IND Application for a Phase Ⅲ Clinical Study of KN026 Combined with Albumin-bound Docetaxel as Neoadjuvant Treatment for Breast Cancer was Approved

SUZHOU, China, Oct. 17, 2024 /PRNewswire/ -- Alphamab Oncology (stock code: 9966 HK) and CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK) jointly announced that an application for a phase III clinical study (Study ID: KN026-004) of the anti-HER2 bispecific antibody KN026 combined with albumin-bound Docetaxel HB1801 has been approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) as neoadjuvant treatment for HER2-positive early or locally advanced breast cancer.

Breast cancer is one of the most common malignant tumors in women. According to the latest data released by the International Agency for Research on Cancer (IARC) in 2024, there were 2.31 million new cases of breast cancer worldwide in 2022, with 357,000 new cases in China. Approximately 15%-20% of breast cancer patients are HER2-positive, a subtype characterized by high malignancy, rapid disease progression, prone to lymph node metastasis, and poorer prognosis. In recent years, both domestic and international breast cancer treatment guidelines have recommended anti-HER2 neoadjuvant therapy to further optimize treatment outcomes.

KN026 is an anti-HER2 bispecific antibody independently developed by Alphamab Oncology. Results from a phase II clinical study of KN026 combined with docetaxel as first-line treatment for HER2-positive recurrent or metastatic breast cancer (KN026-201, NCT04165993) demonstrated promising efficacy and tolerability. In terms of neoadjuvant therapy, data from a phase II clinical study of KN026 combined with docetaxel as neoadjuvant treatment for HER2-positive early or locally advanced breast cancer (KN026-208, NCT04881929) presented at the 2023 ESMO Congress showed promising clinical benefit and good tolerability: the total pathological complete response (tpCR) rate was 56.7%, the breast pathological complete response (bpCR) rate was 60%, the confirmed objective response rate (ORR) was 86.7%, and the posterior probability for tpCR rate >40% was 96.7%, suggesting that the neoadjuvant regimen of KN026 combined with docetaxel within the same treatment cycles may be superior to existing standard neoadjuvant therapy regimens.

The approved study is a randomized, controlled, open-label, multicenter phase III clinical study aimed at comparing the efficacy and safety of KN026 combined with HB1801 versus trastuzumab combined with pertuzumab and docetaxel as neoadjuvant therapy in patients with HER2-positive early or locally advanced breast cancer. The primary endpoint is the tpCR rate as evaluated by a blinded independent review committee (BIRC). This study is anticipated to offer a treatment option with improved efficacy and safety for patients with HER2-positive breast cancer.

About KN026

KN026 is an anti-HER2 bispecific antibody independently 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. KN026 has demonstrated potentially superior efficacy compared with 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.

The results of multiple clinical studies in different stages showed that KN026 has good efficacy and safety profiles, even in heavily pretreated patients with HER2-positive breast cancer (BC) and gastric cancer (GC). Currently, several pivotal clinical trials of KN026 for the treatment of BC and GC/ gastroesophageal junction cancer (GEJ) are being conducted. KN026 in combination with chemotherapy for the treatment of patients with HER2-positive GC (including GEJ) who have failed first-line standard treatment was granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA).

In August 2021, the Company entered an agreement with JMT-Bio, a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. ("CSPC") (stock code: 1093.HK), for the development and commercialization of KN026 in Mainland China, pursuant to which, JMT-Bio was granted exclusive license rights of KN026 for the development and commercialization in the indications of BC an GC/GEJ in Mainland China (excluding Hong Kong, Macau and Taiwan).

About Alphamab Oncology

Alphamab Oncology is a leading biopharmaceutical company committed to the development, manufacturing, and commercialization of cutting-edge biotherapeutics for the treatment of cancer. On December 12, 2019, the company was successfully listed on the Main Board of the Hong Kong Stock Exchange, trading under the stock code 9966.

Our integrated platform seamlessly combines research, development, and manufacturing capabilities for biologics. We take pride in our extensive intellectual property portfolio, which encompasses protein/antibody engineering, antibody screening, and multi-module/multi-functional antibody modification.

Distinguished by a globally competitive pipeline, Alphamab Oncology specializes in antibody-drug conjugation, single domain antibody, and multi-functional antibodies. Notably, Envafolimab, the world's first subcutaneously injectable PD-L1 inhibitor, was approved by Chinese authorities in 2021, making a significant breakthrough in the convenience and accessibility of cancer treatment. Three assets are currently undergoing Phase III or pivotal clinical trials, and several other new drug candidates are in early clinical stage.

Our overarching mission is to make cancer manageable and curable by addressing unmet clinical needs in oncology. Alphamab Oncology is dedicated to the development of safe, effective and affordable drugs, leveraging a global competitive edge.

SOURCE Alphamab Oncology