Abiraterone acetate

Decipher前列腺测试已在美国广泛用于帮助识别更可能发生扩散的局限性前列腺癌。它成为首个拥有来自随机试验临床证据的分子测试，表明其可以指导转移性前列腺癌的治疗选择。 根据伦敦大学学院（UCL）研究人员领导的一项新研究，检测肿瘤的分子特征可以识别哪些晚期前列腺癌患者更可能从化疗中获益并延长寿命，从而使不太可能获益的患者免受不必要的副作用困扰。 这项发表在《细胞》杂志上的研究，是首个强有力的证据，表明对常规采集的前列腺组织进行基因表达测试，有助于指导癌细胞已扩散至身体其他部位（转移性癌症）的前列恩癌患者的治疗选择。该测试名为Decipher前列腺基因组分类器测试，由Veracyte公司生产。 该研究纳入了参加STAMPEDE III期试验的1,523名患者，这些患者被诊断患有晚期前列腺癌，并开始接受雄激素剥夺疗法（ADT）治疗，该疗法通过阻断睾酮等可驱动前列腺癌生长的雄性激素来发挥作用。STAMPEDE试验测试了在ADT基础上加用阿比特龙或多西他赛的额外益处，并对研究患者进行了中位14年的随访。 在832名转移性前列腺癌患者中，Decipher前列腺评分高的患者在接受多西他赛治疗后，死亡风险降低了36%；而Decipher评分较低的患者，其死亡风险降低幅度估计不到4%。 这一发现意义重大，因为尽管多西他赛化疗能改善部分患者的生存期，但它也会降低生活质量。该测试或可用于识别哪些患者可能对多西他赛敏感，并能通过多西他赛化疗延长寿命。 Decipher前列腺测试已在美国广泛用于帮助识别更可能发生扩散的局限性前列腺癌。它成为首个拥有来自随机试验临床证据的分子测试，表明其可以指导转移性前列腺癌的治疗选择。 该研究的首席研究员、伦敦大学学院癌症研究所和伦敦大学学院医院的Gert Attard教授说："STAMPEDE试验已经导致晚期前列腺癌患者的治疗方式发生了多项改变。如今，通过大规模分子分析与长期随访数据相结合，我们首次识别出参加试验的患者中，不同组别从治疗中的获益存在显著差异。基于Decipher前列腺测试来个性化制定化疗决策的能力，将极大改善患者护理和预后。通过识别哪些患者最可能从化疗中获得生存益处，我们可以避免不必要的副作用，并为那些不太可能获益的转移性前列腺癌患者开发替代疗法。" 英国每年约有55,100例新发前列腺癌病例，预计今年将有12,000名男性死于前列腺癌。前列腺癌是英国男性第二常见的癌症死因，占该群体所有癌症死亡的14%。大多数前列腺癌死亡发生在首次就诊时即为晚期或转移性疾病的患者中。 在标准护理雄激素剥夺疗法（ADT）的基础上，加用多西他赛进行强化治疗，可以改善转移性前列腺癌患者的生存期。然而，缓解率各不相同，临床医生缺乏有效的工具来识别哪些患者可能获益，哪些不会。Veracyte的Decipher前列腺测试通过提供更个性化的治疗决策方法，来弥补这一空白。 伦敦大学学院的商业化公司UCL Business促成了Veracyte与UCL的合作，将公司在肿瘤表达谱分析方面的专业知识与UCL在临床试验和癌症生物学方面的专长结合起来。除了识别出首个可预测多西他赛疗效的商业化测试外，该合作还发现了几个预测患者预后的新分子分类器。 该研究在UCL癌症研究所的首席研究员之一Emily Grist博士补充说："我们的另一项发现是，识别出了一个标志物，该标志物能指示肿瘤抑制基因PTEN的失活。与PTEN活跃的患者相比，这既预示着接受激素治疗的患者预期寿命更短，也预示着从化疗中的获益更大。我相信我们的研究是将前列腺癌重新分类为不同分子亚型的努力中的一个里程碑。其长期影响将是基于肿瘤分子谱的定制化治疗，这应能改善患者的预后。" 伦敦大学学院商业公司高级业务经理Harriet Story表示："UCL与Veracyte的这次合作展示了基因表达测试通过识别哪些患者将从多西他赛化疗中获益来革新癌症治疗的潜力。看到这项UCL研究的成果已经在美国作为一项可报销的测试投入使用，帮助转移性前列腺癌患者获得更个性化的治疗，令人深感欣慰——这一影响力的实现得益于UCL与全球诊断开发商的合作。"（生物谷Bioon.com） 参考文献： Emily Grist et al, Tumor transcriptome-wide expression classifiers predict treatment sensitivity in advanced prostate cancers, Cell (2025). DOI: 10.1016/j.cell.2025.07.042.

