Full Press Release Details
Adagene Establishes Collaboration for Clinical
Trial of ADG106 in Combination with Nivolumab in Patients
with Non-Small Cell Lung Cancer in Singapore
- Phase 1b/2 trial to be conducted
at the National University Cancer Institute, Singapore and the
National Cancer Centre Singapore, in Collaboration with the Singapore Translational
- ADG106 now being evaluated in combinations
with three leading anti-PD-1 therapies -
SAN DIEGO, Suzhou, China, and SINGAPORE, October
27, 2021 - Adagene Inc. ("Adagene") (Nasdaq: ADAG), 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
"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.
About Non-Small Cell Lung Cancer
There are two major types of lung cancers: small cell lung cancer and
non-small cell lung cancer (NSCLC). About 85 percent to 90 percent of lung cancers are non-small cell lung cancers. The major differences
between these two types of lung cancers are the size and shape of the cancer cell, forms of treatment and the speed at which the cancer
NSCLC is the leading cause of cancer-related deaths worldwide, accounting
for approximately 18 per cent of all cancer deaths. Despite the proven use of low-dose CT scan as a screening tool for lung cancer, most
patients still present with stage 3 or 4 disease and only about 20 percent are operable, with a five-year survival overall of about 10
percent1. Metastatic disease is the primary cause of death from NSCLC.
Until recently, chemotherapy has been the only available therapy for
metastatic disease. However, much effort has been made to understand the molecular underpinning of NSCLC, and in non-squamous NSCLC, molecular
drivers have been uncovered to direct the specific treatment of this subgroup of patients.
ADG106, is a fully human ligand-blocking, agonistic anti-CD137 IgG4
mAb being developed for the treatment of advanced solid tumours and non-Hodgkin's lymphoma. CD137 stimulates the immune system to
attack cancer cells and is a key driver for long-lasting T-cell proliferation and survival. Clinical trials of ADG106 as monotherapy have
been conducted in the U.S. and China. A trial in combination with toripalimab is underway in China, and one in combination with pembrolizumab
is planned in the U.S. and Asia Pacific (APAC).
Nivolumab, marketed globally as Opdivo, is a programmed death-1
(PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumour
immune response. By harnessing the body's own immune system to fight cancer, Nivolumab has become an important treatment
option across multiple cancers, including advanced NSCLC.
Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biopharmaceutical
company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. Adagene combines computational
biology and artificial intelligence to design novel antibodies that address unmet patient needs. Powered by its proprietary Dynamic Precision
Library (DPL) platform, composed of NEObody , SAFEbody , and POWERbody technologies, Adagene's highly differentiated
pipeline features novel immunotherapy programmes. Adagene has forged strategic collaborations with reputable global partners that leverage
its technology in multiple approaches at the vanguard of science.
For more information, please visit: https://investor.adagene.com.
About National University Cancer Institute, Singapore (NCIS)
NCIS offers a broad spectrum of cancer care and management covering
both paediatric and adult cancers, with expertise in prevention, screening, diagnosis, treatment, rehabilitation and palliative care.
The Institute's strength lies in the multi-disciplinary approach taken to develop a comprehensive and personalised plan for each
cancer patient and his or her family. Our award-winning clinician-scientists and clinician-investigators conduct translational research
and clinical trials, providing patients with access to evidence-based cancer diagnostics, technology and therapies.
For more information about NCIS, please visit http://www.ncis.com.sg.
About Singapore Translational Cancer Consortium
STCC aims to strengthen the overall impact of cancer research and translation
in Singapore by bringing together key basic, clinical and translational teams on joint platforms to actively establish and implement collaborative
cancer programmes. STCC strives to establish Singapore as a global leader for oncology in research translation and its applications to
health and economic value creation.
STCC is a business unit under the Consortium for Clinical
Research and Innovation, Singapore (CRIS), a subsidiary of Ministry of Health Holdings (MOHH), and is anchored by the cancer
research programmes and commercialisation platforms of STCC's research partners (NCCS, NCIS, National University of Singapore
[NUS] Cancer Science Institute [CSI] and Agency for Science, Technology and Research [A*STAR]).
STCC is supported with funding from the National Research Foundation,
Singapore and administered by the Singapore Ministry of Health.
For more information, please visit www.stcc.sg.
About the National Cancer Centre Singapore
The National Cancer Centre Singapore (NCCS) is a leading national and
regional tertiary cancer centre with specialists who are experts in treating cancer. NCCS attends to a majority of all cancer cases in
Singapore's public healthcare sector. In addition to offering holistic and multidisciplinary oncology care, our clinicians and scientists