Systimmune Inc. Announces SI-F019 As a Blocker of Viral Entry against SARSCoV-2 with Reduced Inflammatory Risk

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.

FORWARD LOOKING STATEMENT

Any research and development information is provided by SystImmune and is intended for general information purposes only. Such information is not intended to provide complete medical information. We do not offer patient-specific treatment advice and if you have a medical condition, please see your own medical doctor or healthcare provider.

This press release may contain forward-looking statements with the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, which reflect ’s expectations regarding the company’s goals, strategies, results of operations, performance, business prospects and opportunities, including but not limited to the ability to gain Investigational New Drug status for the resulting new product and the ability to develop a successful formulation. Terms such as “anticipates,” “believes,” “expects,” “estimates,” “could,” “intends,” “may,” “plans,” “potential,” “projects,” “will,” “would” and other similar expressions, or the negative of these terms, are generally indicative of forward-looking statements

While SystImmune believes that expectations expressed in the forward-looking statements are based on the company’s reasonable assumptions and beliefs in light of the information available to the company at the time such statements are made, it cannot give assurance that such forward-looking statements will prove to have been correct. Such forward-looking statements are not fact and are subject to uncertainties and other factors that could cause actual results to differ materially from such statements. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

FOR MORE INFORMATION

SystImmune, Inc.
15318 NE 95th Street
Redmond, WA 98052
+1(425)453-6841
[email protected]

High Throughput Application of High Resolution LC-MS for Upstream and Downstream Biotherapeutics Process Development

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ACS National Meeting 2018 - Rapid aggregate reduction of bi-specific antibody model by filtration

Removal of protein aggregates from biologic drug products is critical due to their potential to increase antigenic response and the associated negative impact on the patients. Aggregates may be formed during upstream or downstream operations when suboptimal purification parameters are selected.

Once formed, aggregate removal and/or reduction becomes challenging for the downstream purification process development team. Chromatography is the most traditional purification technology used for aggregate removal; however, chromatography methods could actually increase aggregate formation as the product is exposed to harsh conditions such as low pH or high salt. Column chromatography is also time consuming, requiring several buffers, method development, and costly technology such as purification skids and columns.

SystImmune and Sartorius are exploring an alternate technique exploiting the Virosart® Max filter. The Virosart® Max is an optimized triple-layer polyamide pre-filter specifically designed to remove aggregates and protect the expensive downstream virus removal filter. The Virosart® Max will be operated in a simple flow through mode to demonstrate aggregate reduction in a bi-specific antibody model.

This robust filter-based aggregate removal strategy would offer simple buffer preparation, minimal process development, and the option to replace costly chromatographic skids with inexpensive pumping equipment.

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