Innovent Presents Clinical Data of Two Ophthalmic Bispecific Antibodies IBI302 (anti-VEGF/complement) and IBI324 (anti-VEGF-A/Ang-2) at American Academy of Ophthalmology (AAO) Annual Meeting 2023

Rhea-AI Summary

Innovent Biologics presents latest data of two ophthalmic bispecific antibodies at the AAO 2023 Annual Meeting. Phase 2 study of IBI302 for neovascular age-related macular degeneration (nAMD) showed noninferior BCVA gains compared to aflibercept. Preliminary signal observed for IBI302 in preventing macular atrophy and fibrosis occurrence. Phase 1 study of IBI324 for diabetic macular edema (DME) demonstrated safety and efficacy. Both drugs showed robust efficacy with no new safety risk signals.

Positive

• Phase 2 study of IBI302 showed noninferior BCVA gains compared to aflibercept in nAMD treatment.
• Preliminary signal observed for IBI302 in preventing macular atrophy and fibrosis occurrence.
• Phase 1 study of IBI324 demonstrated safety and efficacy in DME treatment.
• Both drugs showed robust efficacy in their respective indications with no new safety risk signals.

Negative

• None.

ROCKVILLE, Md. and SUZHOU, China, Nov. 5, 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, presents latest data of two ophthalmic bispecific antibodies at the American Academy of Ophthalmology (AAO) 2023 Annual Meeting, including a Phase 2 clinical study of anti-VEGF and anti-complement bispecific fusion protein (IBI302) for neovascular age-related macular degeneration (nAMD) and a Phase 1 clinical study of anti-VEGF-A/Ang-2 bispecific antibody (IBI324) for diabetic macular edema (DME).

A Phase 2 Study of IBI302, an Anti-VEGF-Anti-Complement Dual Targeted Drug, for the Treatment of Neovascular Age-Related Macular Degeneration (nAMD)

Abstract No.: PO509

This is a Phase 2 clinical study evaluating the efficacy and safety of IBI302 in the treatment of nAMD (ClinicalTrials.gov: NCT04820452). A total of 231 subjects with nAMD were randomized 1: 1: 1 to receive 2 mg IBI302, 4 mg IBI302, or 2 mg aflibercept (3 monthly loading doses followed by doses every 8 weeks up to week 52). The primary endpoint was the change from baseline in best-corrected visual acuity (BCVA) in the study eye at 36 weeks. The results showed that:

• 2 mg/4 mg IBI302 BCVA gains were noninferior to 2 mg Aflibercept at 36 weeks: The mean change from baseline in BCVA at week 36 was +10.6 letters in the IBI302 2 mg group, +11.4 letters in the IBI302 4 mg group, and +12.0 letters in the aflibercept 2 mg group. Improvement in central retinal thickness (CST) was comparable among groups.
• Preliminary signal observed for IBI302 in preventing macular atrophy and fibrosis occurrence: The incidence of macular atrophy (MA) on spectral-domain optical coherence tomography (SD-OCT) and fibrosis on color fundus photography (CFP) at week 52 was 5.2% and 16.9% in the IBI302 2 mg group, 5.2% and 11.7% in the IBI302 4 mg group, and 9.1% and 14.3% in the aflibercept 2 mg group.
• In terms of safety, the incidence of adverse events were similar in the IBI302 2 mg group, IBI302 4 mg group, and the aflibercept 2 mg group. No endophthalmitis or retinal vasculitis occurred in the IBI302 group.

Phase 1 Study of IBI324 (Anti-VEGF-A/Ang-2 Bispecific Antibody) for Diabetic Macular Edema (DME)

Abstract No.: PO524

This is a Phase 1 clinical study evaluating the safety, tolerability, and efficacy of IBI324 in the treatment of DME (ClinicalTrials.gov: NCT05489718). The study was divided into two periods, a single dose (SAD) period and a multiple dose (MAD) period. The results showed that:

• In terms of safety, 4 mg/eye was the maximum tolerated dose in the study. No ocular serious adverse events (SAE), intraocular inflammation, or dose-limiting toxicities (DLTs) occurred during the study.
• In the SAD phase, BCVA and CST improved from baseline to Day 42 post-dose in every IBI324 dose group.
• In the MAD phase, BCVA improved from baseline by 6.7±5.4 letters and 7.7±4.7 letters in the IBI324 2 mg and 4 mg groups, respectively, by 4 weeks after the third dose (Day 84).

