Press Releases

Genocea Commences Phase 2 Dose Optimization Trial for GEN-003 HSV-2 Immunotherapy

July 21, 2014 at 8:00 AM EDT

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genocea Biosciences, Inc. (NASDAQ:GNCA), a clinical-stage biopharmaceutical company developing T cell-enabled vaccines and immunotherapies, today announced the start of a Phase 2 dose optimization trial for GEN-003, the Company's immunotherapy candidate against herpes simplex-type 2 (HSV-2).

"Consistent with our long-standing development plans, this Phase 2 trial will compare the best dose of GEN-003 from our Phase 1/2a trial to other combinations of protein and adjuvant to determine the optimal dose for future trials and potentially improve on the current profile of GEN-003," said Seth Hetherington, MD, chief medical officer of Genocea. "This Phase 2 trial builds on our successful Phase 1/2a clinical trial, which we believe was the first time that a therapeutic vaccine has shown an anti-viral effect."

The Phase 2 dose optimization study will enroll approximately 300 subjects from 17 institutions in the United States and will study six combinations of two antigen doses (30 micrograms or 60 micrograms) with each of three adjuvant doses (25 micrograms, 50 micrograms, or 75 micrograms) alongside a placebo. All subjects will receive three doses of GEN-003 or placebo at 21-day intervals. The primary end point for the study is the change from baseline in viral shedding rate. The study is also designed to evaluate the impact on percentage of days with genital herpes lesions as reported by patients. Subjects receiving GEN-003 will be followed for 12 months after the last dose. Previously the Company announced results from its Phase 1/2a clinical trial of GEN-003, which demonstrated, in the 30 microgram dose group, statistically significant reductions from baseline in viral shedding and genital lesion rates of up to 52% and 65% respectively, with a durability of effect to six months after dosing.

"We believe that there is a significant clinical need for an effective immunotherapy to treat HSV-2. Our market research supports that both patients and physicians would welcome a new treatment, such as GEN-003, with efficacy similar to oral antivirals, sustained duration of protection and enhanced convenience through simplified dosing," said Chip Clark, president and chief executive officer of Genocea. "We look forward to announcing interim results from this trial in the middle of 2015."

For more information about this clinical study of GEN-003 please visit www.clinicaltrials.gov.

About GEN-003

GEN-003 is Genocea's lead product candidate and is a T cell-enabled immunotherapy intended to reduce the transmission risk and clinical symptoms of HSV-2. GEN-003 was designed with insights from Genocea's ATLAS™ platform which profiles the comprehensive spectrum of actual T cell responses mounted by humans in response to disease, enabling the identification of antigen targets which drive protective T cell responses with which to design potential new vaccines and immunotherapies.

For more information about GEN-003, please visit http://www.genocea.com/platform-pipeline/pipeline/gen003-for-hsv-2/.

About HSV-2

Herpes simplex virus type 2 (HSV-2), the most common cause of genital herpes, is a sexually transmitted disease that is estimated to infect more than 500 million people worldwide. In the United States roughly 15 percent of the adult population, or 40 million people, are infected. HSV-2 infection can cause recurring, painful genital sores, and can be stigmatizing and produce considerable psychological distress in patients. The disease is particularly severe in immunosuppressed patients and poses significant risk to newborns if it is transmitted from mothers during birth. While antiviral drugs are used widely to treat HSV-2, there is neither a cure nor a vaccine for this disease.

About Genocea

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, in development for HSV-2 therapy; GEN-004, in development 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; that current results may not be predictive of future results; that 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; the 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 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.

For media:
Linnden Communications
Michelle Linn
O: 508-362-3087
M: 774-696-3803
Michelle@linndencom.com
or
For investors:
Genocea Biosciences, Inc.
Bob Farrell
O: 617-674-8261
bob.farrell@genocea.com

Source: Genocea Biosciences, Inc.

News Provided by Acquire Media