Tianyan Pharmaceuticals launches a clinical trial cooperation of ADG106 combined with nivolumab in the treatment of patients with non-small cell lung cancer in Singapore

-Phase Ib/II clinical trials will be conducted at the National University of Singapore Cancer Center and the National Cancer Center of Singapore, and will cooperate with the Singapore Translational Cancer Research Alliance-

-The clinical evaluation of ADG106 in combination with three leading anti-PD-1 therapies is underway-

Suzhou, China, San Diego, USA and Singapore, October 27, 2021/PRNewswire/ - Tianyan Pharmaceutical (hereinafter referred to as the "Company" or "Tianyan") (NASDAQ: ADAG), located in Singapore The National University of Singapore Cancer Center (NCIS), the National Cancer Center of Singapore (NCCS), and the Translational Cancer Research Consortium of Singapore (STCC) at the University Hospital today announced the launch of the combination of anti-CD137 agonist antibody ADG106 and anti-PD-1 antibody nivolumab Phase Ib/II clinical trials used
.

The trial will be led by Professor Wu Wenzi, Senior Consultant and Associate Director (Research) of the Department of Oncology and Hematology of NCIS, and Associate Professor Shaowen Chen, Director of the Department of Clinical Trials and Epidemiology of NCCS and Senior Consultant of the Department of Oncology
.

Professor Wu and Associate Professor Chen lead and are in charge of STCC's cancer clinical trials and medical research department, which brings together multiple centers in Singapore to carry out and efficiently promote more cancer clinical trials

ADG106 is independently developed by Tianyan Pharmaceuticals and is currently undergoing clinical trials in patients with advanced solid tumors and non-Hodgkin's lymphoma
.

The Phase Ib/II trial will evaluate the efficacy of this new combination therapy in advanced non-small cell lung cancer (NSCLC) patients who have progressed after previous treatment

Professor Wu said: "Lung cancer is the cancer with the highest mortality rate in the world, and non-small cell lung cancer is the most common subtype of lung cancer
.

Although there have been some advances in lung cancer treatment recently, most patients are receiving the latest generation of immunotherapy and immune checkpoints.

"The combination of ADG106 and anti-PD-1 drugs has shown promising results in preclinical studies.
We believe this new combination therapy may solve the resistance of metastatic non-small cell lung cancer to immune checkpoint inhibitors.
"Sexuality
.

" Associate Professor Chen Shaowen said, "We plan to use a series of cutting-edge translational studies to deepen our understanding of the mechanism of immune checkpoint inhibitor response and the emergence of drug resistance

"We are pleased to support this clinical trial evaluating the combination therapy of nivolumab, the world's first approved PD-1 antibody, and the potential best-in-class anti-CD137 agonist ADG106.
" Dr.
Peizhi Luo, Executive Officer and Chairman, said, “Based on the clinical safety and efficacy evidence of ADG106 monotherapy, this trial will further explore the potential synergistic effects between it and anti-PD-1 drugs
.

We are also very happy to cooperate with patients in this region.

This phase Ib/II open-label trial aims to evaluate the safety, tolerability and anti-tumor activity of the combination in up to 53 patients with advanced non-small cell lung cancer who have progressed after previous treatment
.

The trial will also target exploratory biomarkers, including analysis of immune cells that respond to treatment

This clinical trial includes the lung cancer project part of the RIE2020 Open Fund – Large Collaborative Grant (OF-LCG) project managed by the National Medical Research Council (NMRC) of the Ministry of Health of Singapore and funded by the National Research Foundation of Singapore, and Associate Professor Shaowen Chen is also the main researcher of the project
.

OF-LCG has a multidisciplinary team composed of clinical scientists, clinicians, researchers, molecular biologists and computational biologists from various research institutes in Singapore

"This cooperation continues STCC's consistent goal of collaborating with Singapore's cancer research capabilities and promoting cooperation between institutions and industry
.

We look forward to further cooperation with global biotechnology companies to innovate in the screening, treatment and care of cancer patients

About non-small cell lung cancer

There are two main types of lung cancer: small cell lung cancer and non-small cell lung cancer (NSCLC)
.
Approximately 85% to 90% of lung cancers are non-small cell lung cancer
.
The main difference between the two types of lung cancer is the size and shape of the cancer cells, the treatment method, and the speed at which the cancer cells spread
.

Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related deaths worldwide, accounting for approximately 18% of all cancer deaths
.
Although low-dose CT scans have been proven to be useful for lung cancer screening, most patients are already in stage 3 or 4 when they are diagnosed, and only about 20% of patients can undergo surgery, and the five-year survival rate is about 10% [ 1]
.
Metastatic disease is the main cause of death from non-small cell lung cancer
.

Until recently, chemotherapy has been the only way to treat metastatic disease
.
However, many efforts have been made to understand the molecular basis of non-small cell lung cancer, and molecular drivers have been found in non-squamous non-small cell lung cancer, which can more accurately select treatment options for this subgroup of patients
.

About ADG106

ADG106 is a fully human ligand-blocking agonistic anti-CD137 IgG4 monoclonal antibody (mAb), currently under evaluation in patients with advanced solid tumors and/or non-Hodgkin’s lymphoma
.
CD137 can stimulate the immune system to attack cancer cells, and is a key driving signal molecule for T cell proliferation and long-lasting survival
.
Tianyan Pharmaceuticals has conducted clinical trials of nearly 100 people with ADG106 monotherapy in the United States and China, and is conducting a joint clinical trial with toripalimab in China, and plans to conduct clinical trials in the United States and Asia Pacific (APAC).
A combined clinical trial of pembrolizumab
.

