GNCA Genocea Biosciences Inc.

2.19
0  0%
Previous Close 2.19
Open 2.29
52 Week Low 1.1
52 Week High 4.03
Market Cap $60,539,863
Shares 27,643,773
Float 16,992,890
Enterprise Value $60,268,862
Volume 264,457
Av. Daily Volume 440,278
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Upcoming Catalysts

Drug Stage Catalyst Date
GEN-009 vaccine
Various cancers
Phase 1/2
Phase 1/2
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GEN-011
Various tumors
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
GEN-004
Universal vaccine candidate against pneumococcus
Phase 2
Phase 2
Topline data did not meet endpoints - September 2015

Latest News

  1. Inhibigens (inhibitory antigens) are detrimental an otherwise protective immunotherapy

    Inhibigens alter the tumor microenvironment and drive tumor hyperprogression

    Inhibigens abolish both global and tumor antigen-specific T cell activity

    CAMBRIDGE, Mass., June 22, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presented preclinical data that offers new and important insights into the biology and behavior of inhibitory neoantigens (Inhibigens™)  at the American Association for Cancer Research (AACR) Virtual Annual Meeting II from June 22-24. The findings build on previous research presented at SITC 2019 which demonstrated that the…

    Inhibigens (inhibitory antigens) are detrimental an otherwise protective immunotherapy

    Inhibigens alter the tumor microenvironment and drive tumor hyperprogression

    Inhibigens abolish both global and tumor antigen-specific T cell activity

    CAMBRIDGE, Mass., June 22, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presented preclinical data that offers new and important insights into the biology and behavior of inhibitory neoantigens (Inhibigens™)  at the American Association for Cancer Research (AACR) Virtual Annual Meeting II from June 22-24. The findings build on previous research presented at SITC 2019 which demonstrated that the presence of an Inhibigen in an otherwise protective immunotherapy can completely reverse anti-tumor responses.

    In the preclinical study, pro-tumor Inhibigen effects were found to be correlated with an increasingly immune-suppressive tumor microenvironment (TME), including reduced TILs and enhanced expression of T cell exhaustion markers. Vaccination of tumor-bearing mice with a formulation containing an inhibigen impaired both tumor antigen specific and nonspecific T cell function by blocking their ability to secrete cytokines and kill tumor cells – an effect that abolished T cell responses to beneficial anti-tumor antigens.

    "This observed downregulation of anti-tumor cytokine responses could be detrimental to cancer immunotherapies," said Victoria DeVault, a Genocea research scientist and lead presenter of the results to be shared at AACR. "Thanks to insights gleaned from our unique ATLAS platform, we are beginning to understand why immunization with Inhibigens leads to a defective immune response and why proper T cell engagement against the right targets is critical to producing an effective vaccination."

    In addition, the poster presentation revealed that immunization with Inhibigens led to a reduction in T cell receptor (TCR) expression of tumor-specific T cells, which further hindered T cell function and activity needed to produce a robust immune response. The analysis also demonstrated that the Inhibigen-specific responses are not mediated by regulatory T cells – a subset of T cells known to suppress immune responses.

    "Taken together, the results add to the growing body of evidence that Inhibigens must be identified and excluded from the rational design of cancer immunotherapies," said Jessica Baker Flechtner, Chief Scientific Officer of Genocea. "ATLAS allows us to pinpoint the underlying potential reasons why such treatments fail in patients. Armed with this critical knowledge, we can design better and smarter personalized vaccines and cell therapies for more favorable patient outcomes."

    AACR POSTER SESSION TITLE: Immune Response to Therapies 2  

    Abstract 7039 / Poster 6680

    Title: Inclusion of inhibitory neoantigens can abolish efficacy of otherwise protective therapeutic anti-tumor vaccines.

    Presenter: Victoria DeVault, Ph.D., Genocea Biosciences, Cambridge, MA

    Date: June 22, 2020

    Time: 9:00 a.m. – 6:00 p.m. EDT

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types.  Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood for which we expect to conduct a Phase 1/2a clinical trial with preliminary clinical results in mid-2021. To learn more, please visit www.genocea.com

    Forward-Looking Statements

    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

     

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  2. CAMBRIDGE, Mass., June 15, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced the filing of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) to begin a Phase 1/2a clinical study of GEN-011 in a range of tumor types, with a focus on patients who have failed standard-of-care checkpoint inhibitor therapy. The GEN-011 trial will evaluate patient safety, T cell proliferation and persistence, and clinical activity, with preliminary data expected mid-2021.

