new data from alphamab oncology’s kn046 and kn026 to be presented at the esmo congress 2022-凯发88

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new data from alphamab oncology’s kn046 and kn026 to be presented at the esmo congress 2022

august 01, 2022 08:40 eastern daylight time

suzhou, august 1, 2022- alphamab oncology (stock code: 9966.hk) announced, data from three clinical studies of kn046 (pd-l1/ctla4 bispecific antibody) and kn026 (anti-her2 bispecific antibody) will be presented in four e-posters at the esmo congress 2022, to be held virtually from september 9th to september 13th.

 

title: a phase ii study of kn046 (a bispecific anti-pd-l1/ctla-4) in patients with metastatic non-small cell lung cancer (nsclc) who failed first line treatment

abstract number: 2973

poster number: 1022p

presentation format: poster presentation

first author: caicun zhou, prof, shanghai pulmonary hospital

 

title: a phase ii study of kn046 (a bispecific anti-pd-l1/ctla-4) in patients with metastatic non-small cell lung cancer (nsclc) who failed prior egfr-tkis

abstract number: 3324

poster number: 1034p

presentation format: poster presentation

first author: caicun zhou, prof, shanghai pulmonary hospital

 

title: two-year follow-up from kn046 in combination with platinum doublet chemotherapy as first-line(1l)treatment for nsclc: an open-label, multi-center phase 2 trial

abstract number: 2791

poster number: 1029p

presentation format: poster presentation

first author: li zhang, prof, sun yat-sen university cancer center

 

title: the preliminary efficacy and safety of kn026 combined with kn046 treatment in her2-positive locally advanced unresectable or metastatic gastric/gastroesophageal junction cancer without prior systemic treatment in a phase ii study

abstract number: 2591

poster number: 1210p

presentation format: poster presentation

first author: lin shen, prof, beijing cancer hospital

 

about kn046

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, thymic cancer, pancreatic 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.

 

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

this press release contains statements related to our future business, financial performance and future events involving alphamab oncology that may constitute forward-looking statements. these statements include projections and estimates and relevant assumptions, statements regarding plans and expectations and statements regarding future activities, operations and performance. these statements may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," or words of similar meaning. such statements are based on the certain assumptions of alphamab oncology’s management and business operations, which are subject to various risks and uncertainties, including but not limited to political, economic, legal and business environment. the actual results, performance or achievements of alphamab oncology may (negatively or positively) vary materially from those described explicitly or implicitly in the relevant forward-looking statements. unless otherwise required by applicable laws, alphamab oncology does not undertake obligation to publicly update any forward-looking statement nor liability for the failure to materialize such forward-looking statements, whether because of new information, future events or otherwise.