Cue Biopharma, Inc. Q2 FY2021 earnings call

The foundational goal is to design, develop, and bring rationally engineered biologics to restore immune balance. CUE-101 is the lead clinical program, with a refractory patient showing a partial response. The CUE-100 series has modularity for targeting different cancer-relevant T cells. Dr. Anish Suri discussed the Immuno-STAT platform for selective IL-2 targeting to tumor-specific T cells. Dr. Ken Pienta and Dr. Matteo Levisetti provided updates on the CUE-101 clinical trial, including enrollment, dosing, tolerability, and pharmacodynamic data. Clinical benefit rate in third-line patients is ~27%, with potential registration paths including monotherapy and combination with KEYTRUDA. Financial results: Collaboration revenue increased, R&D and G&A expenses rose, cash and working capital noted.

Cue Biopharma plans to continue clinical development of CUE-101 and other CUE-100 series programs. Anticipate trial status updates and further data release, including at SITC and later in the year. Registration paths include third-line monotherapy, potential second-line, and combination with pembrolizumab.

Q: With respect to the selection of your dose to take forward into the expansion cohort, does that imply a bell-shaped pharmacodynamic response?

A: Dan Passeri mentioned they saw signals emerging around the 4 mg per kg dose, and Anish Suri discussed that there wasn't a bell curve but favorable tolerability.

Q: Should we expect to get preliminary dose escalation data from the pembro combo cohort at SITC?

A: Ken Pienta said they've finished cohort 1 and are dosing cohort 2, expecting news.

Q: How do you juxtapose the monotherapy approach relative to traditional response rate-based endpoints?

A: Ken Pienta discussed potential single-arm studies based on clinical benefit rate and overall survival, with consideration of FDA requirements.

Q: On patient selection, is there a biomarker for CUE-101?

A: Ken Pienta stated they don't currently have a biomarker but expect to follow data and biomarkers as the trial matures.

Q: How do you think about patient selection for CUE-102?

A: Ken Pienta mentioned they'll use HLA-0201 patients and have a liberal enrollment policy for WT1 expression.