GNCA Genocea Biosciences Inc.

2.06
+0.07  (+3%)
Previous Close 1.99
Open 2.01
52 Week Low 1.65
52 Week High 4.045
Market Cap $117,167,134
Shares 57,015,637
Float 46,532,142
Enterprise Value $70,031,492
Volume 85,661
Av. Daily Volume 164,228
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Upcoming Catalysts

Drug Stage Catalyst Date
GEN-011 (TITAN study)
Various tumors
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
GEN-009
Various cancers
Phase 1/2
Phase 1/2
Phase 1 long-term follow-up clinical and immunogenicity data presented at ASCO June 4, 2021. 4/9 checkpoint inhibitor-sensitive patients experienced responses post vaccination.
GEN-004
Universal vaccine candidate against pneumococcus
Phase 2
Phase 2
Topline data did not meet endpoints - September 2015

Latest News

  1. CAMBRIDGE, Mass., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that Jennifer Herron, Senior Vice President & Chief Commercial Officer at ADC Therapeutics SA ("ADCT"), has joined its board of directors.

    "It is my great pleasure to welcome Jennifer to our board of directors," said Chip Clark, Genocea's President and Chief Executive Officer. "As we advance our pipeline, including GEN-011, our neoantigen-targeted T cell therapy for the treatment of solid tumors, we believe Jennifer's deep industry and commercial expertise will prove invaluable to us."

    Ms. Herron commented on her appointment: "I am delighted to be…

    CAMBRIDGE, Mass., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced that Jennifer Herron, Senior Vice President & Chief Commercial Officer at ADC Therapeutics SA ("ADCT"), has joined its board of directors.

    "It is my great pleasure to welcome Jennifer to our board of directors," said Chip Clark, Genocea's President and Chief Executive Officer. "As we advance our pipeline, including GEN-011, our neoantigen-targeted T cell therapy for the treatment of solid tumors, we believe Jennifer's deep industry and commercial expertise will prove invaluable to us."

    Ms. Herron commented on her appointment: "I am delighted to be joining the Genocea board, and I am excited by the transformational potential of GEN-011. I also believe the company's ATLAS platform shows great promise for optimizing antigen selection for cancer immunotherapies. I look forward to working with the rest of the Genocea board and the leadership team to help advance the company's pipeline."

    Ms. Herron is currently Senior Vice President and Chief Commercial Officer at ADCT, leading global commercialization strategy and execution including the launch of ADCT's first commercial product. Before joining ADCT, Ms. Herron was Executive Vice President and Chief Commercial Officer at ImmunoGen, President and Executive Vice President, Global Commercial, at MorphoSys US, and Executive Vice President and Chief Commercial Officer at Ariad Pharmaceuticals. Earlier in her career, she held commercial leadership roles in major multinational pharmaceutical companies such as Bristol-Myers Squibb, Novartis Oncology, and SmithKline Beecham (now GlaxoSmithKline).

    About Genocea Biosciences, Inc.

    Genocea's mission is to identify the right tumor targets to develop life-changing immunotherapies for people suffering from cancer. Our proprietary ATLAS™ platform can comprehensively profile each patient's T cell responses to potential targets, or antigens, on that patient's tumor. ATLAS zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, Inhibigens™, that drive pro-tumor immune responses. We are conducting a Phase 1/2a clinical trial for GEN-011, our investigational adoptive T cell therapy comprising neoantigen-targeted peripheral cells. We continue to monitor patients in our phase 1/2a clinical trial for GEN-009, our investigational neoantigen vaccine. In addition to our two clinical programs, we are conducting research in several areas where we believe ATLAS could be a key tool in optimizing antigen selection for therapies across a number of diseases. To learn more, please visit https://www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements related to GEN-011, GEN-009 and research updates 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. These factors include, but are not limited to, risks related to the potential failure of our active product candidates which are in an early stage of clinical development; our ability to obtain regulatory approval for our current and future product candidates; potential delays in enrolling patients in our clinical trials; our reliance on third parties to conduct technical development, non-clinical studies and clinical trials for our product candidates; our reliance on third parties to conduct some or all aspects of our product manufacturing; our ability to obtain or protect intellectual property rights related to our product candidates; the potential impacts of COVID-19 on our business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance; our need for additional financing and the risks listed under "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2020 and any subsequent filings with the Securities and Exchange Commission. 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: Media Contact:
    Dan Ferry Sarah O'Connell
    daniel@lifesciadvisors.com soconnell@vergescientific.com



