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Last $26.76 USD
Change Today -0.99 / -3.57%
Volume 4.0M
CLDX On Other Exchanges
As of 8:10 PM 04/17/15 All times are local (Market data is delayed by at least 15 minutes).

celldex therapeutics inc (CLDX) Snapshot

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celldex therapeutics inc (CLDX) Details

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 development, including varlilumab (CDX-1127), a fully human therapeutic monoclonal antibody for cancer indications; CDX-1401, a targeted immunotherapeutic aimed at antigen presenting cells for cancer indications; and CDX-301, an immune cell mobilizing agent and dendritic cell growth factor. The company’s preclinical product candidate includes CDX-014, a fully-human monoclonal antibody-drug conjugate that targets T-cell TIM-1, a molecule, which is upregulated in various cancers comprising renal cell and ovarian carcinomas. It has research collaboration and license agreements with Medarex, Inc.; Rockefeller University; Duke University Brain Tumor Cancer Center; Ludwig Institute for Cancer Research; Alteris Therapeutics, Inc.; University of Southampton; Amgen Inc.; Amgen Fremont; and Seattle Genetics, Inc., as well as clinical trial collaboration with Roche Holding, Bristol-Myers Squibb Company, and Oncothyreon Inc. The company is headquartered in Hampton, New Jersey.

156 Employees
Last Reported Date: 02/24/15

celldex therapeutics inc (CLDX) Top Compensated Officers

Chief Executive Officer, President and Direct...
Total Annual Compensation: $871.4K
Founder, Chief Scientific Officer and Executi...
Total Annual Compensation: $553.5K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $437.7K
Chief Medical Officer and Executive Vice Pres...
Total Annual Compensation: $589.4K
Chief Business Officer and Senior Vice Presid...
Total Annual Compensation: $411.7K
Compensation as of Fiscal Year 2013.

celldex therapeutics inc (CLDX) Key Developments

Celldex Therapeutics Announces Initiation of Phase 1/2 Study of Varlilumab in Combination with Ipilimumab and CDX-1401 in Metastatic Melanoma

Celldex Therapeutics, Inc. announced initiation of a Phase 1/2 safety pilot and expansion study examining the investigational combination of varlilumab and ipilimumab (Yervoy®; Bristol-Myers Squibb) in patients with Stage III or IV metastatic melanoma. Varlilumab is Celldex's fully human monoclonal antibody that targets CD27, a critical co-stimulatory molecule in the immune activation cascade. Ipilimumab, a recombinant, human monoclonal antibody that blocks CTLA-4, is FDA approved for the treatment of unresectable or metastatic melanoma. In the Phase 2 portion of the study, patients with tumors that express NY-ESO-1 will also receive CDX-1401, Celldex's off-the-shelf antibody-based dendritic cell vaccine that targets tumors expressing the NY-ESO-1 oncoprotein. The three agents in this study were specifically selected because they uniquely intervene at key points of immune regulation and because Celldex has observed enhanced activity in preclinical studies when varlilumab is combined with either checkpoint inhibitors or with vaccines. In addition, this study will also build on previous clinical data from the CDX-1401 experience that suggests that CDX-1401 may predispose patients to better outcome on checkpoint inhibitors, including ipilimumab. The Phase 1 portion of the study will assess the safety and tolerability of varlilumab at 0.3 and 3.0 mg/kg in combination with ipilimumab at 3 mg/kg administered every three weeks to identify a recommended dose for the Phase 2 portion of the study. The Phase 2 study will include two cohorts one comprised of patients who are NY-ESO-1 positive and one comprised of patients who are NY-ESO-1 negative. Patients who are NY-ESO-1 positive will also receive CDX-1401 dosed at 1 mg (with poly-ICLC at 2 mg given as an adjuvant) every three weeks in addition to varlilumab and ipilimumab. In total, up to four doses of study treatment will be administered. The primary objective for both cohorts is objective response rate up to 24 weeks (ORR6) using standard, modified World Health Organization response criteria. Secondary objectives for the Phase 2 study include safety and tolerability, immunogenicity, pharmacokinetics and further assessment of anti-tumor activity across a broad range of endpoints.

Celldex Therapeutics Enters into Clinical Trial Collaboration with Roche Holding to Evaluate the Safety, Tolerability and Preliminary Efficacy of a Renal Cell Carcinoma Treatment

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

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.


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