• As of Sep 10, 2022, 20 patients completed the surgery and pathological evaluation, tpCR rate were 50%, bpCR rate were 55.0%, and ORR were 100%.
• In terms of safety, the incidence Grade ≥3 TEAE were 53.3% (16/30)。The incidence of SAE was 6.7% (2/30) with only one case related to KN026.

SUZHOU, China, Dec. 12, 2022 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced that data from phase II clinical study (clinical trial No.: KN026-208) of HER2 bispecific antibody KN026 in combination with docetaxel as neoadjuvant treatment for HER2-positive early or locally advanced breast cancer as a Poster at the San Antonio Breast Cancer Symposium (SABCS 2022).

Presentation Format: Poster presentation
Poster Title: KN026 in combination with docetaxel as neoadjuvant treatment for HER2-positive early or locally advanced breast cancer: A single arm, multicenter, phase 2 study
Poster ID: OT2-16-04
Corresponding author: Prof. Jiong Wu, Fudan University Shanghai Cancer Center
launch time: December 7, 2022, 5:30PM-6:15 PM(CST)

KN026-208 (NCT04881929) is a phase II, open label, multi-center clinical study, evaluating the efficacy, safety, and tolerability of KN026 in combination with docetaxel as neoadjuvant treatment for HER2-positive early or locally advanced breast cancer. patients were enrolled to receive 4 cycles of KN026 (30mg/kg, ivgtt d1, q3w) and docetaxel (75 mg/m2 ivgtt d1, q3w) neoadjuvant treatment. The primary endpoint was total pathological complete response rate (tpCR rate). Secondary endpoints were breast pathological complete response rate (bpCR rate), ORR (objective response rate), safety，PK (pharmacokinetics) and immunogenicity.

As of Sep 10, 2022., a total of 30 patients who are HER2-positive early or locally advanced breast cancer were enrolled. Of the 30 patients, 20 patients completed the surgery and pathological evaluation, in which the tpCR rate was 50% (10/20, 95% CI: 27.2%-72.8%), the bpCR rate was 55.0% (11/20, 95% CI:31.53%-76.94%), and the ORR was 100% (20/20, 95% CI: 83.16%-100%).

In terms of safety, the incidence of TEAE and CTCAE Grade ≥3 TEAE were 100% (30/30) and 53.3% (16/30), respectively. The most common (≥5%）Grade ≥3 TEAE were neutrophil count decreased (50%, 15/30), white blood cell count decreased (40%, 12/30), and lymphocyte count decreased (10%, 3/30). The incidence of SAE and CTCAE Grade ≥3 SAE were both 6.7% (2/30). KN026-related SAE and docetaxel-related SAE occurred in only one patient.

The results preliminarily showed that KN026 demonstrated promising efficacy and well tolerated in combination with docetaxel in patients with early or locally advanced HER2-positive breast cancer.

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 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.

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