suzhou, november 22, 2022 - alphamab oncology (stock code: 9966.hk) announced that results from three clinical studies of kn026 (anti-her2 bispecific antibody) and kn046 (pd-l1/ctla4 bispecific antibody) will be presented as spotlight poster discussion or poster presentation at the 45th san antonio breast cancer symposium (sabcs 2022) from 6-10 december 2022.
breast cancer is the most common malignant cancer for women worldwide. the world health organization's report shows that one breast cancer patient is diagnosed every 1.8 seconds. in china, the incidence of breast cancer is increasing year by year, with 0.42 million new cases and 0.12 million related deaths in 2020. with the advancement of medical sciences, the survival of patients with early breast cancer has been significantly improved. however, her2-positive and triple-negative breast cancer are highly aggressive, highly heterogeneous with a disease progression or drug resistance after first-line treatment occur in a significant portio of patient.
presentation format: spotlight poster discussion
poster title: efficacy, safety, and tolerability of kn046 (an anti-pd-l1/ctla-4 bispecific antibody) in combination with nab-paclitaxel in metastatic triple-negative breast cancer (mtnbc)：final results of the phase ii trial
poster id: pd11-10
corresponding author: prof. binghe xu, cancer hospital chinese academy of medical sciences.
launch time: thursday, december 8, 2022: 7:00 am (cst)
presentation format: spotlight poster discussion
poster title: efficacy and safety results of kn026, a her2-targeted bispecific antibody combined with docetaxel in first-line treatment of her2-positive recurrent/metastatic breast cancer
poster id: pd18-08
corresponding author: prof. qingyuan zhang harbin medical university cancer hospital
launch time: december 9, 2022, 7:30am-8:15 am(cst)
presentation format: poster presentation
poster title: kn026 in combination with docetaxel as neoadjuvant treatment for her2-positive early or locally advanced breast cancer: a single arm, multicenter, phase 2 study
poster id: ot2-16-04
corresponding author: prof. jiong wu, fudan university shanghai cancer center
launch time: december 7, 2022, 5:30pm-6:15 pm(cst)
kn046 is pd-l1/ctla-4 bispecific antibody independently developed by jiangsu alphamab. its innovative designs include: a novel mechanism - ctla-4 fused with pd-l1 single domain antibody; engineered to target the tumor microenvironment with high pd-l1 expression, and treg (suppress tumor immunity) clearing function.
there are about 20 clinical trials of kn046 in different stages covering more than 10 types of tumors including nsclc, pancreatic cancer, thymic cancer, hcc, escc and tnbc in australia, the us and china. the results of these clinical trials have shown an advantage in survival for patients. alphamab oncology has received fda clearance to enter phase ii trial of kn046 based on the clinical results in china and australia. moreover, kn046 has obtained the u.s. fda's orphan drug designation for thymic epithelial tumor in september 2020. four pivotal clinical trials are currently being conducted, among which the interim analysis of the phase iii clinical study of kn046 combined with chemotherapy as the first-line treatment of nsclc successfully met the prespecified pfs endpoint.
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 superior efficacy to 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.
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 clinical trials in china and the united states, for patients with breast cancer, or gastric cancer/gastroesophageal junction cancer, etc. two phase iii pivotal studies of kn026 combined with chemotherapy and the chemo-free regimen of kn026/kn046 combo for the treatment of gastric cancer are ongoing. the results of prior clinical studies showed that kn026 has good efficacy and safety profiles, even in heavily pretreated patients with her2-positive breast cancer.
in august 2021, the company entered an agreement with jmt-bio, a wholly-owned subsidiary of cspc pharmaceutical group co., ltd. (stock code: 1093.hk), for the development and commercialization of kn026 in mainland china. according to the terms of the agreement, jmt-bio will obtain the exclusive license rights of kn026 for the development and commercialization in the indications of breast cancer and gastric or gastroesophageal junction cancers (gc/gej) in mainland china (excluding hong kong, macau and taiwan).
about alphamab oncology
alphamab oncology is a leading biopharmaceutical company dedicated to the discovery, development manufacturing and commercialization of world-class innovative biotherapeutics for cancer treatment. on december 12, 2019, alphamab oncology was listed on the main board of hong kong stock exchange, with the stock code:9966.
we have converged a professional r&d team led by top scientists, and have a complete industrial chain from early research and development of innovative drugs, process development, commercial production to clinical research.
with multiple in-house proprietary platforms of bispecifics, protein engineering and antibody screening, alphamab oncology has established a globally competitive and differentiated pipeline which consists of tumor monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. among them, 2 varieties were selected into the national special project of " new drug development", and 3 varieties were granted 4 orphan drug qualifications by fda. the world's first subcutaneous pd-l1 inhibitor injection (envafolimab) has been obtained the market approval by the chinese national medical products administration. more than 30 clinical studies have been carried out in 6 varieties in china, the united states and australia, among which 8 studies of 3 varieties have entered the critical clinical stage in china and the united states.
to make cancer manageable and curable，alphamab oncology has always been guided by clinical value and patient needs, and focuses on the development of innovative, safe and affordable anti-tumor drugs to benefit patients in china and around the world.
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