Innovent Announces Two Clinical Studies with the Anti-VEGF Monoclonal Antibody IBI305, a Biosimilar Candidate to Avastin (Bevacizumab), Met Primary Endpoints
- Category: Antibodies
- Published on Friday, 14 December 2018 20:17
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SUZHOU, China I December 12, 2018 I Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, announced today that IBI305, a recombinant humanized anti-VEGF monoclonal antibody being developed as a potential biosimilar to Avastin (Bevacizumab), has met pre-defined primary endpoints in two randomized, head to head, clinical trials comparing IBI305 versus branded bevacizumab: a phase III clinical trial (CIBI305A301) in patients with advanced non-squamous non-small cell lung cancer (NSCLC) and a pharmacokinetic study (CIBI305A201) in healthy subjects. The details of these studies will be disclosed in future publications in scientific journals and conferences.
CIBI305A301 is a multi-center, randomized, double-blinded, parallel, positive-controlled phase III clinical trial that enrolled 450 patients to evaluate the efficacy and safety of IBI305 and bevacizumab in the first-line treatment of patients with advanced non-squamous NSCLC. The objective of the study is to compare the clinical activity and safety between IBI305 and bevacizumab when they are in combination with paclitaxel/carboplatin. The primary endpoint is objective response rate (ORR).
CIBI305A201 is a randomized, double-blinded, parallel, positive-controlled single-dose clinical trial to compare the pharmacokinetic profile, safety, tolerability, and immunogenicity between IBI305 and bevacizumab in 100 healthy subjects. The primary objective of the study is to compare the pharmacokinetic (PK) profile of these two agents.
"Lung cancer is the highest incidence cancer in China, and bevacizumab is an important treatment for non-small lung cancer patients. The launch of a high quality bevacizumab biosimilar will improve drug accessibility and benefit more patients," said Professor Li Zhang from the Cancer Hospital of Sun Yat-sen University.
"The current morbidity and mortality of malignant tumors in China are high, and anti-tumor treatment is a significant economic burden for millions of families. Anti-angiogenic drugs are effective anti-tumor treatments, but as of yet there are no approved bevacizumab biosimilars in China. The clinical studies of IBI305, a potential biosimilar of bevacizumab, are encouraging. I hope that IBI305 will be launched soon into the Chinese market, so more cancer patients and their families can benefit from the use of this important medicine," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.
Innovent's IBI305 is a biosimilar of bevacizumab, a recombinant humanized anti-VEGF monoclonal antibody for injection. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. Bevacizumab ultimately produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking the blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells.
Innovent was established in 2011. 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. These capabilities have enabled us to build a robust pipeline of innovative and commercially promising monoclonal antibodies and other biologics in the fields of oncology, ophthalmology, autoimmune, and cardiovascular diseases. Leveraging our platform, we have built up a pipeline of 17 antibody drug candidates in the last seven years, led by our four core products that are in late-stage clinical development in China. In addition, out of our pipeline of 17 antibody drug candidates, ten have entered in clinical development, four have entered Phase III clinical trials and two that have New Drug Applications (NDA) accepted by the NMPA including one with priority review status for sintilimab.
Innovent has built a biopharmaceutical production facility that operates under global standards. The design and operation of our clinical and commercial facilities are in compliance with the cGMP standards of NMPA, FDA and EMA. The existing production lines have already passed GMP audits by an international pharmaceutical company. The company has also entered into various key strategic alliances with Eli Lilly and Company, Adimab and other biopharmaceutical companies. On October 31, 2018, Innovent was successfully listed on the main board of the Hong Kong Stock Exchange and the stock code is 01801.
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. Innovent wishes to work with all relevant parties helping the advancement of China's biopharmaceutical industry, improving the drug availability to ordinary people and enhancing the quality of the patients' life.
SOURCE: Innovent Biologics