Vigeo Therapeutics New Immune Profiling and Biomarker Data Ph I/II Expansion Study in GBM Patients

Vigeo Therapeutics, a clinical-stage immuno-oncology company pioneering novel cancer therapies, has announced encouraging new data from its phase I/II expansion study evaluating single-agent activity of VT1021 in patients with recurrent glioblastoma (GBM). 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).