Celldex Therapeutics Establishes Preclinical Proof of Concept for New Antibody Drug Conjugate CDX-014; Data presented at AACR 2014
"We believe CDX-014 will be another exciting addition to our clinical pipeline," said
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
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.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995:
This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those related to the Company's strategic focus and the future development and commercialization (by Celldex and others) of rindopepimut (CDX-110), glembatumumab vedotin ("glemba"; CDX-011), CDX-1135, CDX-1401, CDX-1127, CDX-301, CDX-014, Belinostat and other products. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of rindopepimut, glembatumumab vedotin and other drug candidates, our ability to obtain additional capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; our ability to adapt our APC Targeting TechnologyTM to develop new, safe and effective vaccines against oncology and infectious disease indications; our ability to successfully complete product research and further development of our programs; the uncertainties inherent in clinical testing; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage research and development efforts for multiple products at varying stages of development; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and other factors listed under "Risk Factors" in our annual report on Form 10-K.
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Sarah CavanaughVice President of Investor Relations & Corporate Communications Celldex Therapeutics, Inc.(781) 433-3161 firstname.lastname@example.org
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