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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 (CUE) has initiated a Phase 1 dose escalation study for CUE-102, targeting WT1-positive recurrent/metastatic cancers. The first patient has been dosed with a starting dose of 1 mg/kg, reflecting a step forward in demonstrating the Immuno-STAT™ platform's potential. CUE-102 shows promise in selectively activating tumor-specific T cells, with preclinical studies indicating significant immune response. The trial aims to enroll around 50 patients and examines safety, tolerability, and anti-tumor activity.
Cue Biopharma reported its second quarter 2022 financial results, highlighting a significant decrease in collaboration revenue to $26,000, down from $2.7 million in Q2 2021. Research and development expenses rose to $9.6 million, while general and administrative expenses fell to $3.8 million. The company extended its cash runway with $23.6 million raised from an equity offering. Notably, the FDA accepted an IND for CUE-102, and a Phase 1 trial is underway, focusing on various cancers.
BOSTON, July 11, 2022 (GLOBE NEWSWIRE) -- Cue Biopharma (Nasdaq: CUE) announced its participation in the Guggenheim I&I Spotlight Series on Treg-based Therapies, scheduled for July 13, 2022, from 9:00 a.m. to 9:45 a.m. EDT. This event highlights the company's innovative approach to cancer treatment through its Immuno-STAT™ platform, which modulates T cells within the body. A live and archived webcast will be available on Cue Biopharma's website.
For more details, visit www.cuebiopharma.com.
Cue Biopharma (Nasdaq: CUE) announced participation in a fireside chat at the JMP Securities Life Sciences Conference on June 16, 2022. The presentation will focus on ongoing clinical trials and corporate development initiatives. The event will be webcast live from 1:00 p.m. to 1:25 p.m. EDT and archived for 30 days. Cue Biopharma is known for its innovative Immuno-STAT™ platform, aimed at targeted T cell engagement for cancer treatment. The company is headquartered in Boston and focuses on developing injectable biologics.
Cue Biopharma announced its participation in the Jefferies Healthcare Conference scheduled for June 8-10, 2022. The company will present updates on its lead candidate, CUE-101, currently in a Phase 1b trial for HPV16+ head and neck cancer, and its second candidate, CUE-102, which received FDA approval for an IND application. CUE-102 will undergo Phase 1 trials for WT1-positive cancers. The presentation is set for June 10 at 1:45 p.m. EDT, with webcasts available for 30 days.
BOSTON, May 26, 2022 – Cue Biopharma (Nasdaq: CUE) announced a poster presentation at the ASCO Annual Meeting from June 3-7 in Chicago. The poster will showcase interim clinical data on CUE-101, an IL-2-based therapeutic for recurrent/metastatic HPV16+ head and neck cancer, both as a monotherapy and in combination with pembrolizumab (KEYTRUDA®). The presentation is scheduled for June 6, 2022, by Dr. Christine Chung of Moffitt Cancer Center. Interested parties can view the poster on Cue Biopharma’s website after the event.
On May 11, 2022, Cue Biopharma announced that the FDA accepted its IND application for CUE-102, initiating a Phase 1 trial for the treatment of WT1-positive recurrent/metastatic cancers, including gastric and pancreatic cancers. The trial will start at a dose of 1 mg/kg, which is expected to streamline the dose escalation process, potentially reducing time and costs. CUE-102 builds on the CUE-100 series biologics, which selectively engage T cells, and follows the encouraging results from the CUE-101 trial.
Cue Biopharma (CUE) reported Q1 2022 financial results, highlighting a cash runway extension with $23.6 million raised through the sale of 3.6 million shares. Collaboration revenue decreased to $1.0 million from $1.6 million year-over-year. R&D expenses rose to $10.1 million, with total operating expenses at $15.2 million, leading to a net loss of $14.3 million. Clinical advancements include the enrollment of 20 patients for CUE-101, demonstrating a favorable tolerability profile in HPV16-driven cancers. The company continues to progress its Immuno-STAT platform.
Cue Biopharma, a clinical-stage biopharmaceutical company, will present at the Oppenheimer 32nd Annual Healthcare Conference on March 17, 2022, at 11:20 a.m. EDT. The discussion will cover clinical updates on CUE-101, targeting HPV+ recurrent/metastatic head and neck cancer. The company also plans to highlight milestones for its pipeline, including CUE-102, with an IND filing expected by the end of Q1 2022. The webcast will be available live and archived for 30 days on their website.
Cue Biopharma (Nasdaq: CUE) announced its participation in the Festival of Biologics World Immunotherapy Congress in San Diego from March 9-11, 2022. Dr. Matteo Levisetti will present on the Immuno-STAT™ platform and recent clinical trial data for CUE-101, targeting HPV+ recurrent/metastatic head and neck cancer. The data illustrates favorable tolerability and promising anti-tumor activity. Cue Biopharma aims to differentiate its IL-2 based therapies with CUE-101's selective targeting mechanism, indicating potential alterations in cancer treatment.
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