Cue Biopharma, Inc. Q2 FY2022 earnings call

Anish Suri introduced the company's mission to selectively activate anti-tumor T-cells using the Immuno-STAT platform and CUE-100 series. Ken Pienta discussed clinical updates for CUE-101, including monotherapy in head and neck cancer showing anti-tumor activity, prolonged survival trends, and combination with pembrolizumab showing early signs of activity. Matteo Levisetti mentioned CUE-102's IND acceptance at 1 mg/kg, leveraging platform derisking from CUE-101. Dan Passeri spoke about corporate strategy, including Neo-STAT derivative for personalized cancer immunotherapy and strategic discussions for autoimmune disease. Kerri Millar provided financial updates, noting cash position and expense details.

Potential registration path for CUE-101 monotherapy by end of 2023. Preliminary overall response rate data for CUE-101 plus pembrolizumab expected in Q2 2023. Data from CUE-102 dose escalation study to be read out mid-2023.

Uncertainty around cancer resistance mechanisms, challenges in biomarker acceptance by regulatory agencies, and dependence on clinical trial outcomes for validating the platform's efficacy.

Q: With respect to the updated CUE-101 data, do you have a median duration of treatment at this point? And about post-study therapy and CUE-102 eligibility.

A: Ken Pienta responded that median therapy is two cycles. Regarding post-study therapy, data collection is ongoing. For CUE-102, eligibility is IHC-based with a minimal requirement of 1% of tumor cells expressing WT1.

Q: Talk about biomarker data, pathological CR, and neo-adjuvant study for CUE-101.

A: Ken Pienta discussed cell-free DNA assays and stable disease patients. Anish Suri mentioned the neo-adjuvant study for locally advanced head and neck cancer is recruiting patients with biopsies planned.

Q: Upcoming interactions with FDA regarding CUE-101's registrational trial and CUE-102 biopsies.

A: Ken Pienta stated they anticipate mature median overall survival data by end of 2023 for registrational trial. For CUE-102, paired biopsies are optional in the trial but mandatory in the neo-adjuvant study.