suzhou, march 11, 2021 - alphamab oncology (stock code: 9966.hk) announced that data from phase ib/ii clinical study (clinical trial no.: kn046-203) of pd-l1/ctla-4 bispecific antibody kn046 in combination with nab-paclitaxel for the treatment of patients with metastatic triple-negative breast cancer (mtnbc) will be presented in a poster at the 112th american association for cancer research (aacr 2021 virtual meeting) in april 2021.
founded in 1907, the american association for cancer research (aacr) is one of the largest cancer meetings in the world and widely considered by the global cancer community to be the touchstone event that sets the cancer research agenda. it attracts nearly 20,000 professionals from all over the world each year with its spectrum of cancer science and excellent reputation, accelerates the dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances the public understanding of cancer. due to the pandemic, the 2021 aacr will be held virtually from april 10-15 and may 17-21, local time (eastern time).
the abstract of the research:
preliminary safety, tolerability and efficacy results of kn046 (anti-pd-l1/ctla-4 bispecific antibody) in combination with nab-paclitaxel in metastatic triple-negative breast cancer (mtnbc)
presentation format: poster
poster launch time: april 10, 2021, 8:30 a.m.et, u.s. time
kn046-203 is a phase ib/ii, open label, multi-center clinical study, evaluating the efficacy, safety, and tolerability of kn046 combined with nab-paclitaxel in patients with metastatic tnbc. a total of 27 patients with treatment-naïve locally advanced inoperable or metastatic tnbc were enrolled in the study. the results show that kn046 is well tolerated and effective as a treatment for advanced triple-negative breast cancer, especially in pd-l1-positive tnbc patients, showing a progression-free survival (pfs) benefit.
breast cancer is the most common malignant tumor among women in the world, and its morbidity and mortality are increasing year by year. among them, triple-negative breast cancer lacks the expression of estrogen receptor (er), progesterone receptor (pr) and human epidermal growth factor receptor 2 (her2). tnbc is highly invasive, has a high recurrence rate, and a poor prognosis. endocrine therapy and her-2 targeted therapy are not effective for tnbc. chemotherapy is currently a common choice for systemic treatment of tnbc, but its side effects are obvious, and once a patient develops resistance to chemotherapy drugs, the tumor may quickly recur and metastasize.
kn046 is pd-l1/ctla-4 bispecific antibody independently developed by jiangsu alphamab. its innovative designs include: a different 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, tnbc, escc, hcc and pancreatic cancer in australia and china. the results of these clinical trials have shown an advantage in survival for patients. alphamab 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. two pivotal clinical trials are currently being conducted.
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 multifunctional 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 an 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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