Suzhou, Jan 17, 2021--Kintor Pharmaceutical Limited (HKEX: 9939) is pleased to release the positive data in phase II clinical trial of combination therapy of GT90001 and Nivolumab (Opdivo) (“combination therapy”) for the second line therapy of advanced hepatocellular carcinoma(“HCC”) in Taiwan (the “phase II clinical trial”) at the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO-GI) held between January 15 to 17, 2021. The preliminary data of the ongoing phase II clinical trial showed positive efficacy and safety results. Dr. Chiun Hsu is the principal investigator of the clinical trial.

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 for all the oncological areas 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-label and two-stage clinical trial. The phase II clinical trial mainly observed the safety, tolerability and anti-tumor activity of the combination therapy. 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. Patients wouldn’t suspend treatment until experiencing disease progression or intolerable toxicity was developed. The primary endpoint was safety and tolerability of this combination regimen. The secondary endpoints included objective response rate (RECIST v1.1) assessed by investigators, the duration of response (DOR) and others.

Between July 2019 and September 2020, 20 patients were enrolled for this study in Taiwan.

Safety Results: No patient discontinued the treatment due to AE and no treatment-related death events were reported.

Pharmacokinetic Parameters: The pharmacokinetic parameters of GT90001 and Nivolumab are similar to those of Nivolumab as a monotherapy.

Efficacy Results: The results showed that among the 20 evaluable patients, eight patients (40.0%) were observed partial remission (PR). Two patients had duration of response more than 1 year.

Dr. Tong Youzhi, the founder, chairman and CEO of Kintor Pharmaceutical, said, “We are pleased to see that 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.”