Welcome to our dedicated page for Cue Biopharma news (Ticker: CUE), a resource for investors and traders seeking the latest updates and insights on Cue Biopharma stock.
Cue Biopharma Inc (NASDAQ: CUE) is a clinical-stage biopharmaceutical company pioneering targeted immunotherapies through its innovative Immuno-STAT platform. This page serves as the definitive source for official company announcements, research developments, and strategic updates.
Investors and industry observers will find curated press releases covering clinical trial progress, regulatory milestones, and partnership announcements. Our collection includes updates on CUE-100 series candidates for oncology applications and autoimmune disease programs, along with financial reporting and executive commentary.
All content is sourced directly from company filings and authorized communications, ensuring reliability for those monitoring advancements in T cell-modulating therapies. Key focus areas include phase 1/2 trial results, platform technology enhancements, and collaboration updates with leading research institutions.
Bookmark this page for streamlined access to Cue Biopharma's latest scientific achievements and corporate developments in the competitive immunotherapy landscape. Check regularly for real-time updates on this innovative biologics developer.
ImmunoScape (CUE) announced an exclusive in-licensing deal with Cue Biopharma (Nasdaq: CUE) on November 13, 2025 to combine Cue's clinical-stage Immuno-STAT® molecules with ImmunoScape’s precision TCR therapy in a novel "Seed-and-Boost" approach for solid tumors.
The program targets the WT1 antigen across multiple solid tumors and hematologic malignancies, has compelling preclinical efficacy, and plans IND-enabling studies to enable clinical trials by 2027. Leadership updates include board appointments of Usman Azam and Adrian Bot, and SAB appointment of Pamela Munster. The platform aims to enable in vivo expansion of tumor-targeting T cells while limiting systemic IL-2 toxicity.
Cue Biopharma (Nasdaq: CUE) reported Q3 2025 results and business highlights on November 12, 2025. Key items: a strategic collaboration and license with ImmunoScape including $15M upfront cash (scheduled $10M in Q4 2025, $5M in Nov 2026) plus a 40% equity stake; leadership transition naming Usman Azam CEO effective Sept 29; clinical update reporting a confirmed 50% ORR and new complete response in the Phase 1 CUE-101 + pembrolizumab trial, with 12‑month OS 88% and median OS 32.7 months.
Quarterly finance highlights: collaboration revenue $2.1M, R&D $4.8M (down from $9.4M), G&A $4.9M (up from $2.9M), net loss $7.45M, and cash and equivalents $11.7M as of Sept 30, 2025.
Cue Biopharma (Nasdaq: CUE) and ImmunoScape announced a collaboration and license to co-develop a novel “Seed-and-Boost” T cell therapy for solid tumors using Cue’s CUE-100 Immuno-STAT molecules paired with ImmunoScape’s proprietary TCRs.
Key terms: Cue is entitled to $15 million upfront ($10M in Q4 2025, $5M in Nov 2026) and a 40% equity stake in ImmunoScape plus eligible high-single-digit royalties. IND-enabling studies are on track for a 2027 IND submission. Preclinical data show activity in pancreatic and ovarian tumor models; CUE-100 Phase 1 datasets reported clinical activity without significant IL-2 toxicities.
Cue Biopharma (Nasdaq: CUE) announced a strategic leadership transition, appointing Dr. Usman "Oz" Azam as President and CEO effective September 29, 2025. Current CEO Daniel Passeri will transition to Strategic Advisor.
Dr. Azam brings over 25 years of drug development leadership experience, including notable roles at Inspirna, Empyrean Neuroscience, Tmunity Therapeutics, and Novartis, where he helped secure the first FDA approval for CAR-T cell therapy. The transition aligns with Cue Biopharma's strategic focus on autoimmune disease, particularly advancing their first-in-class tolerogenic biologic CUE-401, which aims to restore immune homeostasis and potentially revolutionize autoimmune disease treatment.
Cue Biopharma (Nasdaq: CUE), a clinical-stage biopharmaceutical company, will participate in a fireside chat at the Cantor Global Healthcare Conference in New York from September 3-5, 2025. The company's CEO, Daniel Passeri, will present on September 5, 2025, at 8:00 a.m. EDT.
