Suzhou, August 12, 2021 - Alphamab Oncology (stock code: 9966.HK) announced, phase II clinical study (study number: KN026-208) of the company's proprietary HER2 bispecific antibody KN026 for the neoadjuvant treatment of HER2 positive early or locally advanced breast cancer recently completed the first drug administration.
Breast cancer is the number one malignant tumor that seriously threatens the health of women in the world, and it is also the most frequent tumor in Chinese women. HER2 positive breast cancer is one of the most aggressive subtype of breast cancer, accounting for about 15%-30%, with rapid progression and poor prognosis. Early-stage breast cancer is a malignant tumor with a high cure rate. Neoadjuvant therapy may also enable patients with locally advanced breast cancer to have radical surgery. HER2 targeted drug combination therapy is regarded as the standard neoadjuvant treatment, hence pCR rate and progression-free survival still needs to be improved, there is still a huge unmet clinical need in HER2-positive breast cancer.
KN026-208 is a phase II multicenter clinical study evaluating the efficacy, safety and tolerability of KN026 combination therapy as a neoadjuvant treatment for HER2 positive early or locally advanced breast cancer. Treatment naïve HER2 positive early or locally advanced breast cancer patients will receive KN026 combined with docetaxel for 4 cycles of neoadjuvant therapy. After neoadjuvant therapy, patients who meet the surgical conditions will undergo surgery and pathological remission assessment. The study plans to recruit about 30 patients, with pathological complete response rate (pCR) as primary study endpoint.
Dr. Ting Xu, Chairman and CEO of Alphamab Oncology commented, “HER2 expression is an important marker of poor prognosis in breast cancer. Several clinical studies have shown that KN026 has significant anti-tumor activity and good safety against HER2-positive advanced breast cancer. Through the KN026-208 trial, we look forward to bringing new adjuvant treatments with better efficacy and safety to patients with early or locally advanced breast cancer, improving the chances of cure through a higher rate of radical surgery. "
KN026 is an anti-HER2 bispecific antibody 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 equivalent efficacy compared with Trastuzumab and Pertuzumab alone or 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 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, 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 fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline includes fifteen tumor monoclonal antibodies and bispecific antibodies and a Covid-19 bispecific antibody. Four products have advanced into phase I-III clinical trials or pre-marketing stage in China, the United States, Japan and Australia. The BLA for Envafolimab (KN035) has been accepted and granted Priority Review by the National Medical Products Administration (NMPA).
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.
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