Key Developments For Celldex Therapeutics, Inc.
Celldex Therapeutics, Inc. (CLDX.O) (Consolidated Issue listed on NASDAQ Global Market)
Celldex Therapeutics, Inc. Presents Positive Clinical Data From Phase 1 Studies Of Antibody-Based Cancer Vaccine Candidate, CDX-1307
Celldex Therapeutics, Inc. announced the positive results from Phase 1 studies of CDX-1307 in patients with advanced epithelial cancers, including breast, colon, bladder and pancreatic cancer. CDX-1307, the first candidate from the Company`s Precision Targeted Immunotherapy Platform, utilizes monoclonal antibodies to deliver vaccine directly to the patient`s immune system and focuses the immune system against hCG beta (hCG-β), a cancer-associated target believed to play a role in more aggressive forms of the disease. The data, presented at the 24th Annual Meeting of the International Society for Biological Therapy of Cancer (iSBTc) in Washington, D.C., demonstrated enhanced immunological and biological responses and support the planned initiation of Phase 2 clinical trials in hCG-β expressing cancers. The Phase 1 studies investigated the safety and immunogenicity of CDX-1307 alone and in combination with adjuvants, including GM-CSF and Toll-like Receptor (TLR) agonists (poly-ICLC or Hiltonol and R848 or resiquimod). The studies enrolled more than 80 patients with heavily pretreated, advanced-stage breast, colon, bladder and pancreatic cancer, with an average of 4.6 prior therapies across the treatment population. All patient cohorts demonstrated a favorable safety profile with no dose limiting toxicity to date.
Celldex Therapeutics, Inc. Announces Completion Acquisition Of CuraGen Corporation
Celldex Therapeutics, Inc. announced the completion of its acquisition of CuraGen Corporation pursuant to the previously disclosed Agreement and Plan of Merger, dated as of May 28, 2009, by and among CuraGen, Celldex and Celldex`s merger subsidiary, Cottrell Merger Sub, Inc. The Agreement and Plan of Merger was approved by CuraGen`s stockholders and the issuance of shares of Celldex common stock was approved by Celldex`s stockholders at special stockholder meetings held on September 30, 2009. Concurrent with the closing of the merger, Celldex added one position to its Board of Directors and Dr. Timothy Shannon, President and Chief Executive Officer of CuraGen, joined the Celldex Board of Directors. The purchase price for CuraGen was approximately $93.5 million after giving effect to the adjustments described in the Agreement and Plan of Merger to reflect CuraGen`s net cash balance of approximately $53.5 million. As a result of the merger, CuraGen has become a wholly owned subsidiary of Celldex.
Celldex Therapeutics, Inc. Announces Appointment Of Larry Ellberger As Chairman
Celldex Therapeutics, Inc. announced that Larry Ellberger has been appointed Chairman of the Board of Directors, effective September 3, 2009. Charles R. Schaller will remain on the Board as a Director for the remainder of his term.
Celldex Therapeutics, Inc. Announces CDX-1307 Clinical Data
Celldex Therapeutics, Inc. announced that promising clinical data from two Phase 1 studies of CDX-1307 were presented at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida. CDX-1307 is a dendritic cell targeted immunotherapy designed to stimulate an immune response against hCG Beta (hCG-β), a target antigen frequently expressed in epithelial tumors. The comprehensive Phase 1 studies include over 70 patients and were designed to investigate the safety and immunogenicity of CDX-1307 using different routes of administration and in combination with immunostimulants, including GM-CSF and toll-like receptor agonists (poly-ICLC/Hiltonol or R848/resiquimod). CDX-1307 was well tolerated with no dose limiting toxicity to date. Robust immune responses were generated, and seven patients with breast, colorectal and pancreatic cancers experienced disease stabilization for 2.2+ to 6.5+ months. CDX-1307 is in early-stage development for the treatment of colorectal, pancreatic, bladder, ovarian and breast cancers that express the beta chain of human chorionic gonadotropin (hCG-β), an antigen often found in these tumors but not in most normal tissues. CDX-1307 is a fusion protein composed of the hCG-β antigen attached to a human monoclonal antibody that specifically targets the mannose receptors on dendritic cells.
Pfizer And Celldex Therapeutics, Inc. Present Update On CDX-110 (PF-04948568) Phase 2 Brain Cancer Studiesat
Pfizer and Celldex Therapeutics, Inc. announced the presentation of updated data from two clinical trials of CDX-110 in newly-diagnosed glioblastoma multiforme (GBM) at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO). CDX-110, an investigational immunotherapeutic vaccine that targets the tumor-specific molecule, epidermal growth factor receptor variant III (EGFRvIII), was developed by Celldex Therapeutics and is now partnered with Pfizer. Data from the 40 evaluable patients in ACTIVATE and ACT II continue to suggest that vaccination with CDX-110 may be able to improve time to tumor recurrence and overall survival when used in patients with newly-diagnosed GBM. This single arm Phase 2 study, 18 patients with newly diagnosed and optimally resected EGFRvIII-positive GBM received CDX-110 as a monotherapy following completion of chemoradiation with concurrent temozolomide. Median overall survival (OS) was 26 months and median time to progression (TTP) was 14.2 months. Additionally, three patients remain without relapse more than 4 years from surgery and continue to receive the vaccine within the clinical trial.
