Alphamab Oncology Announces First Patient Dosed in Phase II Trial of KN026 in Combination with Pfizer’s Ibrance® (Palbociclib) and Fulvestrant for HER2-Positive Metastatic Breast Cancer

SuzhouMay 27, 2022PR Newswire -- Alphamab Oncology (Stock Code: 9966.HK) announced that the first patient has been dosed in its Phase II clinical study (KN026-205) evaluating KN026, a HER2 bispecific antibody developed in-house, in combination with Pfizer's Ibrance® (palbociclib) and fulvestrant for the treatment of locally advanced unresectable or metastatic HER2-positive breast cancer. In 2020, the company entered into a clinical collaboration agreement with Pfizer to advance the clinical trial of KN026 in combination with the oral CDK4/6 inhibitor Ibrance® (palbociclib) and received NMPA approval to conduct the clinical study.

KN026-205 is a multicenter, open-label phase II study for breast cancer patients with disease progression after trastuzumab and taxane treatment. It evaluates the efficacy, safety, and tolerability of KN026 in combination with palbociclib and fulvestrant in patients with locally advanced unresectable or metastatic HER2-positive breast cancer. The study plans to enroll approximately 36 patients, with the primary endpoint being the objective response rate (ORR) assessed by investigators according to RECIST 1.1 criteria.

The principal investigator of this study, Professor Wu Jiong from the Fudan University Shanghai Cancer Center, stated:"Breast Cancer as the Global Incidence RateFirstThe malignant tumor seriously threatens the physical and mental health of women. HER2 gene amplification or overexpression occurs in 15%-30% of breast cancer cases, and this type of breast cancer is highly malignant with a poor prognosis. Although anti-HER2 monoclonal antibodies have improved patient survival benefits, disease progression remains difficult to avoid. KN026, as an innovative bispecific antibody, can simultaneously bind to two non-overlapping epitopes of HER2. We are highly anticipating that the combination of KN026 with CDK4/6 inhibitors and estrogen receptor antagonists will provide better treatment options for patients.

AboutKN026

KN026 is a HER2 bispecific antibody developed by Alphamab Oncology using its proprietary Fc heterodimer platform technology (CRIB). It can simultaneously bind to two non-overlapping epitopes of HER2, leading to the blockade of HER2 signaling. This demonstrates superior efficacy compared to trastuzumab or pertuzumab alone and achieves the combined effect of trastuzumab and pertuzumab, such as exhibiting higher affinity and demonstrating enhanced tumor suppression in HER2-positive tumor cell lines. Additionally, KN026 also shows inhibitory effects on tumors with medium to low HER2 expression and trastuzumab-resistant cell lines.

KN026 IND was approved by China's National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) in 2018, respectively. It is currently undergoing multiple Phase I/II clinical trials in China, while advancing in Phase I clinical trials in the United States. The results of the Phase I clinical trial demonstrated that KN026 has good tolerability and safety, showing significant anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 therapy.

About Alphamab Oncology

Alphamab Oncology is dedicated to the research, development, manufacturing, and commercialization of innovative anti-cancer drugs. On December 12, 2019, the company was listed on the Main Board of the Hong Kong Stock Exchange, with the stock code: 9966.

Alphamab Oncology has a full industrial chain discovery, research and development, and manufacturing platform in bispecific antibodies and protein engineering. The company’s highly differentiated pipeline consists of novel anti-cancer drugs including monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. Among these, five products are in Phase I-III clinical trials in China, the United States, Japan, and Australia. In November 2021, Envada® (Envonli monoclonal antibody injection) was officially approved for marketing in China, indicated for the treatment of adult patients with advanced solid tumors who have unresectable or metastatic high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).

The company owns several proprietary technology platforms, such as heterodimer and hybrid antibodies, along with large-scale production capabilities that comply with cGMP standards in China, the United States, and the European Union. It also has a comprehensive quality system that has passed multiple audits, including those by EU QPs. The company is committed to building an internationally leading, multi-dimensional drug development and industrialization platform, focusing on multifunctional biologic macromolecule drugs to benefit patients in China and around the world.

Welcome to the company website:www.alphamabonc.com