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Last $28.87 USD
Change Today -0.16 / -0.55%
Volume 1.5M
CLDX On Other Exchanges
As of 8:10 PM 05/29/15 All times are local (Market data is delayed by at least 15 minutes).

celldex therapeutics inc (CLDX) Snapshot

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03/19/15 - $32.82
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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: $814.1K
Executive Vice President, Founder and Chief S...
Total Annual Compensation: $543.0K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $419.1K
Chief Medical Officer and Executive Vice Pres...
Total Annual Compensation: $556.4K
Chief Business Officer and Senior Vice Presid...
Total Annual Compensation: $419.6K
Compensation as of Fiscal Year 2014.

celldex therapeutics inc (CLDX) Key Developments

Celldex Therapeutics, Inc. Initiates Phase 1/2 Study of Varlilumab in Combination with Sunitinib in Metastatic Clear Cell Renal Cell Carcinoma

Celldex Therapeutics, Inc. announced the initiation of an open-label, Phase 1/2 safety and tolerability study examining the investigational combination of varlilumab and sunitinib (SUTENT) in patients with metastatic clear cell renal cell carcinoma (CC-RCC). Varlilumab is Celldex's fully human monoclonal agonist antibody that binds and activates CD27, a critical co-stimulatory molecule in the immune activation cascade. Sunitinib is approved by the FDA as monotherapy for the treatment of advanced renal cell carcinoma (RCC), as well as certain advanced gastrointestinal stromal tumors and pancreatic neuroendocrine tumors. Varlilumab is currently being studied in four Phase 1/2 combination studies, and additional combination studies will be initiated in 2015. Sunitinib blocks the function of receptor tyrosine kinases (RTKs), of which several are implicated in tumor growth, angiogenesis and metastasis. Sunitinib was selected for an investigational combination with varlilumab because it has demonstrated the potential to modulate anti-tumor immunity and reverse immune suppression in the tumor microenvironment. The Phase 1 portion of the study will assess the safety and tolerability of varlilumab at 0.3, 1.0 and 3.0 mg/kg combined with sunitinib at 50 mg in order to identify a recommended dose for the Phase 2 portion of the study. In both phases of the trial, varlilumab will be administered once every three weeks for up to eight six-week cycles (a total of up to 16 varlilumab doses). In each six-week cycle, sunitinib 50mg will be administered orally once daily for four weeks followed by two weeks without administration. The primary objective of the Phase 2 portion of the study is to assess the preliminary anti-tumor efficacy of the varlilumab/sunitinib combination measured by the overall response rate (ORR). Secondary objectives include safety and tolerability, pharmacokinetics, immunogenicity and further assessment of anti-tumor activity across a broad range of endpoints.

Celldex Therapeutics, Inc. Announces Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2015

Celldex Therapeutics, Inc. announced unaudited consolidated earnings results for the first quarter ended March 31, 2015. For the quarter, total revenue was $486,000 against $416,000 a year ago. The increase in the first quarter of 2015 was primarily due to clinical trial collaboration with BMS, partially offset by a decrease in revenue related to Rockefeller University services agreement. Operating loss was $30,981,000 against $31,489,000 a year ago. Net loss was $30,174,000 against $29,903,000 a year ago. Basic and diluted net loss per common share  was $0.33 against $0.33 a year ago.

Celldex Therapeutics, Inc. Announces Preclinical Results That Support Varlilumab's Expansion into Combination Studies with PD-1 Inhibitors

Celldex Therapeutics, Inc. announced preclinical results that further support varlilumab's expansion into combination studies with PD-1 inhibitors. The data were presented in a poster session entitled Synergistic anti-tumor activity of PD-1 signaling blockade and CD27 costimulation correlates with enhanced ratio of effector to regulatory T cells at the tumor site at the 2015 American Association for Cancer Research Annual Meeting. Varlilumab is a fully human immunoglobulin (Ig)G1 agonist antibody that binds to and activates CD27, a critical T-cell co-stimulatory molecule in the immune-activation cascade. Specific and controlled activation of CD27 in the presence of T-cell receptor (TCR) signaling by varlilumab results in enhanced immune responses with a favorable safety profile. Varlilumab is in clinical development for a range of cancers in combination with other therapies that target potentially synergistic points of immune-regulation, including with Opdivo®, BMS's PD-1 blocking antibody and with MPDL3280A, Roche's anti-PDL1 investigational cancer immunotherapy. Key findings: The combination of varlilumab and anti-PD-L1 resulted in a significant improvement in survival over monotherapy in multiple preclinical tumor models, including a CT-26 colon model, an E.G7 thymoma model and a BCL1 disseminated lymphoma model. The properties of the BCL1 lymphoma model allowed for further analysis into the mechanism of synergy between varlilumab and anti-PD-L1. Importantly, mice cured by the combination therapy were shown to have developed protective immunity against the BCL1 tumor, demonstrating that a long lasting and potent memory response was generated during treatment. Additional key observations were made by analyzing the spleens (the primary site of tumor growth) following treatment. The major changes associated with the combination therapy included: a greater reduction in tumor cells (as measured by % decrease in CD19+ cells); Increased numbers of functional CD4+ and CD8+ T cells (as measured by IFN? production); an increase in the ratio of CD8+ T cells (effector T cells) to regulatory T cells or Tregs; a notable increase in myeloid cells, particularly neutrophils. These changes at the site of tumor growth, particularly the balance between effector T cells and regulatory T cells, are consistent with an immune-mediated effect resulting in the destruction of tumor cells. The increase in myeloid cells merits further investigation into their role in the combination therapy effect. Other changes including increases in natural killer cells and decreased PD-1 expression on T cells were noted, but these were similar in magnitude to the monotherapy treatments.


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