Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy: a Multicenter, Prospective, Randomized, Double-blind, Non-inferiority Clinical Trial

Evaluating the Optimal Effective Dose and Safety of Conbercept in Treating Retinopathy of Prematurity (ROP)

Start Date29 Nov 2024

Sponsor / Collaborator

Xijing Hospital

ChiCTR2400084218

/ SuspendedNot ApplicableIIT

Observation of macular blood flow density and changes of cytokines in anterior chamber water after treatment of diabetes macular edema with Conbercept combined with dexamethasone vitreous implant

Start Date01 Jun 2024

Sponsor / Collaborator-

ChiCTR2400089058

/ RecruitingPhase 4IIT

Comparison of subretinal versus intravitreal injection of tissue type plasminogen activator combined with conbercept and C3F8 in the treatment of acute macular hemorrhage

Start Date17 Apr 2023

Sponsor / Collaborator-

100 Clinical Results associated with Conbercept

100 Translational Medicine associated with Conbercept

100 Patents (Medical) associated with Conbercept

404

Literatures (Medical) associated with Conbercept

08 Nov 2024·Cureus Journal of Medical Science

Recurrence of Retinopathy of Prematurity Following Anti-vascular Endothelial Growth Factor (Anti-VEGF) Therapy: A Systematic Review and Meta-Analysis

Review

Author: Dablouk, Mohammed ; Chhabra, Amit ; Masoud, Ahmed T

Retinopathy of prematurity (ROP) is a neovascular disorder which affects premature infants and can lead to childhood blindness. Treatment includes laser photocoagulation and intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections, both effective options. However, laser photocoagulation can lead to refractive errors, while anti-VEGF therapy can result in disease recurrence. Our systematic review aimed to evaluate the recurrence rates of ROP following treatment with anti-VEGF agents compared to other anti-VEGF agents and laser photocoagulation. We also aimed to measure the retreatment intervals and assess successful retreatment rates to identify the most effective treatment modality. Our review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and included both randomized controlled trials (RCTs) and non-randomized comparative studies (NCS). A thorough search of MEDLINE, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials (CENTRAL) databases was performed. Studies were assessed using the Cochrane Risk of Bias (RoB2) tool and the Newcastle-Ottawa Scale (NOS). Random-effects and fixed-effects models were used to measure pooled estimates. The outcomes were reported as risk ratios (RR) and standardized mean differences (SMD). A total of 21 studies (six RCTs and 15 NCS) with 6,152 eyes were included. Overall, anti-VEGF agents showed a higher risk of recurrence compared to laser photocoagulation (RR=2.14, 95% CI: 1.06-4.33, p=0.03). Conbercept demonstrated a significantly lower risk of recurrence than laser photocoagulation and ranibizumab (RR=0.47, 95% CI: 0.39-0.58, p<0.00001), while aflibercept showed a higher recurrence risk compared to bevacizumab (RR=12.61, 95% CI: 6.43-24.73, p<0.00001). Bevacizumab was associated with a longer retreatment interval than laser photocoagulation (SMD=0.89, 95% CI: 0.61-1.17, p<0.00001). No significant differences in retreatment success rates between bevacizumab and laser photocoagulation were observed. Anti-VEGF therapy is effective in the treatment of ROP; however, it is associated with a higher risk of recurrence compared to laser photocoagulation. Conbercept shows greater efficacy in reducing recurrence risk and prolonging the retreatment interval compared to ranibizumab. Aflibercept demonstrated inconsistent outcomes. No significant difference in recurrence rates was observed between bevacizumab and ranibizumab. Recurrences occurred significantly later when anti-VEGF therapy was used compared to laser photocoagulation. Successful retreatment rates between bevacizumab and laser photocoagulation were similar.