Sept. 17, 2025 -- The world’s first therapeutic drug to be equipped with NovalGen’s pioneering AutoRegulation (AR) technology has been approved for evaluation in the clinic by the UK’s Medicine and Healthcare Products Regulatory Agency (MHRA). NVG-222, a next-generation, AutoRegulating T cell engager has been developed to increase the safety and durability of immunotherapies; and following confirmation of Clinical Trial Authorisation (CTA) by the MHRA, it is set to begin clinical evaluation later this year. The Phase I/II adaptive basket study will be sponsored and managed by Cancer Research UK’s Centre for Drug Development (CDD) and will enrol patients across the UK with a range of ROR1-positive haematological malignancies. First patient dosing is expected in Q4 2025. In entering clinical evaluation, NVG-222 which is manufactured under licence agreement by Polish-based company Mabion, marks a major milestone for cancer research and patients. Built on NovalGen’s proprietary AR platform, NVG-222 introduces precision control of immune activation. This novel mechanism reduces the risk of life-threatening toxicities, while crucially preserving long-term T cell fitness and reducing the risk of exhaustion from chronic stimulation—an innovation designed to fundamentally change the safety and durability of immunotherapies. Now, through the CDD’s unique expertise and track record of advancing novel treatments into the clinic, this breakthrough technology is being translated from the laboratory into patients for the very first time. Beyond its AR-enabled safety profile, NVG-222 holds broad therapeutic potential as it targets ROR1, a protein expressed across multiple malignancies, including several blood cancers. Importantly, NVG-222 has been clinically de-risked by NVG-111, a precursor molecule with the same ROR1- and CD3-binding domains but without AR functionality, which has demonstrated encouraging activity in patients with haematological malignancies. Professor Amit Nathwani, Founder and CEO of NovalGen, commented: “The MHRA’s acceptance of the NVG-222 clinical trial application represents a transformative moment for patients with hard-to-treat blood cancers. NVG-222 is not just a next-generation T cell engager—it is the first step towards a new era of self-regulating immunotherapies designed to work in harmony with the immune system. We are proud to partner with Cancer Research UK, whose expertise and commitment to advancing novel therapies to patients is second to none. This first-in-human study would not be possible without the sponsorship and expertise of Cancer Research UK’s CDD, whose unparalleled commitment to pioneering therapies has brought countless innovations into the clinic.” NovalGen, a London-headquartered immunotherapy pioneer founded in 2019, is dedicated to transforming patient lives through cutting-edge innovations. At the core of its research is a proprietary AutoRegulation platform technology, driving the development of next-generation immunotherapies with enhanced safety and efficacy through its in-built precision control of immune cell activation. Our unique drug discovery approach has yielded a robust and diverse pipeline addressing critical unmet needs in oncology and autoimmune diseases. Our lead programme, NVG-222, is set to enter clinical development in Q4 2025. Cancer Research UK has an impressive record of developing novel treatments for cancer. The Centre for Drug Development has been pioneering the development of new cancer treatments for 30 years, taking over 170 potential new anti-cancer agents into clinical trials in patients. Six of these new agents have made it to market, including temozolomide for brain cancer, abiraterone for prostate cancer, and rucaparib for ovarian cancer. Two other drugs are in late development Phase 3 trials. Thirteen agents remain in active development with the potential to reach the market. It currently has a portfolio of 16 projects in preclinical development, Phase 1, or early Phase 2 clinical trials. Mabion S.A. (WSE: MAB) is a Polish biopharmaceutical company founded in 2007. In 2023–2024, the company underwent a strategic transformation into a biologics-focused Contract Development and Manufacturing Organization (CDMO), offering an integrated range of services. Mabion provides a broad spectrum of CDMO solutions for small and mid-sized projects across various stages of development – from early-stage cell line development to commercial manufacturing. The company’s core competencies include monoclonal antibody and recombinant protein technologies (based on both mammalian and insect cell expression systems), advanced analytical capabilities, as well as the production of both Drug Substances (DS) and Drug Products (DP). Mabion operates in accordance with globally recognized quality standards, including GMP and ISO. Mabion employs approximately 200 highly qualified professionals, including scientists, engineers and specialists in quality, manufacturing and analytical development of biologics. Headquartered in the heart of Europe, in Poland – a member state of the European Union – Mabion offers seamless access to highly regulated international markets. The company’s mission is to be a trusted global partner in the development and manufacturing of biologic medicines. Mabion is a publicly listed company, traded on the Warsaw Stock Exchange. The content above comes from the network. if any infringement, please contact us to modify.