Core Insights - TuHURA Biosciences has demonstrated for the first time that the Delta Opioid Receptor (DOR) is expressed on tumor-associated myeloid-derived suppressor cells (MDSCs) and tumor-associated macrophages (TAMs), indicating a new target for overcoming resistance to cancer immunotherapy [1][2][4] - The research highlights the potential of DOR antagonism to reprogram the immunosuppressive capabilities of MDSCs and TAMs, which are critical components of the tumor microenvironment [2][4] - TuHURA is set to present these findings at the 67th American Society of Hematology (ASH) Annual Meeting in December 2025, showcasing the implications of DOR inhibition in enhancing cancer treatment efficacy [1][3][4] Company Developments - TuHURA is developing novel technologies aimed at overcoming both primary and acquired resistance to cancer immunotherapy, which are common reasons for treatment failure [6][8] - The company is advancing its lead innate immune agonist, IFx-2.0, in a Phase 3 trial as an adjunctive therapy to Keytruda (pembrolizumab) for advanced or metastatic Merkel Cell Carcinoma [7][8] - TuHURA has also acquired TBS-2025, a VISTA inhibiting monoclonal antibody, which is moving into Phase 2 development for patients with mutant NPM1 relapsed/refractory acute myeloid leukemia (AML) [8] Research Presentations - An oral presentation titled "Delta Opioid Receptor (DOR) Expression on Myeloid-Derived Suppressor Cells (MDSCs) Represents a Novel Target to Overcome Resistance to Immune Checkpoint Inhibitors (ICIs)" will be presented by Mike Turner, Ph.D., on December 7, 2025 [3] - A poster presentation on "Delta Opioid Receptor (DOR): A Novel Target for Reprogramming Tumor-Associated Macrophage (TAM) Immunosuppressive Phenotype" will be presented by Krit Ritthipichai, D.V.M., Ph.D., on December 6, 2025 [4] - The Moffitt Cancer Center will also present findings on the pathogenic role of DOR-expressing MDSCs in patients with myeloid dysplastic syndrome (MDS) [4]

Core Viewpoint - Akeso, Inc. has initiated a global Phase II registrational trial for cadonilimab, a bispecific antibody, to treat advanced hepatocellular carcinoma (HCC) in patients previously treated with atezolizumab and bevacizumab, marking a significant step in cancer immunotherapy development [1][2]. Group 1: Clinical Trials and Development - The COMPASSION-36 trial is the first global registrational Phase III trial for cadonilimab, currently being conducted in China, the U.S., and Europe, highlighting Akeso's commitment to advancing cancer treatment [2]. - Additional Phase III clinical trials for cadonilimab are in preparation, with a focus on both in-house development and open collaboration to enhance treatment accessibility [3]. - Patient enrollment for a Phase III trial of cadonilimab as adjuvant therapy for high-risk recurrence after curative surgery for HCC has been completed, and another trial combining cadonilimab with lenvatinib and TACE is ongoing [8]. Group 2: Market Need and Treatment Landscape - There is a critical need for effective second-line treatment options for patients with advanced malignancies who have progressed after immune checkpoint inhibitor (IO) combination therapies, as current options are limited [4]. - Hepatocellular carcinoma (HCC) is a prevalent malignancy, with approximately 865,000 new cases reported globally in 2022, and there are currently no FDA-approved second-line therapies available in the U.S. for patients who progress after first-line treatment [5]. - The combination of cadonilimab with other therapies has shown promising results in overcoming IO resistance and achieving high disease control rates in various studies [6][7]. Group 3: Company Overview - Akeso is a leading biopharmaceutical company focused on developing innovative biological medicines, with a robust pipeline of over 50 assets in various disease areas, including cancer [13]. - The company utilizes a comprehensive end-to-end drug development platform and has developed a unique integrated R&D innovation system, positioning itself as a globally competitive entity in the biopharmaceutical industry [13].