Celldex Therapeutics Initiates Phase 2 Combination Study of CDX-3379 and Cetuximab in Head and Neck Squamous Cell Carcinoma
November 17 2017 - 8:01AM
Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today that
enrollment has opened in its open-label Phase 2 study of CDX-3379
in combination with cetuximab in patients with
cetuximab-refractory, advanced head and neck squamous cell
carcinoma (HNSCC). CDX-3379 is Celldex’s human monoclonal antibody
that selectively binds and inhibits the activity of ErbB3, also
known as HER3. ErbB3 may be an important receptor regulating cancer
cell growth and survival as well as resistance to targeted
therapies, and it is expressed in many cancers, including HNSCC.
Cetuximab, which is marketed under the brand name Erbitux®, is a
monoclonal antibody that specifically binds EGFR and inhibits its
signaling pathway.
“ErbB3 is a central enabler for known oncogenic drivers,
including EGFR, a validated target with approved targeted
therapeutics, such as cetuximab. Unfortunately, resistance to
targeted treatments often develops, and we believe CDX-3379 may
play an important role in overcoming it. CDX-3379 specifically
blocks ErbB3 with potent binding affinity and locks it into a
deactivated state, blocking both its mechanisms of interacting with
its ligand and also with other oncogenic drivers,” said Christopher
Turner, M.D., Vice President, Clinical Science at Celldex
Therapeutics. “In a Phase 1b study, we saw evidence of antitumor
activity among the nine patients with HNSCC who were treated with
CDX-3379 in combination with cetuximab, including a durable
complete response in a patient who had previously progressed on
single-agent cetuximab.”
Study OverviewThis multicenter, open-label,
Phase 2 study of CDX-3379 in combination with cetuximab will enroll
approximately 30 patients with cetuximab-resistant, advanced HNSCC
who have previously been treated with an anti-PD1 checkpoint
inhibitor, a population with limited options and a particularly
poor prognosis. CDX-3379 (12 mg/kg) will be administered once every
three weeks, and cetuximab (400 mg/m2 initial dose, then 250 mg/m2)
will be administered every week. Treatment will continue until
disease progression or intolerance, and assessments will occur
every six weeks.
Using a Simon two-stage design, the first stage of study will
enroll 13 patients, and if at least one patient achieves a partial
response or complete response, enrollment will progress to the
second stage. The primary objective is to assess the anti-tumor
efficacy of CDX-3379 in combination with cetuximab as measured by
objective response rate. Secondary objectives of the study include
analyses of safety, pharmacokinetics, immunogenicity and further
assessment of anti-tumor activity across a broad range of
endpoints, such as clinical benefit rate, duration of response,
progression-free survival and overall survival, for the
combination. Tumor response assessments will be performed by the
investigator according to standardized, objective response criteria
(RECIST 1.1).
More information about this study is available on
www.clinicaltrials.gov (Identifier: NCT03076372).
About CDX-3379CDX-3379 is a human
immunoglobulin G1 lambda (IgG1λ) monoclonal antibody that
selectively binds and inhibits ErbB3 activity. ErbB3 may be an
important receptor regulating cancer cell growth and survival as
well as resistance to targeted therapies, and it is expressed in
many cancers, including head and neck, thyroid, breast, lung and
gastric cancers, as well as melanoma. The proposed mechanism of
action for CDX-3379 sets it apart from other drugs in development
in this class due to its ability to block both ligand-independent
and ligand-dependent ErbB3 signaling by binding to a unique
epitope. It has a favorable pharmacologic profile, including a
longer half-life and slower clearance relative to other drug
candidates in this class. CDX-3379 also has potential to enhance
anti-tumor activity and/or overcome resistance in combination with
other targeted and cytotoxic therapies to directly kill tumor
cells.
Erbitux® is a registered trademark of Eli Lilly & Co.
About Celldex Therapeutics, Inc.Celldex is
developing targeted therapeutics to address devastating diseases
for which available treatments are inadequate. Our pipeline
includes antibodies, antibody-drug conjugates and other
protein-based therapeutics derived from a broad set of
complementary technologies which have the ability to engage the
human immune system and/or directly inhibit tumors to treat
specific types of cancer or other diseases. Visit
www.celldex.com.
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Company Contact
Sarah CavanaughSenior Vice President, Corporate Affairs &
AdministrationCelldex Therapeutics, Inc.(781)
433-3161scavanaugh@celldex.com
Charles LilesAssociate Director, Investor Relations & Corp
CommunicationsCelldex Therapeutics, Inc.(617)
383-3433cliles@celldex.com
Dan BudwickFounder, 1AB Media(973) 271-6085dan@1abmedia.com
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