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1 Trial |  |
146 News |  |
- || GEN-009 / Genocea
Trial completion: Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine (clinicaltrials.gov) - Apr 19, 2022
P1/2, N=24, Completed, Sponsor: Genocea Biosciences, Inc.
Active, not recruiting --> Completed
- GEN-009 / Genocea
GEN-009, a personalized neoantigen vaccine candidate, elicits diverse and durable immune responses associated with clinical efficacy outcomes (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_455;
P1/2
ATLAS™ is a cell-based recall assay that, without predictions, screens each patient‘s mutanome to identify neoantigens for vaccine inclusion and deleterious Inhibigens™ for exclusion...These data support that GEN-009, in combination with checkpoint blockade, represents a unique approach to treat solid tumors. ETHICS STATEMENT This study was approved by Western Institutional Review Board, approval number 1-1078861-1
- GEN-009 / Genocea
Long term results from a phase 1 trial of GEN-009, a personalized neoantigen vaccine, combined with PD-1 inhibition in advanced solid tumors (Poster Hall) - Oct 1, 2021 - Abstract #SITC2021SITC_439;
P1/2
Preliminary data demonstrate induction of robust, durable neoantigen-specific immune responses and epitope spreading in the presence of PD-1 CPI. Broad immunity against tumor specific targets and encouraging patient outcomes support further study.Trial Registration clinicaltrials.gov identifier: NCT03633110
- ||| GEN-009 / Genocea
Enrollment change, Trial completion date, Trial primary completion date: Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine (clinicaltrials.gov) - Jun 25, 2021
P1/2, N=24, Active, not recruiting, Sponsor: Genocea Biosciences, Inc.
Broad immunity against tumor specific targets and encouraging patient outcomes support further study.Trial Registration clinicaltrials.gov identifier: NCT03633110 N=99 --> 24 | Trial completion date: Dec 2022 --> Mar 2022 | Trial primary completion date: Dec 2022 --> Mar 2022
- GEN-009 / Genocea
[VIRTUAL] Long term results from a phase 1 trial of GEN-009, a personalized neoantigen vaccine, combined with PD-1 inhibition in advanced solid tumors. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_2670;
P1/2
Preliminary data demonstrate induction of broad neoantigen-specific immune responses and epitope spreading in the presence of PD-1 CPI . Broad immunity against tumor specific targets and encouraging patient outcomes support further study.
- GEN-011 / Genocea, GEN-009 / Genocea
[VIRTUAL] InhibigensTM subvert otherwise-efficacious cancer vaccines and immunotherapies in conjunction with alterations in the tumor microenvironment () - Mar 13, 2021 - Abstract #AACR2021AACR_4182;
Genocea’s GEN-009 and GEN-011 phase 1/2 clinical trials utilize ATLAS to identify optimal neoantigens and omit Inhibigens from cancer vaccines and T cell therapies. Ongoing exploration of Inhibigen phenotypes and mechanisms will illuminate new paradigms of cancer immunology and potentially pave the way for novel cancer immunotherapies.
- |||| HSV vaccine (GEN-003) / Genocea, Shionogi, GEN-011 / Genocea, GEN-009 / Genocea
Monotherapy: $GNCA rocket thru EOY: •#ASCO21: GEN-009 part A (monotherapy) and part B (GEN-009 + ICI) data update •Shionogi GEN-003 deal pending •May 19, 2020, license option agreement agreement made w/ Shionogi⏱ •EOY’21: GEN-011 initial trial data •$IOVA is worried;) (Twitter) - Mar 11, 2021
- GEN-009 / Genocea
[VIRTUAL] InhibigenTM-specific responses suppress anti-tumor immunity and promote tumor growth () - Oct 14, 2020 - Abstract #SITC2020SITC_1555;
P1/2
Results In the GEN-009 personalized neoantigen vaccine trial (NCT03633110), Inhibigens were observed in 92% of patients (N=39)...Furthermore, in mice, CPI co-administration has a modest (anti-CTLA4) or no (anti-PD1) effect on Inhibigen-accelerated tumor growth suggesting that Inhibigen profiling could guide CPI selection or predict clinical outcome. These data confirm the benefits of the ATLAS platform for neoantigen and Inhibigen identification.
- GEN-009 / Genocea
[VIRTUAL] GEN-009, a personalized neoantigen vaccine, elicits robust immune responses in individuals with advanced or metastatic solid tumors () - Oct 14, 2020 - Abstract #SITC2020SITC_1444;
P1/2
Several patients achieved clinical responses that were possibly attributable to vaccine; efforts are underway to explore T cell correlates of protection. These data support that GEN-009, in combination with checkpoint blockade, represents a unique approach to treat solid tumors.
- GEN-009 / Genocea
[VIRTUAL] Emerging safety and activity data from GEN-009-101: A phase 1/2a trial of GEN-009, a neoantigen vaccine in combination with PD-1 check-point inhibitors (CPI) in advanced solid tumors () - Oct 14, 2020 - Abstract #SITC2020SITC_1421;
- GEN-009 / Genocea
[VIRTUAL] InhibigenTM-specific responses suppress anti-tumor immunity and promote tumor growth () - Oct 14, 2020 - Abstract #SITC2020SITC_820;
P1/2
Results In the GEN-009 personalized neoantigen vaccine trial (NCT03633110), Inhibigens were observed in 92% of patients (N=39)...Furthermore, in mice, CPI co-administration has a modest (anti-CTLA4) or no (anti-PD1) effect on Inhibigen-accelerated tumor growth suggesting that Inhibigen profiling could guide CPI selection or predict clinical outcome. These data confirm the benefits of the ATLAS platform for neoantigen and Inhibigen identification.
