C3b inhibitors(complement C3b inhibitors), C4B inhibitors(Complement factor C4-B inhibitors), Complement receptors antagonists(Complement receptors antagonists)

Therapeutic Areas

Congenital DisordersEye DiseasesCardiovascular Diseases+ [1]

Active Indication

Inactive Indication

Choroidal Neovascularization

Originator Organization

Innovent Biologics (Suzhou) Co. Ltd.AP Biosciences, Inc.

Active Organization

AP Biosciences, Inc.

Innovent Biologics (Suzhou) Co. Ltd.

Inactive Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

Gene Sequence

Sequence Code 25108715

Source: *****

Clinical Trials associated with Efdamrofusp alfa

CTR20232229 / RecruitingPhase 3

一项评估在新生血管性年龄相关性黄斑变性受试者中玻璃体腔注射IBI302的疗效和安全性的随机、双盲、活性对照的III期临床研究

[Translation] A randomized, double-blind, active-controlled Phase III clinical study to evaluate the efficacy and safety of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration

与2 mg阿柏西普每8周一次治疗相比，8 mg IBI302在新生血管性年龄相关性黄斑变性（nAMD）受试者中的最佳矫正视力（ BCVA）变化是否能达到非劣效性

[Translation]

Whether IBI302 8 mg achieves non-inferiority in change in best corrected visual acuity (BCVA) compared with aflibercept 2 mg every 8 weeks in subjects with neovascular age-related macular degeneration (nAMD)

Start Date21 Sep 2023

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

NCT05972473 / RecruitingPhase 3

A Phase 3, Randomized, Double-masked, Active-Controlled Study to Evaluate the Efficacy and Safety of Intravitreal IBI302(Efdamrofusp Alfa) in Subjects With Neovascular Age-Related Macular Degeneration

The study is designed for multi-center,randomized,double-masked,active-contralled study to evaluate effective and security of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.

Start Date15 Aug 2023

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

CTR20221283 / Active, not recruitingPhase 2

一项评估在新生血管性年龄相关性黄斑变性受试者中长间隔玻璃体腔注射IBI302的疗效和安全性的随机、双盲、活性对照的临床研究

[Translation] A randomized, double-blind, active-controlled clinical study to evaluate the efficacy and safety of long-interval intravitreal injections of IBI302 in subjects with neovascular age-related macular degeneration

评价IBI302在新生血管性年龄相关性黄斑变性（Neovascular Age-Related Macular Degeneration, nAMD）受试者中的视力疗效

[Translation]

To evaluate the visual acuity efficacy of IBI302 in subjects with neovascular age-related macular degeneration (nAMD)

Start Date27 Jun 2022

Sponsor / Collaborator

Innovent Biologics (Suzhou) Co. Ltd.

100 Clinical Results associated with Efdamrofusp alfa

100 Translational Medicine associated with Efdamrofusp alfa

100 Patents (Medical) associated with Efdamrofusp alfa

Literatures (Medical) associated with Efdamrofusp alfa

01 Apr 2023·American journal of ophthalmology

A Novel Bispecific Fusion Protein Targeting C3b/C4b and VEGF in Patients With nAMD: A Randomized, Open-Label, Phase 1b Study

Article

Author: Li, Tong ; Gong, Yuanyuan ; Lu, Shujie ; Wang, Fenghua ; Jia, Huixun ; Feng, Liqi ; Liu, Haiyun ; Qian, Lei ; Sun, Xiaodong ; Liu, Wenjia ; Wan, Qiuchen ; Chen, Jieqiong ; Wang, Hong ; Sun, Junran ; Liu, Xiaoling

PURPOSE:

To evaluate the safety, tolerability, and efficacy of efdamrofusp alfa in patients with neovascular age-related macular degeneration (nAMD).

DESIGN:

Prospective randomized, open-label, multiple ascending-dose, phase 1b study.

