Last $20.83 USD
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celldex therapeutics inc (CLDX) Snapshot

Open
$20.71
Previous Close
$20.46
Day High
$21.28
Day Low
$20.11
52 Week High
02/24/14 - $33.33
52 Week Low
05/9/14 - $10.76
Market Cap
1.9B
Average Volume 10 Days
6.9M
EPS TTM
$-1.23
Shares Outstanding
89.6M
EX-Date
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Current Stock Chart for CELLDEX THERAPEUTICS INC (CLDX)

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celldex therapeutics inc (CLDX) Details

Celldex Therapeutics, Inc., a biopharmaceutical company, focuses on the development, manufacture, and commercialization of novel therapeutics for human health care primarily in the United States. Its lead drug candidates include rindopepimut (CDX-110), a targeted immunotherapeutic in a pivotal Phase III study for the treatment of front-line glioblastoma and a Phase II study for the treatment of recurrent glioblastoma; and Glembatumumab vedotin (CDX-011) is a targeted antibody-drug conjugate in a randomized study for the treatment of triple negative breast cancer. The company also has various earlier stage drug candidates in clinical development, including varlilumab (CDX-1127), a fully human therapeutic monoclonal antibody for cancer indications; CDX-301, an immune cell mobilizing agent and dendritic cell growth factor; and CDX-1401, a targeted immunotherapeutic aimed at antigen presenting cells for cancer indications. Its preclinical product candidate includes CDX-014, a human monoclonal antibody-drug conjugate that targets TIM-1, a molecule that is expressed on renal and ovarian cancers with minimal expression in normal tissues. The company has research collaboration and license agreements with Medarex, Inc.; Rockefeller University; Duke University Brain Tumor Cancer Center; Ludwig Institute for Cancer Research; University of Southampton; Amgen Inc.; Amgen Fremont; Seattle Genetics, Inc.; and Bristol-Myers Squibb Company. Celldex Therapeutics, Inc. is headquartered in Hampton, New Jersey.

120 Employees
Last Reported Date: 03/3/14

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, Inc. Provides Interim Update from Randomized Phase 2 ReAct Study of Rindopepimut in Recurrent Bevacizumab-Naive Glioblastoma Demonstrates Statistically Significant Survival Benefit

Celldex Therapeutics, Inc. announced an interim update from the Phase 2 ReACT study of rindopepimut in EGFRvIII-positive glioblastoma (GBM). The ReACT results demonstrate clear signs of clinical activity in patients with recurrent glioblastoma, including groups both naïve and refractory to bevacizumab (Avastin(R)). Rindopepimut (RINTEGA(R)) 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. Group 1 - Recurrent GBM; bevacizumab (bev) naïve (randomized: rindo + bev vs. control + bev): Primary endpoint of PFS-6 (% alive without progression at 6 months)--rindopepimut 27% vs. control 11%; p=0.048. Statistically significant overall survival benefit--hazard ratio of 0.47; p=0.0208; rindopepimut median 12.0 months vs. control median 8.8 months. An increase in clinically meaningful tumor shrinkage. Rindopepimut plus bevacizumab was well tolerated; no serious adverse events attributed to rindopepimut. Early anti-EGFRvIII immune response correlates with survival benefit Group 2/2C - Recurrent GBM; bev refractory (single arm: rindo + bev). Rare, but prominent anti-tumor activity did not meet high hurdle for expanded accrual of Group 2C. Noteworthy overall survival compared to historical comparisons. Rindopepimut plus bevacizumab was well tolerated; no serious adverse events attributed to rindopepimut. Early anti-EGFRvIII immune response correlates with survival benefit. ReACT is a Phase 2 exploratory study designed to determine if adding rindopepimut to standard of care bevacizumab improves the outcomes for patients with EGFRvIII-positive recurrent glioblastoma across multiple measures. The study includes 3 groups: Group 1 - bevacizumab naive, n=72, patients randomized to receive either rindopepimut or Keyhole Limpet Hemocyanin (KLH) (administered as a control), each along with bevacizumab. Group 2 - bevacizumab refractory (defined as having progressed/grown through bevacizumab by RANO criteria within two months of prior bev treatment), n=25, patients receive rindopepimut plus bevacizumab in a single treatment arm. Group 2C (C = Confirmatory) - bevacizumab refractory expansion, n=up to 75 (Simon two-stage design; 1st cohort n=28), patients receive rindopepimut plus bevacizumab in a single treatment arm.

