and the internalization was confirmed by quantitative imaging flow symmetry. The ADC CDX-014 was produced by the covalent linkage of the anti-TIM-1 antibodies to monomethyl auristatin E (MMAE), a potent cytotoxin. CDX-014 demonstrated in vitro cytostatic or cytotoxic activity against a variety of TIM-1 expressing cell lines, but did not impact TIM-1 negative cell lines. Significant anti-tumor activity was observed in predictive preclinical xenograft models of human renal clear cell carcinoma, human ovarian adenocarcinoma and human lung carcinoma. The results were presented in a poster entitled “Development of an Antibody-drug Conjugate Targeting TIM-1 for the Treatment of Ovarian and Renal Cell Carcinoma” by Lawrence J. Thomas, PhD, DABT, ATS, Senior Director Preclinical Research and Development at Celldex Therapeutics.
About Celldex Therapeutics, Inc.
Celldex is developing targeted therapeutics to address devastating diseases for which available treatments are inadequate. Our pipeline is built from a proprietary portfolio of antibodies and immunomodulators used alone and in strategic combinations to create novel, disease-specific therapies that induce, enhance or suppress the body’s immune response. Visit www.celldex.com.
SOURCE: Celldex Therapeutics
Post Views: 160
