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 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 (CUE) has appointed Tamar Howson to its board of directors, enhancing its business development capabilities. Howson, a veteran in the biopharmaceutical industry with over 30 years of experience, has held significant roles in renowned companies. Her expertise is anticipated to significantly aid Cue Biopharma's corporate development efforts in targeted immunotherapy. This leadership change aims to strengthen the company's strategic execution and foster growth as it advances its proprietary platform, Immuno-STAT™, designed to engage targeted T cells effectively.
On September 15, 2020, Cue Biopharma announced the publication of groundbreaking preclinical data in Nature Methods focusing on their Immuno-STAT platform, which utilizes dimeric protein scaffolds for targeted detection of tumor antigen-specific T cells. This innovative immuno-positron emission tomography (immunoPET) approach enhances the ability to visualize T cells within tumors, potentially transforming treatment methodologies for cancer and other diseases. The feasibility of using these techniques for prognostics and diagnostics was also highlighted, showcasing strong clinical implications.
Cue Biopharma (NASDAQ: CUE) announced its participation in several healthcare conferences, including the Baird Global Healthcare Conference on September 9, Morgan Stanley Global Healthcare Conference on September 17, and Oppenheimer & Co. Fall Healthcare Life Sciences and MedTech Summit on September 23, 2020. The company will present its Immuno-STAT™ platform and updates on its pipeline, focusing on its lead candidate CUE-101 for HPV16-driven head and neck cancer. For more details, visit www.cuebiopharma.com.
Cue Biopharma (CUE) reported positive progress in its Phase 1 trial for CUE-101, aimed at treating HPV+ head and neck cancer. The company successfully completed dosing cohorts 4 and 5 and is moving to cohort 6. Financially, Cue Biopharma reported $1.1 million in collaboration revenue for Q2 2020, with R&D expenses increasing to $8.1 million, reflecting growing clinical costs. As of June 30, 2020, the company has $85 million in cash and marketable securities, ensuring funding for ongoing development through 2022.
On August 24, 2020, Cue Biopharma (NASDAQ: CUE) announced a poster presentation of its Neo-STAT biologics at the 16th Annual PEGS Boston Summit. This next-generation platform targets tumor-specific T cells with enhanced antigen modularity, enabling incorporation of diverse T cell epitopes. The presentation, led by Dr. Ahmet S. Vakkasoglu, will occur from August 31 to September 4, 2020. The Neo-STAT platform aims to advance cancer immunotherapy while exploring applications for infectious diseases. Cue Biopharma is focused on transforming treatment strategies through its proprietary Immuno-STAT technology.
Cue Biopharma announced the publication of novel research on immune modulation, focusing on the PD-L1:B7-1 co-inhibitory immune complex. Conducted at Albert Einstein College of Medicine, the study enhances Cue's Immuno-STAT and Neo-STAT platforms, which are designed to engineer T cells for targeted therapies in cancer and autoimmune diseases. The ongoing Phase 1 trial of CUE-101 shows promising early results, including safety and tolerability, alongside encouraging pharmacokinetic and pharmacodynamic metrics.
On June 15, 2020, Cue Biopharma announced progress in its Phase 1 trial of CUE-101 for HPV+ recurrent and metastatic head and neck squamous cell carcinoma. The trial has enrolled 13 patients, with ongoing data generation showing dose-proportional increases in drug exposure and evidence of selective T cell expansion. Preliminary results indicate clinical activity, with one patient experiencing stable disease after treatment. The drug has been well-tolerated, with primarily mild adverse events. Further patient enrollment at the 1.0 mg/kg dose is planned to refine CUE-101's therapeutic window.
Cue Biopharma, Inc. (CUE) provided a business update for Q1 2020, reporting collaboration revenue of $0.9 million, up from $0.4 million in Q1 2019. R&D expenses rose to $9.9 million due to ongoing clinical trials, including the CUE-101 mono-therapy and a collaboration with Merck on KEYTRUDA®. The company ended the quarter with a net loss of $12.8 million, slightly higher than the previous year. Cue Biopharma raised $34.3 million through an ATM offering in April, enhancing its cash position amidst pandemic challenges.
Cue Biopharma (CUE) announced a poster presentation at the AACR Virtual Annual Meeting II, showcasing pre-clinical data on its drug candidates CUE-102/A02 and CUE-102/A24 from the CUE-100 series. These Immuno-STATs™ selectively target Wilms’ tumor 1 (WT1) specific T cells for cancers like AML and breast cancer. The presentation, led by Dr. Saso Cemerski, will occur on June 22, 2020. The CUE-100 series aims to engage T cells directly in patients, potentially reducing toxicities seen in traditional therapies. Cue Biopharma is focused on transforming cancer treatment with its innovative approach.
Cue Biopharma (NASDAQ: CUE) has announced a research collaboration with Dr. Michael Dustin and the University of Oxford to explore the IL-2-based CUE-100 series Immuno-STAT biologics. This partnership aims to investigate molecular mechanisms of T cell activation and modulation related to cancer treatment. The findings are expected to enhance understanding of the mechanism of action of the lead asset, CUE-101, currently in clinical trials for head and neck cancer, potentially advancing the development of new therapies for solid and hematological cancers.
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