GEN-011 / Genocea - LARVOL DELTA

ATLAS-identified Inhibigen-specific responses accelerate tumor growth in mouse melanoma and pancreatic cancer (AACR 2022) - P1 | "Genocea’s GEN-011 neoantigen-targeted peripheral T cell (NPT) therapy candidate, designed using ATLAS-identified neoantigens and omitting Inhibigens, is being evaluated in an ongoing clinical trial (NCT04596033). Continued exploration of mechanisms of action of Inhibigen-specific responses may reveal new paradigms of cancer immune evasion. 1H Lam et al, Cancer Discov 2021;11:1-18"

Preclinical • Gastrointestinal Cancer • Melanoma • Oncology • Pancreatic Cancer • Solid Tumor • CD4 • CD8

The PLANET manufacturing process reproducibly generates high-quality neoantigen-targeted peripheral T cells (NPTs) for adoptive T cell therapy in the TiTAN clinical trial (AACR 2022) - P1 | "Patient-specific neoAgs against which their T cells were responsive were identified with ATLAS, and up to 30 neoAgs were prioritized for manufacture; pro-tumor Inhibigens™ were excluded. NPTs can routinely be manufactured in a GMP setting to treat patients with solid tumors. By expanding fresh, non-exhausted NeoAg-specific T cells with known tumor specificity from the periphery, GEN-011 has the potential to provide clinical benefits of TIL with greater accessibility and minimal irrelevant T cells. The TiTAN trial is ongoing."

Clinical • IO biomarker • Tumor-specific neoantigens • Head and Neck Cancer • Lung Cancer • Melanoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • CD4 • CD8

TiTAN: a phase 1 study of GEN-011, a neoantigen-targeted peripheral blood-derived T cell therapy with broad neoantigen targeting. (AACR 2022) - "Maximum grade 2 CRS and one grade 2 ICANS peaked around day 8 in parallel to cell expansion and no patients required tocilizumab or corticosteroids. Taken together, these early data support the biological activity of GEN-011. Using a personalized immune assay to identify neoantigens, and to exclude Inhibigens, to generate tumor specific T cells may offer a more accessible and promising ACT for treating solid tumors."

P1 data • Tumor-specific neoantigens • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

GEN-011-101 (the TiTAN-1 trial): Phase 1 study to evaluate the safety, proliferation and persistence of GEN-011, an autologous neoantigen-targeted peripheral T cell therapy in solid tumors (SITC 2021) - P1 | "ATLAS will also identify Inhibigens™, antigen targets of T cells that promote tumor growth.1 Autologous peripheral T cells will be specifically stimulated by up to 30 ATLAS-identified neoantigens, avoiding Inhibigens, to generate an adoptive T cell product. Patients will be followed for safety, immunogenicity, and anti-tumor activity over approximately a 5-month treatment period. A long-term follow-up will continue through 2 years after the initial dose of GEN-011.Trial Registration clinicaltrials.gov identifier: NCT04596033"

Clinical • P1 data • Tumor-specific neoantigens • Anal Carcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Renal Cell Carcinoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer • CD4 • CD8 • IL2

TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy (clinicaltrials.gov) - P1 | N=49 | Terminated | Sponsor: Genocea Biosciences, Inc. | Active, not recruiting ➔ Terminated; Business reasons

Trial termination • Anal Carcinoma • Cutaneous Melanoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer

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

TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy (clinicaltrials.gov) - P1 | N=49 | Active, not recruiting | Sponsor: Genocea Biosciences, Inc. | Recruiting ➔ Active, not recruiting | N=24 ➔ 49 | Trial completion date: May 2024 ➔ Jun 2022 | Trial primary completion date: May 2024 ➔ Jun 2022

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Anal Carcinoma • Cutaneous Melanoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Non-melanoma Skin Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer

Genocea Presents Encouraging Initial Data from GEN-011 Phase 1/2a Trial at AACR 2022 (GlobeNewswire) - P1/2a | N=24 | TITAN (NCT04596033) | Sponsor: Genocea Biosciences, Inc | "The early results presented at AACR show anti-tumor activity despite the lower intensity regimens and heavily pretreated tumors. Stable disease was seen at the initial Day 57 scan in four of the five patients. While all patients had progressive disease (PD) at their Day 113 scan, three of the five experienced clear biologic changes after infusion. These included palpable improvement in peripheral nodal disease and resolution of severe neuropathy causing arm paralysis and pain in patients with refractory SCCHN. A patient with metastatic non-small cell lung cancer (NSCLC) experienced a 10% reduction in tumor diameters (approx. 30% reduction in volume), also with resolution of tumor associated cough. The potential for drug product proliferation and persistence for months is supported by translational assays, and clinical activity is associated with declines in detectable circulating tumor DNA (ctDNA)..."

P1 data • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Genocea Presents Encouraging Initial Data from GEN-011 Phase 1/2a Trial at AACR 2022 (GlobeNewswire) - "Additional data presented at AACR highlights ongoing work characterizing inhibitory antigens, or Inhibigens - putatively pro-tumor antigens that are uniquely identifiable by ATLAS and present in nearly every cancer patient profiled by Genocea. With the benefit of ATLAS, Genocea excludes T cells to Inhibigens from GEN-011. A preclinical poster presented at the meeting demonstrates how detrimental these Inhibigens are to the efficacy of cancer therapeutics in mouse models of melanoma and pancreatic cancer."