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  2. CAMBRIDGE, Mass., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, announced that senior leadership plans to present at the following virtual conferences in September.

    Scientific conferences:

    Event:Next Generation Cancer Vaccine Development Summit – Details
    Topic:Neoantigen selection to identify immunogenic tumor specific targets personalized to each patient's tumor and immune system
    Format:Post Conference Workshop
    Date:Thursday, September 9th
    Time:1:00 p.m. ET

    Investor conferences:

    Event:H.C. Wainwright 22nd Annual Global Investment Conference (virtual) – Details
    Format:Presentation
    Date:Monday, September 13th
    Time:7:00 a.m. ET


    Event:Baird

    CAMBRIDGE, Mass., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, announced that senior leadership plans to present at the following virtual conferences in September.

    Scientific conferences:

    Event:Next Generation Cancer Vaccine Development Summit – Details
    Topic:Neoantigen selection to identify immunogenic tumor specific targets personalized to each patient's tumor and immune system
    Format:Post Conference Workshop
    Date:Thursday, September 9th
    Time:1:00 p.m. ET

    Investor conferences:

    Event:H.C. Wainwright 22nd Annual Global Investment Conference (virtual) – Details
    Format:Presentation
    Date:Monday, September 13th
    Time:7:00 a.m. ET



    Event:Baird Global Healthcare Conference 2021 (virtual) – Details
    Format:Presentation
    Date:Wednesday, September 15th
    Time:11:25 a.m. ET

    About Genocea Biosciences, Inc.

    Genocea's mission is to identify the right tumor targets to develop life-changing immunotherapies for people suffering from cancer. Our proprietary ATLAS™ platform can comprehensively profile each patient's T cell responses to potential targets, or antigens, on that patient's tumor. ATLAS zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, Inhibigens™, that drive pro-tumor immune responses. We are conducting a Phase 1/2a clinical trial for GEN-011, our investigational adoptive T cell therapy comprising neoantigen-targeted peripheral cells. We continue to monitor patients in our phase 1/2a clinical trial for GEN-009, our investigational neoantigen vaccine. In addition to our two clinical programs, we are conducting research in several areas where we believe ATLAS could be a key tool in optimizing antigen selection for therapies across a number of diseases. To learn more, please visit https://www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements related to GEN-011, GEN-009 and research updates 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. These factors include, but are not limited to, risks related to the potential failure of our active product candidates which are in an early stage of clinical development; our ability to obtain regulatory approval for our current and future product candidates; potential delays in enrolling patients in our clinical trials; our reliance on third parties to conduct technical development, non-clinical studies and clinical trials for our product candidates; our reliance on third parties to conduct some or all aspects of our product manufacturing; our ability to obtain or protect intellectual property rights related to our product candidates; the potential impacts of COVID-19 on our business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance; our need for additional financing and the risks listed under "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2020 and any subsequent filings with the Securities and Exchange Commission. 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

    daniel@lifesciadvisors.com

    Media Contact:

    Sarah O'Connell

    soconnell@vergescientific.com  

     



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  3. GEN-011 neoantigen-targeted peripheral T cell therapy clinical trial continues

    GEN-009 neoantigen vaccine candidate shows promising long-term clinical results

    Conference call today at 8:30 a.m. E.T.

    CAMBRIDGE, Mass., July 29, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today provided a business update for the second quarter ended June 30, 2021.