01 Nov 2024·Clinical Colorectal Cancer

Efficacy and Safety of KH903 Plus FOLFIRI as a Second-Line Treatment in Unresectable Recurrent or Metastatic Colorectal Cancer: A Randomized Phase 2 Study

Article

Author: Lin, Rongbo ; Xu, Jiangming ; Qian, Xiaoping ; Cheng, Ying ; Ba, Y I ; Li, Jian ; Yin, Xianli ; Shen, Lin ; Shen, Yali ; Xu, Nong ; Wang, Jufeng ; Zhang, Yanqiao ; Ke, Xiao ; Zhou, Jianfeng ; Ying, Jieer ; Wu, Rong

BACKGROUND:

Patients with recurrent or metastatic advanced colorectal cancer (mCRC) often face the clinical dilemma as this unresectable disease is continuously progressing and endangering the patients' lives. In the current study, we explored the clinical feasibility of KH903 in combination with FOLFIRI chemotherapy as a new clinical indication for mCRC.

METHODS:

Patients (N = 122) were randomized 1:1 to 4mg/kg q1w KH903 or 5mg/kg q2w KH903, and both groups of patients were treated with the fixed regimen of FOLFIRI (every 2 weeks) along with the KH903 therapy. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were Overall Survival (OS), objective response rate (ORR), and disease control rate (DCR).

RESULTS:

As of December 30, 2020, median (m)PFS was 5.68 months (95% CI, 4.67-7.13) with 4mg/kg q1w versus 5.19 months (95% CI, 4.04, 5.78) with 5mg/kg q2w (HR, 0.76; 95% CI, 0.50-1.16),and mOS was 13.14 months (95% CI, 10.61-19.52) versus 16.03 months (95% CI, 10.28- NE), respectively (HR, 1.11; 95% CI, 0.65-1.89), The ORR was 15.9% and 11.9% for both groups, respectively, and The DCR for both groups was 85.7% and 83.1%, respectively. Grade 3 or higher treatment-related adverse event rates for both groups were 68.3% vs.52.5%, respectively.

CONCLUSIONS:

KH903 in combination with FORFIRI in second-line treatment of patients with mCRC showed prolonged mPFS and mOS, comparing to the similar agents (Avastin®, ZALTRAP®, Cyramza®) and no new safety signals were observed.

18 Oct 2024·International Journal of Ophthalmology

Vascular endothelial growth factor/connective tissue growth factor and proteomic analysis of aqueous humor after intravitreal conbercept for proliferative diabetes retinopathy

Article

Author: Rong, Ao ; Rong, Ao ; Cui, Hong-Ping ; Lyu, Xiao ; Cui, Hong-Ping ; Li, Hou-Shuo ; Xu, Wei ; Xu, Wei ; Bi, Yan-Long ; Bi, Yan-Long

AIM: To investigate the role of connective tissue growth factor (CTGF) and vascular endothelial growth factor (VEGF) in the protein profile of the aqueous humor in patients with proliferative diabetic retinopathy (PDR) following intravitreal injection of conbercept. METHODS: This study included 72 PDR patients and 8 cataract patients as controls. PDR patients were divided into 3 groups according to the intervals of 3, 5, and 7d between intravitreal conbercept (IVC, 0.5 mg/0.05 mL) injection and pars plana vitrectomy (PPV) performed. Aqueous humor samples were collected before and after IVC and PPV for VEGF and CTGF levels detected with enzyme-linked immunosorbent assay (ELISA). The differential proteomics of 10 patients who underwent PPV surgery 5d after IVC and 8 normal controls was studied, Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) analysis were performed on the data, and the protein interaction network of 23 differential proteins was studied. RESULTS: Post-IVC, VEGF levels decreased and CTGF levels increased significantly in aqueous humor, with the CTGF/VEGF ratio rising significantly at all intervals. Liquid chromatography tandem mass spectrometry (LC-MS/MS) identified differentially expressed proteins between pre- and post-IVC samples. GO and KEGG analyses revealed involvement in immune response, stress response, complement and coagulation cascades, ferroptosis, and PPAR signaling pathways. PPI analysis highlighted key proteins like APOA1, C3, and transferrin (TF). ELISA assay confirmed the differential expression of proteins such as HBA1, SERPINA1, COL1A1, and ACTB, with significant changes in the IVC groups. CONCLUSION: The study demonstrates that IVC effectively reduces VEGF levels while increasing CTGF levels, thereby modifying the CTGF/VEGF ratio, and IVC significantly alters the protein profile in the aqueous humor of patients with PDR. Proteomic analysis reveals that these changes are associated with critical biological pathways and protein interactions involved in immune response, stress response, and cellular metabolism.