    Powered by ATLAS™, GEN-011 offers several advantages over TIL therapies, the gold standard for solid tumor adoptive cell therapy. Unlike…

    CAMBRIDGE, Mass., June 15, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced the filing of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) to begin a Phase 1/2a clinical study of GEN-011 in a range of tumor types, with a focus on patients who have failed standard-of-care checkpoint inhibitor therapy. The GEN-011 trial will evaluate patient safety, T cell proliferation and persistence, and clinical activity, with preliminary data expected mid-2021.

    Powered by ATLAS™, GEN-011 offers several advantages over TIL therapies, the gold standard for solid tumor adoptive cell therapy. Unlike TILs, GEN-011 does not require extra surgery or collection of viable tumor samples and uses peripheral blood in a rapidly scalable manufacturing process. This may enable access to a broader population of patients with advanced cancers, and may result in a cost of therapy that is favorable compared to TIL-based approaches. GEN-011 may also offer lasting clinical efficacy by targeting up to 30 relevant neoantigens with CD4+ and CD8+ memory T cells and avoiding pro-tumor Inhibigens™ that may be detrimental to clinical response.  

    "In only 18 months the Genocea team took GEN-011 from whiteboard to IND filing," said Chip Clark, President and Chief Executive Officer of Genocea. "We look forward to sharing data from yet another program demonstrating that targets matter."

    About Genocea Biosciences, Inc.

    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types.  Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood for which we expect to conduct a Phase 1/2a clinical trial with preliminary clinical results in mid-2021. To learn more, please visit www.genocea.com

    Forward-Looking Statements

    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:

    Dan Ferry

    617-430-7576

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  3. Data show immune responses occur rapidly after only two vaccinations and can be sustained for more than one year

    Part B is exploring the vaccine's ability to reduce tumor size beyond the standard-of-care therapy alone

    CAMBRIDGE, Mass., May 29, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presents updated durability, safety and immunogenicity clinical data from Part A of its ongoing Phase 1/2a trial for GEN-009, the company's lead neoantigen vaccine candidate. Data will be shared by Roger Cohen, M.D., University of Pennsylvania Abramson Cancer Center, during a video poster presentation (Abstract #3107) at the virtual 2020 American Society…

    Data show immune responses occur rapidly after only two vaccinations and can be sustained for more than one year

    Part B is exploring the vaccine's ability to reduce tumor size beyond the standard-of-care therapy alone

    CAMBRIDGE, Mass., May 29, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today presents updated durability, safety and immunogenicity clinical data from Part A of its ongoing Phase 1/2a trial for GEN-009, the company's lead neoantigen vaccine candidate. Data will be shared by Roger Cohen, M.D., University of Pennsylvania Abramson Cancer Center, during a video poster presentation (Abstract #3107) at the virtual 2020 American Society of Clinical Oncology (ASCO) Annual Meeting on May 29, 2020 from 8:00 – 11:00 am EDT.

    ASCO POSTER SESSION: Developmental Therapeutics – Immunotherapy
    Abstract 3107

    Title: GEN-009, a neoantigen vaccine containing ATLAS-selected neoantigens, to generate broad sustained immunity against immunogenic tumor mutations and avoid inhibitory peptides.

    The analysis evaluates eight patients from Part A of the trial who were vaccinated with GEN-009 as adjuvant therapy, focusing on the onset and duration of induced immunity and clinical outcomes. Seven out of the eight patients enrolled have continued without progression with a median follow up of over one year. All patients received dosing as planned, with five doses given over a six-month period with immune responses occurring rapidly after only two vaccinations. No significant adverse side effects were reported with the administration of GEN-009, with only mild symptoms associated with the vaccine adjuvant. In addition, there are several notable patient outcomes:

    • Prior to the GEN-009 trial, one patient diagnosed with melanoma (low PDL-1) had progressed after treatment with a PD-1 antibody, an experimental vaccine and a CTLA-4 inhibitor. After GEN-009, the patient continues in remission for more than 12 months.
    • A patient diagnosed with squamous cell cancer of the head and neck had experienced successively shorter remissions but is now exceeding previous remissions and approaching nine months progression free with GEN-009.