- GEN-009 / Genocea
[VIRTUAL] GEN-009, a personalized neoantigen vaccine, elicits robust immune responses in individuals with advanced or metastatic solid tumors () - Oct 14, 2020 - Abstract #SITC2020SITC_709;
P1/2
Several patients achieved clinical responses that were possibly attributable to vaccine; efforts are underway to explore T cell correlates of protection. These data support that GEN-009, in combination with checkpoint blockade, represents a unique approach to treat solid tumors.
- GEN-009 / Genocea
[VIRTUAL] Emerging safety and activity data from GEN-009-101: A phase 1/2a trial of GEN-009, a neoantigen vaccine in combination with PD-1 check-point inhibitors (CPI) in advanced solid tumors () - Oct 14, 2020 - Abstract #SITC2020SITC_686;
- GEN-009 / Genocea
[VIRTUAL] Clinical results of a pilot trial of GEN-009, a neoantigen vaccine containing immunogenic tumour specific neoantigens, in combination with PD-1 inhibitors in advanced cancers (On-Demand) - Jul 24, 2020 - Abstract #ESMO2020ESMO_1827;
P1/2
Funding: Genocea Biosciences. Clinical trial identification: NCT03633110.
- GEN-009 / Genocea
Inclusion of inhibitory neoantigens can abolish efficacy of otherwise protective therapeutic anti-tumor vaccines (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_3604;
P1/2
These data promote rational methods for neoantigen identification and highlight the potential advantages of excluding deleterious inhibigens from cancer vaccines and immunotherapies. GEN-009, a personalized cancer vaccine filtered for inclusion of only ATLAS-identified neoantigens (excluding inhibigens) is currently being evaluated in a Phase 1/2a clinical trial (NCT03633110).
- || GEN-009 / Genocea
Enrollment closed: Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine (clinicaltrials.gov) - May 6, 2020
P1/2, N=99, Active, not recruiting, Sponsor: Genocea Biosciences, Inc.
GEN-009, a personalized cancer vaccine filtered for inclusion of only ATLAS-identified neoantigens (excluding inhibigens) is currently being evaluated in a Phase 1/2a clinical trial (NCT03633110). Recruiting --> Active, not recruiting
- GEN-009 / Genocea
[VIRTUAL] GEN-009, a neoantigen vaccine containing ATLAS selected neoantigens, to generate broad sustained immunity against immunogenic tumor mutations and avoid inhibitory peptides. (Poster Board 171) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1382;
P1/2
Initial clinical data show that ATLAS antigen selection may be critical to the induction of broad, rapid and sustained immunity against tumor specific neoantigens. Clinical vaccination with PD-1 blockade is in process.
- GEN-009 / Genocea
Vaccine neoantigens empirically identified through the ex vivo ATLAS platform promote potent therapeutic responses to cancer in mice (Prince George's Exhibition Halls AB) - Oct 2, 2019 - Abstract #SITC2019SITC_1036;
P1/2
These studies demonstrate proof of concept for ATLAS-based neoantigen vaccine selection and establish a model for further mechanistic study. In a recent interim analysis, 91% of vaccine neoantigens selected as stimulatory by ATLAS, elicited T cell responses in patients participating in the GEN-009 Phase 1/2 clinical trial of a personalized cancer vaccine (NCT03633110).
- GEN-009 / Genocea
Broad immunogenicity from GEN-009, a neoantigen vaccine using ATLAS™, an autologous immune assay, to identify immunogenic and inhibitory tumor neoantigens (Prince George's Exhibition Halls AB) - Oct 2, 2019 - Abstract #SITC2019SITC_781;
P1/2
Immunogenicity data show that ATLAS can, with very high frequency, identify relevant neoantigens and exclude putatively deleterious (immune inhibitory) antigens. Clinical vaccination together with Standard of Care PD-1 blockade-based regimens is in progress.
- Hiltonol (poly-ICLC) / Oncovir, GEN-009 / Genocea
ATLAS™ identifies relevant neoantigens for therapeutic anti-tumor vaccination and may serve as a biomarker for efficacy of immunotherapy of solid tumors (Prince George's Exhibition Halls AB) - Oct 2, 2019 - Abstract #SITC2019SITC_778;
P1/2
ATLAS will be useful for profiling epitope spread in tumor-bearing subjects post-vaccination. The proportion of inhibitory to stimulatory neoantigen-specific responses may be a biomarker of immunotherapy success.
- GEN-009 / Genocea
A phase I trial of GEN-009, a neoantigen vaccine using ATLAS™, an autologous immune assay, to identify immunogenic and inhibitory tumour mutations (Bilbao Auditorium (Hall 5)) - Sep 11, 2019 - Abstract #ESMO2019ESMO_3264;
P1/2
Immunogenicity data show that ATLAS can, with very high frequency, identify relevant neoantigens and exclude suppressive peptides. Clinical vaccination with PD-1 blockade is in process.
- | GEN-009 / Genocea
New P1/2 trial: Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine (clinicaltrials.gov) - Aug 16, 2018
P1/2, N=124, Recruiting, Sponsor: Genocea Biosciences, Inc.