METHODS:

Patients aged 50 years or older with active choroid neovascularization (CNV) secondary to nAMD were screened from 2 hospitals in 2 provinces in China. The first 9 patients were randomized 2:1 to intravitreally receive efdamrofusp alfa 2 mg at weeks 0, 4, and 8 or aflibercept 2 mg at weeks 0, 4, 8, and 16. After the dose-limiting toxicity assessment, 9 additional patients were randomized 2:1 to intravitreally receive efdamrofusp alfa 4 mg at weeks 0, 4, and 8 or aflibercept 2 mg at weeks 0, 4, 8, and 16. All patients were followed until week 20. Primary outcomes were safety and tolerability of efdamrofusp alfa. Secondary outcomes included changes from baseline in best-corrected visual acuity (BCVA), central subfield thickness (CST) as measured by spectral domain optical coherence tomography (SD-OCT), and CNV area as measured by fluorescein angiography (FA).

RESULTS:

A total of 18 patients were enrolled. Six each of them received efdamrofusp alfa 2 mg, efdamrofusp alfa 4 mg, or aflibercept 2 mg, respectively. No dose-limiting toxicity was reported, and all patients completed the study. No ocular serious adverse events were reported. All ocular treatment-emergent adverse events were intravitreal injection related and were mild or moderate in severity. At week 20, mean changes from baseline in BCVA were 5.64 ± 3.56, 8.93 ± 3.59, and 7.92 ± 3.55 letters for patients receiving efdamrofusp alfa 2 mg, efdamrofusp alfa 4 mg and aflibercept 2 mg, respectively. Meanwhile, CST and CNV area reductions indicative of anatomic improvement were observed in the majority of the patients receiving both doses of efdamrofusp alfa and aflibercept.

CONCLUSIONS:

Intravitreal efdamrofusp alfa dosed up to 4 mg every 4 weeks was well tolerated in nAMD patients with similar vision acuity and anatomic improvements.

01 Jun 2022·Science translational medicineQ1 · MEDICINE

Targeting C3b/C4b and VEGF with a bispecific fusion protein optimized for neovascular age-related macular degeneration therapy

Q1 · MEDICINE

Article

Author: Li, Tong ; Song, Yanping ; Jia, Huixun ; Wang, Tao ; Gu, Qing ; Liang, Jian ; Wang, Fenghua ; Zhai, Yuanqi ; Li, Yiming ; Wan, Xiaoling ; Qian, Lei ; Li, Xiaomeng ; Lu, Shujie ; Luo, Xueting ; Yang, Shiqi ; Li, Min ; Liu, Junjian ; Sun, Xiaodong ; Yu, Dechao ; Gao, Min ; Yang, Xiaotong ; Huang, Zhen

Antiangiogenesis therapies targeting vascular endothelial growth factor (VEGF) have revolutionized the treatment of neovascular ocular diseases, including neovascular age-related macular degeneration (nAMD). Compelling evidence has implicated the vital role of complement system dysregulation in AMD pathogenesis, implying it as a potential therapeutic strategy for geographic atrophy in dry AMD and to enhance the efficacy of anti-VEGF monotherapies in nAMD. This study reports the preclinical assessment and phase 1 clinical outcomes of a bispecific fusion protein, efdamrofusp alfa (code: IBI302), which is capable of neutralizing both VEGF isoforms and C3b/C4b. Efdamrofusp alfa showed superior efficacy over anti-VEGF monotherapy in a mouse laser-induced choroidal neovascularization (CNV) model after intravitreal delivery. Dual inhibition of VEGF and the complement activation was found to further inhibit macrophage infiltration and M2 macrophage polarization. Intravitreal efdamrofusp alfa demonstrated favorable safety profiles and exhibited antiangiogenetic efficacy in a nonhuman primate laser-induced CNV model. A phase 1 dose-escalating clinical trial (NCT03814291) was thus conducted on the basis of the preclinical data. Preliminary results showed that efdamrofusp alfa was well tolerated in patients with nAMD. These data suggest that efdamrofusp alfa might be effective for treating nAMD and possibly other complement-related ocular conditions.

