Suzhou, May 27, 2022 - Alphamab Oncology (stock code: 9966.HK) announced, phase II clinical study (KN026-205) of its proprietary anti-HER2 bispecific antibody KN026 combined with Pfizer’s Ibrance® (palbociclib) and fulvestrant in the treatment of locally advanced unresectable or metastatic HER2-positive breast cancer has completed the dosing of the first patient. In 2020, the company has entered a clinical supply agreement with Pfizer to advance a clinical study to investigate KN026 in combination with Ibrance® (palbociclib) and received approval for the IND application from the National Medical Products Administration (NMPA) of China.
KN026-205 is a multi-center, open-label phase II study to evaluate the efficacy, safety and tolerability of KN026 combined with palbociclib + fulvestrant in patients with locally advanced unresectable or metastatic HER2-positive breast cancer who have failed the treatment with Trastuzumab and Taxanes. The study plans to enroll approximately 36 patients, with objective response rate (ORR) assessed by investigator according to the RECIST 1.1 as the primary endpoint.
The principal investigator of the study, Professor Jiong Wu from Fudan University Cancer Hospital, commented, “Breast cancer is the most common malignant tumor in the world, posing a serious threat to women's physical and mental health. HER2 gene amplification or overexpression has been identified in 15%-30% of breast cancers, and is associated with a high degree of malignancy and poor prognosis. Although anti-HER2 monoclonal antibody improves the survival benefit of patients, disease progression is still inevitable. As an innovative bispecific antibody, KN026 can bind two non-overlapping epitopes of HER2 simultaneously. We hope that KN026 combined with a CDK4/6 inhibitor and estrogen receptor antagonist could bring better treatment options to patients."
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 equivalent efficacy compared with Trastuzumab and Pertuzumab in combination, and was superior to either single agent, 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 phase I/II clinical trials in China and phase I clinical trial in the United States. The results of Phase I clinical trials show KN026 has good safety, tolerance and potentially superior anti-tumor activity in HER2-positive breast cancer patients who progressed after multiple lines of anti-HER2 treatment.
About Alphamab Oncology
Alphamab Oncology is focusing on innovation, including discovery, development, production and commercialization of anti-tumor drugs. On December 12, 2019, the Company was listed in the mainboard of Hong Kong Stock Exchange with stock code 9966.
Alphamab has a fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline consists of tumor monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. Five products have advanced into phase I-III clinical trials in China, the United States, Japan and Australia and in November 2021, one of these products, the unique PD-L1 antibody for subcutaneous administration, Envafolimab, received marketing authorization from the Chinese National Medical Products Administration (NMPA) for the treatment of previously treated MSI-H/dMMR advanced solid tumors.
The Company also has state-of-the-art manufacturing capabilities designed and built to meet NMPA and EU/FDA’s cGMP standards and a complete quality system which has passed the on-site inspection of a European Union qualified person. Alphamab Oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in China and around the world.
Alphamab Oncology Forward-Looking Statements
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