Innovent Announces First Subject Dosed in the Phase 1 Clinical Trial of Anti-IL-23 Monoclonal Antibody

Rhea-AI Summary

Innovent Biologics has announced the completion of first healthy subject dosing in its Phase I clinical trial (CIBI112A101) for IBI112, a recombinant anti-interleukin 23p19 subunit antibody. This randomized, double-blind, placebo-controlled trial aims to evaluate the safety and tolerability of IBI112 in healthy Chinese subjects. IBI112 targets IL-23, playing a pivotal role in autoimmune diseases such as psoriasis and inflammatory bowel disease. Innovent aims to address significant unmet medical needs in these conditions, with promising preclinical data supporting the drug's efficacy and safety.

Positive

• Initiation of Phase I trial for IBI112 demonstrates progress in drug development.
• IBI112 targets IL-23, addressing significant medical needs in autoimmune diseases.
• Promising safety and efficacy observed in preclinical studies.

Negative

• None.

SAN FRANCISCO, and SUZHOU, China, Aug. 31, 2020 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announced that the Phase I clinical study (CIBI112A101) of recombinant anti-interleukin 23p19 subunit antibody injection (IBI112) has completed the first healthy subject dosing in China.

The study CIBI112A101 is a randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical trial to evaluate the safety and tolerability (primary objective) in addition with PK/PD of IBI112 when administered as a single subcutaneous or intravenous dose in healthy Chinese subjects.

IBI112 is an interleukin-23 (IL-23) antibody, a cytokine with pro-inflammatory effect secreted by activated macrophages and dendritic cells. IL-23 promotes Th17 cell expansion, and the inflammatory response caused by various cytokines and chemokines such as IL-17 and IL-22 secreted by Th17 cells is associated with a variety of autoimmune diseases. IL-23 is composed of two subunits, p19 and p40, of which the p40 subunit is common to IL-23 and IL-12. IBI112 is a monoclonal antibody that selectively targets the p19 subunit of IL-23 but not the p40 subunit, so it can treat autoimmune diseases such as psoriasis by inhibiting the IL-23/Th17 pathway without affecting IL-12-mediated pathogenic defense and tumor immune surveillance.

Dr. Lei Qian, Senior Medical Director of Medical Science and Strategic Special Diseases Department of Innovent, stated: "Currently, there are 2-3% of the world's population suffering from psoriasis, and about 6 million psoriasis patients in China. Regarding inflammatory bowel disease (IBD), the incidence trend is also rising significantly in the last few years. However, neither psoriasis nor IBD therapies have met the huge medical needs. Recently, IL-23 and other biological drugs have been attracting more and more attention due to the superior efficacy and safety profiles, but there are still no drugs targeting IL-23p19 independently developed in China yet. IBI112 is an innovative monoclonal antibody, independently developed by Innovent, that can specifically bind to IL-23p19 subunit and block IL-23-mediated signaling pathway to achieve anti-inflammatory effect. It has potential to treat psoriasis, IBD and other autoimmune diseases. We saw good safety and efficacy data in the preclinical studies and believe this clinical progress of IBI112 is of great importance. We look forward to the results of subsequent clinical studies of IBI112 and hope to provide new treatment options for patients in need."

About IBI112

IBI112 is a monoclonal antibody independently developed by Innovent, with independent intellectual property rights. This product specifically binds to IL-23p19 subunit thereby preventing IL-23 from binding to cell surface receptors, blocking the IL-23 receptor-mediated signaling pathway. Preclinical data demonstrated a clear target, clear mechanism of action, and significant anti-inflammatory effect of IBI112, which indicate that IBI112 may provide a more effective treatment option for patients with autoimmune diseases.

About the CIBI112A101 study

The study CIBI112A101 is a randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical study to evaluate the safety and tolerability (primary objective) in addition with PK/PD of IBI112 when administered as a single subcutaneous or intravenous dose in healthy Chinese subjects.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of oncology, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully-integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 23 valuable assets in the fields of oncology, metabolic, autoimmune diseases and other major therapeutic areas, with 2 products, TYVYT® (sintilimab injection) and BYVASDA® (bevacizumab injection), on market, 2 assets under NDA review with priority review status, 4 assets in Phase III or pivotal clinical trials, and additional 15 molecules in or close to clinical trials. TYVYT® (sintilimab injection) has been the only PD-1 inhibitor included in the NRDL since 2019.

Innovent has built an international team with broad expertise in high-end biological drug development and commercialization. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Alector, Hanmi and other international pharmaceutical companies. For more information, please visit: www.innoventbio.com.

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SOURCE Innovent Biologics, Inc.

FAQ

What is the purpose of Innovent's Phase I clinical trial CIBI112A101 for IBI112?

The trial aims to evaluate the safety and tolerability of IBI112 in healthy subjects.

What diseases could IBI112 potentially treat?

IBI112 has potential applications for treating autoimmune diseases like psoriasis and inflammatory bowel disease.

What results have been seen in preclinical studies for IBI112?

Preclinical studies have shown promising safety and efficacy data for IBI112.

When was the first subject dosed in the CIBI112A101 trial?

The first subject was dosed on August 31, 2020.

What does IBI112 target in the immune response?

IBI112 selectively targets the p19 subunit of IL-23, blocking its pro-inflammatory signaling.