News (Medical) associated with Conbercept

21 Dec 2022

·www.prnewswire.com

Gastric Cancer Pipeline Space Brims With Novel Emerging Therapies with Over 200 Key Companies Working in the Domain | DelveInsight

The prevalence of gastric cancer has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of cancer, the robust pipeline, and the growing research and development activities to develop novel therapies to treat Gastric Cancer drive the market. The companies developing the potential therapies in the last stage of development include Henlix Biotech, Eli Lilly and Company, Jiangsu Hengrui Medicine, and several others. LAS VEGAS, Dec. 21, 2022 /PRNewswire/ -- DelveInsight's ' Gastric Cancer Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline gastric cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the gastric cancer pipeline domain. Key Takeaways from the Gastric Cancer Pipeline Report DelveInsight's gastric cancer pipeline report depicts a robust space with 200+ active players working to develop 230+ pipeline therapies for gastric cancer treatment. Key gastric cancer companies such as EMD Serono, Sumitomo Pharma, LintonPharm Co., Ltd., Rapa Therapeutics LLC, Jiangsu HengRui Medicine Co., Ltd., Janssen Pharmaceutical K.K., Genentech, Exelixis, Bristol-Myers Squibb, Pieris Pharmaceuticals, Inc., Pfizer, Leap Therapeutics, CSPC ZhongQi Pharmaceutical, Ellipses Pharma, Amgen, Hanmi Pharmaceutical, Taiho Oncology, Inc., Shanghai Henlius Biotech, LianBio LLC, Chengdu Kanghong Biotech,Eisai Inc., AB Science, Maxinovel Pharmaceuticals, Shanghai Miracogen Inc., GlaxoSmithKline, Hoffmann-La Roche, Merck Sharp & Dohme, Hutchison Medipharma Limited, Genome & Company, Minneamrita Therapeutics LLC, Suzhou Suncadia Biopharmaceuticals Co., Ltd., MacroGenics, ALX Oncology Inc., Codiak BioSciences, Turning Point Therapeutics, Inc., TCRx Therapeutics, InxMed (Shanghai) Co., Ltd., Imugene Limited, SOTIO Biotech, CARsgen Therapeutics Co., Ltd., Zymeworks Inc., NextCure, Inc., Phanes Therapeutics, Pieris Pharmaceuticals, Inc., Athenex, Inc., Curis, Inc., Qurient Co., Ltd., Acepodia Biotech, Inc., Sichuan Baili Pharmaceutical Co., Ltd., Tarus Therapeutics, Inc., Lumicell, Inc., Legend Biotech,Cue Biopharma, TORL Biotherapeutics, LLC, OBI Pharma, Inc, Astellas Pharma, HiberCell, Inc., Celon Pharma SA, Linnaeus Therapeutics, Inc., Inspirna, Inc., Klus Pharma Inc., Genzada Pharmaceuticals, Shanghai PerHum Therapeutics, VM Oncology, LLC, Immunomic Therapeutics, Peptron, and others are evaluating new gastric cancer drugs to improve the treatment landscape. Promising gastric cancer pipeline therapies in various stages of development include Avelumab, BBI608, Camrelizumab, Catumaxomab, RAPA-201, SHR-1210, Amivantamab, Atezolizumab, Bevacizumab, Cabozantinib, Cinrebafusp alfa, Crizotinib, DKN-01, DP303c, Eflornithine, EP0057, Epacadostat, FLX475, Futibatinib, GEN-001, HLX07, HLX22, Infigratinib, KH903, Lenvatinib, Masitinib, MAX-40279, MRG002, MRG003, Niraparib, Savolitinib, Minnelide, SHR-1701, Margetuximab, Bemarituzumab, Evorpacept, Lenvatinib, CDK-004, TPX-0022, TCRx_T Cells, IN10018, IMU-131, SOT102, CT041, AB011, Zanidatamab, NC410, PT 