01 Jan 2021·Ophthalmic research

Protective Effect of a Bispecific Fc-Fusion Protein on the Barrier of Human Retinal Pigment Epithelial Cells

Article

Author: Wang, Yishen ; Liu, Qiuhui ; Tian, Rong ; Li, Jia ; Luo, Yan ; Wang, Jing ; Lin, Shaofen ; Yu, Dechao

Introduction: The aim of the study was to evaluate the protective effects of IBI302, a bispecific Fc-fusion protein that theoretically can bind vascular endothelial growth factor (VEGF), complement C3b, and C4b in the barrier of the cultured human retinal pigment epithelial (hRPE) cells. Methods: Primary hRPE cells were isolated and cultured to monolayer barrier. hRPE monolayers were divided into the PBS control group, VEGF-Trap group, complement receptor 1 (CR1) group, and IBI302 group. Identification of hRPE cells, barrier function, inflammation factors, and immune response products was tested by immunofluorescent staining, transepithelial resistance (TER), and ELISA. Results: IBI302 treatment significantly improved the TER of the barrier of hRPE cells after complement-activated oxidative stress compared with the PBS control group, VEGF-Trap group, and CR1 group. The maximum effect of IBI302 on protecting hRPE cell viability was observed at the concentration of 1 μg/mL. The elevated expression of VEGF, chemokine (C-C Motif) ligand 2, C3a, C5a, and membrane attack complex was reduced by IBI302. Conclusion: IBI302 could protect the barrier function of hRPE cells. IBI302 might be a potentially effective drug for the RPE barrier-associated ocular diseases.

