Cue Biopharma Announces Initiation of Investigator Sponsored Trial of CUE-102 in Recurrent Glioblastoma Multiforme

First patient dosed with CUE-102 for recurrent glioblastoma multiforme (rGBM) at Dana-Farber Cancer Institute (DFCI)

Excerpt from the Press Release:

BOSTON, Aug. 13, 2025 (GLOBE NEWSWIRE) — Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, announced today the initiation of an investigator sponsored trial (IST) in rGBM at the DFCI with the first patient in the trial having been dosed with CUE-102. The trial (NCT06917885) is a Phase 1b, open-label study of adjuvant CUE-102, the Company’s drug product candidate targeting Wilms’ Tumor 1 protein (WT1) expressing cancers. The principal investigator of the Phase 1b trial, David A. Reardon, MD, is the Clinical Director of the Center for Neuro-Oncology at DFCI and a leader in the field of immunotherapy for the treatment of brain cancer. The goal of the study is to evaluate the tolerability and clinical activity of CUE-102 in patients with GBM at first recurrence.

“Glioblastoma remains one of the most aggressive and hard-to-treat cancers, and as a result, there is a pressing need for more effective therapies. Investigational treatments targeting WT1 in GBM have shown a potential correlation between expansion of antigen-specific T cells and survival,” said Dr. Reardon. “CUE-102 is designed to target tumor cells by activating WT1 specific T cells, which may improve clinical outcomes in recurrent GBM.”

Matteo Levisetti, MD, chief medical officer at Cue Biopharma, added, “Glioblastoma is an immunologically ‘cold’ tumor representing a disadvantage for treatment with standard immunotherapies such as checkpoint inhibitors, but is known to express high levels of the Wilms’ Tumor 1 oncofetal protein. We believe the mechanism of action of CUE-102, to preferentially activate and expand WT1 tumor-specific T cells, has the potential to activate and generate an enhanced anti-tumor immune response against glioblastoma.

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