VT1021 / Vigeo Therap - LARVOL DELTA

GBM AGILE: A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma (clinicaltrials.gov) - P2/3 | N=1280 | Recruiting | Sponsor: Global Coalition for Adaptive Research | Trial completion date: Jun 2028 ➔ Jun 2030 | Trial primary completion date: Jun 2026 ➔ Jun 2028

Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Hematological Disorders • Oncology • Solid Tumor

Assessing CD36 and CD47 expression levels in solid tumor indications to stratify patients for VT1021 treatment. (PubMed, NPJ Precis Oncol) - "We have developed VT1021 that induces the expression of thrombospondin-1 (TSP-1) in myeloid-derived suppressor cells (MDSCs) recruited to the tumor microenvironment (TME). Our studies identified CD36 and CD47 as dual biomarkers that can be used as patient stratifying tools and prognostic biomarkers for VT1021 treatment."

Biomarker • Journal • Oncology • Solid Tumor • CD36 • CD47 • SCARB1

Phase 1 dose expansion and biomarker study assessing first-in-class tumor microenvironment modulator VT1021 in patients with advanced solid tumors. (PubMed, Commun Med (Lond)) - P1, P2/3 | "VT1021 is safe and well-tolerated in patients with solid tumors in a phase I expansion study. VT1021 has advanced to a phase II/III clinical study in glioblastoma (NCT03970447)."

Biomarker • Journal • Metastases • P1 data • Tumor microenvironment • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • THBS1

EVALUATING THE PRE-CLINICAL EFFICACY OF VT1021 (A CLINICAL STAGE DRUG CANDIDATE) IN MULTIPLE EXPERIMENTAL MODELS OF INFLAMMATORY BOWEL DISEASE (CCCongress 2024) - "Immunohistochemistry staining of colon tissue samples confirmed that VT1021 treatment stimulated TSP-1 expression in the MDSCs.Altogether, these findings show that VT1021 treatment has equivalent efficacy to anti-TNFa treatment, while significantly reducing damage to colon tissue. We believe VT1021 will show significantly greater efficacy in patients with longer term use, while avoiding the systemic deleterious side effects common to current approved therapies."

Preclinical • Crohn's disease • Gastroenterology • Gastrointestinal Cancer • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • MPO

First-in-human phase I dose escalation trial of the first-in-class tumor microenvironment modulator VT1021 in advanced solid tumors. (PubMed, Commun Med (Lond)) - P1 | "VT1021 is safe and well-tolerated across all doses tested. RP2D has been selected for future clinical studies. PR and SD with tumor shrinkage are observed in multiple patients underscoring the single-agent potential of VT1021. Expansion studies in GBM, pancreatic cancer and other solid tumors at the RP2D have been completed and results will be communicated in a separate report."

Biomarker • Journal • Metastases • P1 data • Tumor microenvironment • Fatigue • Gastrointestinal Cancer • Hepatology • Immune Modulation • Immunology • Oncology • Pancreatic Cancer • Solid Tumor • Thymoma • Thymus Cancer • CD36 • SCARB1 • THBS1

GBM AGILE: A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma (clinicaltrials.gov) - P2/3 | N=1030 | Recruiting | Sponsor: Global Coalition for Adaptive Research

Trial completion date • Trial primary completion date • Brain Cancer • CNS Tumor • Glioblastoma • Hematological Disorders • Oncology • Solid Tumor

Global Coalition for Adaptive Research in Collaboration with Cure Brain Cancer Foundation Announce the Opening of Glioblastoma Clinical Trial in Australia (Businesswire) - "The Global Coalition for Adaptive Research (GCAR) in collaboration with Cure Brain Cancer Foundation (CBCF), today announced the opening of GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment – NCT03970447) in Australia. GBM AGILE is a revolutionary patient-centered, adaptive platform trial for registration that evaluates multiple therapies for patients with newly-diagnosed and recurrent glioblastoma (GBM) – the deadliest form of brain cancer."

Licensing / partnership • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor

Vigeo Therapeutics Provides Clinical Update on VT1021 Treatment of GBM Expansion Patient (PRNewswire) - P1 | N=116 | NCT03364400 | Sponsor: Vigeo Therapeutics, Inc. | "Vigeo Therapeutics...is pleased to announce that a complete response patient (CR) in Glioblastoma (GBM) cohort from first in human study VT1021-01...has now completed 3 full years of dosing with VT1021. When joining the study in July of 2020 the patient had a recurrent case of GBM. After multiple cycles of dosing with VT1021, the tumor was no longer detectable. Now, after 3 years of dosing the tumor continues to be undetectable on regular MRI scans."

P1 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

The Role of CD36 in Cancer Progression and Its Value as a Therapeutic Target. (PubMed, Cells) - "We will also review existing approaches to targeting CD36 in pre-clinical studies, as well as discuss the only CD36-targeting drug to advance to late-stage clinical trials, VT1021. Given the roles of CD36 in the etiology of metabolic disorders, such as atherosclerosis, diabetes, and non-alcoholic fatty liver disease, the clinical implications of CD36-targeted therapy are wide-reaching, even beyond cancer."

