Innovent Announces First Patient Dosed in Phase I Clinical Trial of IBI318 Bispecific Antibody in China

SUZHOU, China, April 23, 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 in China has been successfully dosed in a Phase I clinical trial of a recombinant fully human bispecific antibody targeting programmed cell death receptor-1 (PD-1) and programmed cell death ligand-1 (PD-L1) (IBI318), an innovative antibody developed in collaboration with Eli Lilly and Company.

CIBI318A101 is a Phase I clinical study conducted in China to evaluate IBI318 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and initial efficacy of IBI318.

IBI318 is a recombinant fully human IgG1 bispecific antibody targeting PD-1 and PD-L1, and may offer a novel solution to patients' unmet medical needs. IBI318 simultaneously binds to PD-1 and PD-L1, blocks PD-1 and PD-L1 signaling, bridges PD-1-expressing T cells to PD-L1-expressing tumor cells, and enhances the formation of immune synapses, thereby potentially enhancing anti-tumor activities and increased anti-tumor efficacy. 

"Immunotherapies such as checkpoint-blocking antibodies targeting PD-1 and PD-L1 are playing increasingly important roles in oncology therapy. However, there are still many challenges in their clinical application. Particularly, for patients without predictive biomarkers, the clinical response rate is approximately 20%. Many patients also have primary or acquired resistance to anti-PD-1/PD-L1 antibodies. We still need to actively develop the next generation of immunotherapy. We are looking forward to seeing the clinical results of IBI318," said Professor Xu Ruihua, Director of Sun Yat-Sen University Cancer Center.

"IBI318 is the world's first PD-1/PD-L1 bispecific antibody to enter clinical development. Therefore, the development of IBI318 has unique clinical value. We will evaluate the potential clinical value of this drug candidate and hope to provide a more effective treatment option and ultimately benefit more patients," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.

About IBI318

IBI318, was discovered through the collaboration between Innovent and Eli Lilly and Company and has been developed in China by Innovent. IBI318 is a recombinant fully human immunoglobulin bispecific antibody that blocks both PD-1 binding to PD-L1 and PD-L2 and PD-L1 binding to CD80, which will restore T cell activation and generate anti-tumor activities. In preclinical studies, PD-1-expressing T cells and PD-L1-expressing tumor cells can be bridged by IBI318, which enhances immune synapse formation and anti-tumor activities. The cell bridging induced by IBI318 could further enhance the anti-tumor activities generated through modulating the PD-1/PD-L1 signaling pathway.

About CIBI318A101

CIBI318A101 is a Phase I clinical study conducted in China to evaluate IBI318 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and initial efficacy of IBI318.

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.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. 

To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.

About Innovent Biologics' strategic collaboration with Eli Lilly and Company

Eli Lilly and Company (Lilly) and Innovent Biologics (Innovent) in March 2015 announced one of the largest biotech drug development collaborations in China to date between a multi-national and domestic company. Under the terms of the agreement, Lilly and Innovent will collaborate on the development and potential commercialization of at least three cancer treatments over the next decade. In October 2015, they announced an expansion of their drug development collaboration. The Innovent and Lilly partnership is one of the most comprehensive strategic collaborations between a Chinese company and a multinational partner in terms of the scope and breadth ranging from discovery to commercialization and involving up to six therapeutic antibodies for cancers.

SOURCE Innovent Biologics, Inc.