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Cue Biopharma, Inc. (Nasdaq: CUE) is a pioneering clinical-stage biopharmaceutical company located in Boston, Massachusetts. The company focuses on developing a novel class of injectable biologics designed to selectively engage and modulate disease-specific T cells directly within the patient's body. Cue Biopharma’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells), aims to harness the body’s intrinsic immune system as T cell engagers, minimizing the need for ex vivo manipulation and broad systemic immune modulation.
The company's leading clinical programs include CUE-101 and CUE-102. CUE-101 is being evaluated for the treatment of recurrent/metastatic HPV16+ head and neck squamous cell carcinoma both as a monotherapy and in combination with pembrolizumab (KEYTRUDA®). Recent data from Phase 1 trials have shown promising results, including prolonged overall survival and enhanced clinical activity when combined with pembrolizumab.
CUE-102 targets Wilms' Tumor 1 (WT1)-expressing cancers such as colorectal, gastric, and pancreatic cancers. Early Phase 1 trial data for CUE-102 has demonstrated expansion of WT1-specific T cells and favorable tolerability, pointing to potential therapeutic benefits for cancers resistant to traditional treatments.
Additionally, Cue Biopharma is advancing its preclinical program CUE-401 for autoimmune and inflammatory diseases in collaboration with Ono Pharmaceutical. This program aims to redirect virus-specific T cells to deplete B cells in autoimmune conditions.
Financially, Cue Biopharma reported increased collaboration revenue due to its strategic agreement with Ono Pharmaceutical. Despite higher research and development expenses, the company maintains a strong cash position, with approximately $41 million in cash and equivalents expected to fund operations into the first quarter of 2025. The management team, led by CEO Daniel Passeri, continues to focus on strategic corporate objectives, including potential registrational trials for CUE-101 and advancing other therapeutic candidates.
With an experienced leadership and independent Board of Directors, Cue Biopharma is well-positioned to make significant strides in the fields of oncology and autoimmune disease treatment, aiming to deliver transformative therapies for patients while creating value for its shareholders.
Cue Biopharma announced the issuance of two new U.S. patents (Nos. 11,117,945 and 11,104,712) that enhance its intellectual property portfolio. These patents cover CUE-101, Cue's lead clinical candidate for treating HPV16-related cancers, currently in a Phase 1b trial. The drug has shown a 40% clinical benefit rate in early patients. The second patent focuses on the combination of CUE-101 with KEYTRUDA for similar cancer treatments. These developments bolster the company's position in immunotherapy and support its ongoing clinical trials.
Cue Biopharma, a clinical-stage biopharmaceutical company, will participate in two virtual fireside chats at major healthcare conferences. The first is Baird's 2021 Global Healthcare Conference from September 14-15, where they will discuss their lead clinical program, CUE-101, targeting HPV+ recurrent/metastatic head and neck cancer. The second event is the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit from September 20-23. Presentations will highlight the latest updates and pipeline progress. Webcasts will be available for conference participants and archived for later viewing.
On August 17, 2021, Cue Biopharma provided a business and clinical update for Q2 2021, highlighting progress in its IL-2 based CUE-100 series, including a confirmed partial response in a patient from the CUE-101 trial. The trials for CUE-101 continue to advance, with a focus on its combination therapy with KEYTRUDA. Cue Biopharma reported approximately $2.7 million in collaboration revenue for Q2 2021, up from $1.1 million in Q2 2020. Operating expenses rose to $13 million, leading to a net loss of $10.3 million. The firm remains financially stable with $73.9 million in cash and equivalents.
Cue Biopharma, a clinical-stage biopharmaceutical company, will host a conference call and webcast on August 17, 2021, at 4:30 p.m. EDT to share a business update. The session will provide updates on its lead drug candidate CUE-101, currently in Phase 1b trials for treating HPV+ head and neck cancer. The management team will discuss updates from ongoing clinical trials, including combination trials with Merck’s KEYTRUDA, and advancements in their Immuno-STAT™ technology platform. Details for accessing the call and webcast are available on their website.
On August 3, 2021, Cue Biopharma (Nasdaq: CUE) announced participation in the BTIG Virtual Biotechnology Conference scheduled for August 9-10, 2021. During the fireside chat on August 10, at 3:00 p.m. EDT, the company will share updates on its clinical programs, particularly the CUE-101 therapeutic for HPV+ recurrent head and neck cancer. The discussion will also cover advancements in their pipeline, including the upcoming Phase 1 trial for CUE-102 targeting the Wilms' tumor 1 (WT1) antigen expected to start in early 2022.
On June 14, 2021, Cue Biopharma (CUE) announced participation in the JMP Securities Life Sciences Conference on June 16-17, 2021. The company will discuss the Phase 1a/1b clinical trial of CUE-101 for treating HPV+ recurrent/metastatic head and neck cancer. Notable updates include the initiation of patient expansion in Part B at a recommended dose of 4 mg/kg, enrolling up to 20 patients. Encouraging trial results show six stable disease cases and one partial response. Cue Biopharma will also highlight additional projects, including CUE-102 and CUE-401.
On June 10, 2021, Cue Biopharma (CUE) announced it has dosed the first patient in the Part B expansion phase of its Phase 1 monotherapy clinical trial for CUE-101, targeting HPV+ head and neck squamous cell carcinoma. This trial will expand to enroll up to 20 patients, following promising results from Phase 1a, where six patients had stable disease and one demonstrated a 50% tumor reduction. The company aims for CUE-101 to potentially enter registration-directed trials based on these encouraging findings, highlighting its innovative approach to cancer treatment.
Cue Biopharma (Nasdaq: CUE) announced plans to present at the 2021 Federation of Clinical Immunology Societies Annual Meeting from June 8-11, 2021. Anish Suri, the company's president, will discuss preclinical data on CUE-401, aimed at treating autoimmune diseases. CUE-401 is a bispecific molecule designed to induce regulatory T cells (iTregs) in vivo. The presentation is scheduled for June 10, 2021, and will highlight its effectiveness in inducing iTregs from healthy donors and patients with autoimmune conditions like rheumatoid arthritis.
Cue Biopharma (CUE) has announced its participation in the Jefferies Virtual Healthcare Conference from June 1-4, 2021. The company will showcase its advancements, particularly focusing on CUE-101, an Immuno-STAT™ therapeutic being tested for HPV+ recurrent/metastatic head and neck cancer. Additionally, Cue Biopharma will discuss CUE-102, a drug candidate targeting Wilms Tumor 1 (WT1), with an IND filing expected in the first half of 2022. The presentation is scheduled for June 3, 2021, at 8:30 a.m. EDT, and will be available for live streaming.
On May 17, 2021, Cue Biopharma provided a clinical and business update for Q1 2021. The company reported a confirmed partial response in a patient from its Phase 1 monotherapy trial of CUE-101, with stable disease observed in five patients. Cue Biopharma's collaboration revenue increased to approximately $1.6 million, while R&D expenses slightly decreased to $9.8 million. The firm strengthened its financial position by raising $10.4 million through its ATM facility. The company ends Q1 2021 with cash and equivalents of $73.3 million, supporting operations through Q4 2022.
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