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 February 22, 2021, Cue Biopharma (NASDAQ: CUE) announced that Dr. Anish Suri, president and chief scientific officer, will present at the 7th Annual Immuno-Oncology 360° Conference on February 25, 2021. He will discuss the Immuno-STAT™ platform, focusing on the CUE-100 series, which includes CUE-101 and CUE-102, targeting T cells for cancer treatments. The presentation aims to show the mechanistic advantages of this approach, offering a novel way to engage T cells in vivo. The event will also include a panel on vaccine expert discussions.
Cue Biopharma has appointed Dr. Matteo Levisetti as Senior Vice President of Clinical Development, effective February 22, 2021. Dr. Levisetti brings extensive experience in drug development from his roles at prominent pharmaceutical companies. He will oversee Cue Biopharma’s ongoing CUE-101 Phase 1 dose escalation trial and the combination trial KEYNOTE-A78, evaluating CUE-101 with KEYTRUDA® for HPV+ R/M HNSCC. Additionally, he will assist in the CUE-102/A02 program targeting WT1 specific T cells. The appointment aims to strengthen the company's immunotherapy pipeline.
On February 1, 2021, Cue Biopharma (Nasdaq: CUE) commenced a Phase 1 dose escalation clinical trial for CUE-101, combined with Merck's KEYTRUDA (pembrolizumab), aimed at treating HPV+ recurrent/metastatic head and neck squamous cell carcinoma. Preliminary results from monotherapy trials indicate CUE-101 is well tolerated and shows early evidence of clinical activity. The trial seeks to explore the synergistic effects of the combination therapy, potentially enhancing anti-tumor responses.
Cue Biopharma (Nasdaq: CUE) announced its participation in the Piper Sandler 32nd Annual Virtual Healthcare Conference from December 1-3, 2020. A pre-recorded fireside chat will be available for participants starting November 23, 2020, at 10:00 a.m. EST, on the Company’s website. Cue Biopharma is focused on engineering a new class of injectable biologics aimed at selectively engaging and modulating T cells to treat cancer, infectious, and autoimmune diseases using its proprietary platform, Immuno-STAT™.
On November 19, 2020, Cue Biopharma (CUE) announced the extension of its research collaboration with Merck, originally established in 2017, aimed at developing therapies for type 1 diabetes and another autoimmune disease. This extension is supported by promising preclinical data and will provide Cue Biopharma with additional financial research support to further explore biologics aimed at identifying clinical candidates. The company emphasizes the potential of its Immuno-STAT™ platform in targeting T cells effectively within the body.
Cue Biopharma, Inc. (Nasdaq: CUE) reported a business update for Q3 2020, highlighting progress in the Phase 1 trial of CUE-101, now entering cohort 7 dosing at 8mg/kg. The company recorded collaboration revenue of $704,000, down from $984,000 in Q3 2019. Operating expenses rose to $10.8 million, driven by increased clinical activities and R&D costs. Net loss was $10.0 million, compared to a loss of $7.0 million in the prior year. As of September 30, 2020, Cue Biopharma held $91.8 million in cash and marketable securities, expected to fund operations into Q2 2022.
Cue Biopharma (Nasdaq: CUE) has announced participation in two upcoming virtual healthcare conferences: the Stifel Virtual Healthcare Conference on November 18, 2020, and the Jefferies Virtual London Healthcare Conference on November 19, 2020. Presentations will cover the company's Immuno-STAT™ platform, ongoing Phase 1 trial of CUE-101 for HPV16-driven head and neck cancer, and highlight future milestones. Webcasts for both events will be available on Cue Biopharma's website.
Cue Biopharma (Nasdaq: CUE) announced a conference call on November 17, 2020, at 4:30 p.m. EST, to update stakeholders on its business progress. The executive team will discuss findings from cohorts 4, 5, and 6 of its ongoing Phase 1 clinical trial of CUE-101, targeting HPV16-driven head and neck cancer. The call will also cover advancements in technology platforms, pipeline updates, and strategic milestones. Access to live and archived versions of the event will be available on the company's website.
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