Systimmune Inc, a clinical-stage biopharmaceutical company developing multi-specific antibody therapies in oncology, today announces manufacturing development and production of a SARS-CoV-2 neutralizing protein SI-F019 at levels ready for preclinical testing.
The SI-F019 protein incorporates the natural receptor for the virus that causes CoVID-19 disease, angiotensin-converting enzyme 2 (ACE2), as a means of neutralizing viral binding to cells lining the lungs and gastrointestinal tract, therefore blocking viral infection.
SI-F019 is specifically designed to mimic the naturally occurring human ACE2 protein target of CoVID19 and act as a neutralizing decoy. A bivalent architecture combined with the natural high affinity of CoVID-19 spike protein for this target is designed to synergistically out-compete viral adhesion to epithelial cells and reduce overall infection and disease severity. SI-F019 fusion technology comprises an Immunoglobulin Fc domain which provides both dimerization and half-life extension properties. Importantly, this domain has been engineered to eliminate immune activation which could lead to undesirable outcomes in some patients.
Systimmune, in conjunction with its parent company Biokin Co., Ltd has already completed production of 5 preclinical lots for cGMP process development. Creation of a stably expressing cell line is in progress, with pilot scale production run completion anticipated in early May of 2020. cGMP scale up production run is scheduled in June 2020. Animal efficacy, pharmacokinetics, pharmacology and toxicology studies will be finished by November 2020. The company is targeting to have accelerated IND approval from the US Food and Drug Administration and the Chinese National Medical Products Administration, and to have a clinical trial in progress in the US and China by the end of 2020.
ABOUT SYSTIMMUNE INC.
Systimmune Inc., located in Redmond, Washington, is a clinical stage immune-oncology biopharmaceutical company focused on the development of multi-specific antibody therapies. The company is a wholly owned subsidiary of Biokin Pharmaceutical Co., Ltd., a pharmaceutical company founded in 1996 in Chengdu, China. Biokin Pharmaceutical Co., Ltd has 2 R&D centers, 2 GMP small molecules manufacturing facilities, 1 GMP biological & ADC manufacturing facility and 1 GMP API manufacturing facility. SystImmune and Biokin have two bispecific antibody programs in phase 1 clinical trials, three first-in-class multi-specific antibody programs will be filing IND in 2020.
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