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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) announced its Q3 2022 financial results and a $30 million PIPE financing, intending to bolster its cash runway into 2024. The Company reported collaboration revenue of just $68,000, down from $2.4 million year-over-year. R&D expenses decreased to $7.6 million, and G&A expenses fell to $3.5 million. Key clinical updates include a 40% overall response rate for CUE-101 in combination with pembrolizumab for recurrent HPV+ head and neck cancer, and a median overall survival exceeding 12 months for patients on monotherapy. A business update call is scheduled for November 14, 2022.
Cue Biopharma (CUE) announced a $30 million PIPE financing agreement with accredited investors, including a new life sciences-focused investment fund. The deal entails the sale of 7,656,966 shares and pre-funded warrants for an aggregate of 1,531,440 shares, at $3.265 each. Accompanying warrants allow for an additional 9,188,406 shares at an exercise price of $3.93. The funds will advance clinical development of CUE-101 and support business activities. The transaction is expected to close by November 16, 2022, pending customary conditions.
Cue Biopharma (CUE) reported promising results from its Phase 1 trial of CUE-101, an interleukin 2-based biologic, for treating HPV+ recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The study revealed a 40% overall response rate (ORR) and a 70% clinical benefit rate (CBR) in patients receiving the drug in combination with pembrolizumab. Additionally, CUE-101 monotherapy resulted in a median overall survival (mOS) exceeding 12 months in third-line patients, significantly outperforming the current standard of care. The company aims to define a registrational trial for CUE-101 by mid-2023.
BOSTON, Nov. 09, 2022 – Cue Biopharma (Nasdaq: CUE) announced presentations at two investor conferences this November. The Stifel Healthcare Conference will be held on November 15-16, and the Jefferies London Healthcare Conference will take place November 15-17. Cue Biopharma will discuss updates on CUE-101, part of its IL-2-based CUE-100 series, in a Phase 1 trial for HPV+ recurrent/metastatic head and neck cancer, along with CUE-102 for WT1 positive cancers. CEO Daniel Passeri will present both sessions, with webcasts available post-event.
BOSTON, Nov. 07, 2022 – Cue Biopharma, a clinical-stage biopharmaceutical company, will host a conference call and webcast on November 14, 2022, at 4:30 p.m. EST. The event will provide a business update, including a summary of data from the Society for Immunotherapy of Cancer’s 37th Annual Meeting. Key highlights include ongoing clinical trials of its lead biologic, CUE-101, for recurrent/metastatic HPV+ head and neck cancer, and updates on its second candidate, CUE-102. Access to the webcast is available on the company’s website.
Cue Biopharma (Nasdaq: CUE) announced three poster presentations at the Society for Immunotherapy of Cancer’s 37th Annual Meeting (SITC 2022), scheduled for November 8-12, 2022, in Boston. The presentations focus on CUE-101 and CUE-102, innovative biologics targeting specific cancer types. Dr. Christine Chung will present on CUE-101 for HPV16+ head and neck cancer, while Dr. Steven Margossian discusses CUE-102 for WT1-positive cancers. All posters will also be available as virtual e-posters and on the company’s website.
Cue Biopharma (Nasdaq: CUE) announced that the FDA has granted Fast Track designation to its lead drug candidate, CUE-101, for treating HPV16+ recurrent/metastatic head and neck squamous cell carcinoma. This designation highlights the urgent need for targeted therapies in this patient population. CUE-101 has shown favorable tolerability and initial anti-tumor activity in clinical trials, and a registrational trial for monotherapy is anticipated by mid-2023. The Fast Track process may allow for expedited development and review of the drug.
Cue Biopharma (CUE) is set to present at two scientific conferences this September. The first event, The Promise of Interleukin-2 Therapy, runs from September 14-17 in Paris. Matteo Levisetti, M.D. will present data on CUE-101, targeting HPV+ recurrent/metastatic head and neck cancer. The second event, Next Generation Protein Therapeutics Summit, takes place September 28-30 in Boston, where Anish Suri, the company’s CSO, will highlight the Immuno-STAT platform and its IL-2 based candidates. These advancements reflect Cue Biopharma’s commitment to innovative cancer therapies.
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.
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