CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genocea Biosciences, Inc. (NASDAQ: GNCA), a clinical-stage biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced the initiation of a Phase 2a trial for GEN-004, the Company’s universal vaccine candidate against pneumococcus. The trial is designed to evaluate the effect of dosing with GEN-004 on the frequency, magnitude and duration of colonization by pneumococcus in the nasopharynx of healthy adults.
“Following the positive Phase 1 data results, which we announced in June, this Phase 2a human challenge study is an important step towards demonstrating proof of concept for GEN-004,” said Seth Hetherington, MD, chief medical officer of Genocea. “The objective of this study is to demonstrate that GEN-004 can prevent or reduce colonization of the nasopharynx, the first and necessary precursor to establishment of infection.”
The Phase 2a study will enroll approximately 90 healthy adult subjects from one site in the United Kingdom. Subjects will be randomized to placebo or GEN-004. Those subjects receiving GEN-004 will be dosed three times at one month intervals with 100 micrograms per protein and 350 micrograms of alum. All subjects will be challenged with pneumococcus after the third dose of GEN-004 or placebo.
“Available pneumococcal vaccines protect by inducing B cell, or antibody, immune responses directed towards a minority of the more than 90 known serotypes of pneumococcus. Furthermore, serotypes not included in the available vaccines are increasingly responsible for causing pneumococcal disease,” said Chip Clark, president and chief executive officer of Genocea. “We have a novel T cell directed approach for the development of a universal vaccine and look forward to announcing interim results from this trial in the middle of 2015.”
For more information about this clinical study of GEN-004 visit www.clinicaltrials.gov.
GEN-004, Genocea’s second clinical candidate, is a potential universal pneumococcal vaccine designed based on insights from the Company’s ATLAS™ platform. GEN-004 contains three unique conserved pneumococcal protein antigens, SP0148, SP1912, and SP2108, shown by ATLAS™ to be associated with protective TH17 T cell responses against pneumococcus in humans. ATLAS profiles the comprehensive spectrum of actual T cell responses mounted by humans in response to disease, 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 naturally 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.
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; our 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; our 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.