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Veru Reports Positive Results from Phase 2b QUALITY and Maintenance Extension Study Showing Enobosarm Significantly Reduced Body Weight Regain, Prevented Fat Regain, and Preserved Lean Mass After Semaglutide Discontinuation
Globenewswire· 2025-06-24 12:30
Core Insights - Veru Inc. announced positive topline efficacy and safety results from the Phase 2b QUALITY clinical study, particularly highlighting the effectiveness of enobosarm in weight management after discontinuing semaglutide treatment [1][15] - Enobosarm 3mg significantly reduced body weight regain by 46% and completely prevented fat regain compared to placebo, while preserving lean mass [1][4] - The company has been granted a meeting with the FDA to discuss advancing enobosarm into Phase 3 clinical trials [1][15] Efficacy Results - In the placebo group, participants regained 43% of the body weight lost during the initial study phase after stopping semaglutide, while the enobosarm 3mg group regained only 1.41% (2.73 lbs) [1][4] - Enobosarm treatment resulted in up to 93% greater fat loss and 100% preservation of lean mass compared to the placebo group at the end of the study [1][4][6] - The enobosarm plus semaglutide regimen preserved 100% of lean mass, with 99% of body weight loss attributed to fat [2][5] Safety Profile - Enobosarm monotherapy maintained a positive safety profile with essentially no gastrointestinal side effects observed during the maintenance period [1][10] - There were no significant adverse events related to liver injury or increases in prostate-specific antigen levels, and no reports of suicidal ideation were noted [11][12] Study Design - The Phase 2b Maintenance Extension study involved 148 participants who discontinued semaglutide and received either placebo, enobosarm 3mg, or enobosarm 6mg for 12 weeks [3][15] - The study aimed to assess the role of enobosarm in preserving lean mass and preventing weight regain after stopping semaglutide [3][8] Future Outlook - The company anticipates reporting full Phase 2b QUALITY and Maintenance Extension clinical trial data at leading scientific conferences and in publications [2][15] - Enobosarm is positioned as a next-generation drug that enhances weight reduction by GLP-1 RA drugs, focusing on fat loss while preserving lean mass [14][15]
Bio-Techne and USP Announce Collaboration to Accelerate Monoclonal Antibody and Gene Therapy Product Development
Prnewswire· 2025-06-24 11:00
Core Insights - Bio-Techne Corporation has entered into a distribution agreement with the U.S. Pharmacopeia (USP) to sell USP monoclonal antibody (mAb) and recombinant adeno-associated virus (AAV) reference standards, enhancing support for mAb and gene therapy development globally [1] - The need for consistent mAb quality is increasingly critical as patent protections expire and biosimilars emerge, necessitating rigorous testing of quality attributes during development and manufacturing [2] - Gene therapy, utilizing recombinant AAV, is rapidly growing but faces challenges such as low yields and high costs; USP reference standards provide benchmarks for analytical testing to ensure product quality [3] - USP mAbs and AAV reference standards can be used with Bio-Techne's analytical instruments, facilitating reliable characterization of complex biologics throughout the development process [4] - The collaboration between Bio-Techne and USP aims to address quality challenges in biotherapeutics, ensuring safety and efficacy for patient care [5] Company Overview - Bio-Techne Corporation is a global life sciences company that provides innovative tools and bioactive reagents for research and clinical diagnostics, generating approximately $1.2 billion in net sales in fiscal 2024 [6]
iBio and AstralBio Unveil Obesity Program with Novel Amylin Agonist Antibody Demonstrating Promising In Vivo Results
Globenewswire· 2025-06-24 11:00
Core Insights - iBio, Inc. announced preclinical data showing that an engineered amylin receptor agonist antibody reduced acute food intake in a mouse model of obesity by 60%, comparable to a leading amylin peptide agonist which achieved a 67% reduction [1] - The findings support the potential of antibody-based agonists to meet the increasing demand for safer, longer-acting treatments for obesity and cardiometabolic diseases [1][3] - The collaboration between iBio and AstralBio has resulted in multiple novel engineered antibody agonists targeting the amylin receptor, a promising therapeutic target for obesity [2] Company Developments - The engineered antibody's selective activation of the amylin receptor may match or exceed the efficacy of dual agonism seen with DACRA, while improving tolerability [3] - iBio's proprietary Drug Discovery Platform and advanced AI capabilities enable the discovery of innovative antibodies with exceptional selectivity and potency, targeting specific amylin receptor subtypes [3] - The company aims to develop next-generation therapies to address the limitations of current obesity treatments, leveraging its advanced technology [3] Market Context - Other amylin analogs in clinical development have shown weight loss results of up to 22.7% when combined with semaglutide and 11.8% as monotherapy, indicating a competitive landscape for obesity treatments [4] - iBio's approach may enhance weight-loss efficacy compared to GLP-1 receptor agonists and provide options for patients who are intolerant or unresponsive to existing GLP-1-based therapies [4]
NAYA Biosciences (INVO) Earnings Call Presentation
2025-06-23 11:45
A Portfolio Company Corporate Presentation February 2025 1 This Presentation is not an Offer or a Representation. This Presentation does not constitute an offer, or a solicitation of an offer, to buy orsell any securities, investment or otherspecific product, or a solicitation of any vote or approval, norshall there be any sale ofsecurities, investment or otherspecific product in any jurisdiction in which such offer,solicitation orsale would be unlawful priorto registration or qualification underthe securit ...
