Suzhou, China /PRNewswire/ - Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, announced today 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.
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 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.
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.
About Kintor Pharmaceutical Limited
Kintor Pharmaceutical Limited is developing and commercializing a robust pipeline of innovative small molecule and biological therapeutics for androgen-receptor-related disease areas with unmet medical needs, including COVID-19, prostate, breast and liver cancer, alopecia, and acne. For more information, visit www.kintor.com.cn.
About Alphamab Oncology
Alphamab Oncology is focusing on innovation, production and commercialization of anti-tumor drugs. On December 12, 2019, the Company was listed in the mainboard of Hong Kong Stock Exchange with stock code 9966.
Alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline includes fifteen tumor monoclonal antibodies and bispecific antibodies and a COVID-19 multifunctional antibody. Four products have advanced into phase I-III clinical trials or pre-marketing stagein China, the United States, Japan and Australia. The BLA for Envafolimab (KN035) has been accepted and granted Priority Review by the National Medical Products Administration (NMPA).
The Company also has state-of-the-art manufacturing capabilities designed and built to meet NMPA and EU/FDA's cGMP standards and a complete quality system which has passed the on-site inspection of a European Union qualified person. Alphamab Oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multi-functional biological innovative drugs, and to benefit patients in China and around the world.