News (Medical) associated with Efdamrofusp alfa

20 Mar 2024

·www.biospace.com

Innovent Announces 2023 Annual Results and Business Updates

A transformative year of strong performance and material innovation progress ROCKVILLE, M.D. and SUZHOU, China, March 20, 2024 /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, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces its 2023 annual results and major business updates. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated:"2023 marked a transformative year for Innovent with material progress. We delivered strong revenue growth, improved operational efficiency and financial performance, and enhanced ESG management practices that underline our sustainable business model. Concurrently, we have achieved material innovation progress in both late- and early-stage R&D development, advanced pipeline portfolio across oncology and general biomedicine, and broadened our global pipeline development scope, reinforcing our global innovation strategy. These achievements underscore the dedication to our strategic goals in the second decade – sustainable growth and global innovation. We will continue our high-quality business growth and advance global innovation progress, and create sustainable value for patients, employees, shareholders and society." Solidified business operations with strong revenue performance and improved financials Strong revenue growth: total revenue RMB6,206.1 million in the year of 2023, an increase of 36.2% compared with the year of 2022; product sales revenue RMB5,728.3 million in the year of 2023, an increase of 38.4% compared with the prior year, reflecting robust demand for our innovative portfolio and the advantage of our sustainable business model. Enhanced operational efficiency and financial performance : EBITDA Loss was significantly narrowed, whose key drivers include strong revenue growth, enhanced operational efficiency and remarkable financial improvement. The selling and marketing expenses of total revenue was 49.3%, a year-over-year decrease of 7.3 percentage points The administration and expenses of total revenue was 8.8%, a year-over-year decrease of 5.3 percentage points R&D expenses was RMB1974.9 million; cash and short-term financial assets was RMB10969.6 million, or approximately USD1.5 billion, which enables us to focus on the long-term sustainable development EBITDA loss was RMB600.1 million, a notable year-over-year decrease of 73.0% Note: The financial numbers mentioned above were based on non-IFRS measure. Detailed disclosure can be found at the Company's 2023 annual results announcement. Solidify oncology leadership; build CVM commercialization capability Expansion of commercial portfolio into new approved products, new indications and broader NRDL coverage[1],[2] and patient access: Ten approved products: TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, PEMAZYRE®, Olverembatinib, CYRAMZA®, Retsevmo®, FUCASO® (new product, for the treatment of RRMM) and SINTBILO® (new product, for the treatment of hypercholesterolemia and mixed dyslipidemia). All seven approved indications of TYVYT® (sintilimab injection) were included in the NRDL. It is also the only PD-1 inhibitor in the NRDL for the treatment of GC and EGFR-mutated NSCLC. As for market expansion, TVYVT® (sintilimab injection) was newly approved in the Macau market in February 2024. Olverembatinib's first indication was included in the NRDL; and its second indication was newly approved to benefit broader CML patients. All indications of BYVASDA® (bevacizumab injection), HALPRYZA® (rituximab injection) and SULINNO® (adalimumab injection) were also included in the NRDL. Oncology and general biomedicines as key growth pillars of the company: Oncology: we have launched eight products including TYVYT® (sintilimab injection), established a mature commercial presence of nearly 3,000 employees, nationwide patient access and a well-recognized brand image. We will continue to solidify leadership and expand business in oncology. General biomedicine: we have made considerable progress in past years advancing and expanding our pipeline in general biomedicine, including cardiovascular and metabolism (CVM), autoimmune, and ophthalmology, which we believe will result in substantially increased commercial opportunities and diversified long-term growth. Therefore, as part of the strategic plan, we have been steadily establishing our commercialization capability in the CVM field with systematic approaches. We plan to implement a comprehensive structure and form strategies for key factors, such as patient access, distribution channels, and marketing activities, to ensure all capabilities, personnel and strategies are in place to facilitate effective operations of our business, and to foster long-term brand image and competitive advantage in this new area. Material innovation progress in both late- and early-stage clinical development 8 assets are in NDA review or pivotal registrational clinical trials, and 18 assets are in early Phase 1/2 clinical studies Oncology: robust leadership spanning all phases of R&D and novel modalities Deepened synergies of product portfolio with two target therapies for lung cancer under NDA priority review, which are anticipated to launch in 2024: IBI344 (ROS1, taletrectinib): 1L and 2L ROS1 positive NSCLC IBI351 (KRAS G12C, fulzerasib): 2L KRAS G12C mutated NSCLC