Baili Announces Clinical Trial Collaboration to Evaluate SI-B001, an EGFR x HER3 bispecific Antibody, in Combination with Tagrisso® in Patients with Non-Small Cell Lung Cancer

Chengdu , China, Seattle, US, and London, UK, May  13, 2022 -- BAILI-BIOPHARMACEUTICAL CO., LTD. (“Baili”) and its wholly owned subsidiary, SystImmune, Inc (“SystImmune”), announced today that it has entered into a clinical trial collaboration and supply agreement with AstraZeneca (LSE/STO/NYSE: AZN) to evaluate the combination of Baili’s cancer therapy, SI-B001, an EGFR x HER3 bispecific antibody, in combination with AstraZeneca’s third-generation, irreversible epidermal growth factor receptor (“EGFR”) TKI, TAGRISSO® (osimertinib), in a new Phase 2a study, sponsored and conducted by Baili, for patients with non-small cell lung cancer (“NSCLC”).  

Dr. Yi ZHU, Founder, Chairman, and CEO of Baili commented, "SI-B001 has demonstrated good tolerability and early sign of efficacy during Phase 1 trial in China. We are excited about the collaboration with AstraZeneca to investigate the combination of SI-B001 and a leading third-generation EGFR TKI for patients with NSCLC. By combining SI-B001 with Osimertinib, we believe it has the potential to provide more effective treatment options for patients with NSCLC." 

The financial terms of the non-exclusive collaboration have not been disclosed.  

About SI-B001 

SI-B001 is a bispecific antibody designed with the proprietary platform technology developed by Baili and SystImmune. It can bind to EGFR and HER3, and simultaneously inhibits the ligand induced EGFR×EGFR homodimers, the formation of EGFR×HER3 heterodimers and the activation of its downstream signal pathway. SI-B001 can also induce endocytosis of EGFR and HER3, and down-regulate the levels of EGFR and HER3 tumor cells. In preclinical studies, SI-B001 has demonstrated superior tumor killing activities. SI-B001 Phase 1 trials have shown good safety and preliminary efficacy.  

About NSCLC and EGFR  

Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.  More than a third of the world’s lung cancer patients are in China. Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC. The majority of NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis. For patients with resectable tumors, the majority of patients eventually develop recurrence despite complete tumor resection and adjuvant chemotherapy.  

Approximately 10-25% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFR-mutated NSCLC. These patients are particularly sensitive to treatment with an EGFR TKI which blocks the cell-signaling pathways that drive the growth of tumor cells. 

About Baili 

Baili is a biopharmaceutical company focusing on the research and development, manufacturing, and commercialization of medicines for cancer and other diseases. With strong R&D teams in both China and US, it has developed fully integrated proprietary platforms in bispecific, multi-specific antibodies and antibody-drug conjugates. Its highly differentiated platforms have generated a pipeline of six clinical stage anti-cancer drug candidates. The Company also has state-of-the-art manufacturing capability designed and built to meet cGMP standards. 

With multiple in-house proprietary platforms for innovative biopharmaceuticals, Baili has built a robust pipeline to benefit cancer patients around the world. 


SystImmune Inc Announces Appointment of Martín Sebastian Olivo, M.D. as Chief Medical Officer

Martín Sebastian Olivo, M.D

Redmond WA, February 7th, 2022- SystImmune, Inc, a clinical-stage company developing innovative cancer therapeutics, including novel bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs), today announced the appointment of Martin Sebastian Olivo, M.D. as Chief Medical Officer. Dr. Olivo joined SystImmune from Protara Therapeutics where he served as the Chief Medical Officer and led the advancement of the early-stage clinical effort in the area of non-muscle invasive bladder cancer. Dr. Olivo brings decades of experience in oncology clinical research and global drug development.

“It is our honor to welcome Dr. Olivo to our team,” said Dr. Yi Zhu, the Chief Executive Officer of SystImmune. “As the leader of the clinical development arm of SystImmune, Dr. Olivo will be instrumental in advancing and expanding the global clinical impact of our pipeline. With several ongoing Phase II & Phase I trials, there is a huge opportunity for Dr. Olivo to leverage his strengths in product development among several oncology indications.”

“I feel fortunate to join SystImmune at this stage” said Dr. Olivo. “SystImmune has the potential to play a meaningful role in the treatment of difficult to treat cancers and I’m looking forward to working with the many talented individuals to advance transformative therapies for people with cancer”.

Before assuming his most recent role at Protara, Dr. Olivo led late-stage clinical efforts in breast cancer therapeutics development as the Vice President of Clinical Development at Gilead Sciences, Inc., (formerly Immunomedics, Inc) from Aug 2018 to April 2021. Earlier, Dr. Olivo served as the Global Clinical lead at Daiichi Sankyo Cancer Enterprise, where he established a comprehensive clinical development plan to advance ADC therapeutics for IND filing in the US. Prior to that, Dr. Olivo served several roles with increasing responsibilities in the oncology group at Eisai Inc.

Dr. Olivo earned his M.D. from the University of Buenos Aires and his M.S. in Clinical and Pharmacological Research from Austral University in Buenos Aires. He also completed advanced training as a Clinical Oncologist at the University of Salvador. Dr. Olivo then held various academic and clinical positions at the School of Medicine at the University of Buenos Aires, Hospital “Dr. Enrique Tornú” and the National Cancer Institute of Canada Clinical Trials Group.

 
ABOUT SYSTIMMUNE INC.

SystImmune Inc., established in 2014, located in Redmond, Washington, is a clinical-stage immune-oncology biotech company focused on the development of bi-specific, multi-specific antibody therapies and antibody-drug conjugates (ADCs). The company is a wholly owned subsidiary of Biokin Pharmaceutical Co., Ltd., a pharmaceutical company founded in 1996 in Chengdu, China. SystImmune has several proprietary multi-specific antibody-based platforms developed as immune cell engagers, checkpoint inhibitors, and tumor growth inhibitors. SystImmune also developed the first in class bi-specific ADC drug platform. Currently, the company has 7 molecules in Phase I or II clinical trials in China, including SI-B001, SI-B003, SI-F019, GNC-038, GNC-039, GNC-035, and BL-B01D1.

 
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 medical conditions, 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 reflects the 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 press release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

 
FOR MORE INFORMATION

SystImmune, Inc.
[email protected]
+1(425)453-6841


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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