The principal investigator of the two clinical studies, Professor Xiaodong Sun, Vice President of the Eye Center of the First People's Hospital of Shanghai Jiao Tong University, and Director of National Clinical Medical Center for Eye Diseases, stated: "Both neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) are eye diseases involving the macular region that may lead to blindness, and could seriously affect the life quality of patients. Anti-VEGF agents are currently the first-line treatment option and can slow disease progression. However, the existing anti-VEGF drugs require frequent injections and long-term follow-up which affect the treatment compliance, leading to poor long-term treatment efficacy in many patients. Developing multi-target drugs based on anti-VEGF is the trend of drug development for ocular fundus diseases. The two ophthalmic drug candidates, IBI302 and IBI324, showed robust efficacy in patients with nAMD and DME, respectively, with no new safety risk signals. We hope that the exploration of multi-target drugs can provide alternative treatment options for  patients with fundus diseases. "

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated: "We are pleased to share the latest clinical development progress of our innovative ophthalmic drugs IBI302 and IBI324 at the AAO conference. IBI302 and IBI324 have demonstrated positive efficacy and safety results in nAMD and DME, respectively. A high-dose Phase 3 clinical trial of IBI302 in extended dosing intervals was initiated recently. In addition to the improvement of visual acuity and retinal thickness, we will also explore the anti-fibrotic and ameliorative macular atrophy potential of IBI302 in the trial. We look forward to advancing the clinical development progress and hope Innovent's innovative medicines can benefit more patients."

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 IBI324

IBI324 is a bispecific anti-VEGF and anti-Ang-2 recombinant fully humanized antibody developed by Innovent Biologics. The N-terminus can block VEGF-A-mediated signaling pathway and inhibit the growth and proliferation of vascular endothelial cells, thereby inhibiting angiogenesis, reducing vascular leakage. The C-terminus of IBI324 is an Ang-2 binding domain screened by Innovent that can specific inhibit the binding of Ang-2 to Tie-2 receptor, and therefore improve the sensitivity to other inflammatory factors, further stabilize blood vessels and inhibit vascular leakage. IBI324 can inhibit inflammation that mediated by VEGF-A and Ang-2, which may bring more clinical benefits to patients with DME.

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. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/

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.

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SOURCE Innovent Biologics

FAQ

What is the latest data presented by Innovent Biologics at the AAO 2023 Annual Meeting?

Innovent Biologics presented the latest data of two ophthalmic bispecific antibodies at the AAO 2023 Annual Meeting. They shared the results of a Phase 2 study of IBI302 for neovascular age-related macular degeneration (nAMD) and a Phase 1 study of IBI324 for diabetic macular edema (DME).

What were the key findings of the Phase 2 study of IBI302 for nAMD?

The Phase 2 study of IBI302 showed that the 2 mg and 4 mg doses of IBI302 had noninferior best-corrected visual acuity (BCVA) gains compared to the 2 mg dose of aflibercept at 36 weeks. There was also a preliminary signal observed for IBI302 in preventing macular atrophy and fibrosis occurrence.

What were the results of the Phase 1 study of IBI324 for DME?

The Phase 1 study of IBI324 demonstrated the safety and efficacy of the drug in the treatment of diabetic macular edema (DME). The maximum tolerated dose was found to be 4 mg/eye, and no ocular serious adverse events or dose-limiting toxicities occurred during the study.

Did the drugs show any safety concerns?

Both IBI302 and IBI324 showed robust efficacy with no new safety risk signals observed in their respective studies.

What are the future plans for the clinical development of IBI302 and IBI324?

A high-dose Phase 3 clinical trial of IBI302 in extended dosing intervals has recently been initiated. In addition to the improvement of visual acuity and retinal thickness, the trial will also explore the anti-fibrotic and ameliorative macular atrophy potential of IBI302. Innovent Biologics aims to advance the clinical development progress of both drugs and hopes they can benefit more patients.