Investor Relations



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Dec 9, 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 clinical programs addressing genital herpes and pneumococcus and research efforts in cancer immunotherapy and infectious diseases:

  • GEN-003, an immunotherapy to treat patients with genital herpes in Phase 2 development.

In September 2016, Genocea announced positive positive results from its ongoing Phase 2b trial evaluating a new Phase 3-ready formulation of GEN-003 for the treatment of genital herpes. The study achieved its primary endpoint, with GEN-003 demonstrating a statistically significant reduction of 40 percent in the rate of viral shedding in the 60 µg per protein / 50 µg of Matrix-M2 dose group compared to both baseline and placebo. The viral shedding rate reduction for this dose was consistent with its performance at the same time point in a prior Phase 2 trial.

Safety in the trial was continuously reviewed by an independent Data Safety Monitoring Board. There was no grade 4 reactogenicity or related serious adverse events in this trial and discontinuations due to adverse events were low and similarly distributed across active dose groups and placebo.

Genocea expects to announce six-month placebo-controlled clinical efficacy data from this trial in January 2017.

In March 2016, we completed a positive 310-subject Phase 2 dose optimization trial designed to confirm the results of the Phase 1/2a trial and to test six combinations of protein ad adjuvant to optimize the dose.

The two most promising doses of 60 µg per protein / 50 µg of Matrix-M2TM adjuvant and 60 µg per protein / 75 µg of Matrix-M2TM adjuvant showed statistically significant and clinically relevant results against a number of endpoints in the trial with the effect of GEN-003 continuing for at least 12 months post dosing. These results were an improvement upon the attractive product profile established in the Phase 1/2a trial.

At these doses, GEN-003 demonstrated a statistically significant 54-66 percent reduction from baseline in the viral shedding rate (p<0.0001), the primary endpoint of the study. In a planned secondary analysis to assess the proportion of patients receiving GEN-003 who were lesion-free at 12 months after dosing, results ranged from 21 to 30 percent, similar to results reported in clinical trials with oral antiviral therapies. Furthermore, GEN-003’s impact on genital lesion rates, a patient-reported measurement of clinical disease, showed sustained and statistically significant reductions from baseline ranging from 47-65 percent.

  • GEN-004, a universal concept vaccine to prevent infections caused by all serotypes of pneumococcus.

In October 2015, we announced that top-line results from the Phase 2a clinical trial for GEN-004 showed consistent reductions versus placebo in the prespecified endpoints of the rate and density of upper airway colonization in a human challenge model, but that neither of the endpoints achieved statistical significance. GEN-004 was safe and well tolerated by subjects.

Although we did not achieve statistical significance in this study, the consistent apparent effect gives us confidence in the vaccine concept and in the potential for GEN-004. While internal development of GEN-004 has been suspended, we continue to seek partners to advance GEN-004 into a Phase 1/2 clinical trial targeting toddler and infant populations.

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.

  • Cancer immunotherapy research. Genocea has two ongoing collaborations with leading cancer research institutions.

We announced a research collaboration with the Dana-Farber Cancer Institute in 2014 to apply the ATLAS platform in immuno-oncology. This collaboration centered on ATLAS's potential to identify patterns of T cell response in melanoma patients receiving checkpoint inhibitor ("CPI") therapy. By analyzing the immune responses of both responders and non-responders to CPI therapy, ATLAS successfully identified the cancer antigens to which either (or both) CD4+ or CD8+ T cells became activated. Although this research was not powered to draw firm conclusions, the analysis of T cell responses in patients receiving CPI therapy revealed a pattern indicating a greater breadth of T cell activation for responders than non-responders. The study also revealed preliminary evidence that different characteristics of T cell responses emerge when comparing patients who respond and those who do not. Some T cell responses did not correspond with improved patient outcomes, and may be classified as “decoys,” further validating the ability of ATLAS to distinguish clinically relevant targets of T cell response. The collaboration with Dana-Farber is ongoing as we continue to analyze more tumor samples to characterize T cell response profiles that may be prognostic of CPI efficacy, and to identify T cell antigens that may be included in novel immunotherapies.

In November 2015, we also announced a collaboration with the Memorial Sloan Kettering Cancer Center to screen the T cell responses of melanoma and non-small cell lung cancer patients treated with CPIs against the complete repertoire of patient-specific putative cancer neoantigens. The goals of the collaboration are to identify signatures of T cell response in cancer patients associated with response or non-response to CPI therapy and to discover new T cell cancer vaccine antigens. ATLAS will be used in conjunction with Memorial Sloan Kettering’s patient-specific cancer neoantigen sequences and blood samples from the same cancer patients.

Genocea also has an ongoing research program focused on Epstein-Barr Virus infections which are linked to a number of cancers with high unmet needs.

  • Infectious disease research.

We have ongoing research programs in next generation HSV-2 therapies and chlamydia and a research program funded by the Bill & Melinda Gates Foundation in malaria.

Press Releases

Genocea to Host Virtual R&D Day on December 14th, 2016
CAMBRIDGE, Mass., Dec. 08, 2016 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed ...

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Genocea's Proprietary ATLAS™ Technology Identifies Unique Candidate Antigens for Potential Personalized Cancer Vaccines
- ATLAS discovers neoantigens, through functional T cell responses, which were not identified by predictive algorithms - - Majority of antigens p...

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Events & Presentations

Dec 14, 2016 at 8:30 AM ET
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