English 中文简体 中文繁体

Four IND Applications Accepted by NMPA CDE for KN046 and KN026 New Therapies

February 24, 2020 22:00 Eastern Daylight Time

Suzhou, February 20, 2020 – Alphamab Oncology (stock code: 9966.HK) announced that the Company's four Investigational New Drug (IND) applications for new therapies of KN046, a recombinant humanized PD-L1/CTLA-4 bispecific antibody, and KN026, an anti-HER2 bispecific antibody, have recently been accepted by the Center for Drug Evaluation (CDE) of National Medical Products Administration(NMPA) of China.


CXSL2000029 / CXSL2000030

KN046 and KN026 combination therapy

KN046 and KN026 are two innovative bispecific antibodies independently developed by Alphamab Oncology. Both products have shown good safety, tolerability and preliminary efficacy in clinical trials. The clinical trial under application aims to study KN046 in combination with KN026 for the treatment of HER2-positive or expressing solid tumors, including but not limited to HER2-positive or expressing breast cancer, gastric cancer/gastroesophageal junction cancer, esophageal cancer, colorectal cancer, pancreatic cancer, bile duct cancer, ovarian cancer, urothelial cancer and lung cancer.


CXSL2000023

KN046 and Ningetinib combination therapy

Alphamab Oncology and Sunshine Lake Pharma Co., Ltd. reached a cooperation agreement on KN046 and Ningetinib Toluenesulfonate for the treatment of hepatocellular carcinoma (HCC) in January 2019. This IND application aims to study the safety, tolerability and preliminary efficacy of KN046 in combination with Ningetinib Toluenesulfonate for hematology malignancies and solid tumors including advanced hepatocellular carcinoma.


CXSL2000031

KN026 Injection

Previously, the IND of lyophilized dosage form of KN026 was approved by China NMPA and the US Food and Drug Administration (FDA) in 2018, and is currently undergoing phase I clinical trials in the United States and phase II clinical trials in China for a variety of indications. The recent IND application for KN026 Injection is filed for liquid dosage form developed by the Company. It targets first-line treatment of recurrent or metastatic HER2-positive or expressing breast cancer.


Dr. Ting Xu, Founder, Chairman and CEO of Alphamab Oncology, commented : "KN046 and KN026 are the next-generation bispecific drugs for cancer treatment with great potential, and the anti-tumor effects of the two products have been preliminarily demonstrated in a variety of clinical trials. These IND applications mark that Alphamab Oncology is entering the stage of clinical study of combination therapy. The Company will further study the clinical potential of the product pipeline through combination therapies including combination of KN046 and KN026, striving to provide world-class biological therapy for cancer patients and make contributions to 'Healthy China 2030'".


About KN046

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


Previously, KN046's phase I clinical trials in Australia and China have shown an preliminary profile of good safety and promising efficacy, and several phase II clinical trials are ongoing in China for NSCLC, TNBC and ESCC.


About KN026

KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. In pre-clinical studies, KN026 has demonstrated potentially equivalent or superior efficacy compared with Trastuzumab and Pertuzumab alone or in combination, such as increased binding affinity, as well as better tumor inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines. KN026 phase I trials in China have shown good safety and preliminary efficacy.


KN026 received IND approval from the National Medical Products Administration of China and U.S. Food and Drug Administration in 2018. Currently, it is under phase I clinical trial in the United States and phase II clinical trial in China targeting at many indications.


About Ningetinib Toluenesulfonate

Ningetinib toluenesulfonate is a multi-target small molecule inhibitor independently developed by Sunshine Lake. On the one hand, it can block MAPK/ERK and PI3K/AKT cancer signaling pathways by inhibiting HGF/c-Met and Gas6/AXL/Mer and thus directly inhibit tumor growth. On the other hand, it can also block the formation of tumor neovascularization through inhibiting VEGF/VEGFR2 and thus inhibiting the growth of tumor cells indirectly.


About Alphamab Oncology

Alphamab Oncology is a biopharmaceutical company focusing on the research and development, manufacturing and commercialization of biologics for oncology. 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 platform 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.  


The Company also has proprietary CRIB and CRAM platforms for bi-specifics and antibody mixtures, and state-of-the-art manufacturing capability designed and built to meet NMPA and EU/FDA’s cGMP standards.


With multiple in-house proprietary platforms for innovative biopharmaceuticals, Alphamab Oncology has built a robust pipeline in oncology/immunology to benefit cancer patients around the world.

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