    "I am pleased with the GEN-011 program progress. We continue to believe that GEN-011 has the potential to represent a major advancement in solid tumor T cell therapies based on the use of optimal T cells and targets. These T cells are derived from easily accessible peripheral blood as opposed…

    GEN-011 neoantigen-targeted peripheral T cell therapy clinical trial continues

    GEN-009 neoantigen vaccine candidate shows promising long-term clinical results

    Conference call today at 8:30 a.m. E.T.

    CAMBRIDGE, Mass., July 29, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today provided a business update for the second quarter ended June 30, 2021.

    "I am pleased with the GEN-011 program progress. We continue to believe that GEN-011 has the potential to represent a major advancement in solid tumor T cell therapies based on the use of optimal T cells and targets. These T cells are derived from easily accessible peripheral blood as opposed to the tumor itself and are activated to pursue the surface-presented neoantigens of anti-tumor CD8+ and CD4+ T cell responses, prioritized by our proprietary ex vivo discovery platform, ATLAS™," said Chip Clark, Genocea's President and Chief Executive Officer.

    Clinical updates

    GEN-011 (investigational neoantigen-targeted peripheral T cell therapy – or NPT)

    • Genocea previously announced dosing of the first patient in its GEN-011 TiTAN™ clinical trial. GEN-011 is a next-generation solid tumor therapy comprised of neoantigen-targeted peripheral T cells ("NPTs") selectively expanded on neoantigens of anti-tumor CD8+ and CD4+ T cell responses identified by ATLAS. The TiTAN trial is an open-label, multi-center Phase1/2a trial evaluating safety, tolerability, T cell persistence and proliferation and clinical efficacy. Preliminary clinical response data from an initial subset of patients is expected in late Q4 2021 or Q1 2022.

    GEN-009 (investigational neoantigen vaccine)

    • At the American Society of Clinical Oncology ("ASCO") 2021 Annual Meeting in June, the Company presented long-term follow-up clinical and immunogenicity data from its ongoing Phase 1/2a clinical study demonstrating that GEN-009 continues to generate broad immune responses against neoantigens that can lead to sustained clinical responses. In Part B of the clinical trial, of the nine CPI-sensitive patients, the data show four patients experienced novel reduction in tumor volume post-GEN-009 dosing and achieved independent RECIST responses after vaccination, including three partial responses ("PRs") and one complete response ("CR"). This is an increase from the two PRs and one CR previously reported at the Society for Immunotherapy of Cancer's ("SITC") 2020 Annual Meeting. The remaining five CPI-sensitive patients all achieved disease stabilization. Across the CPI-sensitive cohort, the median duration without disease progression after initial GEN-009 vaccination was 15 months. Of the seven CPI-refractory patients, two achieved stable disease after initial GEN-009 vaccination for up to 10 months. Expanded immunogenicity data revealed that vaccine-specific T cell responses were detected ex vivo after the first dose of the vaccine and continued to rise with each subsequent dose. Vaccine-specific T cell responses remained significantly elevated over baseline and post-CPI, pre-vaccine timepoints for at least 6 months, showing persistence of the vaccine response.

    Research updates

    Strengthened Scientific Advisory Board

    • Marcela Maus, M.D., Ph.D. joined the Company's Scientific Advisory Board. Dr. Maus, the Director of the Cellular Immunotherapy Program at Mass General Cancer Center and an Associate Professor of Medicine at Harvard Medical School, is internationally known for her work as a translational physician-scientist in the field of immunology, particularly T cell immunotherapies and cellular therapies in the treatment of cancer.

    Upcoming presentations

    Bioprocessing Summit - Event Details

    • Presentation Title: GEN-011 PLANET Process: A Robust and Rapidly Scalable Manufacturing Process to Generate Neoantigen-Targeted Peripheral T Cells (NPTs)

    Date/Time: Thursday, August 19 - 12:40 p.m. ET

    Financial and other updates

    Second quarter 2021 financial results

    • Cash position: As of June 30, 2021, cash and cash equivalents were $60.4 million compared to $79.8 million as of December 31, 2020.

