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Simcere Doses First Patient in US Phase 1 Oncology Trial of its First-in-class TNFR2 Inhibitor, SIM0235

Release time:2022-11-01

-        Simcere launches first oncology trial in the US

-        SIM0235 (SIM1811-03 injection) is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that targets and inhibits TNFR2

NANJING, China and BOSTON, USA, October 31, 2022 -- Simcere Pharmaceutical Group Limited (2096.HK) (the “Company”), an innovative global biopharmaceutical company, has recently dosed the first patient at the Carolina BioOncology Institute in a Phase 1 clinical trial to evaluate SIM0235 (former code: SIM1811-03), a first-in-class humanized anti-tumor necrosis factor receptor 2 (TNFR2) monoclonal antibody, being investigated as a potential treatment of advanced solid tumors and cutaneous T-cell lymphoma (CTCL).

Developed in-house by Simcere’s single B-cell cloning platform,SIM0235 is also being investigated in a Phase 1 clinical study in China. The Chinese Phase 1 data of SIM0235 shows a good safety profile at several doses.


MOA of TNFR2 antagonist

“In our pre-clinical models, we observed the anti-tumor efficacy of SIM0235 by inhibiting TNFR2. We now look forward to investigating the pharmacology and safety of this first-in-class monoclonal antibody as a potentially new precision medicine for these cancers,” said Dr. Bijoyesh Mookerjee, M.D., Chief Medical Officer, Oncology, Simcere Pharmaceutical Group. “SIM0235 is our first oncology program to begin dosing patients in the US, and this event represents important progress for Simcere in its journey to become a fully integrated global biopharmaceutical company that develops unique approaches to the world’s most challenging diseases.”

About SIM0235

TNFR2 is a member of the tumor necrosis factor receptor superfamily and is primarily expressed on the surface of tumor cells and suppressive immune cells in the tumor microenvironment, but rarely in normal human tissues or peripheral immune cells. TNFR2 is understood to be a potential driving force for immune escape and tumor proliferation.

SIM0235 (1811-03) is a potential first-in-class humanized immunoglobulin G1 (IgG1) monoclonal antibody that targets and inhibits TNFR2. The antibody is able to kill associated TNFR2-expressing immune suppressive cells including regulatory T cells (Tregs) and bone marrow-derived suppressor cells, through a process using antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP) and other Fc-receptor functions. Additionally, the molecule can block the activation of TNFR2 by endogenous tumor necrosis factor (TNF), and affect the immunosuppressive function and proliferation mediated by TNFR2 to enhance the body's immune response to tumors. SIM0235 is able to also bind to TNFR2 on the surface of tumor cells and kill the tumor cells directly.

The Phase 1 clinical trial aims to evaluate the safety, efficacy, and pharmacokinetic/ pharmacodynamic characteristics of SIM0235 in subjects with advanced solid tumors and subjects with CTCL.

About Simcere Pharmaceutical Group

Simcere Pharmaceutical Group Limited (2096.HK) is an innovation and R&D-driven pharmaceutical company. The Company focuses on three therapeutic areas, oncology, central nervous system and autoimmune diseases, with a forward-looking vision toward disease areas that may have significant clinical needs in the future, aiming to achieve the mission of "providing today's patients with medicines of the future." Leveraging its R&D capability and commercialization excellence, Simcere has built a market-leading product portfolio in China. Its vigorous in-house R&D efforts and extensive R&D collaborations have made it a strategic cooperation partner with world leading innovative companies and research institutes.

For more information, please visit: http://en.simcere.com/

Media contact:  simcere.mediarelations@simcere.com

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding its: strategy, business plans and objectives for the SIM0235 antibody program; and plans and timelines for the clinical development of Simcere Pharmaceuticals’ product candidates, including the therapeutic potential and clinical benefits thereof. The words "may," “might,” "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," “expect,” "estimate," “seek,” "predict," “future,” "project," "potential," "continue," "target" and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on countries or regions in which we have operations or do business, as well as on the timing and anticipated results of our current preclinical studies and future clinical trials, strategy and future operations; the delay of any current preclinical studies or future clinical trials or the development of Simcere Pharmaceuticals’ drug candidates; the risk that the results of current preclinical studies may not be predictive of future results in connection with future clinical trials; Simcere Pharmaceuticals’ ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of the Company’s planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. In addition, any forward-looking statements represent Simcere Pharmaceuticals’ views only as of today and should not be relied upon as representing its views as of any subsequent date. Simcere Pharmaceuticals explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.