(Taipei, May 7, 2019) – Suzhou Kintor Pharmaceuticals, Inc. (“Kintor”) successfully launched clinical trials for its “GT90001-Nivolumab combination therapy for the treatment of metastatic hepatocellular carcinoma” at the MacKay Memorial Hospital in Taiwan today. The launch marks the fourth clinical trial carried out by Kintor outside of mainland China, following Kintor’s previous clinical trials in prostate cancer and hair loss conducted in the United States. As Kintor’s first clinical trial for liver cancer, the Phase II clinical trial of Kintor’s ALK-1 and PD-1 combination therapy for the treatment of liver cancer represents a key initiative for the Company within the field of large molecule drugs.
MacKay Memorial Hospital in Taiwan, one of the partner hospitals for Kintor’s clinical trials of ALK-1 and PD-1 combination therapy for the treatment of liver cancer
In addition to the MacKay Memorial Hospital, the clinical trials will also be conducted at the affiliated hospitals of National Taiwan University and National Cheng Kung University. The principal investigators of the three hospitals – Professor ZHANG Yifang, Professor XU Jun and Professor YAN Jiarui – are all highly experienced in liver cancer treatment clinical research in Taiwan. Professor XU Jun previously participated in the KEYNOTE-028 trial of pembrolizumab and has extensive experience and knowledge in the clinical research of large molecules. Professor ZHANG Yifang currently serves as the Director of the Cancer Center and the Clinical Trial Management Center of the MacKay Memorial Hospital, and has complemented his deep expertise in clinical trials with many years of clinical experience in oncology. Professor YAN Jiarui has been involved in numerous clinical studies for liver cancer treatment ranging from Phase I to III clinical trials and from large to small molecules. Kintor hopes that through close cooperation with the Principal Investigators, it will be able to conduct a highly effective and efficient clinical trial in Taiwan.
Dr. TONG Youzhi discussing with Professor ZHANG Yifang and his team at the clinical trial kick-off meeting
Targeted therapy represents one of the key areas of focus for liver cancer treatment in the future. Activin receptor-like kinase-1, or ALK-1, is expressed primarily on vascular endothelial cells and is related to the growth and migration of endothelial cells. By blocking the receptor, ALK-1 can inhibit cancer blood vessel growth, blood flow and tumor angiogenesis, thus effectively slowing down tumor growth. ALK-1 provides a unique type of targeted therapy as it is able to produce a wide range of effects in tumor biology, which not only inhibits tumor angiogenesis, but also cause changes within the tumor microenvironment. As a drug that changes the tumor microenvironment, ALK-1, in combination with PD-1 antibodies, represents a modern brand of oncological combination therapy designed to combat liver and other various types of cancer.
The first clinical trials were conducted at the MacKay Memorial Hospital, where Principal investigator Professor ZHANG Yifang, other participating investigators, nurses and related project personnel all came together to participate in the clinical trials’ initiation meeting. Representatives from the clinical trial’s sponsor and the PPC Group were also present to introduce the clinical trial’s GT0001 (ALK-1 antibody) and Nivolumab combination therapy program for the treatment of advanced liver cancer.
Dr. TONG Youzhi and Professor ZHANG Yifang posing for a photograph at the initiation meeting
“We are committed to exploring innovative solutions for tumor treatment and developing world-class drugs through our clinical trials. After receiving the exclusive worldwide rights from Pfizer to develop, manufacture and commercialize the ALK-1 antibody drug for tumor treatment, we have decided to launch new clinical trials as soon as possible to examine the combination regimen based on the approvals obtained for innovative immunotherapy for liver cancer treatment. We are pleased to announce that we are joined by three well-known clinical experts and hospitals on this multi-center Phase II clinical study to evaluate the safety, tolerability and efficacy of ALK-1 and PD-1 in the treatment of patients with advanced hepatocellular carcinoma. Through the clinical trial, we hope that we can define the strategy for international multi-center later-stage clinical trials for ALK-1 antibody and develop a more effective and safer solution for patients with liver cancer, especially for those with advanced tumors, as soon as possible.” said Dr. TONG Youzhi, Chairman and CEO of Kintor.
Founded in March 2009, Kintor is focused on developing a full R&D and commercialization platform for “best-in-class” and “first-in-class” novel drugs. The Company’s products are all Type 1.1 new drugs for prostate cancer, breast cancer, liver cancer, hair loss and other indications. Kintor holds more than 50 patents globally and has several R&D projects with subsidies granted from the country’s “Significant New Drugs Development” Program under the 12nd/13th Five-year Plan. The Phase I-III clinical trials for Proxalutamide, one of Kintor’s lead products, are being conducted in both China and the US concurrently. Two Phase III clinical trials for mCRPC as second- and first-line therapies have been launched in China with Phase II trial ongoing in the US, and the Phase I/Ib clinical trial for AR positive metastatic breast cancer indications is ongoing in China. The ALK-1 monoclonal antibody project marks Pfizer’s first license granted to a Chinese company for global development of a novel antibody drug in tumor therapy, with Phase I clinical trials involving 100 subjects completed in the US and other countries. KX-826, which treats androgenic alopecia, is undergoing Phase I clinical trial in both China and the US. Kintor’s product pipeline also includes PI3K/mTOR kinase inhibitor, Hedgehog/SMO inhibitor, cMyc inhibitor and AR-Degrader.
About Pfizer licensing
On 24 January 2018, Kintor was granted the exclusive worldwide rights to develop, manufacture and commercialize an ALK-1 antibody drug by Pfizer. The drug is expected to become the world’s first fully human therapeutic monoclonal antibody that targets ALK-1. Pfizer would support Kintor with the preclinical and Phase I clinical trial results and proprietary technologies under the Agreement.
Pfizer – Kintor Press Conference on Development of an Innovative Antibody Drug for Cancer