Innovent Announces First Patient Dosed in Phase I Clinical Trial of Anti-CD47 Monoclonal Antibody in the U.S.

SUZHOU, China, March 18, 2019 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, today announced that the first patient has been successfully dosed in a Phase I clinical trial of anti-cluster of differentiation 47 (anti-CD47) monoclonal antibody drug candidate (IBI188) in the United States (U.S.).

The CIBI188A102 study (CIBI188A102) is a Phase I clinical study conducted in the U.S. to evaluate IBI188 in patients with advanced malignant tumors. The primary objectives are to evaluate the safety and tolerability, and to define the Phase II clinical trial recommended doses of IBI188 as monotherapy and as part of combination therapy on subjects with advanced malignant tumors. The Phase 1a study will explore initial and maintenance doses of IBI188 as monotherapy. CIBI188A102 will be launched simultaneously with the CIBI188A101 study (CIBI188A101) conducted in China, with the aim of evaluating the pharmacokinetic (PK) and pharmacodynamics (PD) profiles of IBI188 in both the U.S. and China.

Cluster of differentiation 47 (CD47) is one of the key targets in the field of anti-tumor immunotherapy, an important component of a critical inhibitory immune pathway that is different from T cell targets such as programmed cell death protein 1 (PD-1), PD-1 ligand 1 (PD-L1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). CD47 targets macrophages and suppresses phagocytosis by interacting and activating the inhibitory receptor signal regulatory protein-α (SIRPα). The CD47-SIRPα mechanism is hijacked in many malignant tumors to escape immune mediated clearance. IBI188, an anti-CD47 antibody, blocks the CD47-SIRPα signaling pathway, restores macrophages' ability to recognize tumor cells and its antigen-presenting ability, and achieves anti-tumor effects through both innate immunity and adaptive immunity.

"IBI188 is a pivotal product in our pipeline of cancer immunotherapies. There is preliminary evidence that anti-CD47 monoclonal antibodies, as monotherapy or as part of combination therapy, have shown positive biologic activities in solid tumors and in refractory/relapsed non- Hodgkin Lymphoma. Multiple different antibodies targeting the CD47-SIRPα signaling pathway are in development worldwide, most are in either preclinical or Phase I stage. IBI188 is the first anti-CD47 monoclonal antibody drug candidate of China approved for clinical trials in the United States. We would like to assess the potential clinical value of the drug candidate through the simultaneous clinical studies in China and the United States," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.

About IBI188

IBI188 is a fully human monoclonal antibody targeting CD47. In vitro and in vivo experiments have shown that IBI188 can bind to the CD47 antigen on the surface of tumor cells, block the CD47-SIRPα signaling pathway, inhibit the "do not eat me" signal, and promote the phagocytosis of tumor cells by macrophages, thereby exerting an anti-tumor effect. Innovent will launch several clinical trials to assess its safety and efficacy in multiple tumor types, including non-Hodgkin's lymphoma and ovarian cancer.

About CIBI188A101

CIBI188A101 is a Phase I clinical study conducted in China to evaluate IBI188 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and the recommended doses for Phase II clinical trial of IBI188 as a monotherapy and as part of a combination therapy. The Phase 1a study explores priming and maintenance dosing of IBI188 as monotherapy.

About CIBI188A102

CIBI188A102 is a Phase I clinical study conducted in the United States to evaluate IBI188 in patients with advanced malignant tumors. The primary objectives are to evaluate the safety and tolerability, and to define the Phase II clinical trial recommended doses of IBI188 as monotherapy and as part of combination therapy on subjects with advanced malignant tumors. The Phase 1a study will explore initial and maintenance doses of IBI188 as monotherapy. CIBI188A102 will be launched simultaneously with the CIBI188A101 conducted in China, with the aim of evaluating the PK and PD profiles of IBI188 in both the U.S. and China.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop 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, autoimmunity 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 it was founded, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built up a robust pipeline of 20 innovative assets in the fields of oncology, ophthalmology, autoimmunity, and cardiovascular diseases. Fourteen assets have entered into clinical development, four have entered Phase III clinical trials, two monoclonal antibodies have their New Drug Application (NDA) under review, and one, Tyvyt^® (sintilimab injection), is now approved for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL).

Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com.

SOURCE Innovent Biologics, Inc.

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