Company Overview of Celldex Therapeutics, Inc.
Celldex Therapeutics, Inc., a biopharmaceutical company, develops, manufactures, and commercializes novel therapeutics for human health care in the United States. The company’s lead drug candidates comprise rindopepimut (CDX-110), a targeted immunotherapeutic in a pivotal Phase III study for the treatment of front-line glioblastoma, as well as in Phase II study for the treatment of recurrent glioblastoma; and Glembatumumab vedotin (CDX-011), a targeted antibody-drug conjugate in a randomized Phase IIb study for the treatment of triple negative breast cancer, as well as in Phase II study for the treatment of metastatic melanoma. It also has various earlier stage drug candidates in clinical de...
Perryville III Building
53 Frontage Road
Hampton, NJ 08827
Key Executives for Celldex Therapeutics, Inc.
Chief Executive Officer, President and Director
Total Annual Compensation: $871.4K
Founder, Chief Scientific Officer and Executive Vice President
Total Annual Compensation: $553.5K
Chief Financial Officer, Principal Accounting Officer, Senior Vice President, Treasurer and Secretary
Total Annual Compensation: $437.7K
Chief Medical Officer and Executive Vice President
Total Annual Compensation: $589.4K
Chief Business Officer and Senior Vice President
Total Annual Compensation: $411.7K
Compensation as of Fiscal Year 2013.
Celldex Therapeutics, Inc. Key Developments
Celldex Therapeutics Enters into Clinical Trial Collaboration with Roche Holding to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Renal Cell Carcinoma Treatment
Mar 17 15
Celldex Therapeutics has entered into a clinical trial collaboration with Roche Holding to evaluate the safety, tolerability and preliminary efficacy of a renal cell carcinoma treatment. The clinical trial will test varlilumab, Celldex's CD27 targeting investigational antibody, and MPDL3280A, Roche's investigational cancer immunotherapy in a Phase 1/2 study. Preclinical data suggest the combination of these two mechanisms are synergistic and may enhance anti-tumor immune response compared to either agent alone. Roche will provide study drug and Celldex will be responsible for conducting and funding the study, which is expected to begin in 2015. Varlilumab and MPDL3280A are part of a new class of investigational medicines known as cancer immunotherapies designed to use the body's own immune system to fight cancer through separate but complementary mechanisms of action that may enable the activation of T cells, restoring their ability to effectively detect and attack tumor cells.
Celldex Therapeutics, Inc. Reports Unaudited Consolidated Earnings Results for the Fourth Quarter and Year Ended December 31, 2014; Provides Capital Expenditure Guidance for the Full Year 2016
Feb 24 15
Celldex Therapeutics, Inc. reported unaudited consolidated earnings results for the fourth quarter and year ended December 31, 2014. For the quarter, the company’s total revenue was $1.5 million compared to $0.6 million for the comparable periods in 2013. The increase in the fourth quarter of 2014 was primarily due to the company’s clinical trial collaboration with BMS and the company’s Rockefeller University services agreement. Net loss was $31.8 million, or $0.36 per basic and diluted share, compared to a net loss of $22.1 million, or $0.27 per basic and diluted share for the comparable periods in 2013. Operating loss was $32,051,000 compared to $22,114,000 a year ago.
For the twelve months, the company’s total revenue was $3.6 million, compared to $4.1 million for the comparable periods in 2013. The decrease in the twelve months ended December 31, 2014 was primarily due to the decrease in Rotarix royalty revenue. Net loss was $118.1 million, or $1.32 per basic and diluted share, compared to a net loss of $81.6 million, or $1.02 per basic and diluted share for the comparable periods in 2013. Operating loss was $122,430,000 compared to $81,442,000 a year ago.
The company provided capital expenditure guidance for the full year 2016. The company expects that its cash, cash equivalents and marketable securities will be sufficient to fund the company’s operating expenses and capital expenditure requirements through 2016, however, this could be impacted by the company’s clinical data results from the Rintega program and their potential impact on the company's pace of commercial manufacturing and the rate of expansion of the company’s commercial operations.
Celldex Therapeutics, Inc. Receives FDA Breakthrough Therapy Designation for the Treatment of Adult Patients with EGFRvIII-Positive Glioblastoma
Feb 23 15
Celldex Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted rindopepimut (Rintega Breakthrough Therapy Designation for the treatment of adult patients with EGFRvIII-positive glioblastoma (GBM). This application was based on data from the Phase 2 ReACT study in recurrent GBM, the Phase 2 ACT III study in newly diagnosed GBM and additional supportive Phase 2 studies. An international Phase 3 study of rindopepimut, called ACT IV, in newly diagnosed GBM completed enrollment (n=745) in December of 2014. Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. Rindopepimut (Rintega) is an investigational immunotherapy that targets the tumor specific oncogene EGFRvIII. Patients with EGFRvIII-positive glioblastoma typically have a worse prognosis than the overall glioblastoma population, including poor long term survival. Rindopepimut (Rintega is an investigational immunotherapy that targets the tumor specific oncogene EGFRvIII (v3), a functional and permanently activated variant of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy. Expression of EGFRvIII correlates with increased tumorigenicity in mouse models and poor long term survival in clinical studies of patients with glioblastoma (GBM). In addition, EGFRvIII-positive cells are believed to stimulate proliferation of non-EGFRvIII cells through IL-6 cell-to-cell signaling and to release microvesicles containing EGFRvIII, which can merge with neighboring cells, transferring tumor-promoting activity. EGFRvIII expression may also be associated with tumor stem cells that have been identified in GBM. These stem cells contribute to resistance to cytotoxic therapy and tumor recurrence. EGFRvIII is expressed in tumors in about 30% of patients with GBM. It has not been detected at a significant level in normal tissues; therefore, targeting of this tumor-specific molecule is not likely to impact healthy tissues. Three Phase 2 trials of rindopepimut, ACTIVATE, ACT II, and ACT III, have been completed in newly diagnosed EGFRvIII-positive GBM and have shown consistent improvements in both overall survival and median progression-free survival. The most common adverse events for rindopepimut include injection site reactions, fatigue, rash, nausea and pruritus. Rindopepimut is currently being studied in two clinical trials in EGFRvIII-positive GBM ”an international Phase 3 study called ACT IV in newly diagnosed GBM and a Phase 2 study called ReACT in recurrent GBM.
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