Genocea Biosciences Completes Enrollment In Phase IIa Human Challenge Study Of GEN-004 For The Prevention Of Infection By Pneumococcus

Top-Line Data Expected in the Fourth Quarter of 2015

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 2a human challenge study of GEN-004, Genocea’s universal vaccine candidate for the prevention of infection by all serotypes of pneumococcus. The Company anticipates reporting top-line data from this study in the fourth quarter of 2015.

“Colonization in the nasopharynx is a necessary precursor to infection by pneumococcus and success in this trial will provide further evidence of the potential of GEN-004 to control colonization and strongly position us to advance GEN-004 into further efficacy studies in 2016.”

"The objective of this trial is to demonstrate proof of concept that GEN-004 can reduce the frequency, magnitude or duration of colonization of pneumococcus in the nasopharynx of healthy adults,” said Seth Hetherington, M.D., Chief Medical Officer of Genocea. “Colonization in the nasopharynx is a necessary precursor to infection by pneumococcus and success in this trial will provide further evidence of the potential of GEN-004 to control colonization and strongly position us to advance GEN-004 into further efficacy studies in 2016.”

The Phase 2a trial enrolled 98 healthy adult subjects at one site in the United Kingdom. Subjects are randomized to receive 3 doses of either placebo or GEN-004 at 100 micrograms per protein and 350 micrograms of alum adjuvant. All subjects are challenged with pneumococcus after the third dose of the assigned treatment and subsequently tested for the establishment of colonization. The current study follows positive Phase 1 results, demonstrating that GEN-004 met its safety, tolerability and immunogenicity goals, including increases in blood T helper 17 (T_H17) cells, a rare cell type that provides important protective immunity at epithelial and mucosal surfaces.

For more information about this Phase 2a clinical study of GEN-004 visit www.clinicaltrials.gov.

About GEN-004

GEN-004 is a potential universal pneumococcal vaccine designed based on insights from the Company’s ATLAS™ platform. GEN-004 contains three unique pneumococcal protein antigens, SP0148, SP1912, and SP2108, shown by ATLAS™ to be associated with protective T_H17 T cell responses against pneumococcus in humans. All three antigens are conserved across all sequenced serotypes of pneumococcus. ATLAS™ profiles the comprehensive spectrum of actual T cell responses mounted by humans in response to a pathogen, enabling the identification of antigen targets with which to design new vaccines and immunotherapies. For more information about GEN-004, please visit http://www.genocea.com/platform-pipeline/pipeline/gen004-for-pneumococcus/.

About pneumococcus (Streptococcus pneumoniae)

Streptococcus pneumoniae, also known as pneumococcus, is a major cause of infectious disease-related death worldwide. The World Health Organization (WHO) estimates that up to 1.6 million people, including 800,000 children, die each year globally as a result of pneumococcal infection. Pneumococcus colonizes the nasopharynx, or nose and throat, as a precursor to infection. Pneumococcus causes non-invasive pneumococcal disease (NIPD) when it spreads from the nasopharynx into the upper and lower respiratory system to cause diseases such as otitis media (ear infection) and non-bacteremic pneumonia. When it enters the bloodstream, pneumococcus can cause invasive pneumococcal disease (IPD), including life-threatening illnesses such as sepsis, meningitis and bacteremic pneumonia.

In childhood, immunity to pneumococcus is developed prior to the establishment of protective antibody responses. Scientists believe that this immunity is driven by a rare type of T cells called TH17 CD4+ T cells, which prevent establishment of disease by clearing pneumococcus from the nasopharynx.

About Genocea Biosciences, Inc.

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 clinical-stage T cell-enabled product candidates includes GEN-003 for genital herpes, GEN-004 for the prevention of infection by all serotypes of pneumococcus, and earlier-stage programs in chlamydia, genital herpes prophylaxis, malaria and cancer immunotherapies. 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; anticipated clinical trial results; current results may not be predictive of future results; even if the data from preclinical studies or clinical trials is positive, regulatory authorities may require additional studies for approval and 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; risks associated with the manufacture and supply of clinical and commercial product; 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 rate of cash utilized by Genocea in its business and the period for which existing cash will be able to fund such operation; Genocea’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, 2014 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.