– Superior ATLASTM platform for neoantigen selection (1) –
– Exploring strategic alternatives for GEN-003 –
– Announces corporate restructuring –
CAMBRIDGE, MA, USA I September 25, 2017 I Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company discovering and developing novel vaccines and immunotherapies targeting T cell antigens, today announced a strategic shift to immuno-oncology and a focus on the development of neoantigen cancer vaccines, including GEN-009, its lead candidate for which it expects to file an Investigational New Drug (IND) application by early 2018. Genocea also announced it is exploring strategic alternatives for GEN-003, its Phase 3-ready investigational immunotherapy for the treatment of genital herpes. Consequently, Genocea is ceasing GEN-003 spending and activities and is reducing its workforce by approximately 40 percent.
Genocea has confidence that it is positioned for leadership in the development of neoantigen cancer vaccines through its unique antigen identification capabilities and vaccinology expertise. More specifically, the company believes that antigen selection is a crucial determinant of neoantigen vaccine efficacy and that previously presented head-to-head data show that ATLAS, the only platform to comprehensively identify the actual neoantigens to which a patient’s CD4+ and CD8+ T cells respond, is a superior approach for identifying neoantigens for personalized vaccines compared to methods used by others developing similar products.
The company plans to initiate a Phase 1 clinical trial for GEN-009 in a range of tumor types in the first half of 2018 and expects to report initial immunogenicity data in the first half of 2019. GEN-009 is an adjuvanted peptide vaccine designed to direct a patient’s T cells to attack their tumor. Antigens in a patient’s vaccine are selected by Genocea’s proprietary ATLAS platform.
Chip Clark, president and chief executive officer of Genocea, commented: “With our research and development efforts now focused entirely on neoantigen cancer vaccines, we believe the power of ATLAS to identify the right vaccine antigens, combined with our vaccinology expertise, gives us the opportunity to create value for our shareholders by developing best-in-class vaccines for cancer patients and achieving leadership in this exciting field.
“To our teammates who’ve given so much to advance GEN-003, we offer our profound thanks for their dedication. Due to their efforts, GEN-003 has the potential to serve as a cornerstone treatment for genital herpes infections. We see this strategic process, which is already underway, as the best way to drive to commercial launch of and maximize shareholder value from GEN-003.”
Financial Guidance
As a result of the workforce restructuring, which is anticipated to be completed by the end of the third quarter, Genocea estimates annualized savings of approximately $6.5 million in personnel-related costs, with estimated one-time severance and related costs of approximately $1.1 million in the third quarter of 2017. Genocea now expects that its existing cash and cash equivalents are sufficient to support its operating expenses and capital expenditure requirements into the middle of 2018.
About Genocea Biosciences, Inc.
Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. While traditional immunotherapy discovery methods have largely used predictive methods to propose T cell targets, or antigens, Genocea has successfully developed ATLAS™, its proprietary technology platform, to identify clinically relevant antigens of T cells based on actual human immune responses. Genocea is currently using ATLAS in immuno-oncology applications to develop neoantigen cancer vaccines and exploring partnership opportunities for general cancer vaccines and a vaccine targeting cancers caused by Epstein-Barr Virus. Genocea is exploring strategic alternatives for GEN-003, its Phase 3-ready immunotherapy candidate for the treatment of genital herpes. For more information, please visit www.genocea.com.
About Neoantigen Cancer Vaccines and GEN-009
Neoantigens are personalized tumor mutations that are seen as ‘foreign’ by an individual’s immune system(2). Data published in recent years have indicated that an individual’s response to neoantigens drives checkpoint inhibitor efficacy(3) and that it is possible to vaccinate an individual against their own neoantigens(4), GEN-009 is an adjuvanted neoantigen peptide vaccine that is designed to direct a patient’s immune system to attack their tumor. GEN-009’s neoantigen peptides are identified by Genocea’s proprietary ATLAS platform, which recalls a patient’s pre-existing CD4+ and CD8+ T cell immune responses to their tumor. Following ATLAS neoantigen identification, Genocea will manufacture a personal vaccine for each patient.
