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Cue Biopharma, Inc. reports developments in clinical-stage immunology therapeutics and immune-modulating biologics. Company updates center on its Immuno-STAT platform, the autoimmune and inflammatory disease candidate CUE-401, a clinical-stage dual-mechanism anti-IgE antibody for allergic diseases, and collaboration activity involving B cell depletion programs such as CUE-501.
Recurring news also covers leadership changes, inducement equity awards, shareholder-approved capital actions, research presentations, milestone payments, licensing activity, and other corporate matters tied to Cue Biopharma's Nasdaq-listed common stock and clinical-stage operating model.
Cue Biopharma has announced a collaboration with Ono Pharmaceutical for the development of CUE-401, a bispecific protein targeting regulatory T cells to treat autoimmune and inflammatory diseases. This partnership marks a significant step in Cue Biopharma's strategy, providing funding and resources to advance CUE-401 towards clinical trials. Ono will cover all research costs and, upon exercising its option to license CUE-401, Cue Biopharma could receive up to $220 million in milestone payments along with tiered royalties. This collaboration allows Cue Biopharma to retain co-development rights in the U.S.
On February 16, 2023, Cue Biopharma announced a strategic collaboration with Dr. Michael Dustin's lab to explore the mechanisms behind its Immuno-STAT platform, designed to engage disease-specific T cells. The company will present findings at the 67th Biophysical Society Annual Meeting from February 18-22, 2023. The research supports the differentiated action of Immuno-STAT biologics, particularly the CUE-100 series, in selectively activating ‘killer’ T cells while minimizing off-target effects. Clinical progress of CUE-101 in HPV+ head and neck cancer shows promising T cell activation results, indicating potential for broader cancer treatment applications.
BOSTON, Feb. 16, 2023 – Cue Biopharma announced the appointment of Dr. Rafi Ahmed to its Scientific Advisory Board. Dr. Ahmed is a distinguished immunologist recognized for his research on T cell responses in viral infections and cancer. His insights are expected to bolster Cue's IL-2-based CUE-100 series targeting tumor-specific T cells, showcasing promising clinical data with CUE-101 for head and neck cancer and ongoing trials for CUE-102. Dr. Ahmed, also the Director of the Emory Vaccine Center, expressed excitement about contributing to Cue's innovative Immuno-STAT™ platform, aiming to advance targeted cancer therapies with fewer side effects.
BOSTON, Feb. 01, 2023 (GLOBE NEWSWIRE) -- Cue Biopharma, a clinical-stage biopharmaceutical company, announced that its President and Chief Scientific Officer, Anish Suri, Ph.D., will participate in two upcoming scientific conferences in February: Immuno-Oncology 360 in New York and the FASEB Catalyst Conference virtually. Dr. Suri will present an overview of the company’s Immuno-STAT™ platform and its IL-2-based CUE-100 biologics, designed for selective targeting of tumor-specific T cells. The presentations are scheduled for February 7 and February 9, 2023. Cue Biopharma focuses on developing biologics to engage disease-specific T cells without broad systemic modulation.
On January 23, 2023, Cue Biopharma announced the promotion of Matteo Levisetti, M.D., to Chief Medical Officer (CMO), effective January 17, 2023. Dr. Levisetti, previously the senior vice president of clinical development, succeeds Kenneth Pienta, M.D., who will transition to a clinical advisory role. CEO Daniel Passeri expressed confidence in Dr. Levisetti's ability to lead the company’s oncology pipeline, particularly the development of CUE-101 and CUE-102. Dr. Levisetti has a robust background in clinical development, having held leadership roles in various pharmaceutical companies. Cue Biopharma focuses on innovative injectable biologics designed to engage and modulate T cells for cancer treatment.
Cue Biopharma (Nasdaq: CUE) is set to participate in two fireside chats at significant healthcare events. The first will occur at the Piper Sandler 34th Annual Healthcare Conference on November 30, 2022, and the second at the JMP Securities Hematology & Oncology Summit on December 6, 2022. CEO Daniel Passeri will provide updates on the company's lead clinical program, CUE-101, and its follow-up asset, CUE-102, both targeting specific cancers. Live webcasts will be accessible on the company’s website, which will also archive the discussions for 30 days.
Public Ventures, LLC, a subsidiary of MDB Capital Holdings, successfully completed its first financing for Cue Biopharma, Inc. (NASDAQ:CUE) through a private investment in public equity (PIPE) transaction, securing approximately $30 million. This funding primarily came from a community of individual and institutional investors previously involved with Cue Biopharma. MDB's CEO, Christopher Marlett, expressed gratitude towards their investor community for their support, highlighting the potential of Cue Biopharma as a market leader in technology.
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.