NEEDHAM, Mass. -- (BUSINESS WIRE) -- Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced upcoming data presentations on two of the Company’s fully human monoclonal antibody programs—CDX-1127 and CDX-011.
Tibor Keler, PhD, Senior Vice President and Chief Scientific Officer, will present a review of the CDX-1127 program at the IBC’s Antibody Engineering & Antibody Therapeutics Meeting on Thursday, December 6, 2012 at 3:15 pm PT (6:15 pm ET) at the Hilton San Diego Bayfront Hotel in San Diego, California. The presentation will include a comprehensive review of preclinical results. CDX-1127 binds CD27, an important co-stimulatory molecule on T cells, and is designed to activate patients' immune cells against their cancer. The Company is currently conducting a two-arm, multi-dose, Phase 1 study in patients with selected malignant solid tumors or hematologic malignancies to determine a Phase 2 dose for further development. The solid tumor arm is completing accrual in the final dose cohort and, to date, has been well tolerated, including at the highest dose level. The Company continues to enroll patients in the hematologic arm and expects to complete enrollment in this arm in the first half of 2013. Clinical results from both studies will be presented at a future medical meeting.
Denise A. Yardley, MD, Senior Investigator in the Breast Cancer Research Program at the Sarah Cannon Research Institute and a lead investigator in the Phase 2b EMERGE study of CDX-011 in metastatic breast cancer, will present mature results in a poster session at the San Antonio Breast Cancer Symposium on Saturday, December 8, 2012 at 7:00 am CT (8:00 am ET) at the Henry B. Gonzalez Convention Center in San Antonio, Texas. The Company anticipates the presentation will include overall survival and duration of response data and updated patient response and progression free survival data. The Company will issue a press release at the time of the presentation and will make a copy of the poster available on their website in the “Product Pipeline, Scientific Presentations” section. CDX-011 targets and binds to GPNMB, a specific protein expressed in breast cancer that promotes the migration, invasion and metastasis of the disease. In May of 2012, the Company reported preliminary positive results from the Phase 2b study, noting particularly impressive response rates in patients with triple negative breast cancer who also have high (≥ 25%) levels of GPNMB expression.
About Celldex Therapeutics, Inc.
Celldex Therapeutics is the first antibody-based combination immunotherapy company. Celldex has a pipeline of drug candidates in development for the treatment of cancer and other difficult-to-treat diseases based on its antibody focused Precision Targeted Immunotherapy (PTI) Platform. The PTI Platform is a complementary portfolio of monoclonal antibodies, antibody-targeted vaccines and immunomodulators used in optimal combinations to create novel disease-specific drug candidates. For more information, please visit www.celldextherapeutics.com.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: This release 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-011, CDX-1135, CDX-1401, CDX-1127, CDX-301, Belinostat 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 limited cash reserves and our ability to obtain additional capital on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; our ability to adapt APC Targeting TechnologyTM to develop new, safe and effective vaccines against oncology and infectious disease indications; our ability to successfully complete product research and further development of our programs; the uncertainties inherent in clinical testing; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage research and development efforts for multiple products at varying stages of development; 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; 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.