    "The fact that seven of eight patients continue without progression is encouraging. The vaccine has been well tolerated with only mild injection site reactions. Vaccinated patients have generated both CD4+ and CD8+ ex vivo immune responses with immunogenicity manifested to 99% of the vaccinated antigens," said Dr. Cohen.

    Both CD8+ and CD4+ responses were measured in both ex vivo and in vitro assays and were detected as early as day 29 extending as far as 12 months.

    The Part B trial continues with patients diagnosed with advanced disease who are receiving GEN-009 in combination with standard of care regimens, including immune checkpoint inhibitors. This cohort will explore the vaccine's ability to reduce tumor size beyond the standard of care therapy alone.

    "Together, these data suggest that ATLAS-identified neoantigens generate broad, sustained T cell responses starting after only 4 weeks and lasting for up to 6 months after the last vaccination," said Thomas Davis, M.D., Chief Medical Officer of Genocea. "We look forward to advancing the GEN-009 Phase 1/2a Part B trial and reporting those results, and additional Part A results, later in 2020."

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood, for which we intend to file an Investigational New Drug Application in the second quarter of 2020. To learn more, please visit www.genocea.com.

    Forward-Looking Statements
    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:
    Dan Ferry
    617-430-7576

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  4. CAMBRIDGE, Mass., May 19, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced it has entered into a material transfer agreement (MTA) and exclusive license option with Shionogi & Co., Ltd. to develop a novel HSV-2 vaccine using Genocea's proprietary HSV-2 antigens from the GEN-003 program, which the company discontinued in 2017. 

    Under the terms of the agreement, Shionogi will pay $2 million for the exclusive option to evaluate the HSV-2 antigens and to negotiate a license prior to expiration of the MTA. Upon exercise of Shionogi's option, terms of the license are expected to include an upfront payment, regulatory and sales milestones…

    CAMBRIDGE, Mass., May 19, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced it has entered into a material transfer agreement (MTA) and exclusive license option with Shionogi & Co., Ltd. to develop a novel HSV-2 vaccine using Genocea's proprietary HSV-2 antigens from the GEN-003 program, which the company discontinued in 2017. 

    Under the terms of the agreement, Shionogi will pay $2 million for the exclusive option to evaluate the HSV-2 antigens and to negotiate a license prior to expiration of the MTA. Upon exercise of Shionogi's option, terms of the license are expected to include an upfront payment, regulatory and sales milestones, as well as tiered royalties. Final terms of the license agreement will be based on results of the MTA evaluation and overall diligence. If licensed, Shionogi will assume responsibility for global development and commercialization of the HSV-2 vaccine product.

    "The HSV-2 antigens were identified by our proprietary ATLASTM platform. This agreement with Shionogi further validates our ATLAS technology to identify clinically relevant and best-in-class antigens across a range of illnesses, including infectious diseases and cancer. We are incredibly pleased to support Shionogi's efforts to develop a novel vaccine for the millions of people seeking more effective treatment options for their genital herpes disease," said Chip Clark, President and Chief Executive Officer, Genocea.

    "The agreement with Genocea is an important step forward in our ability to discover leading vaccines and therapies that address infectious diseases with high unmet medical need – a core research area of ongoing interest for Shionogi. We are committed to helping genital herpes patients better control outbreaks and preventing further epidemic spread of the virus," said Dr. Ryuichi Kiyama, Senior Executive Officer, Executive Vice President, Pharmaceutical Research Division, Shionogi & Co., Ltd.

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types. Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood, for which we intend to file an Investigational New Drug Application in the second quarter of 2020. To learn more, please visit www.genocea.com.

    About Shionogi & Co., Ltd.
    Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to bringing benefits to patients based on its corporate philosophy of "supplying the best possible medicine to protect the health and wellbeing of the patients we serve." Shionogi's research and development currently targets two therapeutic areas: infectious diseases, and pain/CNS disorders.

    For over 50 years, Shionogi has developed and commercialized innovative oral and parenteral anti-infectives. In addition, Shionogi is engaged in new research areas, such as obesity/geriatric metabolic diseases and oncology/immunology.

