Vigeo Therapeutics, Inc.

CAMBRIDGE, Mass., July 13, 2023 /PRNewswire/ -- Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, is pleased to announce that a complete response patient (CR) in Glioblastoma (GBM) cohort from first in human study VT1021-01 (NCT03364400) 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. "The Vigeo Team continues to be encouraged at how well this patient has responded to VT1021 therapy" said Jing Watnick, COO of Vigeo Therapeutics, "Vigeo is currently testing the potential of VT1021 therapy in both newly diagnosed and recurrent GBM patients as part of an ongoing phase II/III clinical study (NCT03970447)." VT1021 is a first-in-class compound that, by binding to MDSCs, induces the expression of thrombospondin-1 (Tsp-1) in the tumor microenvironment (TME). Tsp-1 blocks the CD47 immune checkpoint and engages CD36 to induce tumor cell apoptosis, inhibit angiogenesis, activate cytotoxic T cells (CTL), and reprogram macrophages from the M2 to M1 phenotype. Vigeo recently reported the outcome of a GBM cohort of recurrent subjects treated with VT1021 as a single agent in which a group of 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. Historically, rGBM patients have a response rate of less than 5% and a median progression free survival of 48 days. About VT1021 Vigeo's lead asset, VT1021, is a first-in-class dual-modulating compound that blocks the CD47 immune checkpoint and activates CD36, which induces apoptosis in tumors and endothelial cells, and increases the M1:M2 macrophage ratio. VT1021 achieves these biological effects via stimulation of thrombospondin-1 (Tsp-1). The goal of these dual-modulating effects is conversion of immuno-suppressive, or "cold," tumors that that are associated with poor response to immuno-oncology agents, to immuno-stimulated, or "hot," tumors that are more susceptible to attack from the body's immune system. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors. About Vigeo Therapeutics Based in Cambridge, MA, Vigeo Therapeutics is a clinical-stage immuno-oncology company pioneering novel cancer therapies. The company is building a first-in-class drug development pipeline being led by VT1021, its dual-modulating compound that blocks the CD47 immune checkpoint and reprograms CD36 mediated activities. VT1021 has been investigated as a single agent in a Phase I/II clinical trial in patients with glioblastoma, pancreatic cancer and other solid tumors, and is currently undertaking late-stage clinical studies. For more information visit vigeotx.com

CAMBRIDGE, Mass., June 2, 2023 /PRNewswire/ -- Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, today 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. VT1021 is a first-in-class compound that, by binding to MDSCs, induces the expression of thrombospondin-1 (Tsp-1) in the tumor microenvironment (TME). Tsp-1 blocks the CD47 immune checkpoint and engages CD36 to induce tumor cell apoptosis, inhibit angiogenesis, activate cytotoxic T cells (CTL), and reprogram macrophages from the M2 to M1 phenotype. In a phase I/II clinical study in solid tumors (NCT03364400) VT1021 demonstrated promising single-agent clinical activity against recurrent glioblastoma. 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. Historically, rGBM patients have a response rate of less than 5% and a median progression free survival of 48 days. Confirming the role of VT1021 in altering the tumor microenvironment, immune profiling of the GBM patients on the study showed beneficial and sustained changes in CTL parameters and PD-L1+ MDSCs that correlated with response. Specifically, CR/PR subjects showed decreases in PDL1+ MDSCs along with an increase in total CTLs, proliferating CTLs, and CTL/Treg ratio. In contrast, SD and PD subjects exhibited no change or decrease in these three CTL parameters. "The demonstration of the effect of VT1021 on the tumor immune microenvironment and the correlation with clinical outcome are encouraging signs in the development of new therapies for GBM patients" said Dr. David Peereboom of Cleveland Clinic. "To further advance VT1021 as a therapy for GBM, Vigeo is studying the potential of VT1021 in both newly diagnosed and recurrent subjects in an ongoing phase II/III clinical study (NCT03970447)" said Dr. Jing Watnick, COO and co-founder of Vigeo Therapeutics. Presentation Title: Immune profiling in patients with glioblastoma treated with VT1021 in a phase I/II expansion study. Date & Time: Saturday June 3, 2023 from 4:30PM – 6:00 PM Abstract Session: Central Nervous System Tumors Abstract: 409504 Location: Board # 378 Presenter: David M. Peereboom, MD Professor of Medicine, Cleveland Clinic About VT1021 Vigeo's lead asset, VT1021, is a first-in-class dual-modulating compound that blocks the CD47 immune checkpoint and activates CD36, which induces apoptosis in tumors and endothelial cells, and increases the M1:M2 macrophage ratio. VT1021 achieves these biological effects via stimulation of thrombospondin-1 (Tsp-1). The goal of these dual-modulating effects is conversion of immuno-suppressive, or "cold," tumors that that are associated with poor response to immuno-oncology agents, to immuno-stimulated, or "hot," tumors that are more susceptible to attack from the body's immune system. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors. About Vigeo Therapeutics Based in Cambridge, MA, Vigeo Therapeutics is a clinical-stage immuno-oncology company pioneering novel cancer therapies. The company is building a first-in-class drug development pipeline being led by VT1021, its dual-modulating compound that blocks the CD47 immune checkpoint and reprograms CD36 mediated activities. VT1021 has been investigated as a single agent in a Phase I/II clinical trial in patients with glioblastoma, pancreatic cancer and other solid tumors, and is currently undertaking late-stage clinical studies. For more information visit vigeotx.com