Journal • Review • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Hepatology • Metabolic Disorders • Non-alcoholic Fatty Liver Disease • Oncology • Ovarian Cancer • Solid Tumor • CD36

Vigeo Therapeutics will present New Clinical and Immune Profiling Data from Ph I/II Expansion study in GBM Patients in ASCO Poster Oral Session (PRNewswire) - "Vigeo Therapeutics...announced new data from its Phase I/II expansion study evaluating single-agent activity of VT1021 in patients with recurrent glioblastoma (rGBM). The data will be presented by Dr. David Peereboom of Cleveland Clinic in a poster discussion session tomorrow, June 3, 2023, from 4:30 – 6:00 PM at the American Society of Clinical Oncology (ASCO) annual meeting being held June 2 – June 6, 2023 in Chicago, IL."

P2/3 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Immune profiling in patients with glioblastoma treated with VT1021 in a phase I/II expansion study. (ASCO 2023) - P1, P2/3 | "Here we report that the durable responses of peripheral immune cells to VT1021 may be associated with better clinical outcomes in rGBM subjects. These findings are consistent with the MOA of TSP-1 to reprogram the TME by stimulating immune and inflammatory cell functions. While the interpretation of our data is limited by the lack of a control arm and the small sample size, the results provide a signal and warrant continued analysis of these parameters in the ongoing phase II/III trial."

Clinical • P1/2 data • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • THBS1

Vigeo Therapeutics New Immune Profiling and Biomarker Data Ph I/II Expansion study in GBM Patients (PRNewswire) - P1/2 | N=116 | NCT03364400 | Sponsor: Vigeo Therapeutics, Inc. | "Vigeo Therapeutics...announced encouraging new data from its phase I/II expansion study evaluating single-agent activity of VT1021 in patients with recurrent glioblastoma (rGBM). The data will be presented in a poster session on June 3, 2023 from 1:15PM – 4:15PM at the American Society of Clinical Oncology (ASCO) annual meeting being held June 2 – June 6, 2023 in Chicago, IL....Among 22 evaluable subjects with rGBM, 3 had a complete response (CR), 1 had a partial response (PR), and 6 had stable disease (SD) with an average study duration of over 120 days. One subject continues to receive VT1021 treatment and has been on study for almost 3 years with no remaining measurable lesion."

P1/2 data • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=116 | Active, not recruiting | Sponsor: Vigeo Therapeutics, Inc. | Trial completion date: Jun 2023 ➔ Jun 2024 | Trial primary completion date: Dec 2022 ➔ Jan 2024

Metastases • Trial completion date • Trial primary completion date • Brain Cancer • Breast Cancer • Gastrointestinal Cancer • Glioblastoma • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • BRCA • CD36

Clinical update of VT1021, a first-in-class CD36 and CD47 targeting immunomodulating agent, in subjects with pancreatic cancer and other solid tumors stratified by novel biomarkers (SITC 2021) - P1 | "Based on these findings, the DH expression of CD36/CD47 could be a useful predictive biomarker to stratify subjects for inclusion in future trials in pancreatic cancer, and in other solid tumor indications. Trial Registration NCT03364400"

Biomarker • Clinical • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD36 • CD47 • CD8 • THBS1

[VIRTUAL] A first-in-human Phase 1/2 open label trial evaluating the safety, pharmacology, and preliminary efficacy of VT1021 in subjects with advanced solid tumors (SITC 2020) - P1 | "Conclusions Through all doses tested, VT1021 was safe and well tolerated, with dose proportional PK properties. In addition, VT1021 has demonstrated activities in reprogramming the TME which resulted in a high disease control rate in subjects with tumors expressing both high CD36 and high CD47."

Clinical • P1/2 data • Breast Cancer • Glioblastoma • Oncology • Pancreatic Cancer • Solid Tumor • Thymus Cancer • Triple Negative Breast Cancer • CD36 • THBS1

Global Coalition for Adaptive Research, Biohaven, and Vigeo Announce Commencement of Biohaven’s Troriluzole and Vigeo’S VT1021 in GBM AGILE Trial (Businesswire) - "...The Global Coalition for Adaptive Research (GCAR) in collaboration with Biohaven and Vigeo Therapeutics, today announced the activation of Biohaven's troriluzole and Vigeo's VT1021 in GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment)....Troriluzole and VT1021 will enroll patients with newly-diagnosed and recurrent glioblastoma."