    Contributing to the health and QOL of patients around the world through development in these therapeutic areas is Shionogi's primary goal. For more details, please visit www.shionogi.co.jp/en/

    Forward-Looking Statements
    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:
    Dan Ferry
    617-430-7576

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  5. Seven out of eight patients treated on Part A of the study are without disease progression at one-year median follow-up

    ATLAS™-identified neoantigens generate broad, sustained T cell responses starting after only 4 weeks and lasting for up to 6 months after the last vaccination

    CAMBRIDGE, Mass., May 13, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will present updated durability, safety and immunogenicity clinical data from Part A of its ongoing Phase 1/2a trial for GEN-009, the company's lead neoantigen vaccine candidate at the virtual 2020 American Society for Clinical Oncology (ASCO) Annual Meeting from May 29-31.

    The analysis evaluates…

    Seven out of eight patients treated on Part A of the study are without disease progression at one-year median follow-up

    ATLAS™-identified neoantigens generate broad, sustained T cell responses starting after only 4 weeks and lasting for up to 6 months after the last vaccination

    CAMBRIDGE, Mass., May 13, 2020 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, will present updated durability, safety and immunogenicity clinical data from Part A of its ongoing Phase 1/2a trial for GEN-009, the company's lead neoantigen vaccine candidate at the virtual 2020 American Society for Clinical Oncology (ASCO) Annual Meeting from May 29-31.

    The analysis evaluates eight patients from Part A of the trial who were vaccinated with GEN-009 as adjuvant therapy, focusing on the onset and duration of induced immunity and clinical outcomes. Seven out of the eight patients enrolled have continued without progression with a median follow up of over one year. All patients received dosing as planned with five doses given over a six-month period. No significant adverse side effects were reported with the administration of GEN-009, with only mild symptoms associated with the vaccine adjuvant.

    GEN-009 vaccination also generated immune responses across 99% of neoantigen targets while avoiding inhibitory peptides also known as Inhibigens™, or antigens that drive inhibitory T cell responses. Both CD8+ and CD4+ responses were measured in both ex vivo and in vitro assays, and were detected as early as day 29 extending as far out as 12 months.

    "I am pleased to see early and durable immune responses and favorable patient outcomes in Part A of the GEN-009 trial," said Roger Cohen, M.D., Associate Director of Clinical Research, Abramson Cancer Center. "While we can't assess the specific contribution of the vaccine in the adjuvant setting in this mixed population, the progression-free survival, safety and immunogenicity results support the role that GEN-009 could play in the therapy of multiple tumor types."

    "We are very pleased to find that these patients have done so well with GEN-009 vaccination. The breadth and durability of immune response as well as the clinical outcomes strengthen our excitement to see the effects of combination therapy in patients with measurable tumors," said Thomas Davis, M.D., Chief Medical Officer of Genocea. "We are eager to elaborate further on our latest GEN-009 findings at the upcoming ASCO meeting and look forward to sharing additional data from Part B of this study on the benefits of the vaccine in patients receiving immune checkpoint inhibitors later this year."

    ASCO POSTER SESSION: Developmental Therapeutics – Immunotherapy
    Abstract 3107

    Title: GEN-009, a neoantigen vaccine containing ATLAS selected neoantigens, to generate broad sustained immunity against immunogenic tumor mutations and avoid inhibitory peptides.

    Presenter: Roger B. Cohen, M.D., University of Pennsylvania Abramson Cancer Center
    Date: May 29, 2020
    Time: 8:00 – 11:00 a.m. EDT

    About Genocea Biosciences, Inc.
    Genocea's mission is to conquer cancer by developing personalized cancer immunotherapies in multiple tumor types.  Our unique ATLAS™ platform comprehensively profiles each patient's T cell responses to potential targets, or antigens, on the tumor. ATLAS enables us to optimize the neoantigens for inclusion in our immunotherapies and exclude inhibitory antigens that can exert an immunosuppressive effect. We are advancing two ATLAS-enabled programs: GEN-009, our neoantigen vaccine for which we are conducting a Phase 1/2a clinical trial and expect preliminary clinical results in the third quarter of 2020, and GEN-011, our neoantigen-specific cell therapy using T cells derived from peripheral blood, for which we intend to file an Investigational New Drug Application in the second quarter of 2020. To learn more, please visit www.genocea.com.

    Forward-Looking Statements
    This press release includes forward-looking statements, including statements relating to GEN-009 and GEN-011, within the meaning of the Private Securities Litigation Reform Act. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties that change over time. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Genocea's Annual Report on Form 10-K for the year ended December 31, 2019 and any subsequent SEC filings. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements, except as may be required by law.

    Investor Contact:
    Dan Ferry
    617-430-7576

     

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