Innovent Announces the Results of the Phase Ib Clinical Trial of IBI302, a First-in-class Anti-VEGF and Anti-Complement Bi-specific Fusion Protein for Neovascular Age-Related Macular Degeneration at 2021 American Academy of Ophthalmology

SAN FRANCISCO and SUZHOU, China, Nov. 14, 2021 /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 Ib 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 2021 American Academy of Ophthalmology.

The Phase Ib study of IBI302 is a randomized, open-label, positive-controlled, multi-center, repeated-dose clinical trial to evaluate the safety and tolerability of multi-intravitreal injection of IBI302 in patients with nAMD. A total of 18 subjects were enrolled in the completed Phase Ib clinical trial. All subjects received multi-intravitreal injection of IBI302 or Eylea^®. Treatment with IBI302 was safe and well tolerated, with no report of dose limiting toxicity, treatment related adverse events nor treatment related serious adverse events. Visual acuity improvement and reduction in retinal edema were observed in subjects at 4 weeks after three loading treatments: in the 12 subjects in the IBI302 group, best-corrected visual acuity improved by a mean of 6.4 letters from baseline and mean central zone retinal thickness decreased by 129.3 μm from baseline. In the 4 mg IBI302 group, visual acuity improved by 8.0 letters and mean central zone retinal thickness improved by 134.3 μm.

"The development of intravitreal injection of antibody drugs have become the first-line treatment for nAMD. Although anti-VEGF agents deliver a relatively good therapeutic effect in a majority of patients, patients need repeated injections and the therapeutic effect would deteriorate in a fraction of them. Therefore, there are still huge unmet clinical needs in AMD treatment. The IBI302 Phase Ib clinical trial has shown good safety and tolerability with promising therapeutic effect. In addition to the improved vision and reduction of retinal edema as the trial shown, I am looking forward to more exciting results, such as the control of the occurrence and progression of macular atrophy, bringing a whole new options for treatment of nAMD." said the principal investigator Professor Xiaodong Sun, director of the National Clinical Medical Center for Eye Diseases at 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 be a more targeted treatment and interventions to AMD by including one additional target, thus providing more clinical benefits compared to anti-VEGF antibody. The results presented by the current Phase Ib clinical trial have brought us greater confidence in the next phase of IBI302 research and development. We will explore the efficacy of IBI302 on retinal fibrosis and macular atrophy in addition to focusing on visual acuity and retinal thickness improvement in the next phase of study. I hope that Innovent can benefit the majority of patients with fundus diseases and their families through the development of more innovative targets and molecules." said Dr. Lei Qian, Executive 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 can reach mor than 30% in people over 80 years of age. 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%. Anti-VEGF biologics have become the standard treatment for nAMD; however, a proportion of patients still respond poorly or the therapeutic effect gradually deteriorate, potentially attributing to macular atrophy and retinal fibrosis.

About IBI302

Anti-VEGF therapy is currently the standard treatment for nAMD, 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 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, achieving  the purpose of treating AMD, inhibiting macular atrophy and controlling the formation and progression of fibrosis .

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 stands out among many biopharmaceutical companies by virtue of innovative results and international operating models. Innovent has built a robust pipeline of 26 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, of which 6 assets were selected for the national innovative manufacturing of major new drugs. Five products, TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), Pemazyre® (pemigatinib oral inhibitor) were officially approved for marketing, 1 new drug application was accepted by National Medical Products Administration, the BLA for sintilimab was accepted by U.S. Food and Drug Administration, 5 assets in Phase 3 or pivotal clinical trials, and additional 15 molecules in clinical trials. Sintilimab has successfully entered the national health insurance catalogue in November 2019, becoming the first and the only PD-1 inhibitor to enter the national health insurance catalogue that year.

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:

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)

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, Macau and Taiwan.

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

Disclaimer:

1.  This indication is still under clinical study, which hasn't been approved in China.

2.  Innovent does not recommend any off-label usage.

3.  For medical and healthcare professionals only.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

SOURCE Innovent Biologics

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