Celldex Presents Results from Phase 1 Studies of CDX-1307 with GM-CSF
NEEDHAM, Mass.--(BUSINESS WIRE)--Oct 31, 2008 - Celldex Therapeutics, Inc. (NASDAQ: CLDX) announced initial results from multi-center Phase 1 clinical trials of its cancer vaccine candidate, CDX-1307, combined with GM-CSF, at the International Society for the Biologic Therapy of Cancer (iSBTc) annual meeting in San Diego. These data provide the basis for the ongoing assessment of CDX-1307 combined with more potent adjuvants with data expected in the first half of 2009.
"These CDX-1307 data provide further support for the tolerability and immunogenicity of Celldex's novel Precision Targeted Immunotherapy Platform," said Thomas Davis, M.D., Chief Medical Officer of Celldex Therapeutics. "We believe that specific immunotherapy combinations will provide even more potent clinical effects and, based on the safety and immunogenicity seen in these dose escalation studies, Celldex is now evaluating CDX-1307 in combination with the experimental Toll-Like Receptor agonists that the Company recently accessed."
CDX-1307 is a dendritic cell targeted immunotherapy designed to focus the immune system against hCG Beta, which is frequently expressed in epithelial tumors and has been associated with poor prognosis. The Phase 1 studies are open-label, dose-escalating clinical trials in patients with incurable breast, bladder, pancreatic, or colorectal cancer, all tumors that can express hCG Beta. The studies evaluated the safety and immunogenicity of multiple dosing of CDX-1307 alone and in combination with GM-CSF at multiple dose levels. In one dose escalation scheme 25 patients have received CDX-1307 by local intradermal injection at up to 2.5mg, and in the other Phase 1 study 25 patients have received CDX-1307 systemically via intravenous injection at higher doses of up to 30 mg.
CDX-1307 has been well tolerated at all doses and via both routes of administration without any Dose Limiting Toxicity. The most frequent treatment related toxicities were mild flu-like symptoms and mild local reactions associated with the intradermal injections. The hCG Beta was shown to be localized in antigen presenting cells of the skin in post-treatment biopsies following intradermal administration of CDX-1307. Even in the absence of potent adjuvants, humoral immune responses were seen in approximately half of patients at the higher dose levels despite circulating hCG Beta antigen, with reduction or clearance of hCG Beta in some patients. Enhancement of CD8 T-cell responses after vaccination was also seen in some patients. Despite advanced disease in the majority of patients, 2 patients experienced stable disease for at least 6 months and a minor response was seen in a patient with pancreatic cancer.
Based on the safety and immunogenicity seen in the dose escalation studies, Celldex is now evaluating CDX-1307 in combination with the experimental Toll-Like Receptor (TLRs) agonists that the Company recently accessed (poly-ICLC, a TLR 3 agonist, and resiquimod, a TLR 7/8 agonist) and expects results by mid-2009. Celldex then expects to initiate a Phase 2 clinical trial of CDX-1307 in combination with selected TLR agonists in the second half of 2009.
"The CDX-1307 data define the feasibility and tolerability of Celldex's novel antibody-targeting platform for cancer vaccines, allowing the flexibility to add novel adjuvant combinations such TLR agonists. This will enable the Company to uniquely advance its broad immunotherapy portfolio across a range of disease indications," added Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics, Inc.
About the CDX-1307 Vaccine
The Company has developed an APC Targeting Technology(TM) that utilizes fully human monoclonal antibodies to directly target specialized types of immune system cells, known as antigen presenting cells. The Company is advancing several clinical and preclinical product candidates that use APC Targeting Technology(TM) to manipulate critical types of antigen presenting cells, known as dendritic cells and macrophages, which are key cells within the immune system. Because these cells are largely responsible for initiating the immune system's disease-fighting mechanisms, the Company believes that product candidates using its technology will create more potent immune responses than standard vaccination strategies.