Encouraging progress in the next wave innovation of "IO+ADC" TYVYT® (sintilimab): multiple clinical trial collaborations to explore potential of combination therapy with various ADCs for solid tumors IBI310 (CTLA-4)：plan to initiate a Phase 3 clinical trial for IBI310 in combination with sintilimab in treating neoadjuvant colon cancer IBI343 (CLDN18.2 ADC)：preparing for a MRCT Phase 3 clinical trial for IBI343 in 3L GC, subject to regulatory communications; a PoC trial in PDAC is ongoing Advancing multiple bi-/tri-specific antibodies and ADCs with global potential in early-stage clinical trials IBI363 (PD-1/IL-2) : preliminary PoC signals in multiple IO resistant/unresponsive cancer types; plan to initiate a Phase 2 clinical trial in the U.S. Multiple programs ongoing including IBI389(CLDN18.2/CD3), IBI334 (EGFR/B7H3), IBI3003 (GPRC5D/BCMA/CD3), IBI3001(EGFR/B7H3 ADC), IBI130 (TROP2 ADC), IBI133 (HER3 ADC) CVM : multiple new-generation product candidates achieved substantial R&D milestones SINTBILO® (tafolecimab injection): the first domestic self-developed anti-PCSK9 monoclonal antibody, approved for the treatment of hypercholesteremia and mixed dyslipidemia Mazdutide (GLP-1R/GCGR): globally the first GLP-1R/GCGR dual agonist in the NDA stage. First NDA of mazdutide was accepted for chronic weight management. Five Phase 3 registrational trials and more clinical trials are underway. IBI128 (XOI): potential best-in-class XOI for the treatment of hyperuricemia in gout patients. It is undergoing overseas Phase 3 clinical trials conducted by our partner LG Chem. We plan to initiate Phase 1 and Phase 2 clinical trials in China in pace with the global registrational progress. IBI3016（AGT siRNA）: a new-generation siRNA drug candidate to address unmet need in hypertension. We will collaborate with SanageneBio and plan to initiate a Phase 1 clinical trial in 2024. Next-generation projects will enter into IND-enabling stage in 2024, underscoring our dedication to expanding our strategic presence in the CVM field Autoimmune: address global unmet needs in various autoimmune diseases IBI112 (IL-23p19) : potential long-lasting efficacy advantage and convenient extended dosing intervals for psoriasis. We anticipate completing the Phase 3 registrational clinical trial in support of an NDA submission in 2024. IBI353 (PDE4): the multi-regional Phase 2b clinical study (led by UNION) of IBI353 in psoriasis attained positive topline results. IBI355 (CD40L) , IBI356 (OX40L) and IBI3002 (IL-4Rα/TSLP): innovative autoimmune molecules entered into first-in-human studies to explore other unmet medical needs in various types of autoimmune diseases, such as primary Sjögren's syndrome (pSS), systemic lupus erythematosus (SLE), atopic dermatitis (AD) and asthma. Ophthalmology: a long-standing commitment to elevate standard-of-care IBI302 (VEGF/C): Phase 3 study initiated for the treatment of nAMD, based on the observed stable and robust visual benefit under extended dosing interval and potential inhibition effect in macular atrophy in two Phase 2 studies. IBI311 (IGF-1R): Phase 3 clinical trial met the primary endpoint, demonstrating favorable safety and excellent efficacy; we plan to submit an NDA in 2024 IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) : both are in the Phase 1 stage to explore the potential differentiation clinical values versus existing therapy. Global innovation as unwavering long-term strategic priority Innovent Academy as the innovation powerhouse: In 2023, Innovent Academy has successfully delivered eight high quality novel molecules into IND enabling stage. A significant portion of preclinical programs lies in key non-oncology areas, including CVM, ophthalmology and autoimmune diseases, forming another important growth pillar of global innovation as oncology counterparts. Research innovation published in high-impact scientific journals and medical conferences, such as: Preclinical results publication of IBI363 in Nature Cancer Preclinical results of IBI334 (EGFR/B7H3), IBI343 (CLDN18.2 ADC), IBI3001 (EGFR/B7H3 ADC) are accepted as Late-breaking Researches by the American Association for Cancer Research (AACR) 2024 Manufacturing capacity adhering to high-standard quality: Suzhou manufacturing site: 60,000L antibody production capacity and ADC production lines in operation Hangzhou manufacturing site: 170,000L production capacity (first phase of 80,000L completed construction, second phase of 90,000L in plan) to secure global supply Shanghai R&D center will be operational in 2024 Devoted to responsible business practices and enhancing ESG management practices Innovent has been upgraded to 'A' level in MSCI ESG rating, ranking at the forefront of the biotechnology industry. In active support of the United Nations' sustainable development goals (SDGs) and in fulfilling our social responsibilities, we continued to enhance ESG management across several key dimensions, including: "Excellent governance", "Enjoying good health", "High-quality as key", "People first" and "Green ecology". About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 5 assets in Phase 3 or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte 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 , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). 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. Company Codes: HongKong:1801, OTC-PINK:IVBIY, HongKong:01801