    • Net loss: Net loss was $4.3 million or $0.20 diluted net loss per share for the quarter ended June 30, 2021, compared to $11.3 million or $0.39 per share for the same period in 2020. Net loss was $16.3 million or $0.37 diluted net loss per share for the six months ended June 30, 2021, compared to $24.2 million or $0.84 per share for the same period in 2020.
    • Research and Development ("R&D") expenses: R&D expenses were $10.5 million for the quarter ended June 30, 2021, compared to $8.6 million for the same period in 2020. R&D expenses were $19.3 million for the six months ended June 30, 2021, compared to $18.6 million for the same period in 2020.



      The increase in R&D expenses for the three months ended June 30, 2021 is mainly due to growth in our internal research and manufacturing teams and GEN-011 manufacturing and clinical costs.



      The increase in R&D expenses for the six months ended June 30, 2021 is mainly due to growth in our internal research and manufacturing teams, partially offset by the timing of GEN-011 engineering and clinical manufacturing costs.
    • General and Administrative ("G&A") expenses: G&A expenses were $4.0 million for the quarter ended June 30, 2021, compared to $3.5 million for the same period in 2020. G&A expenses were $7.7 million for the six months ended June 30, 2021, compared to $6.9 million for the same period in 2020.



      The increase in G&A expenses for both periods is mainly due to growth in our internal G&A team, partially offset by decreased facility costs.
    • Other income (expense): Other income (expense) was income of $10.2 million for the quarter ended June 30, 2021, compared to expense of $0.2 million for the same period in 2020. Other income (expense) was income of $10.7 million for the six months ended June 30, 2021, compared to income of $0.4 million for the same period in 2020.



      The increase in other income (expense) for both periods is mainly due to the non-cash impact of the fair-value adjustment for the 33.6 million liability-classified warrants issued in connection with our July 2020 private placement.

    Guidance

    • Genocea's operating plan extends its cash runway to the end of 2022.

    Conference Call

    Genocea will host a conference call and webcast today at 8:30 a.m. E.T. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 6789021. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-and-presentations. A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

    About Genocea Biosciences, Inc.

    Genocea's mission is to identify the right tumor targets to develop life-changing immunotherapies for people suffering from cancer. Our proprietary ATLAS™ platform can comprehensively profile each patient's T cell responses to potential targets, or antigens, on that patient's tumor. ATLAS zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, Inhibigens™, that drive pro-tumor immune responses. We are conducting a Phase 1/2a clinical trial for GEN-011, our investigational adoptive T cell therapy comprising neoantigen-targeted peripheral cells. We continue to monitor patients in our phase 1/2a clinical trial for GEN-009, our investigational neoantigen vaccine. In addition to our two clinical programs, we are conducting research in several areas where we believe ATLAS could be a key tool in optimizing antigen selection for therapies across a number of diseases. To learn more, please visit https://www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements related to GEN-011, GEN-009 and research updates within the meaning of the Private Securities Litigation Reform Act, including statements related to the anticipated timing of top-line results from Genocea's Phase 1/2a clinical trial of GEN-011. 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. These factors include, but are not limited to, risks related to the potential failure of our active product candidates which are in an early stage of clinical development; our ability to obtain regulatory approval for our current and future product candidates; potential delays in enrolling patients in our clinical trials; our reliance on third parties to conduct technical development, non-clinical studies and clinical trials for our product candidates; our reliance on third parties to conduct some or all aspects of our product manufacturing; our ability to obtain or protect intellectual property rights related to our product candidates; the potential impacts of COVID-19 on our business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance; our need for additional financing and the risks listed under "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2020 and any subsequent filings with the Securities and Exchange Commission. 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.



