Innovent Announces the Results of the Phase I Clinical Trial of IBI302, a First-in-class Ophthalmic Recombinant Human Anti-VEGF and Anti-Complement Bi-specific Fusion Protein for Neovascular Age-Related Macular Degeneration at 2020 American Academy of Ophthalmology

SAN FRANCISCO and SUZHOU, China, Nov. 16, 2020 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, announces that the results of the Phase I clinical trial of IBI302, a first-in-class ophthalmic recombinant human anti-VEGF and anti-complement bi-specific fusion protein for neovascular age-related macular degeneration (nAMD) is released in e-poster at 2020 American Academy of Ophthalmology.

The Phase I study of IBI302 is an open-label, multi-center, dose-escalation clinical trial 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 study. All subjects received a single intravitreal injection of IBI302. No serious adverse event or dose limiting toxicity was reported. The study demonstrated good safety and tolerability of IBI302. One week after administration, improved vision and reduction of retinal edema were observed. By 28 days after administration, all 31 patients' best corrected visual acuity increased by 6 letters on average compared to baseline; the average central retinal thickness decreased by 141.2 microns compared to baseline, and the efficacy of some patients lasted until 6 weeks after administration.

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

"IBI302 is an innovative drug independently developed by Innovent for the treatment of fundus diseases. It is globally the first anti-VEGF/anti-complement bispecific molecule and has been supported by the major new drug project of the Ministry of Science and Technology as a Class 1 new drug.  IBI302 was designed to provide more targeted treatment and interventions to the cause of AMD by adding additional targets, and to bring more clinical benefits compared to anti-VEGF antibody. The results presented by the current Phase I clinical trial have brought us greater confidence in the next phase of IBI302 research and development. I hope that Innovent can benefit the majority of patients with fundus diseases and their families through more innovative targets and molecules," said Dr. Lei Qian, Senior Medical Director of Department for Medical Science and Strategies of Special Disease of Innovent.

About AMD

AMD involves macula and causes progressive central visual impairment. As one of the major blinding eye diseases among adults over 50, the incidence of AMD increases with age. In the developed countries or regions, the prevalence of people over 80 years-old can reach more than 30%. It can be divided into dry AMD and nAMD according to clinical manifestations and pathological types. About 80%-90% are dry AMD; and in patients with severe central vision impairment, nAMD accounts for about 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 bispecific anti-VEGF and anti-complement recombinant fully human fusion protein developed by Innovent. The N-terminus can bind to the VEGF family, block VEGF-mediated signaling pathway, inhibit vascular epithelium proliferation and angiogenesis, and reduce vasopermeability and leakage. 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 classic pathway and alternative pathway of complement through the specific binding of C3b and C4b, and reduce the inflammatory response mediated by the complement, so as to achieve the purpose of treating and controlling AMD.

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

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 cancer, metabolic, autoimmune 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 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 23 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, with four products, TYVYT^® (sintilimab injection), BYVASDA^® (bevacizumab biosimilar injection), SULINNO^® (adalimumab biosimilar injection), HALPRYZA^® (rituximab biosimilar injection) officially approved for marketing in China, four assets in Phase 3 or pivotal clinical trials, and additional 15 molecules in clinical trials. TYVYT^® is the only PD-1 inhibitor included in the NRDL.

Innovent has built an international team with expertise in cutting-edge biological drug development and commercialization. The company has also entered into strategic collaborations 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^® (adalimumab biosimilar injection) is not an approved product in the United States.

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

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

SOURCE Innovent Biologics, Inc.