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
SAN FRANCISCO and SUZHOU, China, May 6, 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.
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（2）Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company.
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