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Kintor Pharmaceutical and Alphamab Oncology Announce Partnership to Develop Combination Therapy of GT90001 and KN046

  • Time of issue:2020-07-30

(Summary description)Kintor Pharmaceutical Limited (“Kintor Pharmaceutical” or the “Company”, stock code 9939.HK) announced that the Company has entered a partnership agreement with Alphamab Oncology (stock code: 9966.HK), to jointly develop the combination therapy of ALK-1 monoclonal antibody GT90001 and PD-L1 / CTLA-4 bispecific antibody 
KN046 in hepatocellular carcinoma (HCC).

Kintor Pharmaceutical and Alphamab Oncology Announce Partnership to Develop Combination Therapy of GT90001 and KN046

(Summary description)Kintor Pharmaceutical Limited (“Kintor Pharmaceutical” or the “Company”, stock code 9939.HK) announced that the Company has entered a partnership agreement with Alphamab Oncology (stock code: 9966.HK), to jointly develop the combination therapy of ALK-1 monoclonal antibody GT90001 and PD-L1 / CTLA-4 bispecific antibody 
KN046 in hepatocellular carcinoma (HCC).

  • Categories:Company news
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  • Time of issue:2020-07-30 19:02
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Kintor Pharmaceutical Limited (“Kintor Pharmaceutical” or the “Company”, stock code 9939.HK) announced that the Company has entered a partnership agreement with Alphamab Oncology (stock code: 9966.HK), to jointly develop the combination therapy of ALK-1 monoclonal antibody GT90001 and PD-L1 / CTLA-4 bispecific antibody KN046 in hepatocellular carcinoma (HCC).

Liver cancer is the fourth most common cancer in China and the second leading cause of death by cancer. The most common type of liver cancer is hepatocellular carcinoma (HCC). Despite the development of various new therapies, the overall survival rate of patients is still low. There is an urgent need for better treatment options to benefit patients. This collaboration will explore the safety, tolerability, and efficacy of the combination therapy of GT90001 and KN046 for malignant tumors such as liver cancer. According to the agreement, Kintor Pharmaceutical and Alphamab Oncology will establish a joint-development committee to jointly finance their cooperation on pre-clinical development, IND application, clinical development and registration for the HCC combination therapy and other indications agreed by both parties.

Dr. Youzhi Tong, Founder, Chairman and CEO of Kintor Pharmaceutical commented, "GT90001 (ALK-1 antibody) is considered as a potential ‘first-in-class’ drug in-licensed from Pfizer. The clinical trial data of the combination therapy of GT90001 and immunotherapy for the treatment of liver cancer led by Professor Chiun Hsu from National Taiwan University’s affiliated Hospital in Taiwan shows that it has good safety and anti-tumor activity. Kintor Pharmaceutical will focus on the ALK-1 target by developing antibody biologics to achieve better clinical benefits through the inhibition of multiple signaling pathways, including 1) carry out the registration trial in the HCC second-line treatment with ALK-1 and PD-1 combination therapy as soon as possible; 2) carry out the clinical study in the treatment of other solid tumors with ALK-1 and PD-1 combination therapy; 3) explore new treatments of solid tumors with combination of ALK-1 and other immunotherapeutic bispecific antibodies. This cooperation with Alphamab Oncology is an important step in this direction. We hope to provide more treatment choices for liver cancer patients.”

Dr. Ting Xu, Founder, Chairman and CEO of Alphamab Oncology commented, “KN046 is a recombinant humanized PD-L1/CTLA-4 bispecific antibody invented by Alphamab, with the potential to become the next generation immuno-oncology therapy. Alphamab Oncology is actively deploying KN046's combination therapy development strategy. Currently, it has initiated 7 combination clinical trials. The indications include hepatocellular carcinoma, pancreatic cancer, Her-2 positive or expressing solid tumors, and late stage non-small cell lung cancer. We look forward to successful cooperation with Kintor Pharmaceutical to further unlock the great value of KN046, the PD-L1 / CTLA-4 bispecific antibody, and provide effective treatment options for liver cancer patients.”

