Business
Cue Biopharma Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Business Highlights
Received U.S. Food and Drug Administration (FDA) acceptance of Investigational New Drug (IND) application for CUE-102 in Wilms’ Tumor 1 (WT1)-expressing
About this update from Cue Biopharma, Inc.
[{"type":"text","content":"Received U.S. Food and Drug Administration (FDA) acceptance of Investigational New Drug (IND) application for CUE-102 in Wilms’ Tumor 1 (WT1)-expressing cancers and initiated dosing in a Phase 1 dose escalation monotherapy trial at 1mg/kg.Granted FDA Fast Track Designation for CUE-101 for the treatment of HPV+ recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) as a monotherapy and in combination with pembrolizumab (KEYTRUDA®).Presented new positive data from the ongoing Phase 1 trials of CUE-101 in combination with pembrolizumab and as a monotherapy for HPV+ (R/M HNSCC) at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting on November 10, 2022.Entered into securities purchase agreements with accredited investors for a $30 million private investment in public equity (PIPE) financing. The transaction closed on November 16, 2022.Entered into a strategic collaboration and option agreement with Ono Pharmaceutical for CUE-401, a bispecific protein designed to induce and expand regulatory T cells (Tregs) for the treatment of autoimmune and inflammatory diseases. BOSTON, March 21, 2023 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body, today reported fourth quarter and full year 2022 financial results. “2022 was a strategically important and significant year for Cue Biopharma with the emergence of positive clinical data from our ongoing trials with CUE-101 – our lead oncology drug product candidate from the CUE-100 series – validating and derisking our Immuno-STAT™ platform, and having accessed opportunities to secure a strong financial position that enable us to further execute on our corporate and clinical goals throughout 2023 and well into 2024,” said Daniel Passeri, chief executive officer of Cue Biopharma. “Importantly, we plan to present updated clinical data from our representative programs from the CUE-100 series oncology programs at an upcoming scientific conference with the aim of further demonstrating the potential significance of our platform and clinical development approach for the treatment of multiple cancers. Additionally, we look forward to advancing our lead autoimmune disease asset, CUE-401...