About Nivolumab (Nivolumab)

Nivolumab (Nivolumab, trade name Opdivo) is a programmed death receptor-1 (PD-1) immune checkpoint inhibitor, designed to uniquely use the body's own immune system to help restore the anti-tumor immune response
.
By using the body's own immune system to fight cancer, nivolumab has become an important choice for the treatment of a variety of cancers, including non-small cell lung cancer
.

About Tianyan Pharmaceutical

Tianyan Pharmaceutical (NASDAQ: ADAG) is a platform-driven biopharmaceutical company in the clinical product development stage with independent platform output.
The company is committed to discovering and developing new cancer immunotherapies based on original antibodies
.
Leveraging on computational biology and artificial intelligence, and with its world’s first three-body platform technology (new epitope antibody NEObody™, safe antibody SAFEbody™ and powerful antibody POWERbody™), Tianyan Pharmaceuticals has established a focus on new tumor immunity The unique and original antibody product line of therapies to solve the unmet clinical needs
.
Tianyan has reached strategic partnerships with a number of world-renowned partners, and has empowered partners in the research and development of new drugs with a variety of original cutting-edge technologies
.

For more information, please visit: https://investor.
adagene.
com

About the National University of Singapore Cancer Centre (NCIS)

NCIS provides a wide range of cancer treatment and management, covering childhood and adult cancers, and is very professional in the fields of prevention, screening, diagnosis, treatment, rehabilitation and end-of-life care
.
The advantage of the center lies in the use of a multidisciplinary approach to develop a comprehensive and personalized plan for each cancer patient and his family
.
Our award-winning clinician scientists and clinical researchers conduct translational research and clinical trials to provide patients with evidence-based cancer diagnosis, technology and treatment
.
For more information about NCIS, please visit http:// Singapore Translational Cancer Research Consortium (STCC)

STCC aims to strengthen the overall impact of cancer research and translation in Singapore by gathering key basic, clinical and translational teams on a joint platform to actively establish and implement cancer cooperation projects
.
STCC is committed to turning Singapore into a global leader in oncology research and transformation, and its application in health and economic value creation
.

STCC is a business unit of the Singapore Clinical Research and Innovation Alliance (CRIS), a subsidiary of the Ministry of Health Holdings (MOHH), and STCC is its research partner (NCCS, NCIS, National University of Singapore [NUS] Cancer Science Research It is based on the cancer research project and commercial platform of the Institute of Science and Technology [CSI] and the Agency for Science, Technology and Research of Singapore [A*STAR])
.

STCC is funded by the National Research Foundation of Singapore and is managed by the Ministry of Health of Singapore
.

For more information, please visit National Cancer Centre Singapore (NCCS)

NCCS is a leading tertiary cancer center with a team of experienced cancer treatment experts
.
The majority of cancer cases in Singapore’s public healthcare sector are taken care of by NCCS
.
In addition to providing holistic and multidisciplinary oncology care, our clinicians and scientists also work with local and international partners to carry out robust, cutting-edge clinical and translational research
.
In order to realize the vision of becoming the world's leading cancer center, NCCS provides world-class medical care and shares its rich experience and expertise by training local and overseas medical professionals
.

To meet the growing demand for healthcare, the new NCCS building will be completed in 2022, when capacity will be increased and facilities dedicated to cancer care, rehabilitation, research and education will be expanded
.
In order to give patients the best treatment effect, NCCS will provide advanced and innovative treatment methods, such as proton therapy at the new Wu Qingliang Proton Therapy Center
.

For more information about NCCS, please visit Harbor Statement 

This press release contains forward-looking statements, including the potential impact of the ADG106 and nivolumab combination trial, the potential significance of clinical data to patients, clinical development plans and related clinical trial data, and the potential of our partners’ products and investigational therapies Statement of benefits, safety and effectiveness, as well as Tianyan Pharmaceutical’s advancement and expectations of its candidate products’ preclinical activities, clinical development, regulatory milestones and commercialization
.
Due to various important factors, actual results may differ materially from those shown in the forward-looking statements, including but not limited to Tianyan Pharmaceutical’s ability to prove the safety and effectiveness of its drug candidates; the clinical results of its drug candidates, May not support further development or regulatory approval; the content and time of the decision by the relevant regulatory agency on the regulatory approval of Tianyan Pharmaceutical’s drug candidate; if approved, Tianyan Pharmaceutical’s ability to achieve commercial success for its candidate drug; Tianyan The pharmaceutical industry’s ability to obtain and maintain intellectual property protection for its technologies and drugs; Tianyan Pharmaceuticals relies on third parties for drug development, manufacturing and other services; Tianyan Pharmaceuticals’ limited operating history and Tianyan Pharmaceuticals’ access to additional operating funds and The ability to complete the development and commercialization of its drug candidates; the ability of Tianyan Pharmaceuticals to sign additional cooperation agreements in addition to its existing strategic partnerships or cooperation, and the clinical development, commercial and other operations of COVID-19 on Tianyan Pharmaceuticals The impact of, and those risks discussed more fully in the "Risk Factors" section of Tianyan Pharmaceutical's filing with the US Securities and Exchange Commission
.
All forward-looking statements are based on information currently available to Tianxian Pharmaceutical.
Tianxian Pharmaceutical does not undertake the obligation to publicly update or revise any forward-looking statements due to new information, future events or other reasons, unless required by law
.

[1] Howlader N, Forjaz G, Mooradian MJ, et al.
The Effect of Advances in Lung-Cancer Treatment on Population Mortality.
New England Journal of Medicine 2020;383:640-9

Source: Tianyan Pharmaceutical