On November 2, 2021 Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, reported that the company has enrolled and dosed its first patient with advanced or refractory solid tumors in a clinical trial of ALK-1 antibody (GT90001) in combination with KN046 on November 2 in Taiwan, China (Press release, Suzhou Kintor Pharmaceuticals, NOV 2, 2021, View Source [SID1234594160]).

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This study (NCT04984668) is a two-stage, multicenter, open-label, phase Ib/II clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of ALK-1 antibody in combination with KN046 in patients with advanced or refractory solid tumors, including hepatocellular carcinoma (HCC), gastric carcinoma/gastroesophageal junction adenocarcinoma (GC/GEJ), urothelial carcinoma (UC) and esophageal square cell carcinoma (ESCC).

Dr.Youzhi Tong, founder, Chairman and CEO of Kintor Pharma, commented, "We are continuously enriching the pipeline of biological drugs surrounding the ALK-1 antibody. The phase II clinical trial of ALK-1 antibody combination therapy on patients with advanced hepatocellular carcinoma ("HCC") was commenced in Taiwan, China, the preliminary data of which showed positive antitumor activity and good safety profile. Recently, the clinical trial of ALK-1 antibody combination therapy for the first-line treatment of advanced HCC has also been approved by China NMPA. In 2020, we collaborated with Alphamab to further explore the clinical strategies of ALK-1 antibody in combination with KN046. Following the first patient enrolled and dosed in this clinical trial, we hope to accelerate the clinical process and benefit more patients with advanced or refractory solid tumors."

Dr.Ting Xu, Chairman and CEO of Alphamab Oncology, commented," KN046 is a bispecific antibody that targets both PD-L1 and CTLA-4 immune checkpoints, with a unique anti-tumor mechanism. Data from clinical studies of KN046 in PD-(L)1 refractory NSCLC, thymic cancer, pancreatic cancer and liver cancer have demonstrated impressive survival benefits. We are also advancing the clinical research of KN046 in combination with other therapies to fully explore its clinical value. We look forward to exploring new mechanisms of tumor immunotherapy through the combination of KN046 with Kintor Pharma’s ALK-1 antibody, and bringing new treatment options for patients."

About ALK-1 antibody

ALK-1 antibody is a fully humanized monoclonal, potential first-in-class antibody that inhibits ALK-1/TGF-β signal transduction and tumor angiogenesis.

Kintor Pharma obtained an exclusive global license for ALK-1 antibody from Pfizer, Inc., in February 2018. The preliminary data of the ongoing Taiwan phase II clinical trial was released at the ASCO (Free ASCO Whitepaper) GI 2021 and showed positive efficacy and 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 of ALK-1 antibody for a multi-regional phase II clinical trial for the combination treatment for the second-line treatment of HCC. On 9 October 2021, the clinical trial of combination therapy of ALK-1 antibody for the first-line treatment of advanced HCC was approved by the National Medical Products Administration of China.

About KN046

KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a novel mechanism CTLA-4 domain fused with a PD-L1 single domain antibody; engineered to target the tumor micro-environment with high PD-L1 expression, and Treg（suppresstumor immunity）clearing function.

There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, thymic cancer, pancreatic cancer, HCC, ESCC and TNBC in Australia and China. The results of these clinical trials have shown promising data in terms of survival for patients. Alphamab Oncology has received FDA clearance to enter later stage trials of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA’s orphan drug designation for thymic epithelial tumor in September 2020. Four pivotal clinical trials are currently being conducted.