    (Tables to follow)



    GENOCEA BIOSCIENCES, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

    (In thousands)

      June 30, 2021 December 31, 2020
         
    Cash and cash equivalents $60,399  $79,769 
    Property and equipment, net 5,214  5,123 
    Right of use assets 8,371  9,308 
    Other assets 3,399  4,293 
    Total assets $77,383  $98,493 
         
    Accounts payable and accrued expenses $7,690  $7,878 
    Deferred revenue 1,641  1,641 
    Debt, current and long-term 9,777  13,862 
    Warrant liabilities 44,747  56,118 
    Lease liabilities 9,473  10,012 
    Total liabilities 73,328  89,511 
    Stockholders' equity 4,055  8,982 
    Total liabilities and stockholders' equity $77,383  $98,493 





    GENOCEA BIOSCIENCES, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

    (In thousands, except per share data)

     Three Months Ended

    June 30
     Six Months Ended

    June 30,
     2021 2020 2021 2020
    License revenue$  $906  $  $906 
            
    Operating expenses:       
    Research and development10,513  8,587  19,264  18,574 
    General and administrative4,033  3,480  7,704  6,868 
    Total operating expenses14,546  12,067  26,968  25,442 
    Loss from operations(14,546) (11,161) (26,968) (24,536)
    Other income (expense)10,235  (160) 10,674  362 
    Net loss$(4,311) $(11,321) $(16,294) $(24,174)
            
    Net loss per share:       
    Basic$(0.06) $(0.39) $(0.24) $(0.84)
    Diluted$(0.20) $(0.39) $(0.37) $(0.84)
    Weighted-average number of shares used in computing net loss per share:       
    Basic67,970  29,142  67,074  28,642 
    Diluted70,202  29,142  72,467  28,642 



    Investor Contact:

    Dan Ferry

    daniel@lifesciadvisors.com

    Media Contact:

    Sarah O'Connell

    soconnell@vergescientific.com

     



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  4. CAMBRIDGE, Mass., July 22, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation cancer immunotherapies, will host its second quarter 2021 financial results and corporate update conference call and live audio webcast on Thursday, July 29th at 8:30 a.m. E.T.

    Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 6789021. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-presentations.

    A webcast replay will be available on the Genocea website beginning approximately…

    CAMBRIDGE, Mass., July 22, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation cancer immunotherapies, will host its second quarter 2021 financial results and corporate update conference call and live audio webcast on Thursday, July 29th at 8:30 a.m. E.T.

    Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 6789021. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at https://ir.genocea.com/events-presentations.

    A webcast replay will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

    About Genocea Biosciences, Inc.

    Genocea's mission is to identify the right tumor targets to develop life-changing immunotherapies for people suffering from cancer. Our proprietary ATLAS™ platform can comprehensively profile each patient's T cell responses to potential targets, or antigens, on that patient's tumor. ATLAS zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, Inhibigens™, that drive pro-tumor immune responses. We are conducting a Phase 1/2a clinical trial for GEN-011, our investigational adoptive T cell therapy comprising neoantigen-targeted peripheral cells. We continue to monitor patients in our phase 1/2a clinical trial for GEN-009, our investigational neoantigen vaccine. In addition to our two clinical programs, we are conducting research in several areas where we believe ATLAS could be a key tool in optimizing antigen selection for therapies across a number of diseases. To learn more, please visit https://www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements 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, 2020 and any subsequent filings with the Securities and Exchange Commission. 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:Media Contact:
    Dan FerrySarah O'Connell
    617-430-7576soconnell@vergescientific.com
    daniel@lifesciadvisors.com 



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  5. CAMBRIDGE, Mass., July 13, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced the dosing of the first patient in its TiTAN study, a Phase 1/2a clinical trial testing its GEN-011 therapy. GEN-011 represents a new category of autologous solid tumor cell therapy: neoantigen-targeted peripheral T cells ("NPTs").

