KN026 was Granted Breakthrough Therapy Designation by CDE

SUZHOU, China, Nov. 7, 2023 /PRNewswire/ — Alphamab Oncology (stock code: 9966.HK) and CSPC Pharmaceutical Group Co., Ltd. (stock code: 1093.HK) jointly announced, that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) granted a Breakthrough Therapy designation to KN026 (HER2 bispecific antibody) combined with chemotherapy for the treatment of HER2-positive gastric cancer (including gastroesophageal junction cancer).

Gastric cancer is one of the most common gastrointestinal malignancies in the world, and the number of new cases and deaths of gastric cancer in China every year is close to 42% of the world,that bring a heavy disease burden for patients, especially those with advanced or metastatic gastric cancer. Human epidermal growth factor receptor2 (HER2) is overexpressed in about 15-20% of gastric cancer patients, which is associated with tumor aggressiveness and poor prognosis. Therefore, there is a huge unmet clinical need in the treatment of patients with HER2-positive gastric cancer who progress or relapse after first-line therapy. The clinical study of KN026 in this indication has preliminarily shown a breakthrough in efficacy and good safety, which has obvious clinical advantages compared with existing treatment methods.

According to the results of a Phase II clinical trial evaluating the safety and efficacy of KN026 monotherapy in patients with advanced HER2-expressing gastric Cancer or gastroesophageal junction adenocarcinoma who have failed at least one previous standard therapy, published in the European Journal of Cancer in November 2022, a total of 45 subjects received KN026 monotherapy at least once, of which 27 had high HER2 expression, 14 had low HER2 expression, and 4 had no HER2 expression. Among the 39 patients assessed for efficacy, the HER2-high expression group had an objective response rate (ORR) of 56%, median duration of response (DoR) of 9.7 months, median follow-up of 14.7 months, median progression-free survival (mPFS) of 8.3 months, and median overall survival (mOS) of 16.3 months. No drug-related deaths were reported in the study, and the most common grade ≥3 adverse event was gastrointestinal disease (5 patients, 11%). Meanwhile, in 14 patients with high expression of HER who had been previously treated with trastuzumab, the objective response rate (ORR) reached 50%. The above clinical data show that KN026 is significantly effective in treating patients who have failed previous anti-HER2 therapy.

The Phase III clinical trial of KN026 in this indication is in the enrollment phase, and the trial is currently well underway. KN026 has been granted breakthrough treatment designation, and its development and review speed will be further accelerated, which is expected to become the first anti-HER2 treatment for second-line gastric cancer where HER2-targeted therapy has failed.

About KN026

KN026 is an anti-HER2 bispecific antibody that 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.

Alphamba already initiated multiple clinical trials for KN026 in China and the United States. KN026 showed good efficacy and safety profiles, even in heavily pretreated patients with HER2-positive breast cancer and gastric cancer. Currently, several phase III pivotal studies of KN026 are ongoing for patients with breast cancer, or gastric cancer/gastroesophageal junction cancer, etc.

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 Alphamab Oncology

Alphamab Oncology is a 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.

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.

We have created a biological macromolecule drug discovery, research and development, manufactured technology platform with independent intellectual property rights such as protein/antibody engineering, antibody screening, multi-module/multi-functional antibody modification.

With multiple in-house proprietary technology platforms, Alphamab Oncology has established a globally competitive and differentiated pipeline which consists of tumor single domain antibody/monoclonal antibodies, multi-functional antibodies, and antibody-drug conjugates. Among them, the world’s first subcutaneous PD-L1 inhibitor injection (Envafolimab) has been obtained the market approval by the Chinese National Medical Products Administration, several varieties have entered the critical clinical stage in China and the United States, 2 varieties were selected into the national special project of ” New Drug Development”, and 3 varieties were granted 4 orphan drug qualifications by FDA.

Source : KN026 was Granted Breakthrough Therapy Designation by CDE

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