886, PRS-343, Oraxol, CA-4948, Q702, ACE1702, SI-B001, TT-4, LUM015, LB 1908, CUE-102, TORL-2-307-MAB, OBI-833/OBI-821, ASP2138, NC410, SO-C101, HC-5404-FU, CPL304110, LNS8801, RGX-202-01, A166, GZ17-6.02, HMPL-453, CCT303-406, VMD-928, ITI 4000, PAb 001, and others. In December 2022, Daiichi Sankyo and AstraZeneca's ENHERTU (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with advanced HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. In December 2022, RemeGen Co., Ltd. announced on December 7, 2022, that its latest antibody-drug conjugate (ADC), RC118 for injection, has been granted two orphan drug designations (ODD) by the United States Food and Drug Administration (FDA) for gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer. This marks the Company's fourth, having previously been twice granted ODD for Disitamab Vedotin (RC48) and Telitacicept (RC18) earlier this year. In December 2022, Zhejiang Doer Biologics Co., Ltd. announced that it has entered into a clinical trial collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), to investigate Doer Bio's anti-Claudin18.2 antibody DR30303, in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with Gastric or Gastroesophageal Junction Cancer. Under this agreement, Doer Bio will conduct a clinical study based on a mutually- agreed and finalized protocol to evaluate the safety and efficacy of DR30303 in combination with KEYTRUDA® in patients with Claudin18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GC/GEJ) cancer. In November 2022, Triumvira Immunologics announced preclinical data for its investigational TAC-T cell therapies CLDN18.2-TAC T and GUCY2C-TAC T, and data on HER2-specific TAC-T products. Data was shared in three posters at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting being held virtually and in-person in Boston.Triumvira announced updated data on its novel T cell antigen coupler (TAC)-T cell candidate targeting Claudin 18.2 (CLDN18.2) for the treatment of gastric cancer. The data continue to demonstrate that CLDN18.2-TAC T effectively eliminates CLDN18.2-expressing gastric cancer cells in vitro and in vivo. The study also demonstrated that the activation of CLDN18.2-TAC T cells was specific to target cells that expressed CLDN18.2. In vitro data show strong and persistent anti-tumor activity and in vivo treatment led to complete and sustained tumor clearance with no signs of toxicity. In September 2022, Nuvectis Pharma, Inc. announced positive data for NXP800 in a preclinical xenograft model of ARID1a-mutated gastric carcinoma.Mice in each group were treated with either vehicle or NXP800, and tumor volumes were measured over 28 days. Treatment with NX800 resulted in tumor regression and substantial tumor growth inhibition versus the control. In March 2022, Imugene (ASX: IMU) announced a new clinical trial collaboration and supply agreement with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to evaluate the safety and efficacy of Imugene's HER-Vaxx, B-cell activating immunotherapy, in combination with MSD's anti-PD-1 therapy, pembrolizumab (KEYTRUDA®), in patients with HER-2 positive gastric cancer. Request a sample and discover