About GT90001

GT90001 is ALK-1 (“activin receptor-like kinase-1”), an antagonistic mediator of lateral transforming growth factor-beta/ALK-5 signaling, which is a fully humanized IgG2 neutralizing monoclonal antibody. Kintor entered into a license agreement with Pfizer on ALK-1 in 2018,

pursuant to which we obtained an exclusive global license to develop, manufacture and commercialize ALK-1 for treatment of cancer. ALK-1 binds to its ligands BMP9 and BMP10, regulates SMAD, the fusion of Caenorhabditis elegans SMA genes and the Drosophila MAD

family of genes, phosphorylation, and promotes stable vascular maturation. ALK-1 can inhibit the growth of tumor vessels and reduce their blood flow and vascularization by blocking the receptors, thereby slowing down the development of tumors. As a first-in-class compound, ALK-1 has the potential to become the first fully human monoclonal antibody therapeutic drug for the treatment of a variety of solid tumors.

Pfizer has completed two phase I clinical trials, one in the United States and Italy and the other in South Korea and Japan, for ALK-1 for over 100 patients with advanced solid tumors, of which a favorable safety and preliminary validity profile was demonstrated. Currently GT90001 is in phase II clinical trials carried out by Kintor Pharmaceutical in Taiwan as a combination therapy with Nivolumab, a PD-1, for metastatic HCC (hepatocellular carcinoma).

About KN046

KN046 is the world's first recombinant humanized PD-L1/CTLA-4 bispecific invented by Alphamab. Its innovative designs include: a proprietary CTLA-4 domain antibody with a significantly improved safety profile; a bispecific antibody fused with PD-L1 antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg clearing function. The preclinical and clinical study results of KN046 have shown promising efficacy and significantly reduced toxicity to human peripheral system, with the potential to become the breakthrough immuno-oncology therapy.

Previously, KN046's phase I clinical trials in Australia and China have shown a preliminary profile of good safety and promising efficacy, and several phase II clinical trials are ongoing in China for NSCLC, TNBC, ESCC and pancreatic cancer. US FDA has approved KN046 to enter phase II trial based on the clinical results in China and Australia.

About Kintor Pharmaceutical Limited

Founded in 2009, Kintor Pharmaceuticals concentrates on the R&D and industrialization of “best-in-class” and “first-in-class” innovative drugs, and strives to become a leading enterprise in the R&D and commercialization of innovative therapies. The Company was founded by national-level talents, after years of development, centered upon androgen receptor (AR) related diseases and researched and developed product portfolios in multiple channels covering cancers with a globally high incidence and illnesses yet to meet their clinical requirements, such as prostate cancer, breast cancer, liver cancer and hair loss. Kintor Pharmaceuticals has prospectively deployed a diversified product pipeline that includes small molecule innovative drugs, bio-innovative drugs and combination therapies, including 5 products that are undergoing clinically researched androgen receptor antagonists, ALK-1 monoclonal antibody, mTOR kinase 4 inhibitors and Hedgehog inhibitors, as well as AR-Degrader, c-Myc inhibitors and IDO inhibitors that are undergoing preclinical research. Globally, the Company has more than 60 patents obtained or under review, many of which are listed as the “Major New Drugs Discovery” in National 12th and 13th Five-Year Plans. On 22 May 2020, the Company was officially listed on the Hong Kong Stock Exchange with the stock code 9939.HK.

Visit http://www.kintor.com.cn for more information.

About Alphamab Oncology

Alphamab Oncology is a biopharmaceutical company focusing on innovative biologics medicine in oncology. On December 12, 2019, Alphamab Oncology 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 consists of eight anti cancer drug candidates, four of which have advanced into Phase I – III clinical development phases in China, US and Japan. Alphamab Oncology also has state-of-the-art manufacturing capability designed and built to meet NMPA and EU/FDA’s cGMP standards. Alphamab Oncology is committed to further develop its robust pipeline in oncology/immunology to benefit patients around the world.

Visit http://www.alphamabonc.com for more information.

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