Celldex Therapeutics Presents Safety and Immunogenicity Data on CDX-1401 at the International Society of Biological Therapy of Cancer Meeting
NEEDHAM, Mass., Oct 04, 2010 (BUSINESS WIRE) -- Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that the Company presented initial clinical data on CDX-1401 at the 25th Annual Meeting of the International Society of Biological Therapy of Cancer (iSBTc)in Washington, DC. CDX-1401 is a novel antibody-based targeted cancer vaccine candidate being evaluated as a treatment for patients with melanoma and other cancers that are known to express the tumor antigen NY-ESO-1.
The data presented were from a Phase 1/2 dose-escalating clinical trial evaluating three different doses of the vaccine in combination with resiquimod , which is an activator of toll-like receptors 7 and 8 (TLR7/8) and stimulator of immune cells. The study has enrolled 20 patients with advanced cancer, of which 35% had confirmed NY-ESO-1 expression. Six patients maintained stable disease and were eligible for multiple cycles of the treatment regimen, including 4 patients who have received 3 or more cycles (6 weeks of treatment followed by a 6 week rest), with stable disease of up to 11.5+ months. The treatment was well tolerated and there were no dose-limiting toxicities. Robust anti-NY-ESO-1 immunity was induced with the majority of the patients developing anti-NY-ESO-1 antibody responses and 39% of the patients having increases in NY-ESO-1 specific T cell responses, including both CD4 and CD8 responses. Importantly, the T cell responses were directed against multiple regions of the NY-ESO-1 antigen.
"CDX-1401 represents a new generation of off-the-shelf dendritic cell targeted vaccines built upon excellent preclinical activity data," said Tom Davis, M.D., Chief Medical Officer of Celldex Therapeutics. "The initial data from this ongoing study confirm safety and immunogenicity even in patients with advanced cancer who have received multiple prior therapies. CDX-1401 has passed the initial Phase 1 hurdles and we look forward to forthcoming cohorts that will include additional TLR agonists in combination regimens."
The CDX-1401 study is continuing to enroll patients to additional cohorts that include combination with poly-ICLC (Hiltonol(TM)), a potent TLR3 agonist and stimulator of immune cells. The study is currently being conducted at multiple centers including Yale Cancer Center, Henry Ford Hospital and Medical Group, Memorial Sloan Kettering Cancer Center, and Weill Cornell Medical College.
About the CDX-1401 Vaccine
CDX-1401 is a cancer vaccine designed to activate the patient's immune system against cancers that express the tumor marker, NY-ESO-1. The product 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 multi-year clinical research collaboration with the international Ludwig Institute for Cancer Research. By selectively delivering the NY-ESO-1 antigen to dendritic cells in the body, this product is intended to induce robust immune responses against the antigen-expressing cancer cells.
About Celldex Therapeutics, Inc.
Celldex Therapeutics is an integrated biopharmaceutical company that applies its comprehensive Precision Targeted Immunotherapy Platform to generate a pipeline of candidates to treat cancer and other difficult-to-treat diseases. Celldex's immunotherapy platform includes a complementary portfolio of monoclonal antibodies, antibody-targeted vaccines and immunomodulators to create novel disease-specific drug candidates. For more information, please visit http://www.celldextherapeutics.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: Thisrelease contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including those related to the Company's strategic focus and the future development and commercialization (by Celldex and others) of rindopepimut (CDX-110), CDX-1307, CDX-011, CDX-1135 (formerly TP10), CDX-1401, Belinostat, Rotarix(R) and other products. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties,including, but not limited to, our ability to obtain additional capital on acceptable terms, or at all; our ability to adapt APC Targeting TechnologyTM to develop new, safe and effective vaccines against oncology and infectious disease indications; our ability to successfullycomplete product research and further development of our programs; our development partners' willingness to make announcements with respect to co-developed products; the uncertainties inherent in clinical testing; our ability to manage research and development efforts for multiple products at varying stages of development; our strategy and business plans concerning the continued development and commercialization of rindopepimut (PF-04948568 or CDX-110); our ability to successfully complete the transition of Rindopepimut from Pfizer to Celldex; the uncertainties of any future payments with respect to Belinostat, as the development and commercialization of Belinostat is completely outside of Celldex's control; the uncertainties of any future royalty payments with respect to Rotarix(R), as the commercialization of Rotarix(R) is completely outside of Celldex's control; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; our ability to successfully integrate the businesses, multiple technologies and programs of CuraGen and Celldex; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; and other factors listed under "Risk Factors" in our annual report on Form 10-K.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
SOURCE: Celldex Therapeutics, Inc.
Celldex Therapeutics, Inc.
Anthony S. Marucci, 781-433-0771
President and CEO
Celldex Therapeutics, Inc.
Avery W. Catlin, 781-433-0771
Chief Financial Officer
BMC Communications Group
Matthew Driscoll, 212-477-9007 x20