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Last $27.65 USD
Change Today -0.85 / -2.98%
Volume 1.4M
As of 8:10 PM 06/2/15 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. - Special Call

To discuss the ReACT data

Celldex Therapeutics, Inc. Presents Positive Results from the Company's Randomized, Double-Blind Phase 2 Study of RINTEGA®

Celldex Therapeutics, Inc. presented positive results from the company's randomized, double-blind Phase 2 study of RINTEGA® (rindopepimut) in patients with EGFRvIII-positive, recurrent glioblastoma at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The primary endpoint of the study, progression-free survival at six months (PFS6) was met, and a clear advantage was demonstrated across multiple, clinically important endpoints including overall survival (OS), long-term progression-free survival, objective response rate (ORR) and need for steroids. The data were presented in an oral presentation by David A. Reardon, M.D., Clinical Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute; Associate Professor of Medicine, Harvard Medical School; and President of the Society for Neuro-Oncology, as well as the lead investigator of the ReACT study. RINTEGA is an investigational EGFRvIII specific therapeutic vaccine. Patients with glioblastoma that express the EGFRvIII mutation typically have a worse prognosis than the overall glioblastoma population, including poor long-term survival. Presentation Highlights: ReACT is a randomized, controlled Phase 2 exploratory study designed to determine if adding RINTEGA to standard of care bevacizumab (BV; Avastin®) improves outcomes for patients with EGFRvIII-positive, recurrent glioblastoma across multiple measures. Patients [n=73 intent to treat (ITT); n=67 per protocol (PP)] were bevacizumab-naïve at study entry. Investigator-reported interim data including study results through October 2014 were presented in late 2014. Data presented at ASCO were adjudicated by an independent review committee (IRC) blinded to treatment group assignment and included study results through March 2015 for both ITT and PP populations; tumor responses were evaluated in accordance with RANO criteria. The IRC analyses are statistically equivalent with and confirm the previously reported results. PFS6: The primary endpoint of PFS6 was met. Given the exploratory nature and size of the trial, the ReACT study required a PFS6 1-sided p-value of 0.2 (powered at 80%) for positivity.

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.


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