Phase 3Phase 2Drug ApprovalClinical ResultPhase 1

19 Mar 2024

·www.fiercebiotech.com

Innovent's anti-VEGF drug matches Eylea in phase 2 eye disease trial

Innovent will include a dosing cohort of every 16 weeks in the phase 3 STAR study of IBI302. Innovent’s anti-VEGF drug held its own against Regeneron and Bayer’s blockbuster eye disease therapy Eylea in a phase 2 trial. The study saw 132 participants with neovascular age-related macular degeneration (nAMD) randomized to receive either 6.4 mg or 8 mg doses of Innovent’s IBI302 or 2 mg of Eylea. Individuals on Eylea received their treatment every eight weeks, while those receiving IBI302 received treatment either every eight or 12 weeks depending on how they had responded to a loading therapy. At 40 weeks, both doses of IBI302 were shown to have induced “non-inferior” improvements in best corrected visual acuity (BCVA) in the study eye from baseline when compared to the Eylea group, the study’s primary endpoint. Specifically, the improvement from baseline on an eye test chart was 10.5 letters for the 6.4 mg IBI302 dose group, 11 letters for the 8 mg group and 9.8 letters for the Eylea group. The study also looked at a change in the thickness of the retina. The 6.4 mg group saw a reduction of 163.19 μm, compared to 184.46 μm for the 8 mg group and 108.23 μm for the Eylea group at week 40. Like Eylea, Innovent’s anti-VEGF contender also needs to be injected into the eye. The recommended dosing for Eylea is every four weeks for the first 12 weeks, and then every eight weeks. However, Regeneron and Roche have been locked in a battle to bring down this injection burden. Roche launched Vabysmo as a longer-acting treatment to reduce dosing to just three times a year. In response, Regeneron launched Eylea 8 mg, which is marketed as Eylea HD. Innovent is also keen to reduce the number of IBI302 injections. To this end, Innovent’s trial showed that around 81% and 88% of the 6.5 mg and 8 mg dose groups, respectively, were able to extend their dosing intervals from eight to 12 weeks. As a result of the “excellent long-interval dosing performance” demonstrated by IBI302 in the phase 2 studies so far, Innovent will include a dosing cohort of every 16 weeks in the phase 3 STAR study of the drug—which would match the dosing regimen of Vabysmo. “There are two major trends in drug development for nAMD: extending dosing intervals and reducing the occurrence of macular atrophy,” Lei Qian, vice president of Clinical Development at Innovent, said in today’s release. “In the results of two phase 2 studies, which enrolled over 360 subjects, IBI302 improved BCVA and macular edema in patients with nAMD significantly, extended dosing intervals, and had the potential to prevent the development of macular atrophy.” Regeneron and Roche remain in a struggle to claim their respective treatments are the standard of care in macular degeneration. Innovent isn’t the only one chasing those Big Pharmas to reduce the burden of injections. Earlier this month, 4D Molecular Therapeutics linked a gene therapy to a 90% reduction in treatment burden in wet age-related macular degeneration. 4D’s adeno-associated virus vector delivers transgenes encoding aflibercept, the molecule that Regeneron sells as Eylea, and RNAi that inhibits VEGF-C. The phase 2 win for IBI302 comes a month after another of Innovent’s potential eye disease drugs, IBI311, reported success against thyroid eye disease in a late-stage trial. The company is holding out hopes that the treatment will provide a first shot at the Chinese equivalent of a market that has already been conquered by Amgen’s Tepezza in the U.S.

Clinical ResultPhase 2Phase 3Phase 1Gene Therapy

19 Mar 2024

·www.prnewswire.com

Innovent Announces Primary Endpoint Met in the Second Phase 2 Clinical Trial of IBI302 (anti-VEGF/complement) in Treating Neovascular Age-related Macular Degeneration (nAMD)

