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
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.
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) .
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.
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.
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 :
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..
Story Continues
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.
Cision
View original content:https://www.prnewswire.com/apac/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-2025-302445967.html
SOURCE Innovent Biologics
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
2 hours ago
- Yahoo
AbbVie Secures FDA Approval to Expand Mavyret's Label
AbbVie Inc. (NYSE:ABBV) is one of the best stocks for a . The company announced that the US FDA has expanded the approved use of its oral antiviral drug Mavyret, developed in partnership with Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), for treating Hepatitis C. The updated approval allows Mavyret—made from the antiviral agents glecaprevir and pibrentasvir—to be used in the US for both adults and children aged three and older with acute or chronic Hepatitis C, provided they do not have cirrhosis or have compensated cirrhosis. Eligible patients can complete treatment in eight weeks. This decision is based on results from a Phase 3 study, which showed the therapy to be safe and effective for acute cases. Mavyret was initially approved in 2017 for newly diagnosed adult Hepatitis C patients. AbbVie Inc. (NYSE:ABBV) is an international biopharmaceutical firm dedicated to creating and providing advanced treatments for challenging health conditions. The company concentrates on key areas such as immunology, cancer, neuroscience, eye care, and aesthetics. Its goal is to improve lives by researching, developing, and offering new therapies that address serious medical needs that currently lack effective solutions. While we acknowledge the potential of ABBV as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: and Disclosure. None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
2 hours ago
- Yahoo
Dense Breasts? You Need to Ask Your Doctor for This Type of Mammogram
For millions of women, the words 'you have dense breasts' can feel both vague and unsettling—especially when it comes after a routine mammogram. Breast density isn't just a technical term buried in a radiology report, it's a real risk factor that can make it harder to spot cancer early. Yet many women aren't told what that means for their health or what steps they can take next. One powerful, underused tool? Contrast-enhanced mammography, or CEM. Experts say it could be a game-changer for women with dense breasts, but only if they know to ask for it. More from Flow Space This Menopause Drug May Be the Key to Preventing Invasive Breast Cancer Despite growing awareness, many women still don't know what breast density means for their screening options. In most cases, they're simply advised to return in a year for another mammogram. But experts say that for women with dense breasts, especially those with additional risk factors, there's a powerful tool that could offer earlier, more accurate detection: contrast-enhanced mammography, or CEM. CEM is a relatively new imaging technique that combines the familiar process of a mammogram with an iodine-based contrast dye, similar to what's used in a CT scan. This allows radiologists to see blood flow to areas of the breast—highlighting suspicious areas that might otherwise be hidden by dense tissue. Studies show it can detect more cancers than standard mammography or even 3D mammograms, especially in dense breasts. So why isn't every woman with dense breasts getting one? Experts say it's partly due to lack of awareness—both among patients and healthcare providers—as well as uneven access and insurance coverage. But as more states pass laws requiring women to be notified about their breast density, and as clinical data continues to support CEM's accuracy, the message is becoming clearer: if you have dense breasts, asking your doctor about CEM could be a lifesaving conversation. Contrast-enhanced mammography is much simpler than it sounds. By injecting an iodine-based dye into the vein in combination with a traditional 2D or 3D mammogram, radiologists can have a better view of abnormalities that are more difficult to see on a regular mammogram. The dye serves as a contrast (hence the name) against healthy breast tissue, allowing your provider to more easily view any lesions and determine if they are benign or cancerous. 'Our breasts are made up of glands, connective tissue and fatty tissue,' Dr. Meleen Chuang, chief of obstetrics and gynecology at NYU Langone Hospital Brooklyn, told Flow Space. 'The density of breast is a term used to describe the amount of different types of breast tissue seen on a mammogram. Dense breast tissue has higher amounts of glandular tissue and connective tissue and low amount of fatty tissue.' Dense breasts are common, and almost half of women who are over 40 that get mammograms are found to have dense breast tissue. Doctors use the Breast Imaging Reporting and Data System (BI-RADS) to classify breast density. This system, developed by the American College of Radiology, helps doctors interpret and report back mammogram findings. 'Dense breasts are a risk factor for breast cancer compared to women with fatty breasts,' said Chuang. 'This risk is separate from the effect of dense breasts on the ability for the radiologist to read a mammogram.' There is not yet enough evidence to recommend for or against additional imaging tests, such as ultrasound or MRI to screen for breast cancer in women with dense breasts according to the Recommendation Statement on Breast Cancer Screening by the United States Preventive Services Task Force (USPSTF). 