This section highlights FDA-related milestones and regulatory updates for drugs developed by Cue Biopharma (CUE).
Over the past two years, Cue Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
CUE-101 and CUE-401. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
CUE-101 - FDA Regulatory Timeline and Events
CUE-101 is a drug developed by Cue Biopharma for the following indication: HPV+ recurrent/metastatic head and neck cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CUE-101
- Announced Date:
- July 1, 2025
- Indication:
- HPV+ recurrent/metastatic head and neck cancer
Announcement
Cue Biopharma, provided an update on its most advanced clinical stage asset, CUE-101, representative of the CUE-100 series.
AI Summary
Cue Biopharma recently provided an update on its most advanced clinical stage asset, CUE-101, which is part of the CUE-100 series. In the Phase 1 trial, CUE-101 was studied in combination with pembrolizumab for patients with recurrent metastatic HPV-positive head and neck cancer. The trial showed promising results, with an overall response rate (ORR) of 50% in treatment-naïve patients. Additionally, the study reported a 12‑month overall survival rate of 88% and a median overall survival of 32 months. These early results suggest that CUE-101 may help stimulate and expand tumor-specific T cells, potentially offering a stronger immune response against the cancer.
The positive clinical data highlights CUE-101’s potential as a breakthrough approach in cancer therapy, demonstrating enhanced activity compared to historical data for pembrolizumab alone. These findings may support future strategic partnerships and further development of this innovative treatment.
Read Announcement- Drug:
- CUE-101
- Announced Date:
- June 4, 2024
- Indication:
- HPV+ recurrent/metastatic head and neck cancer
Announcement
Cue Biopharma, announced updated data from its ongoing Phase 1 trial evaluating its lead oncology asset from the CUE-100 series of biologics, CUE-101.
AI Summary
Cue Biopharma announced new update data from its ongoing Phase 1 trial evaluating CUE-101, the lead oncology asset from its CUE-100 series. The trial is testing CUE-101 in combination with the cancer drug pembrolizumab in patients with recurrent or metastatic HPV16+ head and neck squamous cell carcinoma. In the first-line treatment setting, the combination achieved an impressive overall response rate of 46% and a 12-month overall survival rate of 96%. Additionally, when used as a single agent in patients treated in second line and beyond, CUE-101 led to a median overall survival of 20.8 months, significantly longer than historical results from similar treatments. These promising statistics suggest that CUE-101 may offer an improved treatment alternative, potentially benefiting patients battling this aggressive form of cancer.
Read Announcement
CUE-401 - FDA Regulatory Timeline and Events
CUE-401 is a drug developed by Cue Biopharma for the following indication: In the Treatment of Autoimmune Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CUE-401
- Announced Date:
- June 24, 2025
- Indication:
- In the Treatment of Autoimmune Disease
Announcement
Cue Biopharma announced it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA).
AI Summary
Cue Biopharma recently announced it received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA). The feedback focused on the design of their first-in-human trial, including plans for dose escalation, selecting study groups, and a safety monitoring plan. Based on this information, the company plans to file an IND application after completing the final enabling studies.
The feedback is an important step for Cue Biopharma’s lead candidate, CUE-401, which is designed to treat autoimmune diseases. CUE-401 is a unique bispecific fusion protein that works by inducing and expanding regulatory T cells. This approach uses a combination of a modified interleukin 2 (IL-2) and transforming growth factor beta (TGF-β) to help rebalance the immune system and reduce harmful autoimmune responses.
Read Announcement
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