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IND Approved for Pivotal Clinical Study of KN026 Combined with KN046 in the Her2-positive Gastric Cancer or Gastroesophageal Junction Cancer

October 31, 2022 08:50 Eastern Daylight Time

Suzhou, October 31, 2022- Alphamab Oncology (stock code: 9966.HK) announced that the IND application was approved for KN026(Her2 Bispecific) and KN046(PD-L1/CTLA-4 bispecific). The approval is for a randomized phase III registration trila in Her2 positive gastric and gastroesophageal junction cancer(GC and GEJ).

 

GC/GEJ is the fifth most common malignancy and the third leading cause of cancer death worldwide. According to the Global Cancer Statistics Report 2020 released by GLOBOCAN, new incidence and death of gastric cancer in China account for about half of total global cases. 10%-20% of the GC/GEJ cancer is HER2 positive., for those patient with advanced stage disease, Herceptin/Chemo combo is still the SOC with limited therapeutic benefit. Innovative medicines are needed to bring in better efficacy and also better quality of life.

 

The efficacy of Her2 targeted thearpies, e.g. Herceptin, was shown to rely on adaptive immune response. Thus the combination of ICIs and Her2 antibodies would exter synergistic effect as demonstrated by of Keynote-811 trial which demonstrated the benefit of Kytruda on top of SOC(Herceptin+Chemo). Our own data presented at the ESMO Congress 2022 also strongly supported the conclusion. In a phase II study to test the efficacy of KN026/KN046 combo in 1st line Her2+ GC/GEJ patient, 31 patients with late stage cancer were enrolled. For 27 patient with at the least one tumor assessment, the ORR was 77.8% and DCR was 92.6%.

 

This phase Ⅲ study will be conducted in patients with locally advanced unresectable or metastatic HER2-positive GC/GEJ who have not received systemic therapy previously. Overall survival (OS) and progression-free survival (PFS) will be assessed by a blind independent review board (BIRC) with Transtuzumab plus chemo as control arm. We remain very confident that the success of the trial will bring to patient a better therapeutic option.

 

About KN026

KN026 is an anti-HER2 bispecific antibody invented 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. KN026 has demonstrated potentially superior efficacy to Trastuzumab and Pertuzumab 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 received IND approval from the National Medical Products Administration (NMPA) of China and U.S. Food and Drug Administration (FDA) in 2018. Currently, it is in multiple clinical trials in China and the United States, for patients with breast cancer, or gastric cancer/gastroesophageal junction cancer, etc. Two phase III pivotal studies of KN026 combined with chemotherapy and the chemo-free regimen of KN026/KN046 combo for the treatment of gastric cancer are ongoing. The results of prior clinical studies showed that KN026 has good efficacy and safety profiles, even in heavily pretreated patients with HER2-positive breast cancer.

 

In August 2021, the company entered an agreement with JMT-Bio, a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China. According to the terms of the agreement, JMT-Bio will obtain the exclusive license rights of KN026 for the development and commercialization in the indications of breast cancer and gastric or gastroesophageal junction cancers (GC/GEJ) in Mainland China (excluding Hong Kong, Macau and Taiwan).

 

About KN046

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

 

There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, pancreatic cancer, thymic cancer, HCC, ESCC and TNBC in Australia, the US and China. The results of these clinical trials have shown an advantage in survival for patients. Alphamab Oncology has received FDA clearance to enter phase II trial 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, among which the interim analysis of the phase III clinical study of KN046 combined with chemotherapy as the first-line treatment of NSCLC successfully met the prespecified PFS endpoint.

 

About Alphamab Oncology

Alphamab Oncology is a leading biopharmaceutical company dedicated to the discovery, development manufacturing and commercialization of world-class innovative biotherapeutics for cancer treatment. On December 12, 2019, Alphamab Oncology was listed on the Main Board of Hong Kong Stock Exchange, with the stock code:9966.

 

We have converged a professional R&D team led by top scientists, and have a complete industrial chain from early research and development of innovative drugs, process development, commercial production to clinical research.

 

With multiple in-house proprietary platforms of bispecifics, protein engineering and antibody screening, Alphamab Oncology has established a globally competitive and differentiated pipeline which consists of tumor monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. Among them, 2 varieties were selected into the national special project of " New Drug Development", and 3 varieties were granted 4 orphan drug qualifications by FDA. The world's first subcutaneous PD-L1 inhibitor injection (Envafolimab) has been obtained the market approval by the Chinese National Medical Products Administration. More than 30 clinical studies have been carried out in 6 varieties in China, the United States and Australia, among which 8 studies of 3 varieties have entered the critical clinical stage in China and the United States.

 

To make cancer manageable and curable,Alphamab Oncology has always been guided by clinical value and patient needs, and focuses on the development of innovative, safe and affordable anti-tumor drugs to benefit patients in China and around the world.

 

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