ROCKVILLIE, Md. and SUZHOU, China, March 18, 2024 /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, today announced that the primary endpoint has been met in the second Phase 2 clinical study of efdamrofusp alfa high-dose, a recombinant human VEGFR-Fc-Human CR1 fusion protein injection (R&D code: IBI302), in Chinese subjects with neovascular age-related macular degeneration (nAMD). According to the results of the two Phase 2 clinical studies conducted in more than 360 subjects of nAMD, compared with Aflibercept, IBI302 can be administrated in long-interval (every 12 weeks), while providing a stable and robust visual benefit and anatomic improvements, as well as potential inhibition effect in macular atrophy. Based on those results, Innovent advanced IBI302 8mg into a Phase 3 clinical study STAR in October 2023. This was a randomized, double-masked, active-controlled Phase 2 clinical study (NCT05403749), evaluating the longer interval of intravitreal injection of high-dose IBI302 in subjects with nAMD. 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, subjects in IBI302 6.4 mg group and 8.0 mg group were dosed with adjusted intervals of every 8 weeks (Q8W) or every 12 weeks (Q12W), depending on response to loading therapy. 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. The study lasted for 52 weeks. The results showed that the primary endpoint was successfully met: at week 40, the IBI302 6.4 mg and 8.0 mg groups showed non-inferior BCVA gains to the Aflibercept 2.0 mg group. The mean BCVA improvement from baseline was 10.5 ETDRS letters for the IBI302 6.4 mg group, 11.0 ETDRS letters for the IBI302 8.0 mg group, and 9.8 ETDRS letters for the Aflibercept 2.0 mg group at week 40. The mean change from baseline in central subfield thickness (CST) was -163.19 μm for the IBI302 6.4 mg group, -184.46 μm for the IBI302 8.0 mg group, and -108.23 μm for the Aflibercept 2.0 mg group at week 40. In addition, approximately 81%, 88% of subjects in 6.4 mg IBI302 groups and 8.0mg IBI302 groups respectively were able to extend dosing interval to Q12W, similar to that in the proportion of subjects dosed Q12W or longer with Aflibercept 8.0 mg (83% in PULSAR trial)1 or Faricimab (TENAYA & LUCERNE trial, with 79.7% and 77.8% respectively)2 by indirect comparison. Based on the excellent long-interval dosing performance in the Phase 2 studies, the Phase 3 study STAR added Q16W dosing interval regimen for IBI302. The overall safety profile of IBI302 was favorable, comparable to Aflibercept 2.0 mg, and consistent with previous studies. No new safety signals were identified. Detailed study data will be further analyzed and published in the near future. Professor Xiaodong Sun, Principal Investigator of the Study, Head of National Center for Clinical Ophthalmology, Shanghai General Hospital, stated: "Intravitreal injection of anti-VEGF drugs is currently the first-line treatment for nAMD, but there are still unmet clinical needs given their frequent intravitreal injection and gradual loss of visual benefits. Exploring longer interval dosing and anti-macular atrophy are necessary and urgent. IBI302 is a global first-in-class anti-VEGF-anti-complement bispecific molecule. As the principal investigator for IBI302 trials, I am very pleased to see that this Phase 2 study met the primary endpoint and demonstrated the potential for long-interval dosing. These results will be further validated in the pivotal trial of IBI302. I look forward to providing a new treatment option for nAMD patients." Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated: "There are two major trends in drug development for nAMD: extending dosing intervals and reducing the occurrence of macular atrophy. In the results of two Phase 2 studies, which enrolled over 360 subjects, IBI302 improved BCVA and macular edema in patients with nAMD significantly, extended dosing intervals, and had the potential to prevent the development of macular atrophy. Next, we will further investigate the long-interval dosing efficacy and safety of high-dose IBI302 in the Phase 3 STAR trial, hoping to bring a new generation of anti-VEGF agents to patients with nAMD." About neovascular age-related macular degeneration (nAMD) Age-related macular degeneration (AMD) is a progressive ocular disease involving the macular retina, leading to central visual impairment, the incidence of which increases with age. Neovascular age-related macular degeneration (nAMD) is one of the major forms of AMD, accounting for 15% to 20% of all AMD patients and is the leading cause of central vision loss in AMD patients over 65 years3. The incidence of AMD is increasing year by year in China, and it has become the third leading cause of blindness in China. The pathogenesis of nAMD has not been fully elucidated. It is generally accepted that angiogenesis induced by increased expression of VEGF is the main cause of nAMD, and inflammatory reaction mediated by abnormal activation of complement is also considered to be an important cause of AMD. Ocular anti-VEGF agents have led to significant visual benefits and changed the course of nAMD, but the frequent dosing (every 4 or 8 weeks) currently places a heavy burden on patients, families and society. In addition, the visual benefits of anti-VEGF drug therapy are gradually diminished year by year. In approximately two thirds of nAMD patients with a follow-up for over 7 years, the visual gains from anti-VEGF treatment significantly diminish4. Macular atrophy or retinal fibrosis are important causes of vision loss after long-term anti-VEGF therapy. Currently, drug development for nAMD is mainly focusing on extending the dosing intervals, and there are few drugs under investigation for macular atrophy or retinal fibrosis. Two drugs targeting complement have been approved by the US FDA in 20235,6 for the treatment of geographic atrophy secondary to dry AMD. 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 Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies to treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 5 assets in Phase 3 or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte 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 , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s). 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. SOURCE Innovent Biologics

