Vigeo Therapeutics Advances VT1021 Into Phase 2-3 Registrational Study for Glioblastoma

CAMBRIDGE, Mass., Jan. 20, 2022 /PRNewswire/ -- Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, today 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.  

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 then blocks the CD47 immune checkpoint and reprograms the CD36 receptor to induce tumor cell apoptosis, inhibit angiogenesis, and reprogram macrophages from the M2 to M1 phenotype.

GBM AGILE is a patient-centered adaptive platform trial to support registration that tests multiple therapies for patients with newly diagnosed and recurrent glioblastoma (rGBM) - the deadliest form of brain cancer.

VT1021 was selected for inclusion in the global AGILE Phase 2-3 trial based on the unique and relevant mechanism of action and the existing clinical (safety) data from the completed open-label, multicenter Phase 1/2 study (NCT03364400), evaluating the safety and preliminary anti-tumor efficacy of single-agent VT1021 in subjects enrolled in both dose escalation and dose expansion cohorts.

In the rGBM expansion cohort, VT1021 demonstrated significant single agent activity.  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%. In the responder group, the average time on study was over 300 days with 2 subjects on study for over 480 days at the conclusion of the study. These two subjects continued to receive VT1021 through an extension study and have both have gone over 525 days receiving VT1021. 

"We are excited that GCAR selected VT1021 for its Phase 2-3 study for patients with glioblastoma," said Vigeo COO Dr. Jing Watnick. "In the expansion study, VT1021 demonstrated noteworthy single-agent clinical activity in rGBM, particularly in subjects with high expression levels of CD36 and CD47, and we believe it could be an important new treatment option for patients. We look forward to providing an update when the trial commences."   

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.

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 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.

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. Single-agent VT1021 has been investigated in a Phase 1/2 clinical trial in patients with glioblastoma, pancreatic cancer and other solid tumors, and is currently progressing to late-stage clinical development.

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About Global Coalition for Adaptive Research (GCAR)
The Global Coalition for Adaptive Research (GCAR) is a 501(c)(3) nonprofit organization uniting physicians, clinical researchers, advocacy and philanthropic organizations, biopharma, health authorities, and other key stakeholders in healthcare to expedite the discovery and development of treatments for patients with rare and deadly diseases by serving as sponsor of innovative and complex trials including master protocols and platform trials. GCAR is the sponsor of GBM AGILE, an adaptive platform trial for patients with GBM – the most common and deadliest of malignant primary brain tumors. Key strategic partners for the GBM AGILE trial effort include the National Brain Tumor Society, National Foundation for Cancer Research, and Asian Fund for Cancer Research, three nonprofit organizations that are working together to provide philanthropic support as well as assistance in communicating with patients and families and inviting all others to join in supporting this innovating approach to brain tumor treatment development. To learn more about GCAR, visit www.gcaresearch.org

SOURCE Vigeo Therapeutics