The Company's lead APC Targeting Technology(TM) product candidate, CDX-1307, is in development for the treatment of epithelial tumors such as colorectal, pancreatic, bladder, ovarian and breast cancers. CDX-1307 targets the beta chain of human chorionic gonadotropin, known as hCG-Beta, which is an antigen often found in epithelial tumors. The presence of hCG-Beta in these cancers correlates with a poor clinical outcome, suggesting that this molecule may contribute to tumor growth. Normal adult tissues have minimal expression of hCG-Beta; therefore, targeted immune responses are not expected to generate significant side effects.
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: This release includes forward-looking statements that are subject to a variety of risks and uncertainties and reflect Celldex's current views with respect to future events and financial performance. There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by Celldex. These factors include, but are not limited to: (1) the successful integration of the businesses, multiple technologies and programs of Celldex; (2) the ability to adopt Celldex's APC Targeting Technology(TM) to develop new, safe and effective vaccines against oncology and infectious disease indications; (3) the ability to adapt Celldex's vectoring systems to develop new, safe and effective orally administered vaccines against disease causing agents; (4) the ability to successfully complete product research and further development, including animal, preclinical and clinical studies, and commercialization of CDX-110, CDX-1307, CholeraGarde(R) (Peru-15), Ty800,ETEC E. coli vaccine, and other products and Celldex's expectations regarding market growth; (5) the cost, timing, scope and results of ongoing safety and efficacy trials of CDX-110, CDX-1307, CholeraGarde(R) (Peru-15), Ty800, ETEC E. coli vaccine and other preclinical and clinical testing; (6) the ability to negotiate strategic partnerships or other disposition transactions for Celldex's cardiovascular programs, including TP10 and CETi; (7) the ability of Celldex to manage multiple clinical trials for a variety of product candidates; (8) the volume and profitability of product sales of Megan(R)Vac 1, Megan(R)Egg and other future products; (9) GlaxoSmithKline's, or Glaxo's, process of obtaining regulatory approval for the sale of Rotarix(R) in major commercial markets, as well as the timing and success of worldwide commercialization of Rotarix(R) by Glaxo, which is not within our control; (10) Glaxo's strategy and business plans to launch and supply Rotarix(R) worldwide, including in the U.S. and other major markets, which is not within our control, and its payment of royalties to Celldex; (11)Pfizer's and our strategy and business plans concerning the continued development and commercialization of CDX-110; (12) Celldex's expectations regarding its technological capabilities and expanding its focus to broader markets for vaccines; (13) changes in existing and potential relationships with corporate collaborators; (14) the availability, cost, delivery and quality of clinical and commercial grade materials produced at Celldex's own manufacturing facility or supplied by contract manufacturers and partners; (15) the timing, cost and uncertainty of obtaining regulatory approvals; (16) Celldex's ability to develop and commercialize products before competitors that are superior to the alternatives developed by such competitors; (17) Celldex's ability to retain certain members of management;(18) Celldex's expectations regarding research and development expenses and general and administrative expenses; (19) Celldex's expectations regarding cash balances, capital requirements, anticipated royalty payments, revenues and expenses, including infrastructure expenses; (20) the ability to obtain substantial additional funding; (21) Celldex's belief regarding the validity of our patents and potential litigation; and (22) certain other factors that might cause Celldex's actual results to differ materially from those in the forward-looking statements including those set forth under the headings "Business," "Risk Factors" and Management's Discussion and Analysis of Financial Condition and Results of Operations" in each of Celldex's Annual Report on Form 10-K, its current Reports on Form 8-K, as well as those described in Celldex's other press releases and filings with the Securities and Exchange Commission, from time to time. You should carefully review all of these factors, and you should be aware that there may be other factors that could cause these differences. These forward-looking statements were based on information, plans and estimates at the date of this press release, and Celldex does not promise to update any forward-looking statements to reflect changes in underlying assumptions or factors, new information, future events or other changes.
Celldex Therapeutics, Inc.
Anthony S. Marucci, 781-433-0771
President and CEO
Avery W. Catlin, 781-433-0771
Chief Financial Officer
BMC Communications Group
Dan Budwick, 973-271-6085
Posted: October 2008