the recent advances in gastric cancer drug treatment @ Gastric Cancer Pipeline Report The gastric cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage gastric cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the gastric cancer clinical trial landscape. Gastric Cancer Overview Stomach cancer is cancer that begins within the stomach or on the stomach wall. It is also known as gastric cancer. Stomach cancer is more common in the elderly. People aged 75 and above account for approximately 50 out of every 100 cases (around 50%). It affects men more than women. The exact gastric cancer causes are not known. Stomach cancer is linked to Helicobacter pylori, a bacteria that lives in the stomach. The most common gastric cancer symptoms are difficulty swallowing (dysphagia), weight loss, persistent indigestion (dyspepsia), feeling full after eating small amounts, feeling or being sick, and fatigue due to low red blood cell count (anaemia). Several tests, such as ultrasound, imaging tests, blood tests, and others, are used for gastric cancer diagnosis. Gastric cancer patients can receive a variety of treatments. Standard gastric cancer treatment consists of seven types: surgery, endoscopic mucosal resection, chemotherapy, radiation therapy, chemoradiation, targeted therapy, and immunotherapy. Find out more about chemotherapy drugs for gastric cancer @ New Gastric Cancer Drugs A snapshot of the Gastric Cancer Pipeline Drugs mentioned in the report: Learn more about the emerging gastric cancer pipeline therapies @ Gastric Cancer Clinical Trials Gastric Cancer Therapeutics Assessment The gastric cancer pipeline report proffers an integral view of gastric cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Gastric Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Antibody-dependent cell cytotoxicity, Programmed cell death-1 receptor antagonists, T lymphocyte stimulants, Apoptosis stimulants, Macrophage stimulants, Natural killer cell stimulants, Cyclin-dependent kinase 4 inhibitors, Cyclin-dependent kinase 6 inhibitors, Antibody-dependent cell cytotoxicity, Angiogenesis inhibitors, Epidermal growth factor receptor antagonists, EIF 2 kinase inhibitors Key Gastric Cancer Companies: EMD Serono, Sumitomo Pharma, LintonPharm Co., Ltd., Rapa Therapeutics LLC, Jiangsu HengRui Medicine Co., Ltd., Janssen Pharmaceutical K.K., Genentech, Exelixis, Bristol-Myers Squibb, Pieris Pharmaceuticals, Inc., Pfizer, Leap Therapeutics, CSPC ZhongQi Pharmaceutical, Ellipses Pharma, Amgen, Hanmi Pharmaceutical, Taiho Oncology, Inc., Shanghai Henlius Biotech, LianBio LLC, Chengdu Kanghong Biotech,Eisai Inc., AB Science, Maxinovel Pharmaceuticals, Shanghai Miracogen Inc., GlaxoSmithKline, Hoffmann-La Roche, Merck Sharp & Dohme, Hutchison Medipharma Limited, Genome & Company, Minneamrita Therapeutics LLC, Suzhou Suncadia Biopharmaceuticals Co., Ltd., MacroGenics, ALX Oncology Inc., Codiak BioSciences, Turning Point Therapeutics, Inc., TCRx Therapeutics, InxMed (Shanghai) Co., Ltd., Imugene Limited, SOTIO Biotech, CARsgen Therapeutics Co., Ltd., Zymeworks Inc., NextCure, Inc., Phanes Therapeutics, Pieris Pharmaceuticals, Inc., Athenex, Inc., Curis, Inc., Qurient