On May 4, 2022 Kintor Pharmaceutical Limited ("Kintor Pharma," HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecules and biological therapeutics, reported the first patient dosing in the United States of its multi-regional phase II clinical trial (NCT05178043) of ALK-1 antibody (GT90001) and Nivolumab (Opdivo) combination therapy for the treatment of advanced Hepatocellular Carcinoma (HCC) on 2 May 2022 (Press release, Suzhou Kintor Pharmaceuticals, MAY 4, 2022, View Source [SID1234613576]).
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According to Global Cancer Statistics 2020, primary liver cancer is the sixth most commonly diagnosed cancer and the third leading cause of cancer death worldwide, with approximately 906,000 new cases and 830,000 deaths[1]. HCC is the most common form of liver cancer in adults, accounting for about 75%-85% of all liver cancers.[2] Overall, the treatment and prognosis of liver cancer are relatively poor, and the overall survival of liver cancer needs to be further improved with better treatment options.
In recent years, innovative therapies have increased options for patients with advanced liver cancers. In 2020, the combination treatment of Atezolizumab (TECENTRIQ) and Bevacizumab (AVASTIN) ("T+A") was approved in the US to replace Sorafenib (NEXAVAR) or Lenvatinib (LENVIMA) as the first-line standard of care ("SOC") for advanced HCC, following by approval in many other countries and regions. There has been huge unmet needs for a second-line treatment for patients who failed treatment with or did not tolerate T+A.
Dr. Tong Youzhi, founder, Chairman, and CEO of Kintor Pharma, commented, "We are delighted to complete the first patient dosing in the phase II multi-regional clinical trial of GT90001 combined with Nivolumab for the treatment of advanced HCC. We expect this phase II MRCT study would position GT90001 well as a combination candidate with I/O for the second-line treatment of HCC. We are also selecting clinical strategies for GT90001 in other solid tumors and hope to bring more innovative treatment options for patients with unmet needs."
About the Study
This phase II clinical trial was greenlighted by the FDA on February 11, 2021. This is an open label, multi-regional study designed to evaluate the efficacy and safety of GT90001 in combination with Nivolumab in patients with advanced HCC who were intolerant of, or had progressed after first-line treatment with Immune Checkpoint Inhibitors (ICI) such as Atezolizumab and/or Bevacizumab, or ICI plus Tyrosine Kinase Inhibitor (TKI). This study will enroll a total of 105 patients to receive a combination therapy of Nivolumab and GT90001. The proposed dose is GT90001 7 mg/kg in combination with Nivolumab 240 mg, infusion every two weeks. The primary endpoint is to assess the overall response rate (ORR) as evaluated by an independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
About ALK-1 Antibody
ALK-1 antibody is a potential first-in-class, fully human IgG2 neutralizing monoclonal antibody that inhibits BMP9, TGFβ through ALK-1 receptor-mediated signal transduction and tumor angiogenesis. Kintor Pharma obtained an exclusive global license for ALK-1antibody from Pfizer, Inc., in February 2018.
In January 2021, the preliminary data of the ongoing Taiwan phase II clinical trial for advanced HCC was released at ASCO (Free ASCO Whitepaper) GI 2021 and showed positive efficacy and good safety results. The overall response rate ("ORR") was 40 percent.
In February 2021, the U.S. Food & Drug Administration (FDA) granted Kintor Pharma an investigational new drug ("IND") application for ALK-1 antibody as a second-line treatment for HCC. In October 2021, the clinical trial of combination therapy of ALK-1 antibody for the treatment of advanced HCC was approved by the National Medical Products Administration (NMPA) of China.