On November 16, 2021 Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, reported new clinical data from its Phase 1/2 expansion study evaluating the single-agent activity of VT1021 in subjects with recurrent glioblastoma (rGBM) (Press release, Vigeo Therapeutics, NOV 16, 2021, View Source [SID1234595721]). 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.
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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. In the completed open-label, multicenter Phase 1/2 study (NCT03364400), the safety and preliminary anti-tumor efficacy of single-agent VT1021 was evaluated 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 still on study for over 480 days as of October 31, 2021. These two subjects will continue receiving VT1021 through an extension study.
"Glioblastoma is the most common and aggressive form of brain cancer in adults, recurring after treatment in more than 90% of all patients," 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. Vigeo is committed to studying the potential of VT1021 in both newly diagnosed and recurrent GBM subjects in future clinical trials."
Vigeo plans to initiate Phase 2/3 studies in GBM as well as pancreatic cancer during the first half of 2022.
Details for the SNO 2021 presentation are as follows:
Title: Clinical efficacy and biomarker assessment of VT1021, a CD36/CD47 dual-targeting agent, in recurrent glioblastoma
Presenter: Manmeet Ahluwalia, MD
Session: Poster Session
Poster #: CTIM-06
Date and time: November 19, 2021, 7:30 pm – 9:30 pm
About VT1021
Vigeo’s lead asset, VT1021, is a first-in-class dual modulating compound that blocks the CD47 immune checkpoint and activates the apoptotic and macrophage reprogramming activity of CD36. The result of the dual modulating activity is the induction of apoptosis as well as an increase in both CTL:Treg and M1:M2 macrophage ratio. The biological/therapeutic activity of VT1021 is mediated by the stimulation of thrombospondin-1 (Tsp-1). Through these dual-modulating effects VT1021 reprograms the tumor microenvironment (TME) from one that is immune suppressive, or "cold," to immune enhanced (or sensitized), or "hot," that are more susceptible to attack from the immune system. Vigeo is developing VT1021 as a therapeutic agent across a range of cancers, with a current focus on solid tumors.