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.
On April 25, 2023, Cue Biopharma (Nasdaq: CUE) announced the appointment of Dr. Pamela D. Garzone to its board of directors. Dr. Garzone brings over 25 years of experience in the healthcare and pharmaceutical sectors, particularly in drug development and regulatory leadership. Her expertise spans various therapeutic areas, including immuno-oncology, which aligns with Cue Biopharma’s focus on developing innovative biologics aimed at engaging disease-specific T cells within patients. Cue Biopharma aims to enhance treatment options for cancer and autoimmune diseases using its proprietary Immuno-STAT™ platform. The CEO, Daniel Passeri, expressed confidence that Dr. Garzone’s experience will provide strategic insights as the company advances its clinical and preclinical pipeline.
Cue Biopharma (CUE) has announced the appointment of Patrick Verheyen to its Board of Directors, bringing over 35 years of experience from Janssen Pharmaceutical. Verheyen's expertise in business development and M&A is expected to enhance Cue's corporate growth and current drug candidates, CUE-101 and CUE-102. Daniel Passeri, CEO of Cue Biopharma, expressed enthusiasm for Verheyen's insights, aiming to broaden the company’s strategic initiatives in immunotherapy for autoimmune diseases and cancer. Verheyen's past achievements include leading significant acquisitions at Janssen, which expanded its pipeline and established a global innovation presence.
On March 21, 2023, Cue Biopharma reported significant advancements in its clinical initiatives and financial results for 2022. The FDA accepted its IND application for CUE-102 targeting WT1-expressing cancers and started a Phase 1 trial. CUE-101 received Fast Track Designation for HPV+ head and neck cancers. The 2022 collaboration revenue dipped to $1.2 million from $14.9 million in 2021, while net losses increased to $53 million, affected by reduced research funding and expenses. However, cash reserves rose to $76.3 million, expected to support operations until late 2024. The company aims to present updated data on its oncology programs in upcoming conferences.
Cue Biopharma (Nasdaq: CUE) will host a conference call and webcast on March 21, 2023, at 4:30 p.m. EDT to discuss business and clinical updates. The session will detail ongoing trials of CUE-101, an IL-2-based biologic targeting HPV+ head and neck cancer, and CUE-102 for WT1-expressing cancers. The company also plans to discuss its partnership with Ono Pharmaceutical aimed at advancing CUE-401 for autoimmune diseases. Investors can join via phone or webcast, with registration available on the company's website.
BOSTON, March 1, 2023 (GLOBE NEWSWIRE) -- Cue Biopharma, a clinical-stage biopharmaceutical company, will participate in two healthcare investor conferences this March: the Cowen 43rd Annual Health Care Conference (March 6-8) and the Oppenheimer 33rd Annual Healthcare Conference (March 13-15). The presentations will showcase advancements from the IL-2-based CUE-100 series of biologics, including details on ongoing Phase 1 trials for its drug candidate, CUE-101, targeting HPV+ cancers, and CUE-102 for Wilms’ Tumor 1 positive cancers. The company also announced a partnership with Ono Pharmaceutical to advance CUE-401 for autoimmune diseases.
Cue Biopharma has announced a collaboration with Ono Pharmaceutical for the development of CUE-401, a bispecific protein targeting regulatory T cells to treat autoimmune and inflammatory diseases. This partnership marks a significant step in Cue Biopharma's strategy, providing funding and resources to advance CUE-401 towards clinical trials. Ono will cover all research costs and, upon exercising its option to license CUE-401, Cue Biopharma could receive up to $220 million in milestone payments along with tiered royalties. This collaboration allows Cue Biopharma to retain co-development rights in the U.S.
On February 16, 2023, Cue Biopharma announced a strategic collaboration with Dr. Michael Dustin's lab to explore the mechanisms behind its Immuno-STAT platform, designed to engage disease-specific T cells. The company will present findings at the 67th Biophysical Society Annual Meeting from February 18-22, 2023. The research supports the differentiated action of Immuno-STAT biologics, particularly the CUE-100 series, in selectively activating ‘killer’ T cells while minimizing off-target effects. Clinical progress of CUE-101 in HPV+ head and neck cancer shows promising T cell activation results, indicating potential for broader cancer treatment applications.
BOSTON, Feb. 16, 2023 – Cue Biopharma announced the appointment of Dr. Rafi Ahmed to its Scientific Advisory Board. Dr. Ahmed is a distinguished immunologist recognized for his research on T cell responses in viral infections and cancer. His insights are expected to bolster Cue's IL-2-based CUE-100 series targeting tumor-specific T cells, showcasing promising clinical data with CUE-101 for head and neck cancer and ongoing trials for CUE-102. Dr. Ahmed, also the Director of the Emory Vaccine Center, expressed excitement about contributing to Cue's innovative Immuno-STAT™ platform, aiming to advance targeted cancer therapies with fewer side effects.
BOSTON, Feb. 01, 2023 (GLOBE NEWSWIRE) -- Cue Biopharma, a clinical-stage biopharmaceutical company, announced that its President and Chief Scientific Officer, Anish Suri, Ph.D., will participate in two upcoming scientific conferences in February: Immuno-Oncology 360 in New York and the FASEB Catalyst Conference virtually. Dr. Suri will present an overview of the company’s Immuno-STAT™ platform and its IL-2-based CUE-100 biologics, designed for selective targeting of tumor-specific T cells. The presentations are scheduled for February 7 and February 9, 2023. Cue Biopharma focuses on developing biologics to engage disease-specific T cells without broad systemic modulation.
On January 23, 2023, Cue Biopharma announced the promotion of Matteo Levisetti, M.D., to Chief Medical Officer (CMO), effective January 17, 2023. Dr. Levisetti, previously the senior vice president of clinical development, succeeds Kenneth Pienta, M.D., who will transition to a clinical advisory role. CEO Daniel Passeri expressed confidence in Dr. Levisetti's ability to lead the company’s oncology pipeline, particularly the development of CUE-101 and CUE-102. Dr. Levisetti has a robust background in clinical development, having held leadership roles in various pharmaceutical companies. Cue Biopharma focuses on innovative injectable biologics designed to engage and modulate T cells for cancer treatment.
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