Golcadomide Hydrochloride

BOULDER, Colo.--( BUSINESS WIRE )-- Foresight Diagnostics , a leader in ultrasensitive minimal residual disease (MRD) testing, today announced the presentation of multiple studies showcasing Foresight CLARITY™ MRD at the upcoming 66 th American Society of Hematology Annual Meeting and Exposition taking place December 7-10 in San Diego, California. The presentations span various lymphoma types and treatment settings, demonstrating the broad applicability of the Foresight CLARITY MRD detection technology for monitoring treatment response and predicting patient outcomes. The studies include collaborations with multiple pharmaceutical companies and research institutions, including AstraZeneca, Bristol Myers Squibb (BMS), Daiichi Sankyo (DSI), Stanford University, Washington University, and others. "These studies add to the growing body of evidence supporting ultra-sensitive MRD testing as a critical tool in lymphoma care and drug development," said David Kurtz, MD, PhD, Chief Medical Officer and Head of Research at Foresight Diagnostics. "We see in these studies that MRD measurement with Foresight CLARITY consistently enables earlier and more accurate treatment response assessment than conventional imaging-based methods. The ability to monitor disease status in real-time with ultra-sensitive MRD assays like Foresight CLARITY may help accelerate clinical trials and lead to more personalized decision-making for patient care." Results utilizing Foresight CLARITY MRD technology are featured in six abstracts, including three that are co-authored by Foresight. Presentation highlights include: LBCL/DLBCL: ctDNA-MRD as a surrogate endpoint for 2L CAR T – Analysis of the Phase 3 TRANSFORM trial in second-line treatment for large B-cell lymphoma (LBCL) reinforced the potential of circulating tumor DNA (ctDNA) as an earlier endpoint for response assessment and assessment of clinical trial results. In the TRANSFORM study, patients receiving lisocabtagene maraleucel (liso-cel) had significantly improved event-free survival compared to standard of care. Consistent with this result, patients receiving liso-cel also demonstrated higher rates of MRD clearance, demonstrating CLARITY's ability to measure differential treatment responses. MRD Response with novel first-line therapy in high-risk DLBCL – Analysis of a Phase 1b trial CC-220-DLBCL-001 combining golcadomide with R-CHOP in previously untreated aggressive B-cell lymphoma showed promising MRD clearance rates. The data demonstrated that 90% of patients achieved MRD negativity at end of treatment with golcadomide 0.4mg + R-CHOP, with strong responses observed even in high-risk patients. These data further support the ongoing Phase 3 GOLSEEK-1 study investigating this novel combination therapy in high-risk 1L LBCL. Enhanced risk stratification by MRD vs. traditional methods – New research investigates the predictive value of the International Prognostic Index (IPI), currently the primary pre-treatment risk assessment tool for DLBCL. The study revealed that pre-treatment IPI scores did not significantly correlate with end-of-treatment MRD status, with MRD testing being a superior predictor of progression-free survival. Follicular Lymphoma: MRD-based response assessment of novel FL therapies – Two studies