References (1) https://www.genocea.com/assets/Kaufmann_AACR2017.pdf; (2) Yadav, Gubin, 2015; (3) Schumacher, Schreiber, 2015; (4) Ott, Sahin, 2017
SOURCE: Genocea Biosciences
Post Views: 328
– Superior ATLASTM platform for neoantigen selection (1) –
– Exploring strategic alternatives for GEN-003 –
– Announces corporate restructuring –
CAMBRIDGE, MA, USA I September 25, 2017 I Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company discovering and developing novel vaccines and immunotherapies targeting T cell antigens, today announced a strategic shift to immuno-oncology and a focus on the development of neoantigen cancer vaccines, including GEN-009, its lead candidate for which it expects to file an Investigational New Drug (IND) application by early 2018. Genocea also announced it is exploring strategic alternatives for GEN-003, its Phase 3-ready investigational immunotherapy for the treatment of genital herpes. Consequently, Genocea is ceasing GEN-003 spending and activities and is reducing its workforce by approximately 40 percent.
Genocea has confidence that it is positioned for leadership in the development of neoantigen cancer vaccines through its unique antigen identification capabilities and vaccinology expertise. More specifically, the company believes that antigen selection is a crucial determinant of neoantigen vaccine efficacy and that previously presented head-to-head data show that ATLAS, the only platform to comprehensively identify the actual neoantigens to which a patient’s CD4+ and CD8+ T cells respond, is a superior approach for identifying neoantigens for personalized vaccines compared to methods used by others developing similar products.
The company plans to initiate a Phase 1 clinical trial for GEN-009 in a range of tumor types in the first half of 2018 and expects to report initial immunogenicity data in the first half of 2019. GEN-009 is an adjuvanted peptide vaccine designed to direct a patient’s T cells to attack their tumor. Antigens in a patient’s vaccine are selected by Genocea’s proprietary ATLAS platform.
Chip Clark, president and chief executive officer of Genocea, commented: “With our research and development efforts now focused entirely on neoantigen cancer vaccines, we believe the power of ATLAS to identify the right vaccine antigens, combined with our vaccinology expertise, gives us the opportunity to create value for our shareholders by developing best-in-class vaccines for cancer patients and achieving leadership in this exciting field.
“To our teammates who’ve given so much to advance GEN-003, we offer our profound thanks for their dedication. Due to their efforts, GEN-003 has the potential to serve as a cornerstone treatment for genital herpes infections. We see this strategic process, which is already underway, as the best way to drive to commercial launch of and maximize shareholder value from GEN-003.”
Financial Guidance
As a result of the workforce restructuring, which is anticipated to be completed by the end of the third quarter, Genocea estimates annualized savings of approximately $6.5 million in personnel-related costs, with estimated one-time severance and related costs of approximately $1.1 million in the third quarter of 2017. Genocea now expects that its existing cash and cash equivalents are sufficient to support its operating expenses and capital expenditure requirements into the middle of 2018.
About Genocea Biosciences, Inc.
Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. While traditional immunotherapy discovery methods have largely used predictive methods to propose T cell targets, or antigens, Genocea has successfully developed ATLAS™, its proprietary technology platform, to identify clinically relevant antigens of T cells based on actual human immune responses. Genocea is currently using ATLAS in immuno-oncology applications to develop neoantigen cancer vaccines and exploring partnership opportunities for general cancer vaccines and a vaccine targeting cancers caused by Epstein-Barr Virus. Genocea is exploring strategic alternatives for GEN-003, its Phase 3-ready immunotherapy candidate for the treatment of genital herpes. For more information, please visit www.genocea.com.
About Neoantigen Cancer Vaccines and GEN-009
Neoantigens are personalized tumor mutations that are seen as ‘foreign’ by an individual’s immune system(2). Data published in recent years have indicated that an individual’s response to neoantigens drives checkpoint inhibitor efficacy(3) and that it is possible to vaccinate an individual against their own neoantigens(4), GEN-009 is an adjuvanted neoantigen peptide vaccine that is designed to direct a patient’s immune system to attack their tumor. GEN-009’s neoantigen peptides are identified by Genocea’s proprietary ATLAS platform, which recalls a patient’s pre-existing CD4+ and CD8+ T cell immune responses to their tumor. Following ATLAS neoantigen identification, Genocea will manufacture a personal vaccine for each patient.
References (1) https://www.genocea.com/assets/Kaufmann_AACR2017.pdf; (2) Yadav, Gubin, 2015; (3) Schumacher, Schreiber, 2015; (4) Ott, Sahin, 2017
SOURCE: Genocea Biosciences
Post Views: 328
