Adagene Inc. (“Adagene”), the National University Cancer Institute, Singapore (NCIS) at the National University Hospital in Singapore, National Cancer Centre Singapore (NCCS), and the Singapore Translational Cancer Consortium (STCC), today announced the initiation of a phase 1b/2 clinical trial of the anti-CD137 agonist antibody, ADG106, in combination with the anti-PD-1 antibody, Nivolumab.
The trial will be led by Professor Goh Boon Cher, Senior Consultant, Department of Haematology-Oncology and Deputy Director (Research) at NCIS, and Associate Professor Daniel Tan, Head of the Division of Clinical Trials and Epidemiological Sciences and Senior Consultant, Division of Medical Oncology, NCCS. Both Professor Goh and Associate Professor Tan lead the STCC’s Cancer Clinical Trials & Investigational Medicine Unit that brings together centres in Singapore for scaled up capacity, efficiency and expertise in conducting cancer clinical trials.
ADG106 is being developed by Adagene for the treatment of advanced solid tumours and non-Hodgkin’s lymphoma. The phase 1b/2 trial will evaluate this novel combination in advanced non-small cell lung cancer (NSCLC) patients who have progressed on prior therapies.
Professor Goh commented, “NSCLC is the most prevalent type of lung cancer, which is the leading cause of cancer-related deaths worldwide. Despite recent progress, most patients will progress after receiving the newest generation of immunotherapy and immune checkpoint treatments. ADG106 has been shown to enhance the activity of T-cells based on pre-clinical data, including evidence of synergistic effect with anti-PD-1 agents in a refractory NSCLC tumour model. We look forward to evaluating the combination of ADG106 with Nivolumab and exploring the potential of this promising therapy in a patient population with unmet needs.”
“Pre-clinical studies evaluating the use of ADG106 with anti-PD-1 antibodies have shown promising results and we believe that this novel combination therapy can potentially address resistance to immune checkpoint inhibitors in metastatic NSCLC,” said Associate Professor Tan. “Through this study, we plan to utilise a series of cutting-edge translational approaches to understand mediators of response and resistance to checkpoint inhibitors.”
“We are excited to support this trial evaluating ADG106 in combination with Nivolumab, another leading anti-PD-1 therapy to be combined in clinical trials with ADG106 as a potential best-in-class treatment targeting CD137,” said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene.
“Building on the evidence of clinical efficacy demonstrated in our monotherapy trials, this trial will further explore the potential additive effect between ADG106 and anti-PD-1 agents. We are also delighted to partner with esteemed oncology research organisations that are leading cutting-edge care for patients in the region, as well as Bristol-Myers Squibb, a pioneer in research on anti-PD-1 therapy and anti-CD137 agonist antibodies.”
The phase 1b/2 open label trial is designed to evaluate safety, tolerability, and anti-tumour activity of the combination in up to 53 patients with advanced NSCLC who have progressed after prior treatment. The trial will also include exploratory biomarker analyses, including immune cell profiling in response to treatment.
The trial will involve work under the Lung Cancer programme that is supported by the RIE2020 Open Fund – Large Collaborative Grant (OF-LCG) programme, administered by the Singapore Ministry of Health’s National Medical Research Council (NMRC) and supported by the National Research Foundation Singapore, where Associate Professor Tan is the Corresponding Principal Investigator. OF-LCG is composed of a multi-disciplinary team of clinician-scientists, clinicians, researchers, molecular biologists and computational biologists across various research institutes in Singapore.
“This collaboration continues STCC’s goals to synergise cancer research capabilities across Singapore in a concerted approach, and promotes institutional-industry partnerships. We look forward to further collaborations with global biotech companies on innovations in screening, treatment and care for cancer patients,” said Professor Chng Wee Joo, Executive Director of STCC and Director of NCIS.