Genocea Doses First Patients and Completes Enrollment in Part A of Phase 1/2a Clinical Trial for Neoantigen Vaccine Candidate GEN-009
“Dosing the first patients with our GEN-009 vaccine represents a significant milestone for Genocea,” said
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).
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
Source: Genocea Biosciences, Inc.