Co., Ltd., Acepodia Biotech, Inc., Sichuan Baili Pharmaceutical Co., Ltd., Tarus Therapeutics, Inc., Lumicell, Inc., Legend Biotech,Cue Biopharma, TORL Biotherapeutics, LLC, OBI Pharma, Inc, Astellas Pharma, HiberCell, Inc., Celon Pharma SA, Linnaeus Therapeutics, Inc., Inspirna, Inc., Klus Pharma Inc., Genzada Pharmaceuticals, Shanghai PerHum Therapeutics, VM Oncology, LLC, Immunomic Therapeutics, Peptron, and others. Key Gastric Cancer Pipeline Therapies: Avelumab, BBI608, Camrelizumab, Catumaxomab, RAPA-201, SHR-1210, Amivantamab, Atezolizumab, Bevacizumab, Cabozantinib, Cinrebafusp alfa, Crizotinib, DKN-01, DP303c, Eflornithine, EP0057, Epacadostat, FLX475, Futibatinib, GEN-001, HLX07, HLX22, Infigratinib, KH903, Lenvatinib, Masitinib, MAX-40279, MRG002, MRG003, Niraparib, Savolitinib, Minnelide, SHR-1701, Margetuximab, Bemarituzumab, Evorpacept, Lenvatinib, CDK-004, TPX-0022, TCRx_T Cells, IN10018, IMU-131, SOT102, CT041, AB011, Zanidatamab, NC410, PT 886, PRS-343, Oraxol, CA-4948, Q702, ACE1702, SI-B001, TT-4, LUM015, LB 1908, CUE-102, TORL-2-307-MAB, OBI-833/OBI-821, ASP2138, NC410, SO-C101, HC-5404-FU, CPL304110, LNS8801, RGX-202-01, A166, GZ17-6.02, HMPL-453, CCT303-406, VMD-928, ITI 4000, PAb 001, and others. Dive deep into rich insights for new drugs for gastric cancer treatment; visit @ Gastric Cancer Medications Table of Contents For further information on the gastric cancer pipeline therapeutics, reach out @ Gastric Cancer Drug Treatment Related Reports Gastric Cancer Epidemiology Forecast Gastric Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and the gastric cancer epidemiology trends. Gastric Cancer Market Gastric Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key gastric cancer companies, including CSPC ZhongQi Pharmaceutical, Ellipses Pharma, Amgen, Hanmi Pharmaceutical, Taiho Oncology, Inc., Shanghai Henlius Biotech, among others. HER2+ Gastric Cancer Market HER2+ Gastric Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key HER2+ gastric cancer companies, including Pieris Pharmaceuticals, BioInvent International, Bellicum Pharmaceuticals, Mersana Therapeutics, Acepodia Biotech, Inc., Klus Pharma Inc, among others. HER2+ Gastric Cancer Pipeline HER2+ Gastric Cancer Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key HER2+ gastric cancer companies, including Pieris Pharmaceuticals, BioInvent International, Bellicum Pharmaceuticals, Mersana Therapeutics, Acepodia Biotech, Inc., Klus Pharma Inc, among others. HER2+ Gastric Cancer Epidemiology HER2+ Gastric Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and the HER2+ gastric cancer epidemiology trends. Other Trending Oncology Reports Follicular lymphoma | Indolent lymphoma | Severe Toxicities In Lymphoma | Marginal Zone Lymphoma | Vulvar Squamous Cell Carcinoma | Cholangiocarcinoma | Metastatic Cutaneous Squamous cell Carcinoma | Nasopharyngeal Carcinoma | Ductal Carcinoma in Situ | Oncolytic Virus Cancer Therapy | Cancer Cachexia | Intratumoral Cancer Therapies | Brain Cancer Related Cases Studies Competitive Intelligence Market Assessment Product Assessment Epidemiology Assessment Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

