on january 9, 2020, alphamab oncology (stock code: 9966.hk) announced that it has completed dosing of the first patient in the phase ii clinical trial of kn026, an anti-her2 bispecific antibody, for the treatment of low her2 expressing or her2 positive recurrent / metastatic breast cancer (study number: kn026-201).
breast cancer is the no.1 highly prevalent malignant tumor for chinese women, and about 20% of these breast cancer patients have her2 overexpression or amplification (her2 positive breast cancer). data show that about 3-10% of new breast cancer cases in china each year have remote metastasis when breast cancer is diagnosed, and 30-40% may develop into advanced breast cancer with high recurrence, metastasis rate and poor prognosis.
kn026 is an anti-her2 bispecific antibody independently developed by alphamab oncology. it can simultaneously bind two non-overlapping epitopes of her2 and lead to a dual her2 signal blockade, presumedly causing her2 to aggregate on the cell surface and endocytose. kn026 phase i trials in china have shown good safety and preliminary efficacy. phase i clinical trials in the united states and phase ii clinical trials in china for various indications such as gastric cancer with high her2 expression and moderate or low her2 expression are currently being conducted.
kn026-201 is a phase ii clinical study aimed to evaluate the safety and efficacy of kn026 combined with docetaxel in the first-line treatment of breast cancer with her2 expression and kn026 monotherapy for breast cancer with low her2 expression. the trial is led by professor qingyuan zhang from harbin medical university cancer hospital and will be carried out in around 10 clinical sites nationwide.
professor qingyuan zhang from harbin medical university cancer hospital said, “kn026 targets both her2 ii and iv regions and has superior in vitro antitumor activity to trastuzumab, and still has antitumor activity against trastuzumab and pertuzumab-resistant cell lines. in its phase i clinical studies, kn026 showed promising antitumor activity as well as safety in breast cancer patients who failed multiple lines of her2-targeted therapy. it is expected that the kn026-201 study will provide new treatment options for first-line treatment of her2 advanced breast cancer patients.”
dr. ting xu, founder, chairman and ceo of alphamab oncology, said, “china is one of the countries with the fastest growing incidence of breast cancer. there is a huge unmet need for the treatment and prognosis of her2-positive breast cancer and metastatic breast cancer. kn026 is the first product successfully developed based on the company's crib platform. as an innovative bispecific antibody, it has shown encouraging advantages in preclinical and clinical studies. kn026 is currently in the leading clinical stage globally. with the clinical trials being conducted in the united states, we look forward to early launch of global registration clinical trials and bringing benefits to patients as soon as possible.”
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. in pre-clinical studies, kn026 has demonstrated potentially equivalent or superior 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 phase i trials in china have shown good safety and preliminary efficacy.
phase i clinical trials in the united states and phase ii clinical trials in china for various indications such as gastric cancer with high her2 expression and moderate or low her2 expression are currently being conducted.
about alphamab oncology (stock code: 9966.hk)
alphamab oncology is a leading clinical-stage biopharmaceutical company in china with fully integrated r&d and manufacturing platform in bi-specifics and protein engineering. its highly differentiated in-house pipeline consists of eight anti-cancer drug candidates, four of which have advanced into clinical development phase. with multiple in-house proprietary platforms for innovative biopharmaceuticals, alphamab oncology has built a robust pipeline in oncology / immunology to benefit cancer patients around the world.
visit http://www.alphamabonc.com for more information.