Cue Biopharma Reports Positive Phase 1 Data for CUE-101 and CUE-102 in Cancer at SITC Meeting

Cue Biopharma, Inc., a clinical-stage biopharmaceutical company, has recently shared updated findings from its Phase 1 dose escalation and expansion trial for its leading oncology candidate, CUE-101. The company is developing innovative biologics that target and regulate disease-specific T cells for cancer and autoimmune disease treatment. The new data was presented at the Society for Immunotherapy of Cancer’s 39th Annual Meeting (SITC 2024) in Houston, Texas, and online.

CUE-101, part of the Immuno-STAT™ CUE-100 series, is being tested on patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Key findings from the trial include an Objective Response Rate (ORR) of 46%, a 12-month overall survival (OS) rate of 91.3%, and a median overall survival (mOS) of 21.8 months when used in combination with pembrolizumab as a first-line treatment for HPV+ R/M HNSCC patients. Furthermore, in patients with low PD-L1 expression (CPS 1-19), the combination yielded an ORR of 50%.

Additionally, Cue Biopharma is presenting data from its Phase 1 trial for its second clinical asset from the CUE-100 series, CUE-102, which targets late-stage cancers positive for Wilms Tumor 1 (WT1+), including colorectal, gastric, ovarian, and pancreatic cancers. The results showed a 67% overall disease control rate (DCR), with one unconfirmed partial response marked by a 40% reduction in tumor size. Importantly, no dose-limiting toxicities were observed.

Dr. Christine H. Chung of Moffitt Cancer Center highlighted the promising therapeutic responses and tolerance of the CUE-101 and pembrolizumab combination, noting its potential to enhance patient response rates and quality of life. Key data from the CUE-101 trial's expansion phase at the recommended Phase 2 dose (RP2D) of 4mg/kg in combination with pembrolizumab revealed a disease control rate of 75% in patients with a combined positive score (CPS) of 1 or higher, significantly better than the 19% ORR observed with pembrolizumab alone in the historical KEYNOTE-048 trial. The survival metrics showed a 12-month OS of 91.3% compared to 51% in the historical trial, and an mOS of 21.8 months versus 12.3 months historically.

For monotherapy with CUE-101 at RP2D, the median overall survival was 20.8 months in second-line and beyond patients, surpassing historical survival rates from other trials (7.5-8.4 months). The therapy has been well tolerated in both monotherapy and combination settings, with manageable adverse events.

In the CUE-102 trial, data showed a 67% overall disease control rate in late-stage pancreatic cancer patients treated with doses of 2 and 4mg/kg. The therapy led to selective activation and expansion of WT1-specific T cells without increasing non-specific T cell numbers, and no dose-limiting toxicities were reported in the dose escalation phase (1-8mg/kg).

Dr. Matteo Levisetti, Cue Biopharma’s chief medical officer, expressed satisfaction with the positive results from the ongoing CUE-101 and CUE-102 trials, emphasizing the potential of Immuno-STAT biologics to activate and expand tumor-specific T cells, which translates into substantial clinical benefits.

The CUE-101 and CUE-102 therapies are part of Cue Biopharma's unique platform, Immuno-STAT™, which aims to selectively modulate disease-specific T cells, leveraging the body’s immune system for targeted cancer treatment while minimizing the side effects common with broad systemic immune modulation.

Cue Biopharma is headquartered in Boston, Massachusetts, and is guided by a seasoned management team and an independent Board of Directors with significant expertise in immunology, immuno-oncology, and protein biologics clinical development.