ImmunotherapyOrphan DrugDrug Approval

12 Feb 2021

·endpts.com

Roche touts less onerous schedule for its in-the-eye injection faricimab, hoping to sweeten the sales pitch over Eylea

Regeneron has made its name on the back of wet AMD drug Eylea, but the blockbuster’s dosing schedule of into-the-eye shots every eight weeks is no cakewalk for patients. Roche, looking to take the fight to Eylea with faricimab, thinks it has a lighter schedule that could help sway physicians. Roughly half of patients across four Phase III trials eligible for extended dosing of faricimab were able to be treated every four months after one year, subsidiary Genentech announced Friday, and nearly 75% could take the experimental drug every three months. Roche has already prepped a hefty data package for its hopeful Eylea competitor, releasing trickling data from four Phase III trials over the last few months in diabetic macular edema and wet AMD. “These positive results show the potential for faricimab as the first new type of medicine in 15 years for people with neovascular age-related macular degeneration and in close to a decade in diabetic macular edema,” Roche CMO Levi Garraway said in a statement. Two of the trials evaluated faricimab in DME and two studied it in wet AMD. Extending the dosage periods and measuring the proportion of people able to do so was a key secondary endpoint, Roche said. The DME studies showed 52.8% and 51% of patients, respectively, achieved four-month dosing at one year. On top of that, another 21% and 20.1% in each study were able to be dosed every three months. Then, in wet AMD, the studies registered a respective 45.7% and 44.9% of patients who received four-month dosing regimens. Another 34% and 32.9% of individuals managed three months between doses. Each of the four studies saw about 300 patients randomized into the drug arms, and Friday’s data come from a total of 1,225 individuals across all four groups. Roche is expected to present full data from all four trials this weekend, where analysts expect significant warning signs for Eylea’s dominance. The faricimab program has already demonstrated non-inferiority in both diseases, and coupled with the extended time between doses, the candidate has emerged as the “top competitive threat” to the Regeneron franchise, Cowen’s Yaron Werber wrote earlier this week. Faricimab is the first bispecific antibody for AMD, targeting two pathways — angiopoietin-2 and vascular endothelial growth factor-A. The treatment, like Eylea, is injected directly into the eye and designed to prevent inflammation and blood vessels from leaking. Longer time between doses is central to Roche’s pitch, given the inherent discomfort in receiving any sort of eye injectable. Roche hasn’t specified when it’s submitting the data to regulators, but Werber predicts it could make it to the market sometime in 2022. Faricimab isn’t the only potential Eylea competitor, however, with Chengdu Kanghong’s Conbercept and Kodiak’s KSI-301 also making moves. But it’s still too early to say how much impact that program could have, he wrote.

CollaborateAntibody

100 Deals associated with Conbercept

External Link

KEGG	Wiki	ATC	Drug Bank
-	Conbercept	S01LA	DB12460

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Retinal vein occlusion-related macular edema	CN	Chengdu Kanghong Biotechnologies Co., Ltd.	29 Apr 2022
Diabetic macular oedema	CN	Chengdu Kanghong Biotechnologies Co., Ltd.	16 May 2019
Choroidal Neovascularization	CN	Chengdu Kanghong Biotechnologies Co., Ltd.	22 May 2017
Wet age-related macular degeneration	CN	Chengdu Kanghong Biotechnologies Co., Ltd.	27 Nov 2013