During the presentation, the company will discuss updates on their Immuno-STAT® platform and the development progress of CUE-401, their primary autoimmune treatment candidate. The presentation will be available via webcast and archived for 30 days on the company's website.
Cue Biopharma (Nasdaq: CUE) has initiated an investigator sponsored trial (IST) of CUE-102 for recurrent glioblastoma multiforme (rGBM) at Dana-Farber Cancer Institute. The Phase 1b open-label study has dosed its first patient, focusing on evaluating CUE-102's tolerability and clinical activity in GBM patients at first recurrence.
The trial, led by Dr. David A. Reardon, Clinical Director of DFCI's Center for Neuro-Oncology, targets Wilms' Tumor 1 protein (WT1) expressing cancers. CUE-102 is designed to activate WT1-specific T cells against glioblastoma, which typically presents challenges for standard immunotherapies due to its immunologically 'cold' tumor nature but exhibits high levels of WT1 protein.
[ "Initiation of new Phase 1b trial for CUE-102 in glioblastoma treatment", "Partnership with prestigious Dana-Farber Cancer Institute", "Trial targets WT1 protein which is highly expressed in glioblastoma", "Encouraging clinical data from CUE-100 series to date" ]Cue Biopharma (NASDAQ: CUE) reported Q2 2025 financial results and significant business developments. The company secured a strategic collaboration with Boehringer Ingelheim for CUE-501 development, receiving a $12 million upfront payment with potential milestone payments of ~$345 million.
Key highlights include positive FDA feedback on CUE-401's Pre-IND submission for autoimmune disease treatment, and impressive clinical results from the Phase 1 trial of CUE-101 in HPV+ head and neck cancer, showing a 50% overall response rate and 32-month median overall survival. The company strengthened its financial position by raising $20 million through a public offering.
Q2 2025 financial results showed collaboration revenue of $3.0 million, with reduced R&D expenses of $7.9 million compared to $9.5 million in Q2 2024. The company reported a net loss of $8.5 million, an improvement from the $10.2 million loss in Q2 2024.
Cue Biopharma (Nasdaq: CUE) reported significant progress in its Phase 1 trial of CUE-101 combined with pembrolizumab for treating recurrent/metastatic HPV+ head and neck cancer. The trial achieved a 50% overall response rate (ORR) in patients with Combined Positive Score (CPS) ≥1, including those with low CPS scores.
Key highlights include an additional complete response (CR) in a patient with multiple tumors, 12-month overall survival of 88% compared to 57% with pembrolizumab alone, and a median overall survival (mOS) of 32 months versus 12.3 months in the historical KEYNOTE-048 trial. The results demonstrate a significant reduction in death risk (HR 0.23) compared to historical data.
Cue Biopharma (Nasdaq: CUE) announced updated clinical data for CUE-101, its lead therapeutic candidate, in combination with KEYTRUDA® for treating HPV+ head and neck squamous cell carcinoma (HNSCC). The Phase 1 trial demonstrated significant efficacy improvements compared to historical data.
Key results include an overall response rate (ORR) of 50% in treatment-naïve patients with CPS >1, and notably, the same ORR in patients with low CPS scores (1-19). This substantially exceeds the historical 19% ORR observed with pembrolizumab monotherapy in the KEYNOTE 048 trial.
The trial showed remarkable survival metrics, with a 12-month overall survival rate of 88% and a median overall survival of 32 months. These results represent a significant reduction in death risk (HR 0.23) compared to historical data. The company is now pursuing strategic alternatives, including potential partnering opportunities.
Cue Biopharma (Nasdaq: CUE) has received positive Pre-IND feedback from the FDA regarding CUE-401, their lead autoimmune asset. CUE-401 is a first-in-class bispecific fusion protein designed to induce and expand regulatory T cells (Tregs) through the combined activity of TGF-β and modified IL-2.
The FDA reviewed the company's first-in-human trial design, including dose escalation plans, proposed populations, and safety monitoring protocols. Based on this feedback, Cue Biopharma plans to proceed with an IND filing once final enabling studies are completed.
The company believes CUE-401's novel mechanism, combining TGF-β and IL-2 activities, could provide durable immune rebalancing and tolerance across multiple disease indications, potentially disrupting the current Treg-directed therapy landscape.
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