CAMBRIDGE, Mass., May 25, 2023 /PRNewswire/ -- Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, today 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. VT1021 is a first-in-class compound that, by binding to MDSCs, induces the expression of thrombospondin-1 (Tsp-1) in the tumor microenvironment (TME). Tsp-1 blocks the CD47 immune checkpoint and engages CD36 to induce tumor cell apoptosis, inhibit angiogenesis, activate cytotoxic T cells (CTL), and reprogram macrophages from the M2 to M1 phenotype. In a phase I/II clinical study in solid tumors (NCT03364400), VT1021 demonstrated promising single-agent clinical activity against recurrent glioblastoma. 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. Historically, rGBM patients have a response rate of less than 5% and a median progression free survival of 48 days. Confirming the Mechanism of Action (MOA) of VT1021, extensive analysis of tumor immune profiles revealed beneficial and sustained changes in CTL parameters and PD-L1+ MDSCs that correlated with response. Specifically, CR/PR subjects showed decreases in PDL1+ MDSCs along with increases in total CTLs, proliferating CTLs, and CTL/Treg ratio. In contrast, SD and PD subjects exhibited no change or decrease in these three CTL parameters. "Demonstrating that the expected MOA of VT1021 in reprogramming the TME may be associated with better clinical outcomes in rGBM subjects confirms the efforts of our clinical development program," said Vigeo COO and co-founder, Dr. Jing Watnick. Vigeo is already studying the therapeutic effect of VT1021 in both newly diagnosed and recurrent GBM in an ongoing phase II/III clinical study (NCT03970447). Presentation Title: Immune profiling in patients with glioblastoma treated with VT1021 in a phase I/II expansion study. Date & Time: Saturday June 3, 2023 from 1:15PM – 4:15 PM Abstract Session: Central Nervous System Tumors Abstract: 409504 Location: Board # 378 Presenter: Jian Chen, Ph.D. Senior Director of Research at Vigeo Therapeutics. About VT1021 Vigeo's lead asset, VT1021, is a first-in-class dual-modulating compound that blocks the CD47 immune checkpoint and activates CD36, which induces apoptosis in tumors and endothelial cells, and increases the M1:M2 macrophage ratio. VT1021 achieves these biological effects via stimulation of thrombospondin-1 (Tsp-1). The result of these dual-modulating effects is conversion of immuno-suppressive, or "cold," tumors that are associated with poor response to immuno-oncology agents, to immuno-stimulated, or "hot," tumors that are more susceptible to attack from the body's immune system. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors. About Vigeo Therapeutics Based in Cambridge, MA, Vigeo Therapeutics is a clinical-stage immuno-oncology company pioneering novel cancer therapies. The company is building a first-in-class drug development pipeline led by VT1021, its dual-modulating compound that blocks the CD47 immune checkpoint and reprograms CD36 mediated activities. VT1021 has been investigated as a single agent in a phase I/II clinical trial in patients with glioblastoma, pancreatic cancer, and other solid tumors, and is currently undertaking late-stage clinical studies. For more information visit vigeotx.com. SOURCE Vigeo Therapeutics