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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 (Nasdaq: CUE) has announced a strategic shift to prioritize its autoimmune programs, aiming to focus on near-term and intermediate value creation. The company will retain its oncology programs as clinical data continues to mature. This restructuring is expected to reduce annualized capital and workforce requirements by approximately 25%.
Key points:
- Focus on autoimmune programs CUE-401 and CUE-501
- Retention of oncology programs CUE-101 and CUE-102
- Projected annual cash burn reduction to approximately $30 million
- Workforce reduction of about 25% across various departments
- Cash runway expected to extend into mid-year 2025
Cue Biopharma has presented updated data from its Phase 1 trial of CUE-101 at the 2024 ASCO Annual Meeting, revealing promising results for HPV+ head and neck cancer. The combination of CUE-101 and pembrolizumab in first-line (1L) treatment showed a 46% overall response rate (ORR) and a 96% 12-month overall survival (OS). For second-line (2L) and beyond, median overall survival (mOS) was 20.8 months with CUE-101 monotherapy, significantly higher than historical comparisons. No significant safety concerns emerged. Additionally, early data from CUE-102 indicated positive immune response and tolerability.
Cue Biopharma, a clinical-stage biopharmaceutical company, will participate in two significant investor healthcare conferences this June 2024. The company, listed on Nasdaq with the ticker CUE, focuses on developing therapeutic biologics targeting disease-specific T cells.
On June 6, Cue Biopharma will present at the Jefferies Global Healthcare Conference in New York, discussing its progress in oncology and autoimmune platforms. The presentation by Anish Suri, Ph.D., President and Chief Scientific Officer, will be available via webcast.
On June 24, the company will participate in the Oppenheimer Novel Targets and Immunology Summit, also in New York. Dr. Suri will join a panel to discuss repurposing cancer targets for immunology. These events will provide updates on clinical and preclinical advancements and strategic approaches.
Cue Biopharma, Inc. reported their first-quarter 2024 financial results, showcasing an increase in collaboration revenue to $1.7 million due to partnerships. They highlighted advancements in clinical trials for CUE-101 and CUE-102, as well as the expansion of their pipeline to include programs for autoimmune and inflammatory diseases. The company emphasized progress in their autoimmune program, CUE-401, with Ono Pharmaceutical, and the development of the bispecific Immuno-STAT CUE-500 series. Financially, Cue Biopharma reported $41.0 million in cash and cash equivalents as of March 31, 2024, with expectations to fund operations into the first quarter of 2025.
Cue Biopharma, Inc. (Nasdaq: CUE) is set to present at the 20th PEGS Boston Summit with two poster presentations discussing their innovative Immuno-STAT biologics for targeting autoimmune diseases and immuno-oncology. The presentations will cover the CUE-500 series for depleting B cells in autoimmune diseases and the Immuno-STAT platform for cancer and inflammatory diseases.
Cue Biopharma, Inc. (Nasdaq: CUE) will participate in a fireside chat at The Citizens JMP Life Sciences Conference in New York to discuss current oncology and autoimmune disease strategies and progress. The webcast of the chat will be available on the company's website.
FAQ
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