Innovent Announces Oral Presentation of Full Phase 2 Clinical Data for Efdamrofusp Alfa (IBI302), First-in-class anti-VEGF/complement Bispecific Fusion Protein at ARVO 2025

Rhea-AI Summary

Innovent Biologics presented promising 1-year Phase 2 clinical trial results for efdamrofusp alfa (IBI302), their first-in-class anti-VEGF/complement bispecific fusion protein, at ARVO 2025. The study involved 132 patients with neovascular age-related macular degeneration (nAMD), comparing two IBI302 doses (6.4mg and 8.0mg) against Aflibercept 2.0mg. Key findings showed that over 80% of IBI302 patients maintained visual benefits with 12-week dosing intervals. Both IBI302 doses demonstrated noninferiority to Aflibercept, with visual acuity improvements of +10.8 and +11.3 letters at week 52. The drug showed superior anatomical improvements and potentially reduced macular atrophy incidence by 40% compared to Aflibercept (4.9% vs 8.3%). No new safety concerns were identified, positioning IBI302 as a promising treatment option with extended dosing intervals for nAMD patients.

Positive

• Both IBI302 doses (6.4mg/8.0mg) met primary endpoint showing noninferiority to Aflibercept in visual acuity improvement
• Over 80% of IBI302 patients maintained benefits with 12-week dosing intervals, reducing treatment burden
• Superior anatomical improvements vs Aflibercept (CST reductions of 154.58μm and 174.69μm vs 131.18μm)
• 40% reduction in macular atrophy incidence compared to Aflibercept (4.9% vs 8.3%)
• Favorable safety profile with no new safety signals or retinal vasculitis

Negative

• None.

SAN FRANCISCO and SUZHOU, China, May 5, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announces that the latest 1-year results from its Phase 2 clinical trial of efdamrofusp alfa (R&D code: IBI302), a recombinant human vascular endothelial growth factor receptor (VEGFR)-antibody human complement receptor 1 (CR1) fusion protein, in Chinese subjects with neovascular age-related macular degeneration (nAMD) were presented orally at the 2025 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO). The ARVO Annual Meeting 2025 is the premiere gathering of researchers and physicians in vision and ophthalmology to share the latest research findings and collaborate on innovative solutions, to be held from May 4 - 8 in Salt Lake City, Utah, U.S..

Title: Intravitreal High-dose Efdamrofusp Alfa (IBI302) in Patients with Neovascular Age-related Macular Degeneration: A Randomized, Double-masked, Active-controlled, Phase 2 Study
Presentation Number: 443
Presentation Format: Speech/Mini Oral
Presentation Time: May 4, 2:15pm-2:30pm
Presenter: Prof. Xiaodong Sun, Shanghai General Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

The data were from the Phase 2 clinical study of high-dose IBI302 (NCT05403749) to evaluate the efficacy, safety and dosing intervals in patients with nAMD over a one-year treatment period. A total of 132 subjects were randomized 1: 1: 1 to IBI302 6.4 mg group, IBI302 8.0 mg group, or Aflibercept 2.0 mg group. After the loading therapy, IBI302 groups were administrated at personal treatment interval of Q12W or Q8W based on the disease activity assessed at Week 20. Subjects in Aflibercept 2.0 mg group were dosed Q8W after the loading therapy. The primary endpoint was the change in best corrected visual acuity (BCVA) in the study eye from baseline to week 40 and the study lasts 52 weeks. The results showed 6.4 mg/ 8.0 mg IBI302 competitive efficacy and safety profiles:

• Potential for extended dosing interval regiment: Throughout the trial period, over 80% of participants in IBI302 groups maintained visual benefits with a 12-week dosing interval.
• Comparable BCVA gains versus 2.0mg Aflibercept：The trial met the primary endpoint, BCVA gains in 6.4mg/8.0mg IBI302 were noninferior to Aflibercept at week 40，the mean change from baseline +10.5[SD 9.6], +11.0[11.4], and +9.8[8.7] ETDRS letters, respectively. This improvement was sustained through week 52 with +10.8 [10.2], +11.3 [10.3], and +10.0 [9.0] letters compared to baseline.
• Anatomical efficacy improvement versus 2.0mg Aflibercept: At week 52, the mean change of central subfield thickness (CST) reductions from baseline was 154.58 [149.17] μm for the IBI302 6.4 mg group, 174.69 [147.04] μm for the IBI302 8.0 mg group, and 131.18 [102.91] μm reduction for the Aflibercept 2.0 mg group, respectively.
• Potential to inhibit macular atrophy: Data from pooled analyses of two Phase 2 clinical trials (CIBI302A201 and CIBI302A202) suggested that IBI302 treatment may reduce the incidence of MA at Week 52 by nearly 40% compared to aflibercept (4.9% in IBI302 groups vs. 8.3% in Aflibercept group) .
• The incidences of adverse events in IBI302 groups were similar to Aflibercept. No retinal vasculitis occurred in this trial. No new safety signals were identified.

