Cue Biopharma has dosed the first subject in a Phase I dose escalation clinical trial of its drug candidate, CUE-102, as a single agent to treat Wilms’ Tumor 1 (WT1)-positive recurrent/metastatic cancer patients. 

In the initial stage, the trial will focus on gastric, colorectal, ovarian, and pancreatic cancers.

The open-label, multicentre, dose escalation and expansion trial will analyse the safety, tolerability, anti-tumour activity, and immunogenicity of CUE-102.

It will enrol nearly 50 HLA-A*0201-positive WT1-positive recurrent/metastatic cancer patients who have failed standard treatments. 

The second candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics, CUE-102, is in the development stage as a new therapeutic fusion protein. 

It is said to selectively trigger tumour antigen-specific T cells for treating WT1-expressing cancers. 

CUE-102 comprises two WT1 peptide-presenting human leukocyte antigen (HLA) molecules, four affinity-attenuated IL-2 molecules, and an effector attenuated human immunoglobulin G (IgG1) Fc domain. 

Cue Biopharma CEO Dan Passeri said: “Initiating this Phase I clinical study of CUE-102 at a starting dose of 1mg/kg, a clinically active dose in our Phase I CUE-101 clinical trial for HPV+ head and neck cancer, is an important step forward in demonstrating the modularity of our Immuno-STAT platform and the broader clinical potential of our CUE-100 series of biologics. 

“We believe, given the preservation of the core molecular framework between CUE-102 and CUE-101 with the primary exception of the tumour-specific epitope, initiating the dose escalation trial at 1mg/kg will result in reduced time and cost to evaluate tolerability at therapeutically active doses.”

WT1 is a known onco-foetal protein over-expressed in various cancers including hematologic malignancies and solid tumours such as glioblastoma, gastric, pancreatic, endometrial, breast, lung, ovarian, colorectal, and acute myeloid leukaemia.