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ir@genocea.com

NASDAQ: GNCA
$5.00 + 0.05
Aug 26, 2016 at 4:00 PM ET
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Corporate Profile

Genocea aims to transform vaccine discovery and development to improve millions of lives. We use ATLAS™, our proprietary technology platform that rapidly identifies T cell antigens associated with protective immune responses in humans exposed to a pathogen. We have a pipeline of novel vaccine candidates that stimulate the T cell arm of the immune system, which is increasingly recognized as critical to generating protective immunity against a wide array of diseases. Genocea’s pipeline includes programs addressing genital herpes, pneumococcus, chlamydia, malaria and cancer immunotherapy. We currently have two products in Phase 2 clinical development:

  • GEN-003, an immunotherapy to treat patients with genital herpes. We reported positive data from an ongoing Phase 2b dose optimization trial from the 6-month 28-day observation period in October 2015. At the best performing dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant, GEN-003 demonstrated a statistically significant 58 percent reduction from baseline in the viral shedding rate (p<0.0001), the primary endpoint of the study. This reduction was an improvement upon the attractive product profile established in Phase 1/2a trial. In a planned secondary analysis to assess the impact on genital lesion rates, a patient-reported measurement of clinical disease, GEN-003 demonstrated sustained and statistically significant reductions from baseline in five of six dose groups ranging from 43 to 69 percent. In addition, the proportion of patients receiving GEN-003 who were lesion-free at six months after dosing ranged from approximately 30 to 50 percent, similar to results reported in clinical trials with oral antiviral therapies. A further secondary analysis measuring the time to first recurrence after completion of dosing showed a range of 152 days to greater than 180 days among dose groups.

    Data from 12-month observation periods in this trial is expected in first quarter of 2016. Genocea expects  to conduct an end of Phase 2 meeting with the FDA in late 2016 Data from the prior Phase 1/2a trial was the first time a therapeutic vaccine candidate has demonstrated significant reductions in the rates of viral shedding and genital lesions in genital herpes patients.
     
  • GEN-004, a universal concept vaccine to prevent infections caused by all serotypes of pneumococcus. We announced top-line results from a Phase 2 clinical trial for GEN-004 on October 19, 2015. GEN-004 showed consistent reductions versus placebo in the pre-specified endpoints of the rate and density of colonization, but neither of the endpoints achieved statistical significance. GEN-004 was safe and well-tolerated by patients. Pending further review of the data and potential paths forward, Genocea has suspended development of GEN-004.

    In a prior Phase 1 study, GEN-004 met its safety, tolerability and immunogenicity goals, including measurable increases in the blood of T helper 17 (TH17) cells, a rare cell type that provides immunity at epithelial and mucosal surfaces.

Press Releases

Genocea Congratulates Jessica Baker Flechtner, Ph.D. for Recognition on 2016's 40 Women To Watch Over 40 List
CAMBRIDGE, Mass., Aug. 09, 2016 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed ...

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Genocea Reports Second Quarter 2016 Financial Results
CAMBRIDGE, Mass., Aug. 04, 2016 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed ...

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