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.

■ Poster presentation

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 ."