'However, for many women with dense breasts, the radiologist may often recommend spot compression images to redo a mammogram in certain areas after the screening mammogram and would often then review those areas with breast sonogram,' said Chuang. For those with dense breasts, supplemental imaging might be a requirement in your screening plan given your increased risk of breast cancer. What does it mean to have dense breasts? Having dense breasts increases a person's risk of developing breast cancer, and it can also make it more challenging for radiologists to detect cancer on a traditional mammogram. Nearly 50% of women have dense breasts, making it a common breast cancer risk factor. So, what are the most common types of screenings: Ultrasound: Breast ultrasound uses sound waves and their echoes to make computer pictures of the inside of the breast. It can be helpful to show certain breast developments that may be difficult to see on a mammogram, such as differentiating benign fluid-filled cysts from potentially cancerous solid masses. Ultrasound can be used for additional imaging if the patient has dense breasts. MRI: Breast MRI (which stands for magnetic resonance imaging) uses radio waves and strong magnets to make detailed pictures of the inside of the breast. It is typically used to screen high-risk patients or diagnose areas difficult to see under mammography. Like CEM, breast MRIs require a contrast dye to be injected into your vein before the pictures are taken. MRIs historically detect more cancers compared to traditional mammograms and ultrasound, so they're typically recommended for patients with dense breasts or other breast cancer risk factors. CEM: Contrast-enhanced mammography exams are conducted using the same mammography equipment as a traditional mammogram, but they also use contrast dye. Just like ultrasound and MRI, they can be used for additional imaging for patients with dense breast tissue. 3D Mammogram: A 3D mammogram, also known as digital breast tomosynthesis, is an advanced form of breast imaging that creates a three-dimensional picture of the breast using multiple X-ray images taken from different angles. Unlike traditional 2D mammograms, which produce a flat image, a 3D mammogram allows radiologists to examine breast tissue layer by layer, making it easier to detect small tumors that might be hidden by overlapping tissue. This technology is especially helpful for women with dense breasts, where distinguishing between normal and abnormal tissue can be more difficult. While 3D mammography has improved cancer detection rates and reduced false positives, it can still miss cancers that a contrast-based test like CEM might catch. Previous studies have shown that CEM offers a comparable diagnostic performance to contrast breast MRI. Most recently, a study was published that found that CEM is able to detect three times as many cancers in dense breast tissue compared to ultrasound, as well as smaller tumors compared to traditional mammograms. CEM has been gaining wider acceptance in recent years as a possible alternative to MRI, since it is a more comfortable and familiar experience compared to MRI and offers comparable detection rates. Not to mention, patients have reported that they significantly prefer CEM compared to breast MRI due to increased comfort, lower noise levels, decreased feelings of anxiety and greater procedure efficiency. CEM is also more cost effective compared to MRI (typically around 25% of the cost), and CEM patients receive their results within 8-10 minutes compared to 45 minutes with MRI. While standard and 3D mammograms rely solely on differences in tissue density to detect abnormalities, CEM uses an iodine-based contrast dye to illuminate areas where tumors may be growing and drawing blood. This functional imaging approach can reveal cancers that are otherwise hidden in dense breast tissue, which appears white on mammograms—the same color as many tumors. Studies have shown that CEM can detect more cancers than 2D or 3D mammograms alone and has accuracy comparable to breast MRI, which is considered the gold standard for high-risk screening. But unlike MRI, CEM is quicker, more widely available and less expensive. For women who need more sensitive screening but can't access or tolerate an MRI, CEM offers a powerful, accessible alternative that could catch cancer earlier—when it's most treatable. CEM provides a very appealing offer for those who need to get supplemental imaging but have concerns about detection performance with ultrasound or cost or claustrophobia with MRI.
Entrepreneur
4 hours ago
- Entrepreneur
Entrepreneur UK's London 100: Zonder Health Ltd
Zonder leverages AI to lighten provider workloads and deliver top-tier, cost-effective care Opinions expressed by Entrepreneur contributors are their own. You're reading Entrepreneur United Kingdom, an international franchise of Entrepreneur Media. Industry: Healthcare Last, but certainly not least, on the Entrepreneur UK London100 list is Zonder. Founded in 2024, Zonder leverages AI to lighten provider workloads and deliver top-tier, cost-effective care. With over a quarter of the UK population managing chronic conditions — accounting for half of all GP appointments and three-quarters of health spending — the demand on healthcare is immense. Amid a shortage of qualified professionals, Zonder steps in to manage these chronic conditions, easing the burden on primary care providers. By combining AI with a patient-centered approach, Zonder is revolutionising chronic disease management. Its innovative model integrates AI with human expertise, offering a scalable solution that improves patient outcomes while optimizing healthcare resources. The company stands as a beacon of innovation in healthcare, embodying the entrepreneurial spirit that drives progress in the city. Zonder's AI platform streamlines admin enhances patient communication, and meets QoF targets, freeing up providers to focus on delivering care.
