November 09, 2020
Vigeo Therapeutics to Present New Phase 1/2 VT1021 Dose Escalation and Expansion Data at the Society for Immunotherapy of Cancer’s 2020 Annual Meeting
75% of Patients Who Achieved a Partial Response or Stable Disease Had High Expression of Both CD47 and CD36
Dose Escalation Complete; Single-Agent VT1021 Demonstrating Favorable Safety Profile and Early Signals of Clinical Activity
Cambridge MA, November 9, 2020 (PR Newswire) – Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, today announced that interim clinical data from its ongoing Phase 1/2 study evaluating single-agent activities of VT1021 in patients with advanced solid tumors, will be presented in a poster session at the Society for Immunotherapy of Cancer’s (SITC) 2020 Annual Meeting, taking place from November 9-14, 2020.
VT1021 is a first-in-class, dual-modulating compound that blocks the CD47 immune checkpoint and activates CD36, stimulating cytotoxic T-cell functions, inducing apoptosis in tumor and endothelial cells, and increasing the phagocytosis of the tumor by M1 macrophages by stimulating the production of thrombospondin-1 (Tsp-1). Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors.
“The data being presented at SITC are important because they demonstrate that VT1021 as a single-agent has a favorable safety profile, and is showing early signals of clinical activity across a wide variety of solid tumors, including pancreatic cancer and glioblastoma,” said Dr. Devalingam Mahalingam, Associate Professor of Medicine at Northwestern University Feinberg School of Medicine, member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University and lead author of the study. “Notably, in the dose escalation cohort we observed a durable partial response rate in a patient with thymoma and a 43% disease control rate in subjects with tumors expressing both high CD47 and high CD36, which speaks to the potential of this dual-modulating agent in subsets of patients with advanced chemo-refractory solid tumors.”
Lou Vaickus, MD, FACP, interim Chief Medical Officer at Vigeo, stated, “Patients who have high levels of either CD36 or CD47 have a worse prognosis and a greater likelihood of developing resistance to conventional therapies, and currently there are no therapeutics that simultaneously target both receptors. VT1021 is unique because it stimulates the expression of Tsp-1 which then binds with high affinity to its natural receptors CD47 and CD36, blocking CD47 and the “do not eat me” signal and activating CD36, leading to a cascade of beneficial changes to the TME that are believed to enhance anti-tumor effects. We are highly encouraged by this new data and look forward to further elucidating the clinical activity of VT1021 in the dose expansion portion of this study and in combination studies slated to begin during the first half of 2021.”
- VT1021 was found to be safe and well tolerated across all doses tested.
- PK analysis has demonstrated dose proportionality across all dose levels.
- Dose escalation cohort showed preliminary efficacy: Of 28 evaluable patients, one showed partial response (PR) and 11 others achieved stable disease (SD) in 9 different solid tumors with a median of 4.5 prior lines of therapy for a disease control rate of 43%.
- Of the 12 patients who achieved PR/SD’s in the dose escalation cohort, 9 (75%) have showed high CD36 and high CD47 expression as determined by an immunohistochemical (IHC) assay.
- The RP2D of VT1021 has been determined as 11.8mg/kg.
Details for the SITC 2020 presentation are as follows:
Title: 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
Presenter: Devalingam Mahalingam, Associate Professor of Medicine, Feinberg School of Medicine, Northwestern University
Session Type: Poster Session
Abstract Number: 374
Date and Time: Thursday, November 12 from 4:50–5:20 p.m. EST and Saturday, November 14 from 1–1:30 p.m. EST
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 and increases the M1:M2 macrophage ratio. VT1021 achieves this through stimulation of thrombospondin-1 (Tsp-1). The goal of these dual-modulating effects is conversion of immuno-suppressive, or “cold,” tumors that don’t respond to immuno-oncology agents, to immuno-stimulated, or “hot,” tumors that are potentially more receptive to immuno-oncology agents. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors. Pre-clinical results have demonstrated that single-agent VT1021 causes tumor regression at both the primary and metastatic sites.
Single-agent VT1021 is currently being evaluated in a Phase 1/2, open label, multicenter trial (NCT03364400) that assesses the drug’s safety, tolerability, and preliminary anti-tumor efficacy. The trial’s dose escalation phase is now concluded, and the dose expansion phase has been initiated. The expansion phase is expected to enroll 75-100 `patients into one of three cohorts: pancreatic cancer, glioblastoma, and a basket cohort with cancers expressing both high CD47 and high CD36.
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 activates CD36. Single-agent VT1021 is currently being evaluated in a Phase 1/2 clinical trial, and the company expects to initiate combination studies during the first half of 2021. For more information visit vigeotherapeutics.com.
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