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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 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.
Cue Biopharma (CUE) has announced a conference call and webcast scheduled for May 17, 2021, at 4:30 p.m. EDT to share a business update. This includes a clinical update on the ongoing Phase 1a/1b trial of CUE-101, with emphasis on a confirmed partial response in a patient treated for HPV+ recurrent/metastatic head and neck squamous cell carcinoma. The management will also discuss recent advancements in their technology platform and strategic objectives. Investors can access the event via the company's website.
Cue Biopharma (CUE) announced interim clinical data from its Phase 1a/1b study of CUE-101, showing a confirmed partial response (PR) in a patient with HPV+ recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). This marks initial clinical proof of concept for its Immuno-STAT™ platform, highlighting activity in modulating the anti-tumor T-cell repertoire. The study reported favorable tolerability and evidence of immune cell activation. The company plans to discuss these findings in its upcoming quarterly update on May 17, 2021.
On May 6, 2021, Cue Biopharma (Nasdaq: CUE) announced it will present at the virtual New York Academy of Sciences 2021 Frontiers in Cancer Immunotherapy meeting from May 12-14, 2021. The presentation will focus on the Immuno-STAT™ platform, designed to enhance anti-tumor immune responses, alongside its expanding pipeline including lead candidate CUE-101, which targets HPV+ head and neck squamous cell carcinoma. Dr. Steve Quayle will discuss clinical data demonstrating favorable activity for CUE-101 and introduce CUE-102, targeting WT1, expected to enter clinical trials in 2022.
Cue Biopharma provided a business update for Q4 and full-year 2020, focusing on their ongoing clinical trials and financial performance. The company initiated the Phase 1 trial for CUE-101, both as monotherapy and in combination with KEYTRUDA, showing promising early results in treating HPV+ R/M HNSCC. However, collaboration revenues decreased from $3.5 million in 2019 to $3.2 million in 2020. R&D expenses rose to $33.5 million, reflecting increased clinical activity, and the company reported a net loss of $44.8 million.
Cue Biopharma (Nasdaq: CUE) announced its participation in the Oppenheimer 31st Annual Healthcare Conference from March 16-18, 2021. The company will present a corporate update on March 18, 2021, at 9:20 a.m. EDT, focusing on the clinical progress of CUE-101, its lead therapeutic for HPV+ recurrent/metastatic head and neck cancer. Additionally, they will discuss advancements in the CUE-400 series, targeting various autoimmune diseases. The presentation will be available via webcast and archived for 30 days on their website.
Cue Biopharma, based in Cambridge, Massachusetts, announced a conference call on March 16, 2021, at 4:30 p.m. EDT, to provide a business update. The call will cover updates on the CUE-101 Phase 1 dose escalation trial and the KEYNOTE-A78 combination trial with KEYTRUDA for HPV+ recurrent head and neck cancer. Additionally, the management will discuss pipeline developments and strategic milestones. Investors can join via phone or webcast, with details available on the company’s website.
Cue Biopharma, a clinical-stage biopharmaceutical company, announced its participation in the Cowen 41st Annual Health Care Conference from March 1-4, 2021. The company will present an overview of its innovative Immuno-STAT™ platform, highlighting key developments, including updates on its Phase 1 trial for CUE-101 monotherapy and its combination trial with KEYTRUDA® for treating HPV+ recurrent/metastatic head and neck cancer. The presentation is scheduled for March 4, 2021, at 9:10 a.m. EST, and will be available via webcast.
On February 25, 2021, Cue Biopharma announced the appointment of Dr. Abul K. Abbas and Dr. Michael Kalos to its Scientific Advisory Board. These appointments aim to enhance the company’s capabilities in advancing its immune modulation technologies. Dr. Abbas, an expert in immunology, and Dr. Kalos, a leader in T cell therapy, are expected to provide strategic guidance to boost Cue Biopharma’s research and drug development efforts. Their combined experience is anticipated to facilitate the development of treatments targeting cancer and autoimmune diseases through the company's proprietary platforms Immuno-STAT™ and Neo-STAT™.
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