July 28, 2016 3:57 PM 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 Rintega (CDX-110), a therapeutic vaccine in Phase III clinical studies for the treatment of glioblastoma patients that express an epidermal growth factor receptor variant III, as well as in Phase II study for the treatment of recurrent glioblastoma; Glembatumumab vedotin (CDX-011), a targeted antibody-drug conjugate (ADC) 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; and Varlilumab...

Perryville III Building

Suite 200

53 Frontage Road

Hampton, NJ 08827

United States

196 Employees

Phone:

908-200-7500

Fax:

908-454-1911

Key Executives for Celldex Therapeutics, Inc.

Founder, Chief Executive Officer, President and Director
Age: 54
Total Annual Compensation: $862.3K
Founder, Chief Scientific Officer and Executive Vice President
Age: 57
Total Annual Compensation: $569.0K
Chief Financial Officer, Principal Accounting Officer, Senior Vice President, Treasurer and Secretary
Age: 68
Total Annual Compensation: $469.5K
Chief Medical Officer and Executive Vice President
Age: 52
Total Annual Compensation: $599.4K
Chief Business Officer and Senior Vice President
Age: 60
Total Annual Compensation: $435.1K
Compensation as of Fiscal Year 2015.

Celldex Therapeutics, Inc. Key Developments

Celldex Therapeutics, Inc. Initiates Phase 1/2 Clinical Trial of New Product Candidate CDX-014 in Advanced Renal Cell Carcinoma

Celldex Therapeutics, Inc. announced that enrollment has opened in its Phase 1/2 study of CDX-014 in advanced renal cell carcinoma (RCC). CDX-014 is a novel antibody-drug conjugate that targets the transmembrane protein T-cell immunoglobulin mucin-1 (TIM-1). TIM-1 expression is upregulated in several cancers, most notably renal cell and ovarian carcinomas, and is associated with a more malignant phenotype of RCC and tumor progression1,2. TIM-1 has very restricted expression in healthy tissue. The study is open to patients with both clear cell and papillary RCC. The Phase 1 dose-escalation portion of the study will evaluate cohorts of patients receiving increasing doses of CDX-014 to determine the maximum tolerated dose and a recommended dose for Phase 2 study. The Phase 2 portion of the study will enroll approximately 25 patients to assess the anti-tumor activity of CDX-014 at the recommended dose in advanced renal cell carcinoma as measured by objective response rate (RECIST 1.1). Secondary objectives include safety and tolerability, pharmacokinetics, immunogenicity and additional measures of anti-tumor activity, including clinical benefit rate. The study is being conducted in the United States and is expected to include approximately 10 sites. Patients must have advanced/metastatic clear cell or papillary renal cell carcinoma and have experienced progressive disease after at least two prior lines of therapy, including at least one VEGF-targeted tyrosine kinase inhibitor, or be otherwise inappropriate candidates for all approved therapies. Data analysis will be conducted separately in clear cell RCC and papillary RCC, as well as by the total population.

Celldex Therapeutics, Inc. Presents at Cantor Fitzgerald 2nd Annual Healthcare Conference, Jul-12-2016 09:00 AM

Celldex Therapeutics, Inc. Presents at Cantor Fitzgerald 2nd Annual Healthcare Conference, Jul-12-2016 09:00 AM. Venue: Le Parker Meridien, New York, New York, United States. Speakers: Tibor Keler, Founder, Chief Scientific Officer and Executive Vice President.

Celldex Therapeutics, Inc. Announces Results from a Phase 2 Clinical Study Evaluating CDX-1401 and CDX-301 in Patients with Malignant Melanoma

Celldex Therapeutics, Inc. announced results from a Phase 2 clinical study evaluating CDX-1401 and CDX-301 in patients with malignant melanoma, which was conducted by the Cancer Immunotherapy Trials Network (CITN) under a Cooperative Research and Development Agreement (CRADA) between Celldex and the Cancer Therapy Evaluation Program of the National Cancer Institute. CDX-1401 is an NY-ESO-1-antibody fusion protein for immunotherapy, and CDX-301 (recombinant human Flt3 ligand) is a potent hematopoietic cytokine that uniquely expands dendritic cells and hematopoietic stem cells. Results from the study were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago in a poster titled “A Phase 2, Open-label, Multicenter, Randomized Study of CDX-1401, a Dendritic Cell Targeting NY-ESO-1 Vaccine, in Patients with Malignant Melanoma Pre-Treated with CDX-301, a Recombinant Human Flt3 Ligand.” The study randomized 60 patients with resected stage IIb through IV melanoma into two cohorts (n=30 each) to assess whether the immune response to NY-ESO-1 elicited by CDX-1401 could be substantially increased by pre-treatment with CDX-301 to expand the number of dendritic cells, which are key cells in initiating immune responses. As this study was intended primarily for safety and immune endpoints, patients were not selected for NY-ESO-1 expression. Both treatment cohorts received four monthly cycles of CDX-1401 and poly-ICLC (Hiltonol®). Cohort 1 received pre-treatment with CDX-301 for the first two cycles, whereas Cohort 2 did not receive CDX-301. Both combination regimens were well tolerated, and no drug-related adverse events required discontinuation from treatment. NY-ESO-1 specific T cell responses were significantly greater and developed earlier in Cohort 1 compared to Cohort 2. In addition, all patients in Cohort 1 (n=30) achieved a specific NY-ESO-1-specific T cell response compared to 22 out of 30 patients in Cohort 2. Substantial increases in innate immune cells (dendritic cells, natural killer cells and monocytes) and greater increases in antibody titer were observed in the CDX-301 pre-treated Cohort 1. CDX-301: CDX-301 (Flt3L) is a potent hematopoietic cytokine that has demonstrated a unique capacity to increase the number of circulating dendritic cells in both laboratory and clinical studies. In addition, CDX-301 has shown impressive results in models of cancer, infectious diseases and inflammatory/autoimmune diseases. Celldex believes this ligand may hold significant opportunity for synergistic development in combination with other proprietary molecules in the Company's portfolio. CDX-1401: CDX-1401 is an NY-ESO-1-antibody fusion protein for immunotherapy, which is designed to activate the patient's immune system against cancers that express the tumor marker, NY-ESO-1. CDX-1401 consists of a fully human monoclonal antibody with specificity for the dendritic cell receptor DEC-205 genetically linked to the NY-ESO-1 tumor antigen. Celldex has accessed NY-ESO-1 through a licensing agreement with the Ludwig Institute for Cancer Research. By selectively delivering the NY-ESO-1 antigen to dendritic cells in the body, CDX-1401 is intended to induce robust immune responses against the antigen-expressing cancer cells.

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