Boston, Massachusetts — August 13, 2025 — Leads & Copy — Cue Biopharma, Inc. (Nasdaq: CUE) has initiated an investigator-sponsored trial (IST) in recurrent glioblastoma multiforme (rGBM) at the Dana-Farber Cancer Institute (DFCI). The first patient in the trial has been dosed with CUE-102, the company announced today. 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 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, said Dr. David A. Reardon, principal investigator of the Phase 1b trial and Clinical Director of the Center for Neuro-Oncology at DFCI. CUE-102 is designed to target tumor cells by activating WT1 specific T cells, which may improve clinical outcomes in recurrent GBM.
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, said Dr. Matteo Levisetti, chief medical officer at Cue Biopharma. 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.
CUE-102 is Cue Biopharma’s second clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand Wilms’ Tumor 1 (WT1)-specific T cells by presenting the WT1 peptide to the WT1-specific T cell receptor.
Glioblastomas are the most common primary cancer of the brain and the most aggressive type of brain tumor. There are ~13,000 new cases diagnosed each year in the United States. The most common length of survival following diagnosis is ~12 to 15 months, with fewer than ~3 to 5 percent of people surviving longer than five years.
Investor Contact:
Marie Campinell
Senior Director, Corporate Communications
Cue Biopharma, Inc.
mcampinell@cuebio.com
Media Contact:
Jonathan Pappas
LifeSci Communications
jpappas@lifescicomms.com
Source: Cue Biopharma