demonstrated the value of MRD assessment in follicular lymphoma trials, with new treatment approaches showing early clearance. The CD19xCD3 bispecific antibody AZD0486 achieved 89% MRD negativity in relapsed or refractory FL patients by 12 weeks in complete responders. In the 1L setting, the chemotherapy-free combination of mosunetuzumab and polatuzumab vedotin showed similar early MRD clearance, with 7 of 8 complete responders achieving MRD negativity before cycle 3. These results highlight the potential for MRD as an early indicator of therapeutic response in FL clinical trials. PTCL: ctDNA as a prognostic biomarker for T-cell lymphoma – Analysis from the VALENTINE-PTCL01 Phase 2 trial in relapsed/refractory peripheral T-cell lymphoma (PTCL) revealed that patients achieving early, deep ctDNA reduction (>5-fold decrease by Cycle 2 Day 1) experienced significantly longer progression-free survival, establishing ctDNA monitoring as a powerful tool for early response assessment. Information on abstract presentation time and dates can be found below. To meet with Foresight Diagnostics, visit booth #3423 or contact us at BD@foresight-dx.com. Oral Presentations: Circulating Tumor DNA (ctDNA) as an Early Outcome Predictor in Patients with Second-Line Large B-Cell Lymphoma After Lisocabtagene Maraleucel Versus Standard of Care Treatment from the Phase 3, Randomized TRANSFORM Study Presenter: Ash Alizadeh, MD, PhD (Stanford University) Session 628 Date/Time: Saturday, December 7, 2024, 10:45 a.m. Sponsor: Bristol Myers Squibb Co-authored by Foresight Diagnostics Escalating Doses of AZD0486, a Novel CD19xCD3 T-Cell Engager, Result in High Complete Remissions with Rapid Clearance of Minimal Residual Disease in Patients with Relapsed/Refractory Follicular Lymphoma Presenter: Jing-Zhou Hou, MD, PhD (UPMC Hillman Cancer Center) Session 623 Date/Time: Saturday, December 7, 2024, 5 p.m. Sponsor: AstraZeneca Golcadomide (GOLCA) Plus R-CHOP Has High Minimal Residual Disease (MRD) Negativity across High-Risk, Untreated Aggressive B-Cell Lymphoma (a-BCL) Presenter: Jason R. Westin, MD (MD Anderson) Session 627 Date/Time: Sunday, December 8, 2024, 12:30 p.m. Sponsor: Bristol Myers Squibb International prognostic index poorly predicts EOT ctDNA MRD status in DLBCL and has limited impact on its predictive value for outcomes Presenter: Jordan S. Goldstein, MD, MS (Stanford University) Session 626 Date/Time: Sunday, December 8, 2024, 5 p.m. Co-authored by Foresight Diagnostics Poster Presentations: Prediction of Clinical Response by Phased Variants in Circulating Tumor DNA (ctDNA) in the VALENTINE-PTCL01 trial of Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma Presenter: Neha Mehta-Shah, MD, MSCI (Washington University) Abstract #4342, Session 621 Date/Time: Monday, December 9, 2024, 6-8 p.m. Sponsor: Daiichi Sankyo Co-authored by Foresight Diagnostics Mosunetuzumab Plus Polatuzumab Vedotin Induces Early Complete Responses in Previously Untreated High Tumor Burden Follicular Lymphoma Presenter: David A Russler-Germain, MD, PhD (Washington University) Abstract #4414, Session 623 Date/Time: Monday, December 9, 2024, 6-8 p.m. About Foresight Diagnostics Foresight Diagnostics is a privately-held cancer diagnostics company and CLIA-registered laboratory. Its liquid biopsy platform, Foresight CLARITY™, is a novel assay that measures minimal residual disease (MRD) with reported detection limits in parts per million 1. The improved sensitivity of Foresight CLARITY has the potential to provide actionable information to physicians and biopharmaceutical companies to enable more personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit foresight-dx.com and follow us on Twitter and LinkedIn. Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use. 1 Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use.

10月29日，渤健（Biogen）以高达14.5 亿美元的总金额与Neomorph开展研究合作，以发现和开发用于治疗阿尔茨海默病、罕见神经系统疾病和免疫疾病的多个分子胶降解剂。 这是进入10月以来的分子胶降解剂领域的第三笔重磅合作，就在渤健宣布与Neomorph合作的前一天，诺华也宣布以超过22亿美元的总价值收购Monte Rosa Therapeutics的一款处于临床阶段的分子胶MRT-6160；此前的10月15日，辉瑞也宣布以总价超15亿美元与TRIANA合作，以发现包括肿瘤学在内的多个疾病领域的多个靶点的新型分子胶降解剂。 一个月不到，诺华、渤健、辉瑞等跨国MNC接连携带重金跑步入场，分子胶降解剂领域再次走向风口。 1 分子胶降解剂为何备受巨头青睐？ 一直以来，传统小分子药物都占据着重要的一席之地，它们就像是一把把精准的钥匙，能够插入疾病相关蛋白的“锁孔”中，阻断其功能，从而达到治疗疾病的目的。 但是随着研究的深入，传统小分子药物的局限性也逐渐暴露出来。比如，有些蛋白质缺乏疏水口袋，就像是一把没有锁孔的锁，传统小分子药物这把“钥匙”根本无从插入，难以发挥作用；再者，对于那些起到脚手架作用的蛋白，传统小分子药物也束手无策，无法破坏其功能，存在不可成药性，最后，长期使用传统小分子药物，容易让病菌、癌细胞等产生耐药性。 就在传统小分子药物的困境日益凸显的当下，靶向蛋白降解（TPD）技术通过诱导致病靶蛋白的快速降解发挥治疗作用（理论上致病靶点都消失了，不可成药和耐药性的问题自然迎刃而解），成为了小分子药物研发的一种开创性策略。 TPD分为PROTAC（蛋白降解剂）和分子胶降解两大类。PROTAC这几年已逐渐成为新药研发最火热的领域之一，自2013年以来，Arvinas、C4 Therapeutics、Kymera Therapeutics等专注于开发PROTAC技术的企业相继成立，之后，制药巨头默沙东、辉瑞、诺华、勃林格殷格翰、卫材等也纷纷进入该领域。 分子胶降解剂是一类可诱导E3泛素连接酶底物受体与靶蛋白之间发生相互作用, 经泛素化被蛋白酶体降解的小分子。但是与PROTAC不同的是，分子胶对E3泛素连接酶和靶蛋白具有双配体结构特征，兼具同两个蛋白结合的功能, 促进两个蛋白发生泛素化, 对那些非可药性靶标以及蛋白-蛋白相互作用也可因之而降解，具有分子量更小，化学机构更简单，空间干扰少和成药性更好的特点。 基于技术优势，当前分子胶降解技术正如PROTAC备受追捧。 2 超100亿美元资金注入，分子胶交易频发 在医药领域中，MNC的嗅觉无疑是最敏感的，任何一个有利于药物开发的新技术或领域都逃不过MNC的“法眼”。 由于分子胶降解技术在一定程度上可克服了不可成药及耐药难题，可到达传统小分子药物无法企及的“角落”，MNC将它视为未来药物开发的革命性突破口。 近两年分子胶赛道的交易逐渐火热，据不完全统计，分子胶领域近两年已产生13笔交易，总交易金额超过130亿美元，尤其从2023年下半年开始，交易合作频现，其中今年以来赛道更加火热，已经诞生9笔交易。 2023年以来分子胶领域的交易并购盘点，图源：公开数据整理 所有的MNC中，BMS毫无疑问处在领先地位，2019年BMS以740亿美元天价收购Celgene，收获了当时来那度胺（已上市）、CC-92480（Mezigdomide）、CC-99282、CC-220等在研管线，一举稳坐分子胶领域头把交椅。药智数据显示，2005年—2023年，来那度胺累计销售额已达892.1亿美元，于2021年达到销售峰值117亿美元。 2023年，罗氏再次发力分子胶领域，分别于9月、10月与Orionis Biosciences和Monte Rosa Therapeutics两家分子胶明星企业达成超40亿美元合作。 可以说，国际上具备创造性开发技术的分子胶公司如Neomorph、Monte Rosa Therapeutics、VantAI、Orionis Biosciences等都颇受MNC及资本的青睐。其中，Neomorph先后与诺和诺德及渤健达成合作；Monte Rosa Therapeutics与罗氏和诺华合作。 而最亮眼的Biotech还是AI分子胶发现公司VantAI，当前AI技术的发展也为分子胶的突破带来了机遇，虽然其成立至今无任何融资信息，也无产品管线，却先后获得了勃林格殷格翰、BMS等MNC的重金押注。 整体来看，除了罗氏、辉瑞、诺华，其他的MNC如默沙东、礼来、赛诺菲、拜耳、武田、卫材等都在疯狂“围猎”分子胶领域，而且与其他领域引进管线为主不同的是，分子胶领域的交易有很明显的特点是多数MNC以合作开发/引进biotech技术平台为主。 值得注意的是，分子胶领域的交易并不只发生在海外，近两年分子胶的热度也传播到了国内，本土biotech的分子胶出海故事正在发生，今年5月，达歌生物牵手武田制药，利用其GlueXplorer平台，针对武田选定的特定疾病靶点发现、验证和优化分子胶降解剂，潜在交易总额最高可达12亿美元；8月，国内分子胶领域交易再传喜讯，嘉越医药以3.45亿美元与美国Erasca就Pan-RAS(ON) 抑制剂JYP0015达成全球独家授权协议。 结语 越来越多的MNC及Biotech纷纷聚焦分子胶赛道，无疑证明了分子胶具有开启小分子药物研发下一个黄金时代的巨大潜能。 截至目前虽然全球已上市、颇具销售规模的分子胶药并不多，仍停留在三大“度胺”：即沙利度胺（Thalidomide）、来那度胺（Lenalidomide）和泊马度胺（Pomalidomide）阶段，但这三款“度胺”强劲的销售表现，也证明了分子胶的市场潜力不容小觑。 随着技术的不断进步和临床实践的积累，分子胶领域的神秘面纱正逐渐被揭开，各大MNC的加码，必将加速分子胶药物研发，谁能脱颖而出，拭目以待。 参考资料： 《160亿元！诺华「跑步」入场》药智网 《14.5亿美元！渤健和Neomorph合作开发多个分子胶降解剂》凯莱英药闻 本文转载自贝壳社/米朵 免责声明 本文系转载，仅做分享之用，不代表平台观点。图片、文章、字体等版权均属于原作者所有，如有侵权请告知，我们会及时处理。 ------------------------------ 「长按」二维码添加小达「进群」 与更多行业伙伴共探市场前沿资讯 艾美达医药咨询 艾美达（北京）医药信息咨询有限公司，成立于2014年4月，是一家专业的医药行业咨询服务提供商。公司致力于将产业政策研究与真实世界的数据挖掘深度结合，洞悉行业政策对市场的影响，通过专业的研究提供前瞻性的市场分析，为企业产品上市后的市场准入提供整体解决方案。