Professor Xiaodong Sun, Principal Investigator of the Study, Deputy director, Head of National Center for Clinical Ophthalmology, Shanghai General Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, stated: "It is my privilege to present the latest research findings on IBI302 to the global ophthalmic community at the ARVO meeting as the principal investigator. While anti-VEGF drugs remain the first-line therapy for nAMD, the frequency of  intravitreal injections and follow-up visits can significantly impact patient compliance. Current drug development focuses on multi-target strategies and extended dosing intervals to reduce the treatment burden by decreasing injection frequency. Notably, IBI302—a novel global first-in-class bispecific molecule (anti-VEGF/anti-complement) —recently reported Phase 2 data showing that its high-dose cohorts met the primary endpoint. The treatment group achieved approximately 10-letters improvement in visual acuity from baseline at one year, with over 80% subjects demonstrating potential for at least 12-weeks extended dosing intervals. Additionally, preliminary observations in IBI302 group suggest potential efficacy in inhibition of macular atrophy. We anticipate this innovative therapy will successfully complete the Phase 3 registration trial, providing nAMD patients with more effective, patient-friendly options."

Dr. Lei Qian, Senior Vice President of Clinical Development of Innovent, stated: "We are honored to present the latest progress of IBI302 in its second Phase 2 clinical trial at the ARVO annual meeting. High dose IBI302 demonstrates positive efficacy in visual acuity and anatomical improvements, while extend dosing intervals and potential anti-macular atrophy effects. Additionally, no new safety signals were observed during the trial, further validating the favorable safety and tolerability profile of this agent. These encouraging results establish a robust foundation for subsequent development. We will continue collaborating with clinical experts to expedite the Phase 3 clinical trial program, and accelerate the availability of this innovative therapy for patients with nAMD."

About Efdamrofusp Alfa (IBI302)

IBI302 is a recombinant fully human bispecific fusion protein of Innovent Biologics with global proprietary rights. The N- terminal 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- terminal 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

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center.

Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.

Statement:

（1）Innovent does not recommend the use of any unapproved drug (s)/indication (s).

（2）Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company.

Forward-looking statement

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 Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 the Company 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 the Company'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, the Company's competitive environment and political, economic, legal and social conditions.

The Company, the Directors and the employees of the Company 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 is otherwise inaccurate.

View original content:https://www.prnewswire.com/news-releases/innovent-announces-oral-presentation-of-full-phase-2-clinical-data-for-efdamrofusp-alfa-ibi302-first-in-class-anti-vegfcomplement-bispecific-fusion-protein-at-arvo-2025-302445964.html

SOURCE Innovent Biologics

FAQ

What are the key Phase 2 results for Innovent's IBI302 (IVBIY) in treating nAMD?

IBI302 showed noninferiority to Aflibercept with visual acuity improvements of +10.8 and +11.3 letters at week 52, superior anatomical improvements, and over 80% of patients maintained benefits with 12-week dosing intervals.

How does IBI302's dosing schedule compare to existing nAMD treatments?

Over 80% of IBI302 patients maintained visual benefits with 12-week dosing intervals, compared to 8-week intervals for Aflibercept, potentially reducing treatment burden for patients.

What are the safety results for Innovent's IBI302 in Phase 2 trials?

IBI302 demonstrated a favorable safety profile similar to Aflibercept, with no retinal vasculitis and no new safety signals identified during the trial.

How effective is IBI302 in preventing macular atrophy compared to Aflibercept?

IBI302 showed potential to reduce macular atrophy incidence by approximately 40% compared to Aflibercept (4.9% vs 8.3%) at Week 52.

What is the mechanism of action for Innovent's IBI302?

IBI302 is a first-in-class bispecific molecule that combines anti-VEGF and anti-complement mechanisms through a recombinant VEGFR-antibody and complement receptor 1 fusion protein.