Celldex Therapeutics, Inc. Announces Proof of Concept Data from its Phase I Study of Varlilumab

Celldex Therapeutics, Inc. announced proof of concept data from its Phase I study of varlilumab, an anti-cancer agent. Varlilumab is an immunotherapy designed to harness the body's natural immune response by enhancing the activation of T cells that can specifically recognize and kill cancer cells. The clinical and immunological activity data presented add to a growing body of literature supporting the broad study of varlilumab in combination with a number of other anticancer agents including but not limited to checkpoint inhibitors, chemotherapies, targeted therapies and vaccines. The analyses included patients with solid tumors and hematologic malignancies from the dose escalation portion of the Phase I study and patients from expansion cohorts in metastatic melanoma and renal cell carcinoma (dosed at 3 mg/kg weekly). All cohorts showed a consistent change in specific immune biomarkers, however the immune correlates were generally stronger or more consistent with the dose escalation portion of the study, suggesting that less frequent dosing may provide good regimen for promoting sustained CD27 activation with varlilumab. Pharmacokinetic (PK) assessments showed good exposure, including at lower dose levels, with a half-life of 10-13 days. Notably, no anti-varlilumab antibody responses have been detected to date and varlilumab demonstrated continuous binding to circulating T cells even at doses as low as 0.3 mg/kg for at least 29 days post infusion. Biomarker analysis demonstrated significant immunological effects consistent with CD27 costimulation across all dose levels. A serum biomarker profile of the 1mg/kg cohort demonstrated robust and transient stimulation of multiple cytokines and chemokines consistent with varlilumab activation of CD27 signaling. Further assessment of immune cell subsets demonstrated no depletion of B cells or CD8+ T cells, with a concomitant decrease in CD4+ T cells and regulatory T cells (Treg, CD4+ and FoxP3+). Evidence for functional activation of T cells was demonstrated by upregulation of the activation marker, HLA-DR and new or enhanced melanoma antigen-specific T cell responses in select melanoma patients. A total of 86 patients have been dosed. 55 patients have been dosed in dose escalation cohorts (various solid and hematologic B-cell tumors) and 31 patients have been dosed in the expansion cohorts (melanoma and RCC) at 3 mg/kg. In both the solid tumor and hematologic dose-escalations, the pre-specified maximum dose level (10 mg/kg) was reached without identification of a maximum tolerated dose. The majority of adverse events (AE) related to treatment have been mild to moderate (Grade 1/2) in severity, with only three serious AEs related to treatment reported. No significant immune-mediated adverse events (colitis, hepatitis, etc.) typically associated with check-point blockade have been observed. A patient with Hodgkin lymphoma experienced a complete response after 3 cycles at 0.3 mg/kg, which continues at 18.9+ months. This patient's response was delayed and there was no detectable CD27 on their tumor cells leading the Company to conclude the response was immune-mediated response and not ADCC-mediated. A patient with renal cell carcinoma treated in the expansion cohort experienced a partial response after 1 cycle at 3 mg/kg that further improved on the second cycle and continues at 5.5+ months. This patient had five target lesions that have all regressed, including a lung lesion that has completely disappeared. Thirteen patients experienced stable disease (SD) (3-25.5+ months), including: a patient with uveal melanoma (M1c) with SD for 11.5 months; a patient with renal cell carcinoma with SD for 25.5+ months; and a patient with follicular lymphoma with SD for 14 months. Based on the results observed in hematologic malignancies, an expansion cohort has been added to enroll up to 15 patients with Hodgkin Lymphoma and an abbreviated dose escalation in T cell hematologic malignancies is ongoing.

Celldex Therapeutics, Inc. Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2014

Celldex Therapeutics, Inc. reported unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2014. For the quarter, the company reported total revenue of $1,101,000 compared to $980,000 a year ago. Operating loss was $30,342,000 against $23,269,000 a year ago. Net loss was $28,082,000 or $0.31 per basic and diluted share compared to $23,140,000 or $0.29 per basic and diluted share a year ago. For the nine months, the company reported total revenue of $2,109,000 compared to $3,491,000 a year ago. Operating loss was $90,379,000 against $59,328,000 a year ago. Net loss was $86,258,000 or $0.97 per basic and diluted share compared to $86,258,000 or $0.76 per basic and diluted share a year ago.

 

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