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Dystrophy, Macular	Phase 3	US	Chengdu Kanghong Biotechnology Co. Ltd.	25 Sep 2018
Dystrophy, Macular	Phase 3	AR	Chengdu Kanghong Biotechnology Co. Ltd.	25 Sep 2018
Dystrophy, Macular	Phase 3	AU	Chengdu Kanghong Biotechnology Co. Ltd.	25 Sep 2018
Dystrophy, Macular	Phase 3	CA	Chengdu Kanghong Biotechnology Co. Ltd.	25 Sep 2018
Dystrophy, Macular	Phase 3	CL	Chengdu Kanghong Biotechnology Co. Ltd.	25 Sep 2018
Dystrophy, Macular	Phase 3	DE	Chengdu Kanghong Biotechnology Co. Ltd.	25 Sep 2018
Dystrophy, Macular	Phase 3	LT	Chengdu Kanghong Biotechnology Co. Ltd.	25 Sep 2018
Dystrophy, Macular	Phase 3	MX	Chengdu Kanghong Biotechnology Co. Ltd.	25 Sep 2018
Dystrophy, Macular	Phase 3	NL	Chengdu Kanghong Biotechnology Co. Ltd.	25 Sep 2018
Dystrophy, Macular	Phase 3	NZ	Chengdu Kanghong Biotechnology Co. Ltd.	25 Sep 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EURETINA2023	Not Applicable	Diabetic macular oedema	-	Conbercept IVC	fkwnwxuciy(qchtrvqiab) = kbmcmyfncg idtlqlbkjs (uyatsxlzqs ) View more	-	05 Oct 2023
EURETINA2023	Not Applicable	Retinopathy of Prematurity	202	Intravitreal Conbercept 0.25mg	jcthwsrymb(iemrridvez) = vhbraluiws iaoirdppmm (odhvqawhgq )	Positive	05 Oct 2023
				Conbercept (Laser Photocoagulation)	jcthwsrymb(iemrridvez) = vmrwlbabub iaoirdppmm (odhvqawhgq )
COCOA (EURETINA2023)	Phase 4	Wet age-related macular degeneration anti-VEGF intraocular injection	493	Conbercept (3+Treat-and-Extend (T&E) regimen)	saovxrdpnw(hludxkexzn) = htigydngpe buoknoduig (bgdxhqlqpi ) View more	Positive	05 Oct 2023
				Conbercept (3+pro re nata (PRN) regimen)	saovxrdpnw(hludxkexzn) = byxmedotcj buoknoduig (bgdxhqlqpi ) View more
EURETINA2023	Not Applicable	Proliferative retinopathy with diabetes mellitus anti-vascular endothelial growth factor (VEGF)	-	Intravitreal Conbercept (IVC) monotherapy	yscvviwyra(xtedstkxrg) = CMT of IVC monotherapy group decreased faster to a platform than IVC+PRP group gfuqtgzrpa (wzasxfoviz ) View more	Positive	05 Oct 2023
				IVC+PRP group
EURETINA2022	Phase 3	-	255	Intravitreal Conbercept 0.5mg	mtmkxudpfx(ojyjgerdxq) = edkebgznpa lihzcmaxjk (ixntwvtuuj, 171.3) View more	Positive	01 Sep 2022
				Conbercept (Sham Injection)	mtmkxudpfx(ojyjgerdxq) = taaqhojoml lihzcmaxjk (ixntwvtuuj, 209.6) View more
EURETINA2022	Not Applicable	Retinopathy of Prematurity anti-VEGF drugs	-	Conbercept 0.2 mg	ehhanejwsp(olgrsikrdi) = trciewsbku vrurvmugqp (tkavndewgy )	Positive	01 Sep 2022
				Laser therapy	ehhanejwsp(olgrsikrdi) = ujaqdsokhs vrurvmugqp (tkavndewgy )
STAR study (EURETINA2021)	Phase 4	Polypoidal choroidal vasculopathy	304	0.5 mg conbercept 3+Q12W	olfpojakwo(khrkuswbue) = rsedoxdoju zemnfkzqmb (cbjonuyhiv ) View more	Positive	01 Sep 2021
				0.5 mg conbercept 3+TAE	olfpojakwo(khrkuswbue) = iixqbboivi zemnfkzqmb (cbjonuyhiv ) View more
EURETINA2021	Not Applicable	Nonproliferative diabetic retinopathy	54	Intravitreal injection of conbercept	ccdpggqtkr(faguugwvqa) = allstbllue mqffouwevj (dettwsgpuk, 0.16) View more	Positive	01 Sep 2021
				Control group (no conbercept)	ccdpggqtkr(faguugwvqa) = rbcokvzokx mqffouwevj (dettwsgpuk, 0.20) View more
EURETINA2021	Not Applicable	Retinopathy of Prematurity anti-VEGF agents	-	Conbercept	nzghdhubpz(kchdidcuox) = mleqjepctc briawzqphg (rkhnsbrdaa ) View more	Positive	01 Sep 2021
				Ranibizumab	nzghdhubpz(kchdidcuox) = juwjhyvaui briawzqphg (rkhnsbrdaa ) View more
NCT02194634 (Sailing Study, Pubmed \| Br J Ophthalmol)	Phase 3	Diabetic macular oedema	248	conbercept (Laser photocoagulation followed by PRN sham intravitreal injections)	kafbwnyssy(ttgbsrnsnj) = ddoatmqdsv vfdsvongfo (ukehbpyygw )	Positive	17 May 2021
				Sham laser photocoagulation followed by PRN 0.5 mg conbercept intravitreal injections	kafbwnyssy(ttgbsrnsnj) = zqyyfxrzpp vfdsvongfo (ukehbpyygw )

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