Genocea Biosciences Completes Enrollment Early In Phase 2 Dose Optimization Trial Of GEN-003 For Treatment Of Genital Herpes
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today reported that it has completed enrollment in its Phase 2 dose optimization clinical trial for GEN-003 for the treatment of genital herpes. The company expects to report top-line data from the immediate post-vaccination observation period in late Q2 2015.
“The patient response and rapid enrollment we experienced underscore the unmet medical need for new treatment options with novel mechanisms of action for this lifelong disease.”
"The objective of this trial is to build upon the impressive results observed in the prior Phase 1/2a trial. Our goal is to replicate the results of the best performing vaccine dose in that trial, and test other combinations of proteins and adjuvant. By achieving these objectives we will identify and fully justify the best dose to take forward based on an optimal balance of safety and anti-viral activity", said Seth Hetherington, Chief Medical Officer of Genocea. "The patient response and rapid enrollment we experienced underscore the unmet medical need for new treatment options with novel mechanisms of action for this lifelong disease."
The Phase 2 dose optimization study enrolled over 300 subjects from 17 institutions in the United States. Subjects were randomized to one of six dosing groups of either 30 micrograms or 60 micrograms per antigen paired with one of three adjuvant doses (25 micrograms, 50 micrograms, or 75 micrograms). A seventh group received placebo. Subjects will receive three doses of GEN-003 or placebo at 21-day intervals. The primary endpoint for the study is the change from baseline in viral shedding rate, a measure of anti-viral activity. The study is also designed to evaluate the impact on genital lesion rates as well as immunogenicity and safety. Subjects will be followed for 12 months after the last dose.
In the previous Phase 1/2a clinical trial, subjects in the 30 microgram per antigen and 50 microgram of adjuvant dose group experienced, at the immediate post-vaccination observation period, a 52% reduction in viral shedding rate compared to baseline (p<0.001). During that same period, those subjects reported a 48% reduction in genital lesion rates compared to baseline (p<0.001). At six months after the final dose, subjects experienced a 65% reduction in genital lesion rate (p<0.001) and a 40% reduction in viral shedding rate (p<0.001). Twelve months after the final dose, the reduction in the genital lesion rate was 42 percent below baseline for this dose group. Immune responses to the treatment, including T cell, IgG, and neutralizing antibody remained significantly above baseline at the end of the 12 month follow up. GEN-003 was also well tolerated and there were no serious adverse events related to the vaccine.
Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immune response. Using ATLAS™, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea's pipeline of novel clinical stage T cell-enabled product candidates includes GEN-003 for HSV-2 therapy, GEN-004 to prevent infections caused by pneumococcus, and earlier-stage programs in chlamydia, HSV-2 prophylaxis, malaria and cancer immunotherapy. For more information, please visit the company's website at www.genocea.com.
Forward Looking Statements
Statements herein relating to future business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical developments, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including Genocea's ability to progress any product candidates in preclinical or clinical trials; the scope, rate and progress of its preclinical studies and clinical trials and other research and development activities; clinical trial results; current results may not be predictive of future results; even if the data from preclinical studies or clinical trials is positive, the product may not prove to be safe and efficacious; Genocea's ability to enter into future collaborations with industry partners and the government and the terms, timing and success of any such collaboration; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; Genocea's ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; it's ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; the availability of qualified personnel and other factors set forth under "Risk Factors" in Genocea's Annual Report on Form 10-K for the fiscal year ended December 31, 2013 and other filings with the Securities and Exchange Commission (the "SEC"). Further information on the factors and risks that could affect Genocea's business, financial conditions and results of operations is contained in Genocea's filings with the SEC, which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements.