Cue Biopharma Announces FDA Acceptance of IND for Lead Immuno-oncology Candidate CUE-101

Cue Biopharma (NASDAQ:CUE) has announced that the US Food and Drug Administration (FDA) has accepted Cue Biopharma’s investigational new drug application for its lead immuno-oncology candidate, CUE-101 as a potential treatment for HPV-related cancers.

As quoted in the press release:

“FDA acceptance of our IND filing for CUE-101 is an important step toward validating our approach for selective modulation of disease-relevant T cells directly in patients with an “off-the shelf” biologic. Our clinical trial of CUE-101 aims to replicate promising pre-clinical studies that have shown the ability to expand specific T cell populations exhibiting polyfunctionality, which is characteristic of potent anti-tumor activity. We believe CUE-101 will enhance anti-tumor immunity in patients with HPV16-driven malignancies,” said Dan Passeri, M.Sc., J.D., President and CEO of Cue Biopharma. “Representative of the IL-2 based CUE-100 series, CUE-101 is a novel fusion protein designed to activate and expand a population of tumor specific T cells directly in the patient’s body. In this clinical trial, we plan to demonstrate, for the first time, the ability to significantly expand disease modifying T cells without the deleterious off-target side effects typically associated with other approaches.”

“The ability to offer a therapeutic with the potential to activate and amplify cancer-specific T cells directly in a patient’s body differentiates CUE-101 from other immunotherapies in development,” said Ken Pienta, M.D., Chief Medical Officer of Cue Biopharma. “We are pleased to enter the clinic with CUE-101 and provide patients suffering from HPV-driven cancers with this promising new clinical drug candidate.”

The primary objectives of the open-label, multi-center Phase 1 trial, are to assess the safety and tolerability of CUE-101 in patients with recurrent/metastatic HNSCC and to determine the maximum tolerated dose or recommended Phase 2 dose based on markers of biological activity. Pharmacokinetics (PK), anti-tumor immune response, preliminary anti-tumor activity and the potential for immunogenicity will also be assessed. This Phase 1 trial will be conducted in the U.S. and involve approximately 50 patients.

“Our IND filing and subsequent clinical study are based on foundational mechanistic datasets that underscore the impact of the Immuno-STAT platform in selective engagement and activation of tumor-specific T cells while avoiding systemic activation of the broader immune compartment,” added Anish Suri, Ph.D., Senior Vice President and Chief Scientific Officer of Cue Biopharma. “Insights gained from our preclinical studies will directly guide our translational approach including analysis of patient samples to probe for mechanistic signals of T cell activation, expansion and acquisition of effector function for tumor-target killing. Harnessing immune specificity while avoiding collateral damage is a significant challenge in the area of cancer immunotherapy, and we believe rational protein engineering, as applied in the Immuno-STAT biologic framework, can be deployed to circumvent these impediments.”

Click here to read the full press release.