Preclinical • Oncology

"Neoantigens #TargetsMatter GEN-011 beats CAR T and TILS hands down" (@ny1972_47)

Tumor-specific neoantigens

"$GNCA GEN-011 high potential to dominate TIL/TCR market. $IBB #Biotech #AACR22" (@TheBobowski)

Oncology

Genocea to Present Clinical and Preclinical Data at AACR Annual Meeting (GlobeNewswire) - "The findings include late-breaking clinical data from the TiTAN™ clinical trial for the neoantigen-targeted peripheral T cell therapy product candidate GEN-011, results demonstrating successful production of GEN-011 using Genocea’s PLANET™ manufacturing process, and new preclinical data on Inhibigens™, antigens of suppressive immune responses uniquely identifiable by Genocea’s ATLAS™ platform."

Commercial • Late-breaking abstract • P1 data • Preclinical • Oncology • Solid Tumor

"$GNCA undervalued. #Cancer #Immunotherapy #TITAN #GEN011 #Genocea #AACR22 #ASCO22" (@ZskiTexas)

Oncology

Genocea Doses First Patient in Phase 1/2a TiTAN Clinical Trial for GEN-011 Neoantigen-Targeted T cell Therapy (GlobeNewswire) - “Genocea Biosciences…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’)…‘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’.”

P1/2 data • Trial status • 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

[VIRTUAL] Expanded ATLASTM-identified neoantigen-specific peripheral T cells (NPTs) demonstrate considerable neoantigen breadth, polyfunctionality, and effector function. (IMMUNOLOGY 2021) - P1 | "In addition, extracted cells from an immunosuppressive tumor microenvironment (TME) often have impaired functions, low neoantigen-specificity and require high dose cytokine for expansion. All possible reasons for non-responders or post-treatment relapse. Generating T cell therapies specifically expanded against neoantigen targets and derived from peripheral blood lymphocytes may overcome these limitations. The ATLAS bioassay identifies patient-specific neoantigen targets of T cells, and Inhibigens™, tumor antigens that are detrimental to protective immune responses. Using PLANET™, a robust and scalable closed manufacturing process, T cells specific for up to 30 ATLAS-identified neoantigens (excluding Inhibigens) are..."

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

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

[VIRTUAL] Neoantigen directed PBL-based Cell Therapy can Achieve High Breadth and Purity Against Tumor Specific Targets (IO-360 2021) - "This talk will provide updates on GEN-011, a neoantigen and PBL-based cell therapy product and focus specifically on: Neoantigen-specific expansion and how it generates pure and specific autologous NPTs (neoantigen targeted peripheral T cells) in the absence of high dose IL-2. Data showing 96% of the NPTs are neoantigen specific, successfully targeting 89% of intended neoantigen targets with up to 30 mutations included Ongoing pilot study will evaluate safety and tumor targeting in patients with solid tumors"

Tumor-specific neoantigens • Oncology • Solid Tumor

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

Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Genocea Biosciences, Inc.

Clinical • New P1 trial • Anal Carcinoma • Cutaneous Melanoma • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer

Genocea Presents Positive GEN-009 Clinical Results, Update on GEN-011 Program and New Inhibigen Mechanism of Action Data at Virtual SITC 2020 (GlobeNewswire) - "Poster 149 highlights important advantages of GEN-011 over TIL and TCR-T therapies. GEN-011 has been developed with 100% manufacturing success at clinical scale via PLANET™, a process designed to deliver billions of NPTs for every patient. The 16 PLANET runs conducted to date have confirmed GEN-011 comprises over 98% of highly functional, non-exhausted T cells with a mean neoantigen breadth of response nearing 90% of intended targets. In contrast, recent reported data from TIL products showed responses to less than 10% of intended neoantigens. GEN-011 NPTs have an unparalleled breadth of neoantigen coverage, targeting up to 30 relevant antigens."

Preclinical • Oncology

Genocea Provides Third Quarter 2020 Corporate Update (GlobeNewswire) - “Genocea will report additional clinical and immunogenicity data from the remaining GEN-009 Part B patients during the 2020 virtual Society for Immunotherapy of Cancer (SITC) annual meeting from November 9-14. The company will also provide a detailed introduction to GEN-011 and will share new insights on the utility of ATLAS-identified Inhibigens to inform future immunotherapy development.”

Clinical • Clinical data • Oncology

[VIRTUAL] GEN-011: An ATLASTM-guided peripheral-blood derived neoantigen-specific T cell therapy designed to improve on TIL approaches (SITC 2020) - "In conclusion, GEN-011 is a first-in-class transformational T cell therapy candidate with characteristics that should improve accessibility and efficacy for patients with solid tumors. Ethics Approval Informed consent was obtained from all individuals providing samples for this study."

Tumor-specific neoantigens • Hematological Malignancies • Oncology • Solid Tumor • CD8 • IFNG

[VIRTUAL] GEN-011: An ATLASTM-guided peripheral-blood derived neoantigen-specific T cell therapy designed to improve on TIL approaches (SITC 2020) - "In conclusion, GEN-011 is a first-in-class transformational T cell therapy candidate with characteristics that should improve accessibility and efficacy for patients with solid tumors. Ethics Approval Informed consent was obtained from all individuals providing samples for this study."

Tumor-specific neoantigens • Hematological Malignancies • Oncology • Solid Tumor • CD8 • IFNG