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, released the preliminary results of the Phase Ia study of IBI315 (first-in-class anti-Her2/PD-1 bispecific antibody) in an oral presentation at the 2021 Annual Meeting of Chinese Society of Clinical Oncology (CSCO).

By data cutoff date of May 25, 2021, 27 patients have been enrolled and received IBI315 at one of seven pre-specified dose levels of 0.03mg/kg QW to 15mg/kg Q3W. No dose limited toxicity (DLT) was observed, and maximum tolerated dose (MTD) has not been reached. Among 15 patients who have completed at least one post-treatment tumor assessment at active dose levels (≥1mg/kg), objective response rate (ORR) was 20%. Biomarker analyses also supported the clinical results that clinical responders showed higher proliferation and activation of peripheral immune cells.

Professor Xichun Hu from Fudan University Shanghai Cancer Center, stated, "The satisfying safety profile and preliminary efficacy data of IBI315 seen in current study support the concept of bispecific antibody designed with targeted- and immune- therapies. We are confident to expect more positive results from the upcoming trials of IBI315 in more types of tumors expressing Her2. "

"IBI315 is a first-in-class anti-Her2/PD-1 bispecific antibody. We are excited to see that IBI315 was well tolerated with a manageable safety profile. The efficacy signal was also encouraging," said Dr. Hui Zhou, Senior Vice President of Innovent. "These results have proved the druggability and developability of IBI315. We will start a phase Ib study of IBI315 promptly to further explore the efficacy of IBI315 monotherapy and in combination with chemotherapy in Her2 positive and low-expressed tumors. We are expecting to enlarge the anti-Her2 therapeutic area with our first-in-class agent IBI315 and benefit more patients in the near future."

About CIBI315A101 Study

CIBI315A101 is a phase Ia/Ib open label, dose escalation and expansion study to evaluate the safety, tolerability and efficacy of IBI315 monotherapy and in combination with chemotherapy in advanced Her2 expressing solid tumors. This is the first-in-human study of IBI315. The phase Ia part of the study has 7 prespecified dose levels from 0.03mg/kg to 15mg/kg with dosing frequencies of QW, Q2W, or Q3W. The dose escalation follows a classic 3+3 design. The phase Ia part is ongoing. The phase Ib part is cohort expansions of IBI315 monotherapy or in combination with chemotherapy in specific tumor types.  

About IBI315

IBI315 is developed through the collaboration between Innovent and Hanmi, and Innovent is leading its clinical development in China. IBI315 is a first-in-class recombinant fully human IgG1 bispecific antibody that targets PD-1 on the surface of T cells and HER2 expressed by tumor cells simultaneously. In preclinical studies, IBI315 has demonstrated potent anti-tumor activities with blockade of PD-1/PD-L1 and Her2 pathways, as well as a bridging effect between T cells and tumor cells.

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 cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong, S.A.R., China 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 26 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products – TYVYT? (sintilimab injection), BYVASDA? (bevacizumab biosimilar injection), SULINNO? (adalimumab biosimilar injection), HALPRYZA? (rituximab biosimilar injection) and Pemazyre? (pemigatinib oral inhibitor) – officially approved for marketing, 1 asset's NDA under NMPA review, sintilimab's Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 15 molecules in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

Note:

The PFS data comes from label of TYVYT? (sintilimab injection).

TYVYT? (sintilimab injection) is not an approved product in the United States.

BYVASDA? (bevacizumab biosimilar injection) is not an approved product in the United States.

SULINNO? (adalimumab biosimilar injection) is not an approved product in the United States.

HALPRYZA? (rituximab biosimilar injection) is not an approved product in the United States.

Pemazyre? (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre? was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China.

About Hanmi Pharmaceutical

Hanmi Pharmaceutical is a Korea-based global pharmaceutical company focused on the development and commercialization of innovative medicines, fully integrated from R&D through manufacturing, marketing and sales with an established presence in Korea as well as China. The Company invests over 20 percent of its sales in R&D and currently has over 30 programs in its clinical pipeline covering 3 major fields: 1) novel long-acting biologics based on the Company's LAPSCOVERY? platform applied in the key target areas of diabetes, obesity and rare diseases; 2) novel targeted agents against oncology and auto-immune diseases; and 3) Fixed-dose combination programs. The company has worked closely with global partners in various co-development collaborations. More information on Hanmi is available at www.hanmipharm.com

About Innovent Biologics' strategic collaboration with Hanmi

Hanmi pharmaceutical and Innovent Biologics on March 30, 2017 announced a strategic collaboration on a global basis. IBI315 was constructed using the PENTAMBODYTM platform technology that was developed by Hanmi's subsidiary, Beijing Hanmi Pharmaceutical Co., Ltd. PENTAMBODYTM is a next generation bispecific platform technology that allows binding pairs of various targets for both immunotherapy and targeted therapy. It follows a naturally occurring IgG-like antibody format while demonstrating good stability and other important biophysical properties. Multiple bispecific antibodies directed towards various targets using PENTAMBODYTM are being developed by Hanmi.

Innovent Forward-Looking Statements

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Source: Innovent Biologics