Innovent Announces First Patient Dosed in the Phase 3 Clinical Study (STAR) of Efdamrofusp Alfa (IBI302), a First-in-class Ophthalmic Anti-VEGF and Anti-Complement Bispecific Fusion Protein for th...

ROCKVILLE, Md. and SUZHOU, China, Oct. 8, 2023 /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, ophthalmology and other major diseases, announces that the first patient with neovascular age-related macular degeneration (nAMD) has been successfully dosed in the Phase 3 clinical study (STAR) of efdamrofusp alfa (IBI302), a recombinant fully human anti-VEGF and anti-complement bispecific fusion protein.

STAR is a randomized, double-masked, active-controlled Phase 3 clinical study to evaluate the efficacy and safety of intravitreal 8 mg IBI302 in subjects with nAMD to support the potential new drug application for IBI302 (CTR20232229, ClinicalTrials.gov Identifier: NCT05972473). A total of 600 subjects will be enrolled and randomized to 8mg IBI302 arm and 2mg aflibercept arm in a 1: 1 ratio: all subjects will have visits every 4 weeks (Q4W) for the entire study duration; subjects assigned to IBI302 arm will receive 8mg IBI302 intravitreal injections (Q4W) up to Week 8, followed by 8mg IBI302 intravitreal injections according to a personalized treatment intervals (PTI) dosing regimen; subjects randomized to the aflibercept active control arm will receive 2mg aflibercept intravitreal (Q4W) up to Week 8, followed by 2mg aflibercept intravitreal (Q8W). The primary endpoint is change from baseline in best corrected visual acuity (BCVA) letters in the study eye based on an average at week 44, 48, and 52. All subjects will continue to receive intravitreal injections up to Week 96, with a final study visit at Week 100.

IBI302, the first-in-class bispecific fusion protein targeting VEGF and complement, can simultaneously inhibit VEGF-mediated signaling pathways and attenuate inflammatory responses mediated by complement activation. The results of the two Phase 2 clinical studies have demonstrated the favorable safety and efficacy of IBI302 in patients with nAMD, as well as the advantages of long-interval dosing: in terms of efficacy, improvements in BCVA, retinal thickness, and leakage and total area of neovascularization, with potential improvements in macular atrophy and fibrosis have been observed; The overall safety profile was favorable and similar to existing anti-VEGF agents.

Professor Xiaodong Sun, Deputy Director of Shanghai General Hospital, Head of Ophthalmology Centre, Principal Investigator of the study, stated, "Currently, anti-VEGF drugs are the first-line treatment for nAMD. However, this treatment is associated with several limitations, such as frequent injections, long-term efficacy attenuation, and suboptimal outcomes for some patients, imposing significant inconvenience and economic burden to the majority of patients. Therefore, there remains a significant unmet clinical need. IBI302 as a global first-in-class anti VEGF-complement dual targeting drug, has demonstrated promising efficacy signals in completed Phase 1 and Phase 2 clinical studies, including improvements in visual acuity and reduction in retinal edema, while exhibiting favorable safety profiles. Preliminary positive signals have also been observed in the inhibition of fibrosis and macular atrophy. This has instilled great confidence in our researchers. We look forward to the upcoming Phase III STAR trial, and hope that IBI302 will not only overcome the current treatment limitations, prolong dosing intervals, reducing the burden of injections on patients, but also demonstrate its potential advantages in long-term anti fibrosis and macular atrophy improvement. This will ultimately offer a more patient-friendly dosing regimen and longer-lasting visual benefits to patients. "

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated: " As globally the first anti-VEGF and anti-complement bispecific molecule, IBI302 is an innovative drug of Innovent with global proprietary right for the treatment of fundus diseases. The preliminary results of the Phase 1 and Phase 2 clinical studies have demonstrated a favorable safety and efficacy profile, we are encouraged to advance it into next stage of development. In the STAR study, our focus will not only be on improvement of visual acuity and retinal thickness but also on exploring the efficacy of 8mg IBI302 in extended dosing intervals. We look forward to the success of IBI302 in the STAR Phase 3 trial, to provide patients with a more effective and safe clinical treatment regimen as soon as possible."

About neovascular age-related macular degeneration (nAMD)

Age-related macular degeneration (AMD) is a chronic progressive ocular disease that affects the macula of the retina, resulting in central visual impairment, and its incidence increases with age. As a main type of AMD, nAMD accounts for 15% to 20% of all AMD patients and is the leading cause of central vision loss in AMD patients over 65 years of age. AMD has now leapt to the third leading cause of blindness in China with increasing incidence over years.

The pathogenesis of nAMD has not been fully elucidated. It is generally recognized that increased VEGF over expression- induced angiogenesis is the main cause of nAMD. In addition, the inflammatory response mediated by abnormal activation of complement is also considered to be an important cause of AMD. Although ophthalmic anti-VEGF agents have brought significant visual benefits and alter the course of nAMD, the current frequent dosing (every 4 or 8 weeks) poses a heavy burden on patients, families, and the society. Besides, the visual benefits of anti-VEGF therapy are lost by years with prolonged treatment. In about two-thirds of patients with more than 7 years of follow-up, the visual benefit conferred by anti-VEGF therapy is greatly lost. Macular atrophy or retinal fibrosis is primarily responsible for the loss of visual benefits after long-term anti-VEGF treatment. Currently, drug development for nAMD mainly focuses on prolonging dosing intervals, and there are few drugs under development for macular atrophy or retinal fibrosis.

About Efdamrofusp Alfa (IBI302)

IBI302 is a recombinant fully human bispecific fusion protein of Innovent Biologics with global proprietary rights. The N-terminus is a VEGF domain that can bind to the VEGF family, block VEGF-mediated signaling pathway, inhibit vascular epithelium proliferation and angiogenesis, and improve vasopermeability and reduce leakage. The C-terminus of IBI302 is the complement binding domain that 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. IBI302 may exert its therapeutic effect by inhibiting both VEGF-mediated angiogenesis and complement activation pathways.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to discover and develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to discovering and developing, manufacturing and commercializing high-quality innovative medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, and ophthalmology diseases to enhance the quality of the patients' lives. Innovent has 10 products in the market, including TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules), FUCASO® (Equecabtagene  Autoleucel Injection) and SINTBILO® (Tafolecimab Injection). Additionally, 7 assets are in Phase III or pivotal clinical trials, and 17 more molecules are in early clinical stage.

Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. We strive to work with many collaborators to help advance the biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives.

Note:

TYVYT^®, BYVASDA^®, SULINNO^®, HALPRYZA^®, olverembatinib, FUCASO^® and SINTBILO^® are not approved products in the United States.
TYVYT^® (sintilimab injection, Innovent)
BYVASDA^® (bevacizumab injection, Innovent)
HALPRYZA^® (rituximab injection, Innovent)
SULINNO^® (adalimumab 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.
CYRAMZA^® (ramucirumab injection, Eli Lilly). Cyramza^® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.
Retsevmo^® (selpercatinib capsules, Eli Lilly). Retsevmo^® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

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.

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