On June 4, 2024 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, reported updated data from its ongoing Phase 1 trial evaluating its lead oncology asset from the CUE-100 series of biologics, CUE-101 (Press release, Cue Biopharma, JUN 4, 2024, View Source [SID1234644098]). The data will be presented in an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting today June 4, 2024, in Chicago, IL.

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Oral Presentation Details:
Abstract Number: 6004
Session Type and Title: Oral Abstract Session; Head and Neck Cancer
Session Date and Time: June 4, 2024, 9:45 AM-12:45 PM CDT
Title: A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (R/M HNSCC).
Presenter: Douglas R. Adkins, M.D., Professor of Medicine, Washington University School of Medicine

In addition, on Saturday, June 1, 2024, the Company presented a poster on its second clinical asset from the CUE-100 series, CUE-102, in which data-to-date has demonstrated expansion of Wilms’ Tumor 1 (WT1)-specific T cells, anti-tumor activity and favorable tolerability.

"The objective response rate observed with CUE-101 and pembrolizumab is very encouraging. The combination was well-tolerated, and responses appeared to be durable," said Douglas R. Adkins, M.D., Professor, Division of Oncology at the Washington University School of Medicine in St. Louis, and a principal investigator participating in the CUE-101 clinical trial. "These results appear to support the continued development of CUE-101 with the potential of CUE-101 providing an improved treatment alternative for this patient population."

Key data highlights to date from the expansion portion of the trial evaluating CUE-101 at the recommended Phase 2 dose (RP2D) of 4mg/kg in combination with pembrolizumab with 24 evaluable 1L patients (data cutoff of May 1, 2024):

ORR of 46% and Disease Control Rate (DCR) of 79% in patients with combined positive score (CPS) ≥1, compared to an ORR of 19% observed with pembrolizumab alone in the historical third-party KEYNOTE-048 trial. This includes one complete response (CR) and 10 partial responses (PR), in addition to eight durable stable diseases (DSD) of >12 weeks.
12-month overall survival (OS) of 96%.
Median progression free survival (PFS) of 5.8 months compared to 3.2 months with pembrolizumab alone in the third-party KEYNOTE-048 trial.
Key data highlights from the CUE-101 expansion portion of the Phase 1b trial evaluating CUE-101 at the RP2D as monotherapy with 20 evaluable 2L+ patients (majority 3L+):

mOS of 20.8 months, notably longer than the historical mOS of 7.5 and 8.4 months reported in third-party 2L R/M HNSCC trials: CheckMate 141 and KEYNOTE-040, respectively.
No unanticipated, significant safety concerns have emerged in either the combination or monotherapy trials, and adverse events have been readily managed with appropriate medical care.

Matteo Levisetti, M.D., chief medical officer of Cue Biopharma added, "We are pleased with the clinical activity observed in patients treated with CUE-101 in combination with pembrolizumab. We believe that the data provide a strong foundation for further development, supporting our goal of bringing a new treatment option to this patient population."

Key data highlights to date from the fully enrolled CUE-102 dose escalation part of the Phase 1 clinical trial (data cutoff of May 1, 2024) include:

DCR of 43.5%
Two patients at the 2mg/kg dose, one with gastric cancer and one with ovarian cancer have demonstrated reductions in tumor burden.
Selective expansion of WT1-specific T cells in multiple patients.
No dose-limiting toxicities or drug-related serious adverse events have been reported to date in patients treated during the dose escalation phase at doses ranging between 1-8mg/kg of CUE-102.
Expansion at CUE-102 4mg/kg is ongoing.
The CUE-101 oral presentation and CUE-102 poster presentation will be available in the Investors & Media section of the Company’s website at www.cuebiopharma.com under Scientific Publications and Presentations, following ASCO (Free ASCO Whitepaper).

About the CUE-100 Series
The CUE-100 series consists of Fc-fusion biologics that present two signals to T cells. Signal #1 is a tumor-specific peptide linked to a major histocompatibility complex (pMHC) to enable selectivity and specificity. Signal #2 is a rationally engineered interleukin 2 (IL-2) molecule to trigger T cell activation. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

About CUE-101 and the Phase 1 trial
CUE-101 is Cue Biopharma’s lead clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand HPV16 tumor-specific T cells by presenting the HPV E7 protein to the HPV-specific T cell receptor. CUE-101 is currently being evaluated in a fully enrolled Phase 1 open-label, dose escalation and expansion study, for the treatment of HPV16+ driven recurrent/metastatic head and neck squamous cell carcinoma in second line (2L) and beyond patients as a monotherapy, and as a first line (1L) therapy in combination with pembrolizumab (KEYTRUDA).

About CUE-102 and the Phase 1 trial
CUE-102 is Cue Biopharma’s second lead 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. WT1 is a well-recognized onco-fetal protein known to be over-expressed in a number of cancers, including solid tumors and hematologic malignancies. CUE-102 is being evaluated in a Phase 1 open label, two-part dose escalation and expansion study, for patients with late-stage colorectal, gastric/gastroesophageal junction, pancreatic and ovarian cancers that express WT1.