Trial status • Brain Cancer • CNS Tumor • Glioblastoma • Oncology

Phase 1 Study Evaluating VT1021 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=116 | Active, not recruiting | Sponsor: Vigeo Therapeutics, Inc. | Trial completion date: Mar 2022 ➔ Jun 2023 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Breast Cancer • Gastrointestinal Cancer • Glioblastoma • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • CD36

"#VigeoTherapeutics Advances #VT1021 Into Phase 2-3 Registrational Study for #Glioblastoma https://t.co/HEfacjmylf" (@1stOncology)

Brain Cancer • Glioblastoma • Oncology • Solid Tumor

Vigeo Therapeutics Advances VT1021 Into Phase 2-3 Registrational Study for Glioblastoma (PRNewswire) - "Vigeo Therapeutics...announced its lead candidate VT1021 will advance into a Phase 2-3 registrational study through the company's collaboration with the Global Coalition for Adaptive Research (GCAR). VT1021 will be part of GCAR's GBM AGILE Phase 2-3 adaptive platform trial for patients with glioblastoma....Vigeo also plans to initiate efficacy studies in additional solid tumor indications, including pancreatic cancer, with its lead candidate, VT1021 during the first half of 2022."

Trial status • Gastrointestinal Cancer • Glioblastoma • Oncology • Pancreatic Cancer • Solid Tumor

Clinical efficacy and biomarker assessment of VT1021, a CD36/CD47 dual-targeting agent, in recurrent glioblastoma (SNO 2021) - "In conclusion, VT1021 demonstrates promising single-agent clinical activity in rGBM, particularly in subjects with high expression levels of CD36 and CD47. Additional clinical studies have been planned to further investigate the efficacy of VT1021 in rGBM and other solid tumor indications."

Biomarker • Clinical • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • CD36 • CD47

Development of Thrombospondin-1 as a clinical pharmacodynamic biomarker for VT1021, a first-in-class therapeutic agent that reprograms the tumor microenvironment. (SITC 2021) - "For subjects with pancreatic cancer, Tsp-1 protein induction in PBMCs is a potential prognostic biomarker. The predictive/prognostic utility coupled with the ability to measure levels in peripheral blood makes Tsp-1 a powerful biomarker to assess and predict clinical response to VT1021."

Biomarker • Clinical • PK/PD data • Tumor microenvironment • Brain Cancer • Gastrointestinal Cancer • Glioblastoma • Oncology • Pancreatic Cancer • Solid Tumor • CD36 • ITGAM • THBS1

Vigeo Therapeutics Announces New Phase 1/2 Data from its Expansion Study of VT1021 at the Society of NeuroOncology's 2021 Annual Meeting (PRNewswire) - P1, N=116; NCT03364400; Sponsor: Vigeo Therapeutics, Inc.; "Vigeo Therapeutics...announced new clinical data from its Phase 1/2 expansion study evaluating the single-agent activity of VT1021 in subjects with recurrent glioblastoma (rGBM). The data is being presented in a poster session at the Society for NeuroOncology's (SNO) 2021 Annual Meeting, taking place from November 18-21, 2021 in Boston...Among 22 evaluable GBM subjects, 3 had complete response (CR), 1 had partial response (PR), and 7 had stable disease (SD). The overall disease control rate (DCR) was 50%...Vigeo plans to initiate Phase 2/3 studies in GBM as well as pancreatic cancer during the first half of 2022."

P1/2 data • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Vigeo Therapeutics Announces New Phase 1/2 Data from its Expansion Study of VT1021 at the Society for Immunotherapy of Cancer's 2021 Annual Meeting (PRNewswire) - P1, N=116; NCT03364400; Sponsor: Vigeo Therapeutics, Inc; "In the pancreatic cancer expansion cohort, VT1021, when administered as a single agent, was able to induce a reduction in tumor volume in 38% of subjects with measurable disease....Vigeo plans to initiate Phase 2/3 studies in both pancreatic cancer and rGBM during the first half of 2022. Vigeo will present additional results from the GBM expansion cohort at the Society for Neuro-Oncology (SNO) Conference in November 2021 in Boston, MA."

P1 data • Gastrointestinal Cancer • Glioblastoma • Oncology • Pancreatic Cancer • Solid Tumor

Vigeo Therapeutics to Present New Phase 1/2 VT1021 Data from its Pancreatic Cancer Expansion Study at the Society for Immunotherapy of Cancer's 2021 Annual Meeting (PRNewswire) - "The company will present data from the pancreatic cancer expansion cohort with single-agent VT1021 which demonstrated tumor reduction in multiple subjects with measurable disease. The second poster demonstrates the utility of Tsp-1 as a pharmacodynamic biomarker and its correlation with clinical response."

Biomarker • P1/2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

[VIRTUAL] A first-in-human Phase 1/2 open label trial evaluating the safety, pharmacology, and preliminary efficacy of VT1021 in subjects with advanced solid tumors (SITC 2020) - P1 | "Conclusions Through all doses tested, VT1021 was safe and well tolerated, with dose proportional PK properties. In addition, VT1021 has demonstrated activities in reprogramming the TME which resulted in a high disease control rate in subjects with tumors expressing both high CD36 and high CD47."

Clinical • P1/2 data • Breast Cancer • Glioblastoma • Oncology • Pancreatic Cancer • Solid Tumor • Thymus Cancer • Triple Negative Breast Cancer • CD36 • THBS1