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May 05, 2015 7:43 AM ET

Biotechnology

Company Overview of Celldex Therapeutics, Inc.

Company Overview

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

Suite 200

53 Frontage Road

Hampton, NJ 08827

United States

156 Employees

Phone:

908-200-7500

Fax:

908-454-1911

Key Executives for Celldex Therapeutics, Inc.

Chief Executive Officer, President and Director
Age: 52
Total Annual Compensation: $814.1K
Executive Vice President, Founder and Chief Scientific Officer
Age: 55
Total Annual Compensation: $543.0K
Chief Financial Officer, Principal Accounting Officer, Senior Vice President, Treasurer and Secretary
Age: 66
Total Annual Compensation: $419.1K
Chief Medical Officer and Executive Vice President
Age: 50
Total Annual Compensation: $556.4K
Chief Business Officer and Senior Vice President
Age: 58
Total Annual Compensation: $419.6K
Compensation as of Fiscal Year 2014.

Celldex Therapeutics, Inc. Key Developments

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.

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.

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