Innovent announces Phase I clinical trial results of IBI302, a first-class anti-VEGF and anti-complement ophthalmic recombinant human bi-specific fusion protein for age-related neovascular macular degeneration at 2020 AAO

SAN FRANCISCO and SUZHOU, China, November 15, 2020 / PRNewswire / – Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and markets high-quality medicines for the treatment of oncological, metabolic, autoimmune and other major diseases, announces that the results of Phase Clinical I The trial of IBI302, a first-class bi-specific human recombinant ophthalmic fusion protein for neovascular age-related macular degeneration (nAMD) was published in e-poster at the American Academy of Ophthalmology 2020.

The Phase I study of IBI302 is an open-label, multicenter, dose escalation study to evaluate the safety and tolerability of a single intravitreal injection of IBI302 in patients with nAMD. A total of 31 subjects were enrolled in the completed Phase I clinical trial. All subjects received a single intravitreal injection of IBI302. No serious adverse events or dose-limiting toxicity were reported. The study demonstrated good safety and tolerability of IBI302. One week after administration, an improvement in vision and a reduction in retinal edema were observed. Within 28 days of dosing, the best corrected visual acuity of all 31 patients increased by an average of 6 letters from baseline; mean central retinal thickness decreased by 141.2 microns from baseline and efficacy in some patients lasted up to 6 weeks after dosing.

“Intravitreal injection of anti-VEGF drugs has become the first-line treatment for fundus neovascular disease. Although they have a good therapeutic effect on short-term nAMD, a single anti-VEGF treatment regimen requires frequent intraocular injections or even for life, and there are some patients with poor response or declining effect. Therefore, there are still huge unmet clinical needs in the treatment of AMD. Phase I IBI302 research has shown good safety and tolerability with effects I believe and look forward to the following research of IBI302 will prove more positive results, “ said the principal investigator professor Xiaodong Sun by the General Hospital affiliated with Shanghai Jiao Tong University.

“IBI302 is an innovative drug developed independently by Innovent for the treatment of fundus diseases. It is the world’s first bispecific anti-VEGF / anti-complement molecule and has been supported by the major new drug project of the Ministry of Science and New Class 1 drug. IBI302 is designed to provide more targeted treatments and interventions to the cause of AMD by adding additional targets and to bring greater clinical benefit than anti-VEGF antibodies. Results presented from the current Phase I clinical trial have brought more confidence into the next phase of research and development of IBI302. I hope that Innovent can benefit the majority of fundus disease patients and their families through more innovative and molecules, “ said Dr. Lei Qian, senior medical director of Innovent’s department of medical sciences and special disease strategies.

About AMD

AMD involves the macula and causes progressive impairment of central vision. As one of the leading blinding eye diseases among adults over 50, the incidence of AMD increases with age. In developed countries or regions, the prevalence of people over the age of 80 can reach more than 30%. It can be divided into dry AMD and nAMD based on clinical manifestations and pathological types. About 80% -90% are dry AMD; and in patients with severe central vision impairment, nAMD accounts for approximately 90%.

About IBI302

Anti-VEGF therapy is currently the standard treatment for nAMD, but there are still some patients who do not respond well to long-term anti-VEGF therapy and even develop geographic atrophy and fibrosis. IBI302 is a fully human recombinant bispecific anti-VEGF and anti-complement fusion protein developed by Innovent. The N-terminus can bind to the VEGF family, block the VEGF-mediated signaling pathway, inhibit vascular epithelial proliferation and angiogenesis, and reduce vasopermeability and losses. The chronic inflammatory response related to complement activation is the key mechanism in the early stage of AMD. The C-terminus of IBI302 can inhibit the activation of the classical and alternative complement pathways through specific binding of C3b and C4b, and reduce the complement-mediated inflammatory response, so as to achieve the goal of treating and controlling AMD .

The Phase I study of IBI302 is an open-label, multicenter, dose escalation study to evaluate the safety and tolerability of a single intravitreal injection of IBI302 in nAMD patients. Patients enrolled with nAMD received an intravitreal injection of different concentrations of IBI302. The study enrolled 31 patients.

About Innovate

Inspired by the spirit of “Start with Integrity, Success through Action”, Innovent’s mission is to develop and market high quality biopharmaceutical products that are accessible to ordinary people. Founded in 2011, Innovent is committed to developing, manufacturing and marketing innovative, high-quality drugs for the treatment of cancer, metabolic, autoimmune and other major diseases. Above 31 October 2018, Innovent was listed on the Main Board of the Hong Kong Stock Exchange Limited under the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multifunctional platform that includes R&D capabilities, CMC (chemistry, manufacturing and controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a strong pipeline of 23 valuable resources in the fields of cancer, metabolic diseases, autoimmune and other important therapeutic areas, with four products, TYVYT^® (sintilimab injection), BYVASDA^® (biosimilar injection bevacizumab), SULINNO^® (biosimilar injection of adalimumab), HALPRYZA^® (biosimilar injection of rituximab) officially approved for marketing in China, four assets in Phase 3 or pivotal clinical trials, and another 15 molecules in clinical trials. TYVYT^® it is the only PD-1 inhibitor included in the NRDL.

Innovent has created an international team with experience in the development and marketing of cutting-edge biological medicines. The company has also entered into strategic partnerships with Eli Lilly and Company, Roche, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. For more information please visit: www.innoventbio.com.

Note:
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^® (biosimilar injection of adalimumab) is not an approved product in the United States.

TYVYT^® (injection of sintilimab, Innovent)
BYVASDA^® (biosimilar injection bevacizumab, Innovent)
SULINNO^® (biosimilar injection of adalimumab, Innovent)
HALPRYZA^® (biosimilar injection of rituximab, Innovent)

ALIMTA^® and GEMZAR^® are trademarks owned by or licensed to Eli Lilly and Company, its subsidiaries or affiliates.

View original content: http://www.prnewswire.com/news-releases/innovent-announces-the-results-of-the-phase-i-clinical-trial-of-ibi302-a-first-in-class – bi-specific human recombinant ophthalmic fusion protein anti-vegf and anti-complement for age-related neovascular macular degeneration at 202-301173208.html

SOURCE Innovent Biologics, Inc.

Company codes: Hong Kong: 1801, OTC-PINK: IVBIY