Clinical ResultPhase 2Phase 1Drug Approval

100 Deals associated with Efdamrofusp alfa

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Wet age-related macular degeneration	Phase 3	CN	Innovent Biologics (Suzhou) Co. Ltd.	15 Aug 2023
Diabetic macular oedema	Phase 2	CN	Innovent Biologics (Suzhou) Co. Ltd.	19 Nov 2021
Choroidal Neovascularization	Phase 1	CN	Innovent Biologics (Suzhou) Co. Ltd.	28 May 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05403749 (NEWS) Manual	Phase 2	Wet age-related macular degeneration	132	IBI302 6.4 mg	ienjbcjumy(vhofudyhel) = ojhfqkeacy doiztnxyvz (skrlseftke ) Met View more	Positive	19 Mar 2024
				IBI302 8.0 mg	ienjbcjumy(vhofudyhel) = vbcqepuxmz doiztnxyvz (skrlseftke ) Met View more
NCT04820452 (PRNewswire) Manual	Phase 2	Wet age-related macular degeneration	231	IBI302 2 mg	ycmoxngjzl(crivdfbaav) = yhhutivfgk awosjzfksh (dolnssktcu ) View more	Non-inferior	05 Nov 2023
				IBI302 4 mg	ycmoxngjzl(crivdfbaav) = zvkvojhpys awosjzfksh (dolnssktcu ) View more
NCT04370379 (Pubmed) Manual	Phase 1	Wet age-related macular degeneration	18	efdamrofusp alfa 2 mg	oxxrvlgkcu(hswjdsgfye) = fryhdymern rrnbptajtr (vlwkzvjnqf ) View more	Positive	21 Nov 2022
				efdamrofusp alfa 4 mg	oxxrvlgkcu(hswjdsgfye) = ptlxllyyjr rrnbptajtr (vlwkzvjnqf ) View more
NCT04370379 (PRNewswire) Manual	Phase 1	Wet age-related macular degeneration First line	18	IBI302	glqmyubsck(jhgniniihq) = improved by a mean of 6.4 letters from baseline kdkygwunnz (tnohbboooy ) View more	Positive	14 Nov 2021
				Aflibercept
PO325 (AAO2021)	Phase 1	Wet age-related macular degeneration	-	2-mg IBI302	palsmkhxeh(hwpijhiast) = izkndhwtdk icgxeyyeib (jbagknrpxz )	-	13 Nov 2021
				4-mg IBI302	palsmkhxeh(hwpijhiast) = jtaoqrfkdn icgxeyyeib (jbagknrpxz )
NCT03814291 (PRNewswire) Manual	Phase 1	Wet age-related macular degeneration	31	IBI302	jaehiovsgx(jiepzafsjv) = no serious adverse event cvgxxddmue (nvkhxcmuxr ) View more	Positive	15 Nov 2020

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