GEN-009 / Genocea - LARVOL DELTA

Long term results from a phase 1 trial of GEN-009, a personalized neoantigen vaccine, combined with PD-1 inhibition in advanced solid tumors (SITC 2021) - P1/2 | "Background GEN-009 adjuvanted personalized cancer vaccine contains up to 20 neoantigens selected by ATLAS™, an ex vivo bioassay screening autologous T-cells for immune responses against both neoantigens and Inhibigens™. 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"

P1 data • Tumor-specific neoantigens • Oncology • Solid Tumor • CD4 • CD8

[VIRTUAL] InhibigenTM-specific responses suppress anti-tumor immunity and promote tumor growth (SITC 2020) - 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."

IO Biomarker • Melanoma • Oncology • Solid Tumor • CD8 • TMB

[VIRTUAL] GEN-009, a personalized neoantigen vaccine, elicits robust immune responses in individuals with advanced or metastatic solid tumors (SITC 2020) - P1/2 | "Background ATLASTM is a cell-based bioassay that utilizes a cancer patient‘s own monocyte-derived dendritic cells and CD4+ and CD8+ T cells to screen their mutanome and identify neoantigens that elicit robust anti-tumor T cell responses, as well as, deleterious InhibigensTM.1 GEN-009, a personalized vaccine comprised of 4–20 ATLAS-identified neoantigens combined with Hiltonol®, harnesses the power of neoantigen-specific T cells to treat individuals with solid tumors. 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."

Clinical • Tumor-specific neoantigens • Oncology • Solid Tumor • IFNG • TNFA

[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 (SITC 2020) - No abstract available

Clinical • Combination therapy • P1/2 data • Tumor-specific neoantigens • Oncology • Solid Tumor

Vaccine neoantigens empirically identified through the ex vivo ATLAS platform promote potent therapeutic responses to cancer in mice (SITC 2019) - P1/2; "Currently, the only method to reliably and comprehensively identify neoantigen targets and rationally omit potentially deleterious antigens is ATLAS screening using autologous cells. 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)."

IO Biomarker • Preclinical • Tumor-specific neoantigens

Broad immunogenicity from GEN-009, a neoantigen vaccine using ATLAS™, an autologous immune assay, to identify immunogenic and inhibitory tumor neoantigens (SITC 2019) - P1/2; "After next-generation tumor sequencing and ATLAS testing of autologous leukocytes, each personalized vaccine is created using up to 20 stimulatory synthetic long peptides adjuvanted with poly-ICLC. GEN-009 is a neoantigen vaccine that targets tumor specific immune antigens recognized by the individual patient's lymphocytes and likely expressed by tumor cells. 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."

IO Biomarker • PD(L)-1 Biomarker • Preclinical • Tumor-specific neoantigens

ATLAS™ identifies relevant neoantigens for therapeutic anti-tumor vaccination and may serve as a biomarker for efficacy of immunotherapy of solid tumors (SITC 2019) - P1/2; "GEN-009, composed of 4 pools of 1-5 unique ATLAS-identified neoantigen-specific peptides combined with Hiltonol(r) was administered to each subject. Neoantigens selected by immune response data from ATLAS and included in the GEN-009 vaccine were immunogenic and many were not algorithm-predicted, confirming that ATLAS identifies relevant neoantigens. 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."

Biomarker • Clinical • IO Biomarker • Tumor-specific neoantigens

[VIRTUAL] Inclusion of inhibitory neoantigens can abolish efficacy of otherwise protective therapeutic anti-tumor vaccines (AACR-II 2020) - 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)."

