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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, Inc. (CUE), a clinical-stage biopharmaceutical firm, announced a conference call and webcast for January 26, 2022, at 4:30 p.m. EST to provide updates on its clinical trials, particularly for CUE-101, its lead IL-2 based candidate targeting HPV+ recurrent/metastatic head and neck cancer. The call will discuss recent data from the Phase 1b trial and plans for CUE-102, along with strategic objectives and anticipated milestones. The event will be accessible live and archived on the company’s website.
On January 5, 2022, Cue Biopharma announced a major milestone in its collaboration with LG Chem Life Sciences regarding CUE-102, an Immuno-STAT™ biologic targeted at WT1-expressing cancers. The achievement paves the way for a planned IND submission to the FDA in Q1 2022 and includes a $3 million milestone payment from LG Chem. CEO Daniel Passeri expressed optimism about CUE-102's potential in treating solid tumors and hematologic malignancies. Preclinical data reinforces the versatility of the Immuno-STAT platform, aimed at advancing oncology therapies directly in patients.
On December 15, 2021, Cue Biopharma announced the appointment of Patricia Nasshorn as Chief Business Officer. Her extensive experience in business development and partnerships is expected to bolster the company’s growth, particularly amid promising data from the ongoing CUE-101 trial, which highlights the potential of their interleukin 2-based CUE-100 series in immuno-oncology. CEO Daniel Passeri expressed optimism about Nasshorn's contributions to Cue Biopharma’s strategic initiatives and future collaborations.
Cue Biopharma (Nasdaq: CUE) announced its participation in a fireside chat at the JMP Securities Hematology and Oncology Summit on December 6, 2021, from 11:40 a.m. to 12:10 p.m. EST. The session will feature a clinical update on CUE-101, its lead program, evaluating its effectiveness as a monotherapy and in combination with KEYTRUDA® for patients with HPV+ recurrent/metastatic head and neck cancer. The company will also discuss developments in its CUE-100 series pipeline. Interested parties can access the live and archived webcast on their website.
Cue Biopharma (CUE) announced its participation in the Piper Sandler 33rd Annual Virtual Healthcare Conference from November 29 to December 2, 2021. The company will feature a pre-recorded fireside chat, available on its website starting November 22, 2021, at 10:00 a.m. EST. Cue Biopharma is focused on developing a novel class of injectable biologics that engage T cells, aiming to transform treatments for cancer and autoimmune diseases. The archived recording will be accessible for 90 days post-event.
Cue Biopharma (CUE) presented promising interim data for CUE-101, a monotherapy targeting HPV+ head and neck cancer, at SITC 2021. CUE-101 showed durable partial responses and favorable tolerability in its Phase 1 trial, with doses administered exceeding 190. Additionally, early results indicated potential activity when combined with pembrolizumab. CUE-102 demonstrated the ability to activate WT1-specific T cells, supporting its advancement towards clinical trials. The company plans to file for Investigational New Drug status for CUE-102 in Q1 2022, enhancing its development pipeline.
On November 10, 2021, Cue Biopharma (Nasdaq: CUE) announced its participation in two upcoming virtual fireside chats. The first will occur at the Stifel Healthcare Conference from November 15-17, while the second will take place at the Jefferies London Healthcare Conference from November 16-19. Cue Biopharma will update participants on its lead clinical program, CUE-101, and its related CUE-100 series pipeline, addressing treatments for HPV+ recurrent/metastatic head and neck cancer. Webcasts of these discussions will be available on the company's website.
Cue Biopharma announced promising findings from a study published in the Journal of Clinical Investigation, revealing that its Immuno-STAT™ Biologics can activate and expand anti-viral cytotoxic T cells targeting HIV and CMV. The study indicates potential for treating chronic viral infections without ex vivo manipulation of T cells, addressing a critical barrier in HIV treatment. Ongoing Phase 1 trials of CUE-101 also show positive outcomes in cancer therapy. The modularity of the Immuno-STAT platform suggests versatility in treating various infectious diseases.
On September 28, 2021, Cue Biopharma announced a publication in Scientific Reports detailing their innovative peptide-HLA-based platform technologies for selective immune modulation. The research emphasizes the potential of their Immuno-STAT and Neo-STAT platforms to develop targeted therapeutics for cancer, infectious, and autoimmune diseases. Key findings highlight their ability to safely activate T cells, enhancing therapeutic efficacy while minimizing adverse effects. The lead candidate, CUE-101, has shown promising results in clinical trials for HPV+ recurrent head and neck cancer.
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