suzhou, china, may 20, 2019 - a phase ii clinical study protocol symposium of kn019, a fusion protein composed of the fc-fragment of a human igg1 immunoglobulin linked to the extracellular domain of ctla-4, was successfully held in beijing by alphamab oncology on may 20, 2019, the 15th international clinical trials day.
this symposium was chaired by professor xiaofeng zeng of peking union medical college hospital, the leading site, with the participation of more than 60 people, including about 40 experts from over 20 hospitals and institutions, including beijing hospital of the national health and family planning commission, the third affiliated hospital of sun yat-sen university, zhuzhou central hospital, anhui provincial hospital, the first people's hospital of changzhou, the first people's hospital of chenzhou, the first hospital of jilin university, jilin provincial people’s hospital, the first affiliated hospital of kunming medical university, and shanghai guanghua hospital of integrated traditional chinese and western medicine, as well as teams from alphamab oncology and project partners.
professor xiaofeng zeng, the principal investigator of peking union medical college hospital, and dr. ting xu, the founder, chairman and ceo of alphamab oncology, were invited to give welcome speeches.
professor xiaofeng zeng said that kn019 has a new mechanism different from tnf and jak inhibitors in treating rheumatoid arthritis. the success of a clinical study requires contribution from experienced researchers, who will set high standard to conduct high quality clinical trials. researchers who will participate in the phase ii clinical study of kn019 must carry out the study according to the study protocol and ensure the quality of the study. researchers should respect the right of the patients, obtain accurate and reliable clinical data, and provide guidance for future treatment.
dr. ting xu said: "on this special day of the international clinical trials day, we are grateful for the well-being brought by clinical trials to patients, and also very thankful to the clinical trial patients and experts for their efforts on kn019. ctla-4-fc fusion protein, represented by orencia and nulojix, acts on cd80/cd86 to prevent t cell activation, thereby are used to treat autoimmune diseases or organ rejection after transplantation. we expect this clinical trial of kn019 to achieve rapid high quality advancement by the joint efforts of researchers, medical institutions, alphamab oncology and other parties, and to lay a solid foundation for drug registration and commercial launch."
at the meeting, dr. runji liu, senior medical manager of alphamab oncology, introduced kn019-201 project, as well as kn019’s phase i clinical studies and phase ii clinical study protocol. based on the preclinical study data and product characteristics of kn019, in-depth discussion and analysis were conducted on relevant issues of the study protocol by experts. optimization opinions and valuable suggestions were put forward, which laid a good foundation for a procedure-based thorough implementation of the phase ii clinical program.
kn019 is the biosimilar of belatacept (nulojix®), which acts on cd80/cd86 to prevent t cell activation and is approved for prophylaxis of organ rejection in adult patients who receives a kidney transplant. its superior efficacy profile has been demonstrated in long-term outcome studies. belatacept is an improved version of abatacept (orencia®) with superior potency. orencia® is approved for the treatment of moderate and severe active rheumatoid arthritis and has been marketed in more than 40 countries around the world. it achieved global sales of about $2.7 billion in 2017. both drugs are very difficult to manufacture, especially from the biosimilar perspective. however, alphamab oncology have achieved a high yield in the pilot-scale production for kn019. its primary structure, higher-order structure, post-translational modification of protein, as well as pharmacological and toxicological studies results are highly similar to that of belatacept (nulojix®).
the phase i clinical trial of kn019 has been completed, and interim data have shown good safety and pharmacokinetic properties. this phase ii clinical trial will be carried out in over 20 hospitals and institutions.
about alphamab oncology
alphamab oncology is a leading biopharmaceutical company in china dedicated to the development of innovative biologics for cancer therapy globally. thus far, four drug candidates in alphamab oncology's pipeline have advanced into clinical development phase. with multiple in-house proprietary platforms for innovative biopharmaceuticals, alphamab oncology has built a robust pipeline in oncology and immunology to benefit cancer patients around the world.
visit http://www.alphamabonc.com for more information.
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