Clinical • IO Biomarker • Tumor-specific neoantigens • Melanoma • Oncology • Solid Tumor • CD8 • IFNG • LAG3 • PD-1

GEN-009, a personalized neoantigen vaccine candidate, elicits diverse and durable immune responses associated with clinical efficacy outcomes (SITC 2021) - P1/2 | "Background GEN-009, a personalized vaccine candidate comprised of ATLAS™-prioritized neoantigens combined with Hiltonol®, is currently being evaluated in a Phase 1/2a clinical trial (NCT03633110). 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"

Clinical • IO biomarker • Tumor-specific neoantigens • Oncology • Solid Tumor • CD4 • CD8

Genocea Provides Third Quarter 2021 Corporate Update (GlobeNewswire) - “‘We are very excited about our TiTAN™ clinical trial for GEN-011, our neoantigen-targeted peripheral T cell therapy (NPT) candidate, from which we expect to have initial data from a small subset of patients in the first quarter or early in the second quarter next year…’‘We are also pleased that our SITC presentations will continue to showcase the neoantigen selection capabilities of our ATLAS™ platform, through differentiated long-term immunogenicity and clinical response data for GEN-009, our neoantigen-targeted vaccine candidate, and through its potential application to novel autoimmune disease treatments.’”

Clinical data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine (clinicaltrials.gov) - P1/2 | N=24 | Completed | Sponsor: Genocea Biosciences, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cutaneous Melanoma • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • PD-L1

[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. (ASCO 2021) - P1/2 | "Vaccination with GEN-009 in combination with anti-PD-1 CPI in patients with advanced solid tumors shows little additive toxicity . 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."

P1 data • Tumor-specific neoantigens • Fatigue • Musculoskeletal Pain • Oncology • Pain • Solid Tumor • CD4 • CD8 • IFNG

[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 (ESMO 2020) - P1/2 | "Methods After next-generation tumor sequencing and ATLAS testing, GEN-009 is formulated with up to 20 stimulatory peptides and poly-ICLC as adjuvant. Funding: Genocea Biosciences. Clinical trial identification: NCT03633110."

Clinical • Combination therapy • Tumor-specific neoantigens • Oncology • CD8

[VIRTUAL] InhibigenTM-specific responses suppress anti-tumor immunity and promote tumor growth (SITC 2020) - 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."

IO Biomarker • Melanoma • Oncology • Solid Tumor • CD8 • TMB

[VIRTUAL] GEN-009, a personalized neoantigen vaccine, elicits robust immune responses in individuals with advanced or metastatic solid tumors (SITC 2020) - P1/2 | "Background ATLASTM is a cell-based bioassay that utilizes a cancer patient‘s own monocyte-derived dendritic cells and CD4+ and CD8+ T cells to screen their mutanome and identify neoantigens that elicit robust anti-tumor T cell responses, as well as, deleterious InhibigensTM.1 GEN-009, a personalized vaccine comprised of 4–20 ATLAS-identified neoantigens combined with Hiltonol®, harnesses the power of neoantigen-specific T cells to treat individuals with solid tumors. 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."

Clinical • Tumor-specific neoantigens • Oncology • Solid Tumor • IFNG • TNFA

A Phase 1/2a study of GEN-009, a neoantigen vaccine based on autologous peptide immune responses. (ASCO 2019) - P1/2; "GEN-009 is administered with poly-ICLC on weeks 0, 3, 6, 12 and 24. GEN-009 is a neoantigen vaccine that personalizes tumor specific targets and the individual patient’s capacity to respond. Immunogenicity data will assess CD4 and CD8 T cell responses to each vaccine neoantigen. Clinical trial information: NCT03633110"

P1/2 data • Tumor-specific neoantigens

[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 (SITC 2020) - No abstract available

Clinical • Combination therapy • P1/2 data • Tumor-specific neoantigens • Oncology • Solid Tumor

[VIRTUAL] GEN-009, a neoantigen vaccine containing ATLAS selected neoantigens, to generate broad sustained immunity against immunogenic tumor mutations and avoid inhibitory peptides. (ASCO 2020) - P1/2 | "After next-generation tumor sequencing and ATLAS testing of autologous leukocytes, up to 20 stimulatory synthetic long peptides adjuvanted with poly-ICLC comprise each personalized vaccine. GEN-009 identifies tumor specific immune targets from the individual patient’s tumor mutagens. 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."