6月25日开幕,门票即将告罄!2025最Hot的抗体Plus创新峰会
生物世界· 2025-06-23 09:55
主办单位: BioPlus 承办单位: 迫界生物 执行单位: 苏州盛杰 特约支持: BioBAY 分论坛联合主办: 东曜药业、播禾创新、智药局 私董会联合主办: 科百特、纳微科技、恒驭生物 支持单位: 三优生物、 Twist Bioscience、 诺纳生物、布鲁克细胞分析、康源博创、大湾生物、中新生命科学园 Biosparc 合作媒体: 医药笔记、生物世界、新耀俱乐部管理有限公司、A ntibody Research、医药速览、小药说药、新药启航、 丁香园Insight数据库、研在云 基础门票:200元; 含2天公开会议,不含餐 会议门票:500元; 含2天公开会议,2天午餐 免费门票:0元;仅开放 生物医药投资人、Biotech/药企、临床/院校科学家; 兑换码;详情咨询: Times 150 6123 2737 主题: 2025抗体Plus创新峰会 时间:6 月25-26日(周三/四) 地点: 中国 苏州工业园区中茵皇冠假日酒店 参会报名 审核制;扫描下方二维码可报名 ▼ 免费门票即将告罄!符合申请条件的观众,转发本文到朋友圈集赞30个,即可领取。 背景介绍 从1986年FDA批准第一批单克隆抗体(An ...
Early data suggest Roche’s NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A
Globenewswire· 2025-06-23 05:00
Core Insights - Roche announced positive phase I/II data for NXT007, a next-generation bispecific antibody for haemophilia A, supporting its progression to phase III clinical development [1][2] - NXT007 demonstrated a tolerable safety profile with no thromboembolic events reported, indicating its potential for haemostatic normalization in patients without factor VIII inhibitors [1][4] Company Overview - Roche has over 25 years of experience in developing medicines for blood diseases and is committed to advancing care for patients with haemophilia A [9] - The company aims to provide innovative treatment options, including NXT007, to enhance therapeutic choices and reduce treatment burdens for patients [2][6] Clinical Development - NXT007 is currently undergoing a robust clinical development program, with ongoing phase I/II trials and additional phase II data expected later this year [3] - Three phase III studies are planned for 2026, including a head-to-head study with Hemlibra, Roche's existing prophylactic treatment for haemophilia A [3][4] Product Details - NXT007 is engineered to optimize factor VIII-mimetic activity and enhance potency, efficacy, and administration convenience, aiming for sustained elevated bleed protection [6][5] - The clinical trials for NXT007 involve participants aged 12 to 65, with no treated bleeds observed in the highest dose cohorts [4][7] Market Context - Haemophilia A affects approximately 900,000 people globally, leading to significant health concerns due to uncontrolled bleeding [8][7] - The development of inhibitors to factor VIII replacement therapies presents a serious complication, highlighting the need for innovative treatments like NXT007 [8]
X @Elon Musk
Elon Musk· 2025-06-19 11:50
RT Tesla Owners Silicon Valley (@teslaownersSV)"It is possible from the physics standpoint to restore full body functionality."Elon Muskhttps://t.co/xAdBGNPvun ...
X @Tesla Owners Silicon Valley
"It is possible from the physics standpoint to restore full body functionality."Elon Muskhttps://t.co/xAdBGNPvun ...
The Interstitium: Your Body’s Hidden Superhighway | Emily Aguesse | TEDxYouth@SantiagoSTEAM
TEDx Talks· 2025-06-18 16:21
[Music] Have you ever thought of something and no matter what somebody said or did, you wouldn't change your mind. When I was little, I thought that if I put my hands in front of my eyes while playing peekab-boo, nobody could see me. But now that I've grown up and learned more, I know that the person playing with me really can see me.The same thing happens with scientists and experts with some discoveries. They think there's nothing there to unearth and walk away. But then they come back and see that there ...
Corporeality - About touch and the nervous system | Helena Orzechowska | TEDxSapiens UP School Youth
TEDx Talks· 2025-06-17 15:26
Hello ladies and gentlemen, my name is Helena and today I will try to invite you to come to my word, word of the body, body language, connection with the body through we can um use our potential better and um make a better connection with the others. So before I start, I would like to explain the name of my the title of my uh speech corporality. I found that word no I found a word in Polish language but it was impossible to translate it into English.So it won't be a secret if I tell you that helps me. So I ...