A First-in-Class Ophthalmological Recombinant Fully Human Bi-specific Fusion Protein Targeting VEGF and Complement Proteins
SUZHOU, China, April 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 IBI302, a novel recombinant fully human bi-specific fusion protein targeting both vascular endothelium growth factor (VEGF) and complement proteins, for the treatment of wet age-related macular degeneration (wet AMD).
The Phase I study of IBI302 is an open-label, single-center, dose escalation clinical trial to evaluate the safety and tolerability of IBI302 in a single intravitreal injection in patients with wet AMD.
"Antibody drugs targeting vascular endothelial growth factor A (VEGF-A) have now become the standard first-line treatment of neovascular ocular fundus diseases. However, an antibody-like bi-specific fusion protein drug targeting both VEGF and complement proteins has not been studied in clinical trials anywhere in the world. IBI302, an innovative first-in-class category 1 innovative drug candidate developed by Innovent for the treatment of ocular fundus diseases, has been supported by 'The National Major New Drugs Innovation and Development Projects'. We believe IBI302 can potentially become a breakthrough therapy and provide a new treatment option for patients in need," said Professor Xiaodong Sun of the Shanghai General Hospital Affiliated to Shanghai Jiao Tong University.
"Age-related macular degeneration (AMD) is one of the leading causes of irreversible vision impairment among China's elderly population. Although the efficacy of current therapies for wet AMD is adequate, there are still huge unmet medical needs in terms of injection frequency and long-term prognosis for patients. As the world's first antibody-like bi-specific fusion complement protein for ocular fundus diseases, IBI302 is designed to cure AMD by attacking its root causes in addition to relieving the symptoms. Hopefully, through our efforts, IBI302 can benefit AMD patients and their families," said Michael Yu, the Founder, Chief Executive Officer and Chairman of Innovent.
AMD, a disease which results in progressive worsening of vision in the center of the visual field of the macular retina, is one of the leading causes of severe vision loss and blindness in people aged 50 and above in the developed world. The risk of AMD increases with age. In developed countries, the incidence rate is more than 30% for seniors over 80. It can be divided into dry AMD and wet AMD according to clinical manifestations and pathobiology. Dry AMD accounts for approximately 80% to 90% of all AMD cases and wet AMD accounts for approximately 90% of all AMD cases involving severe central vision loss.
VEGF plays a fundamental role in choroidal neovascularization. Anti-VEGF antibody drugs for AMD were a major breakthrough in the treatment of neovascular ocular fundus diseases. However, current anti-VEGF drugs do not target the key upstream factors regulating the production of VEGF and require frequent injections which lead to the medical needs for repeated intraocular injections. Some AMD patients treated with anti-VEGF drugs have the risk of developing non-reversible lesions, such as fibrosis or geographic atrophy, and new treatments are urgently needed. Chronic inflammation related to complement activation is critical in the early stage of AMD and is a common core upstream mechanism involved in regulating the high expression of VEGF in retinal pigment epithelial (RPE) cells, promoting epithelial mesenchymal fibrosis in RPE and triggering photoreceptor cells death. Developing antagonistic drugs targeting complement has become a global focus in this field.
IBI302 is a recombinant fully human bi-specific fusion protein targeting both VEGF and complement proteins developed by Innovent, for the treatment of ocular diseases including wet AMD. The N-arm can bind to the VEGF family to block VEGF-mediated signaling pathways, inhibit vascular epithelium proliferation and angiogenesis, and reduce vascular leakage. The C-arm can inhibit the activation of the classic and alternative pathways of complement through the specific binding of complement components 3b and 4b and reduce the inflammatory response mediated by complement proteins.
The Phase I study of IBI302 is an open-label, single-center, dose escalation clinical trial to evaluate the safety and tolerability of IBI302 in a single intravitreal injection in patients with wet AMD. The patients with wet AMD will receive intravitreal injections with different concentrations of IBI302. 36 patients will be enrolled in the study.
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.
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