IO Biomarker • Tumor-specific neoantigens • CD8

A phase I trial of GEN-009, a neoantigen vaccine using ATLAS™, an autologous immune assay, to identify immunogenic and inhibitory tumour mutations (ESMO 2019) - P1/2; "After next-generation tumor sequencing and ATLAS testing of autologous leukocytes, up to 20 stimulatory synthetic long peptides adjuvanted with poly-ICLC make each personalized vaccine. GEN-009 is a neoantigen vaccine that identifies tumor specific immune targets from the individual patient’s repertoire. 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."

IO Biomarker • P1 data • PD(L)-1 Biomarker • Tumor-specific neoantigens

Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine (clinicaltrials.gov) - P1/2; N=24; Active, not recruiting; Sponsor: Genocea Biosciences, Inc.; N=99 ➔ 24; Trial completion date: Dec 2022 ➔ Mar 2022; Trial primary completion date: Dec 2022 ➔ Mar 2022

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Cutaneous Melanoma • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • PD-L1

Genocea Presents Promising Long-term Results from GEN-009 Neoantigen Vaccine Phase 1 Trial at ASCO 2021 (GlobeNewswire) - P1, N=99; NCT03633110; Sponsor: Genocea Biosciences, Inc.; "Genocea Biosciences...presents updated immunogenicity and clinical response data from the GEN-009 Phase 1 trial that continue to validate the company’s unique and differentiated approach to identifying clinically meaningful immunotherapy targets through the proprietary ATLAS selection process....Long-term results demonstrate that GEN-009 continues to generate broad immune responses against neoantigens that can lead to sustained clinical responses. In Part A of the study, designed to measure safety and immunogenicity only, eight patients with no measurable disease were vaccinated with GEN-009 as a monotherapy....In Part B, patients were enrolled at the initiation of a PD-1 checkpoint inhibitor (CPI)-based standard of care (SOC) regimen for advanced or metastatic disease..."

P1 data • Oncology • Solid Tumor

[VIRTUAL] InhibigensTM subvert otherwise-efficacious cancer vaccines and immunotherapies in conjunction with alterations in the tumor microenvironment (AACR 2021) - "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."

Biomarker • IO biomarker • Tumor microenvironment • Melanoma • Oncology • Solid Tumor • CD4 • CD8

Genocea Provides First Quarter 2021 Corporate Update (GlobeNewswire) - "The TITAN study is designed to explore safety, biomarkers of activity and anti-tumor efficacy...The company expects to have initial efficacy data from a patient subset late in the fourth quarter of 2021 or the first quarter of 2022....GEN-009 Phase 1/2a clinical trial: The Company will provide long-term follow-up clinical and immunogenicity data from the ongoing Phase 1/2a clinical study at the American Society of Clinical Oncology ('ASCO') 2021 Annual Meeting from June 4 - June 8."

P1/2 data • Anal Carcinoma • Bladder Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Urothelial Cancer

"$GNCA rocket thru EOY: •#ASCO21: GEN-009 part A (monotherapy) and part B (GEN-009 + ICI) data update •Shionogi GEN-003 deal pending •May 19, 2020, license option agreement agreement made w/ Shionogi⏱ •EOY’21: GEN-011 initial trial data •$IOVA is worried;)" (@RedditRocker)

Monotherapy

Genocea Provides Fourth Quarter 2020 Corporate Update (GlobeNewswire) - "GEN-011 Phase 1/2a clinical trial (TITAN trial): Genocea has initiated the first two of multiple planned clinical sites and is accruing patients. The company expects to have initial efficacy data from a patient subset late in the fourth quarter of 2021 or the first quarter of 2022. GEN-009 Phase 1/2a clinical trial:...Genocea expects to provide additional clinical and immunogenicity data from these patients in Q2."

P1/2 data • Oncology