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
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Key Executives for Celldex Therapeutics, Inc.
Founder, Chief Executive Officer, President and Director
Total Annual Compensation: $814.1K
Founder, Chief Scientific Officer and Executive Vice President
Total Annual Compensation: $543.0K
Chief Financial Officer, Principal Accounting Officer, Senior Vice President, Treasurer and Secretary
Total Annual Compensation: $419.1K
Chief Medical Officer and Executive Vice President
Total Annual Compensation: $556.4K
Chief Business Officer and Senior Vice President
Total Annual Compensation: $419.6K
Compensation as of Fiscal Year 2014.
Celldex Therapeutics, Inc. Key Developments
Celldex Therapeutics, Demonstrates Phase 2 React Study of RINTEGA(R) in Recurrent Bevacizumab-Naive Glioblastoma
Nov 20 15
Celldex Therapeutics, Inc. presented mature survival data from the Company's randomized, double-blind Phase 2 study of RINTEGA® (rindopepimut) in patients with EGFRvIII-positive, recurrent glioblastoma (GBM) at the 20th Annual Scientific Meeting of the Society for Neuro-Oncology (SNO). The data were presented in a podium 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 and was granted Breakthrough Therapy Designation in February 2014. Patients with recurrent glioblastoma that express the EGFRvIII mutation typically have a worse prognosis than the overall glioblastoma population, including poor long-term survival (median time from recurrence to death for EGFRvIII-positive patients is 8.7 months1). As previously reported, the primary endpoint of the study, progression-free survival at six months (PFS6) has been met. Mature overall survival (OS) data continue to show a marked benefit [hazard ratio = 0.53 (0.32, 0.88); p=0.0137] with a long-term survival benefit clearly seen in the RINTEGA arm. In May, the Company reported a hazard ratio of 0.57 (0.33, 0.98) (p=0.0386) for OS in the study. Nine of 10 patients (one patient lost to follow up) on the RINTEGA arm remain alive since the Company last presented data in May compared to only two out of five patients on the control arm. At two years, the survival rate for RINTEGA patients is 25% versus 0% for control patients in the intent to treat (ITT) population, with five patients extending beyond two years. Five patients in the RINTEGA arm continue survival follow-up without progression per central review, compared to only one patient on the control arm. A clear advantage continues to be demonstrated across multiple, clinically important endpoints including overall survival (OS), long-term progression-free survival (PFS), objective response rate (ORR) and need for steroids. 33% of patients on the RINTEGA arm who were receiving steroids at baseline were able to stop steroids for six months or longer compared to none on the control arm.
Celldex Presents Varlilumab Mechanism Data
Nov 6 15
Celldex Therapeutics, Inc. presented new preclinical data on varlilumab, a fully human monoclonal agonist antibody that binds and activates CD27, a critical co-stimulatory molecule in the immune activation cascade. Results suggest that cancers may respond to CD27 immune modulation by independent mechanisms, such as immune co-stimulation and regulatory T cell (Treg) depletion. Varlilumab has the unique ability to act through both of these mechanisms. The new data were presented in a poster entitled 'The mechanism of anti-tumor immunity induced by varlilumab, a CD27 agonist mAb, is model dependent' at the Society for the Immunotherapy of Cancer (SITC) Annual Meeting. To better understand each mechanism separately, scientists engineered varlilumab to possess either strong co-stimulatory activity (varli-mG1) or strong Treg suppression activity (varli-mG2a) and analyzed their efficacy in several preclinical tumor models. The data indicated that potent co-stimulation activity was required for therapeutic activity in a BCL1 lymphoma model, whereas control of Tregs was required for activity in several other models, such as E.G7 thymoma, CT26 colorectal and colon 26. Importantly, varlilumab has a combination of immune co-stimulation and Treg depleting activity and demonstrated potent anti-tumor activity in all the models. The immune stimulating and Treg depleting effects of varlilumab were also observed in Celldex's Phase 1, single-agent clinical trial of varlilumab in patients with refractory, advanced cancers. Specifically, varlilumab administration was associated with a rapid and transient induction of pro-inflammatory cytokines, activation of T cells as assessed by increased HLA-DR expression and a significant decrease in circulating Tregs. The study also demonstrated promising clinical activity. Two patients experienced durable objective responses including a complete response in Hodgkin lymphoma (18.9+ months) and a partial response in renal cell carcinoma (13.6+ months). Thirteen patients experienced stable disease (3-36.2+ months). Varlilumab was very well tolerated and demonstrated minimal toxicity, even in elderly patients. There was no indication of immune-mediated adverse events often seen with other immunotherapies. Varlilumab is currently being studied in multiple ongoing Phase 1/2 clinical trials with several anti-tumor agents, including nivolumab (Opdivo®), ipilimumab (Yervoy®) and sunitinib (Sutent®) in advanced-stage cancers. Efforts are underway for additional Phase 2 studies with varlilumab, including a combination with atezolizumab (Roche's anti-PDL1 antibody), and the company will provide updates on these studies as they are initiated.
Celldex Therapeutics, Inc. Reports Unaudited Consolidated Earnings Results for the Third Quarter and Nine Months Ended September 30, 2015
Nov 5 15
Celldex Therapeutics, Inc. reported unaudited consolidated earnings results for the third quarter and nine months ended September 30, 2015. For the quarter, the company reported total revenue of $1,026,000 compared to $1,101,000 a year ago. Operating loss was $32,371,000 against $30,342,000 a year ago. Net loss was $31,980,000 or $0.32 per basic and diluted share compared to $28,082,000 or $0.31 per basic and diluted share a year ago.
For the nine months, the company reported total revenue of $3,689,000 compared to $2,109,000 a year ago. The increase was primarily due to clinical trial collaboration with Bristol-Myers Squibb and its research and development agreement with Rockefeller University. Operating loss was $96,103,000 against $90,379,000 a year ago. Net loss was $94,513,000 or $0.98 per basic and diluted share compared to $86,258,000 or $0.97 per basic and diluted share a year ago.
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