Celldex Therapeutics Announces Initiation of Randomized Phase 2 Clinical Trial of CDX-1307 in Front Line Bladder Cancer

NEEDHAM, Mass.--(BUSINESS WIRE)-- Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that the first patient has been screened in a randomized Phase 2 study of the Company’s novel, first-in-class antibody-based vaccine candidate from its Precision Targeted Immunotherapy (PTI) platform. This study will evaluate the CDX-1307 regimen in both neoadjuvant and adjuvant settings in patients with newly diagnosed muscle-invasive bladder cancers that express hCG-beta. hCG-beta is a tumor-associated antigen (TAA) expressed by several different types of cancers, including bladder cancer. hCG-beta appears to directly facilitate cancer progression and has been shown to correlate with poor prognosis. CDX-1307 is a fully human monoclonal antibody designed to selectively deliver the hCG-beta antigen to dendritic cells. The CDX-1307 vaccine regimen, which includes a novel combination of immune stimulating adjuvants, was developed during Phase 1 trials and has been shown to generate a robust immune response against cancer cells expressing hCG-beta.

“Bladder cancer is an understudied disease with a real need for new therapies and hCG-beta is an important molecule in tumor biology that prevents tumor cell death,” said Professor Ray Iles, Middlesex University, London. “CDX-1307 may be a very useful adjuvant therapy in this disease.”

“The CDX-1307 vaccine regimen provides a personalized and targeted intervention for hCG-beta expressing bladder cancer,” said Tom Davis, MD, Chief Medical Officer of Celldex Therapeutics, Inc. “This vaccine offers the potential for an off-the-shelf technology capable of utilizing each patient’s own dendritic cells. Newly diagnosed bladder cancer is an immunologically sensitive disease, and we believe the adjuvant setting provides the best opportunity for a vaccine to interfere with the disease process.”

The Phase 2 study will enroll approximately 60 patients, randomized (1:1), with newly diagnosed hCG-beta expressing muscle-invasive bladder cancer who have not previously received any chemotherapy for their disease. These chemo-naïve patients will be most likely to have intact immune systems that are best able to generate a potent anti-tumor response. Following screening with an hCG-beta diagnostic assay, patients will be randomized (1:1) to receive neoadjuvant therapy with either CDX-1307 and standard of care chemotherapy (gemcitabine and cisplatinum) or standard of care alone, and will then undergo the previously planned bladder resection. Following bladder resection, patients administered neoadjuvant therapy will also receive adjuvant CDX-1307 vaccine for up to one year. Patients will be evaluated for:

1. Pathologic complete response in resected tumors after neoadjuvant therapy and Relapse Free Survival at two years after infiltration;

2. immune response, safety and anti hCG-beta effects on resected tumor, including hCG-beta expression and immune infiltration; and

3. Overall Survival (OS).

These results will evaluate the anti-tumor impact from vaccination with the CDX-1307 regimen both in combination with chemotherapy and as a stand alone adjuvant therapy. Approximately 15-20 U.S. sites will participate in the study. Preliminary data is expected by year-end 2011.

About Bladder Cancer

The American Cancer Society has estimated that 70,980 new cases of bladder cancer and 14,330 deaths from bladder cancer occurred in the United States in 2009. The prognosis and treatment for patients diagnosed with bladder cancer is largely dependent on stage, with more advanced tumors carrying an increased probability of recurrence. For patients with muscle-invasive disease (T2-T4 N0) undergoing radical cystectomy, 5-year recurrence-free survival has been reported to be in the range of 50-89%. However, the subset of bladder cancer patients with hCG-beta expressing cancers (21-47%) fare much worse. One study has indicated a median survival of just four months for Stage T3 bladder cancer patients expressing hCG-beta, compared to twenty-three months for those who did not express the antigen. As hCG-beta appears to directly facilitate cancer progression through a number of mechanisms, an approach targeting hCG-beta in the treatment of bladder cancers may be a particularly effective strategy.

About the CDX-1307 Vaccine

The Company has developed an APC Targeting Technology that utilizes fully human monoclonal antibodies to directly target specialized types of immune system cells, known as antigen presenting cells. The Company’s lead APC Targeting Technology product candidate, CDX-1307, is in development for the treatment of epithelial tumors such as colorectal, pancreatic, bladder, ovarian and breast cancers. CDX-1307 is a cancer vaccine designed to activate the patient’s immune system against the beta chain of human chorionic gonadotropin, known as hCG-beta, which is an antigen often found in epithelial tumors.

hCG-beta appears to directly facilitate cancer progression an has been shown to correlate with poor prognosis. CDX-1307 consists of a fully human monoclonal antibody with specificity for the mannose receptor on dendritic cell, genetically linked to the hCG-beta tumor antigen. By selectively delivering the hCG-beta antigen to dendritic cells and activating them in the body, the CDX-1307 vaccine regimen is intended to induce robust immune responses against the antigen-expressing cancer cells. The presence of hCG-beta in these cancers correlates with a poor clinical outcome, suggesting that this molecule may contribute to tumor growth. The vaccine will be combined with resiquimod (a toll-like receptor “TLR” 7/8 agonist) and Hiltonol (a TLR 3 agonist) as adjuvants, which have been provided by 3M Company and Oncovir, Inc., respectively.

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 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 http://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 CDX-110, CDX-1307, CDX-011, CDX-1135 (formerly TP10), CDX-1401, 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 ability to successfully integrate the businesses, multiple technologies and programs of CuraGen and Celldex; 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; 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; Pfizer’s and our strategy and business plans concerning the continued development and commercialization of CDX-110; 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 obtain additional capital on acceptable terms, or at all; 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 risks detailed from time to time in the Company's filings with the Securities and Exchange Commission, including the Company's Form 10-K for the fiscal year ended December 31, 2009, and its Forms 10-Q and 8-K.



CONTACT:

Celldex Therapeutics, Inc.
Anthony S. Marucci, 781-433-0771
President and CEO
or
Celldex Therapeutics, Inc.
Avery W. Catlin, 781-433-0771
Chief Financial Officer
[email protected]
or
For Media:
BMC Communications Group
Matthew Driscoll, 212-477-9007 x20
[email protected]

KEYWORDS:   United States  North America  Massachusetts

INDUSTRY KEYWORDS:   Health  Biotechnology  Clinical Trials  Oncology  Pharmaceutical

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