Genocea Doses First Patients and Completes Enrollment in Part A of Phase 1/2a Clinical Trial for Neoantigen Vaccine Candidate...
January 02 2019 - 8:00AM
Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical
company developing personalized cancer immunotherapies, today
announced the dosing of the first patients in its Phase 1/2a
clinical trial testing the safety, immunogenicity, and clinical
efficacy of its neoantigen cancer vaccine candidate GEN-009.
Genocea also announced that enrollment of patients in the first
part of the clinical trial has been completed.
“Dosing the first patients with our GEN-009 vaccine represents a
significant milestone for Genocea,” said Tom Davis, M.D., the
company’s Chief Medical Officer. “Importantly, our GEN-009 vaccines
use our ATLAS™ platform for neoantigen identification. Unlike
machine-based approaches that predict neoantigens and only evaluate
the patient’s tumor, ATLAS also uses each patient’s own immune
cells not only to identify true neoantigens that already trigger
anti-tumor cytokine responses, but also to eliminate “inhibitory”
antigens that are frequently selected for vaccine inclusion by such
in silico approaches. I am grateful to the patients eager to
participate in our trial, to our investigators, and to my
colleagues here at Genocea for creating the first vaccine that is
genuinely personalized to each individual’s T cells and their tumor
mutations.”
Dr. Davis added: “With Part A of the trial now fully enrolled,
we are in a better position to predict when we will have the first
immunogenicity data from these patients. As a result, we are
updating our guidance today and look forward to reporting top-line
results from this part of the study late in the second quarter of
this year or early in the third quarter."
This Phase 1/2a GEN-009 clinical trial consists of three parts.
Part A is studying the safety and immunogenicity of GEN-009 as
monotherapy in cancer patients with no evidence of disease, but at
high risk of relapse. This part of the program has accrued nine
patients previously treated for melanoma, non-small cell lung
cancer, head and neck cancer, or urothelial carcinoma. Following
proof of immunogenicity, Genocea expects to study GEN-009 in
combination with checkpoint inhibitors in patients with advanced or
metastatic solid tumors (Part B) and in patients who have
progressed despite checkpoint inhibitor therapy (Part C).
About Genocea Biosciences, Inc.Genocea's
mission is to help conquer cancer by designing and delivering
targeted cancer vaccines and immunotherapies. While traditional
immunotherapy discovery methods have largely used predictive
methods to propose T cell targets, or antigens, Genocea has
developed ATLAS™, its proprietary technology platform, to identify
clinically relevant antigens of T cells based on actual human
immune responses. Genocea is currently studying the safety,
immunogenicity, and efficacy of its lead neoantigen cancer vaccine,
GEN-009, in a Phase 1/2a clinical trial. For more information,
please visit www.genocea.com.
Genocea Forward-Looking Statement This press
release includes forward-looking statements, including statements
relating to the expected clinical development of GEN-009, within
the meaning of the Private Securities Litigation Reform Act. Such
forward-looking statements are subject to risks and uncertainties
that could cause actual results to differ materially from those
expressed or implied in such statements. Genocea cautions that
these forward-looking statements are subject to numerous
assumptions, risks and uncertainties that change over time.
Applicable risks and uncertainties include those identified under
the heading "Risk Factors" included in Genocea's Annual Report on
Form 10-K for the year ended December 31, 2017 and any subsequent
SEC filings. These forward-looking statements speak only as of the
date of this press release and Genocea assumes no duty to update
forward-looking statements, except as may be required by law.
Contact: Jennifer LaVin
617-715-6687jennifer.lavin@genocea.com
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