SHANGHAI, Dec. 10, 2020 /PRNewswire/ -- On December 9, 2020, Kintor Pharmaceutical Limited (HKEx: 9939) is pleased to announce that the Group has collected positive data in phase II clinical trials of combination therapy of ALK-1 (GT90001) antibody and PD-1 (Nivolumab or Opdivo) antibody for the second line therapy of advanced hepatocellular carcinoma ("HCC") in Taiwan (the "Phase II Clinical Trial"). The preliminary data of the ongoing Phase II Clinical Trial showed positive efficacy and safety results. The data collected in the Phase II Clinical Trial will be released at the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI) to be held between January 15-17, 2021.
Abstract Title:
Safety and efficacy of combination of GT90001, an anti-activin receptor-like kinase-1 (ALK-1) antibody, and nivolumab in patients with metastatic hepatocellular carcinoma (HCC)
Abstract Number: 326
First Author: Chiun Hsu, MD
GT90001 is a fully humanised monoclonal antibody that inhibits ALK-1/TGF-β signal transduction and tumor angiogenesis and a potential first-in-class antibody for which we obtained an exclusive global license from Pfizer, Inc. in February 2018. The Phase II Clinical Trial was commenced on May 7, 2019 in Taiwan to evaluate the safety and efficacy of GT90001 in combination therapy with Nivolumab in patients with advanced HCC who were progressed on or intolerant to first line therapy with Sorafenib or Lenvatinib.
The Phase II Clinical Trial (NCT03893695) was a single-arm, open-ended and two-stage clinical trial. The Phase II Clinical Trial mainly observed the safety, tolerability and anti-tumor activity of the combination therapy of GT90001 and Nivolumab. In the first stage (safety evaluation cohort), six patients were enrolled in the dose group of 7mg/kg of GT90001 biweekly and 3mg/kg of Nivolumab biweekly. In the second stage (expanded cohort), 14 patients were enrolled at the same dose for combination therapy. According to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, patients received treatment until experiencing disease progression or intolerable toxicity was developed. The primary efficacy endpoint was the objective response rate (ORR) assessed by the investigators.
From July 9, 2019 to September 30, 2020, among the 20 evaluable patients, eight patients (40.0%) were observed partial remission (PR). The side effects were well tolerated and manageable. The pharmacokinetic parameters of GT90001 and Nivolumab are similar to those of monotherapy.
Dr. Tong Youzhi, the founder, Chairman and CEO of Kintor Pharmaceutical, said, "Upon obtaining the exclusive global rights of GT90001, Kintor has implemented the development strategy to combine GT90001 with immunotherapy. GT90001, in combination with Nivolumab, has showed positive efficacy and safety results. We are actively initiating MRCT phase II/III clinical trials in China and US for the treatment of advanced HCC. Meanwhile, we are exploring innovative therapies for the treatment of other solid tumors."
About GT90001
GT90001 is a fully human monoclonal antibody against ALK-1 (Activin Receptor-Like Kinase-1, Activin Receptor-Like Kinase-1). Kintor Pharmaceutical obtained the global exclusive development, production and commercialization rights from Pfizer in 2018. ALK-1 antibody can inhibit tumor blood vessel growth, reduce blood flow and angiogenesis by blocking the ALK-1 receptor pathway, thereby slowing tumor growth and changing the tumor microenvironment. As a potential first-in-class innovative drug in the world, it is expected to be used in the treatment of various solid tumors.Pfizer has conducted two phase I clinical trials on GT90001 in the United States, Italy, South Korea and Japan, which showed good safety and preliminary effectiveness in more than 100 patients with advanced solid tumors. Currently, Kintor Pharmaceutical is conducting phase II clinical trial of GT90001 combined with Nivolumab (PD-1 antibody) for the treatment of advanced liver cancer in Taiwan.
About Kintor Pharmaceutical Limited
Founded in 2009, Kintor Pharmaceuticals aims to become a leading enterprise in the R&D and commercialization of "best-in-class" and "first-in-class" innovative therapies. The Company initially focused on androgen receptor (AR) related diseases and researched and developed product portfolios in multiple channels covering cancers with a globally high incidence and illnesses yet to meet their clinical requirements, such as prostate cancer, breast cancer, liver cancer and hair loss. Kintor Pharmaceuticals has prospectively developed a diversified product pipeline that includes small molecule innovative drugs, bio-innovative drugs and combination therapies, including 5 products that are undergoing clinically researched androgen receptor antagonists, ALK-1 monoclonal antibody, mTOR kinase inhibitors and Hedgehog inhibitors, as well as PD-L1/TGF-β dual-targeting antibody, AR-Degrader and c-Myc inhibitors that are undergoing preclinical research. Globally, the Company has more than 60 issued patents or under review, many of which are listed as the "Major New Drugs Discovery" in National 12th and 13th Five-Year Plans. On 22 May 2020, the Company was officially listed on the Hong Kong Stock Exchange with the stock ticker 9939.HK. Please visit http://www.kintor.com.cn for more information.