    "Dosing the first patient with GEN-011 represents an exciting milestone for Genocea and the field of neoantigen-targeted T cell therapy," said Thomas Davis, M.D., the company's Chief Medical Officer. "We believe our GEN-011 therapy employs better targeting – using our ATLAS™ platform to select optimal neoantigen targets that…

    CAMBRIDGE, Mass., July 13, 2021 (GLOBE NEWSWIRE) -- Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing next-generation neoantigen immunotherapies, today announced the dosing of the first patient in its TiTAN study, a Phase 1/2a clinical trial testing its GEN-011 therapy. GEN-011 represents a new category of autologous solid tumor cell therapy: neoantigen-targeted peripheral T cells ("NPTs").

    "Dosing the first patient with GEN-011 represents an exciting milestone for Genocea and the field of neoantigen-targeted T cell therapy," said Thomas Davis, M.D., the company's Chief Medical Officer. "We believe our GEN-011 therapy employs better targeting – using our ATLAS™ platform to select optimal neoantigen targets that drive anti-tumor immune responses and avoid immunosuppressive Inhibigens™ - and better T cells, derived from easily accessible peripheral blood as opposed to the tumor itself. We are grateful to the patients eager to participate in our trial, to our investigators, and to our colleagues here at Genocea for their great dedication to improve patients' outcomes. We look forward to reporting top-line results from this study on a subset of patients late in the fourth quarter of 2021 or the first quarter of 2022."

    About GEN-011

    GEN-011 is a next-generation solid tumor therapy comprised of NPTs CD4+ and CD8+ which are specific for up to 30 antigens to limit tumor escape. NPTs have minimal bystander, non-tumor-specific cells, and are devoid of Inhibigen-specific cells which may be detrimental to clinical response.

    About the GEN-011 TiTAN clinical trial

    TiTAN is an open-label, multi-center Phase1/2a trial evaluating safety, tolerability, T cell persistence and proliferation and clinical efficacy. The TiTAN clinical trial is testing two dosing regimens, a repeated lower dose regimen of GEN-011 without lymphodepletion and a single high dose administration of GEN-011 after lymphodepletion. Both groups will receive interleukin-2 after GEN-011 dosing to maximize the tumor-killing potential of the infused cells. Initial data from the TiTAN trial is expected in late Q4 2021 or Q1 2022.

    About Genocea Biosciences, Inc.

    Genocea's mission is to identify the right tumor targets to develop life-changing immunotherapies for people suffering from cancer. Our proprietary ATLAS™ platform can comprehensively profile each patient's T cell responses to potential targets, or antigens, on that patient's tumor. ATLAS zeroes in on both antigens that activate anti-tumor T cell responses and inhibitory antigens, Inhibigens™, that drive pro-tumor immune responses. We are conducting a Phase 1/2a clinical trial for GEN-011, our investigational adoptive T cell therapy comprising neoantigen-targeted peripheral cells. We continue to monitor patients in our phase 1/2a clinical trial for GEN-009, our investigational neoantigen vaccine. In addition to our clinical programs, we are conducting research in several areas where we believe ATLAS could be a key tool in optimizing antigen selection for therapies across a number of diseases. To learn more, please visit https://www.genocea.com.

    Forward-Looking Statements

    This press release includes forward-looking statements related to GEN-011 and research updates within the meaning of the Private Securities Litigation Reform Act, including statements related to the anticipated timing of top-line results from Genocea's Phase 1/2a clinical trial of GEN-011. 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. These factors include, but are not limited to, risks related to the potential failure of our active product candidates which are in an early stage of clinical development; our ability to obtain regulatory approval for our current and future product candidates; potential delays in enrolling patients in our clinical trials; our reliance on third parties to conduct technical development, non-clinical studies and clinical trials for our product candidates; our reliance on third parties to conduct some or all aspects of our product manufacturing; our ability to obtain or protect intellectual property rights related to our product candidates; the potential impacts of COVID-19 on our business and financial results; changes in law, regulations, or interpretations and enforcement of regulatory guidance; our need for additional financing and the risks listed under "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2020 and any subsequent filings with the Securities and Exchange Commission. 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

    daniel@lifesciadvisors.com
    Media Contact:

    Sarah O'Connell

    soconnell@vergescientific.com



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