Histiocytic Sarcoma

7月1日，TRACON制药公司宣布，在envafolima联合伊匹木单抗治疗既往化疗进展的晚期或转移性未分化多形性肉瘤或粘液纤维肉瘤患者的试验ENVASARC中，完全纳入的82例可评估患者中，通过盲法独立中心审查(BICR)获得的客观缓解率(ORR)为5%(4例缓解)，低于生物制剂许可申请(BLA)所需的主要终点BICR的ORR(11%)。因此，公司将终止envafolimab的进一步开发，并在近期完全专注于探索战略替代方案，可能包括但不限于合并、反向合并、收购、其他业务合并、资产销售、授权或涉及公司的其他战略交易。 受此消息的影响，Tracon股价下跌超30%。 ENVASARC是一项多中心、开放标签、随机、非比较、平行队列的注册临床试验，在美国和英国的30个肿瘤治疗中心开展，2020年12月开始给药。TRACON共计划入组160名既往无免疫检查点抑制剂治疗失败的多形性肉瘤(UPS)/纤维组织细胞肉瘤(MFS)患者，80名患者接受Envafolimab单药治疗，80名患者采用伊匹木单抗联合Envafolimab治疗。主要终点为客观缓解率（ORR），次要终点主要包括缓解持续时间。 关于Envafolimab Envafolimab（恩维达®，恩沃利单抗注射液，KN035）是康宁杰瑞自主研发的PD-L1单域抗体Fc融合蛋白，是全球第一个且目前唯一获批上市的皮下注射PD-(L)1抗体。已被美国FDA授予晚期胆道癌孤儿药资格、软组织肉瘤孤儿药资格。 2021年11月，恩维达®在中国获批上市，适用于不可切除或转移性微卫星高度不稳定（MSI-H）或错配修复基因缺陷型（dMMR）的成人晚期实体瘤患者的治疗。 2019年12月20日，康宁杰瑞与思路迪医药（3D Medicines）、TRACON Pharmaceuticals签署合作协议，就新一代PD-L1抗体KN035用于治疗软组织肉瘤，推进在北美的临床开发与商业化。 此次三方合作，TRACON将负责在以美国为主的北美地区针对KN035治疗软组织肉瘤的临床开发和商业化，并向康宁杰瑞和思路迪医药支付销售提成，康宁杰瑞将以协商价格向TRACON供应KN035药品。 资料来源： 1.TRACON官网 2.Tracon Pharmaceuticals ends envafolimab trial after missing endpoint.EditorRachael Rajan.Published 07/01/2024 3.TRACON ends development of envafolimab, exploring strategic options.Jul. 01, 2024.Val Brickates Kennedy 4.Tracon calls time on envafolimab, weighs options.Matthew Dennis.PUBLISHED: JULY 01, 2024 识别微信二维码，添加生物制品圈小编，符合条件者即可加入 生物制品微信群！ 请注明：姓名+研究方向！ 版 权 声 明 本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

CAMBRIDGE, England, NEWCASTLE, England and BENGALURU, India , June 25, 2024 /PRNewswire/ -- SKAN Research Trust (SKAN), promoted by Indian entrepreneur Ashok Soota, today announced a joint research project with the UK-based Wellcome Sanger Institute (Sanger Institute) and University of Newcastle (Newcastle), to study early somatic mutations in blood stem cells that researchers believe drive several cancerous and non-cancerous conditions. The research collaboration will extend cutting-edge stem cell genomic analysis to cancer subtypes such as Langerhans Cell Histiocytosis (LCH), an immune cell disorder that largely afflicts children aged between 0 to 15 years. Continue Reading SKAN, the Wellcome Sanger Institute and University of Newcastle to study early stem cell mutations in rare blood disorder The research project titled Deciphering the Origins of Langerhan Cell Histiocytosis and Related Histiocytic Neoplasms will be led by Dr Jyoti Nangalia, Group Leader at the Wellcome Sanger Institute and Wellcome-MRC Stem Cell Institute. The study will examine the timestamp of the genetic mutations that drives LCH and the presentation of its clinical symptoms. Researchers will work with leading LCH treating research centres worldwide to cover LCH driven by different genetic mutations with SKAN specifically creating a large cohort of Indian children for the study. The study comes at a time when researchers are still grappling with understanding how some genetic mutations that drive LCH result in lesions appearing in different parts of the body at different times. Researchers hope that the study will pave the way for better understanding the disease's progression and possible early interventionist strategies for its management. Mr. Ashok Soota, the Chairman & Managing Trustee of SKAN, said "We are delighted to be partnering with the Sanger Institute and University of Newcastle in a project which gives us dual benefits: understanding the mutation of stem cells and an insight into LCH, an underfunded cancer. The research is expected to develop valuable clinical tests that will aid doctors understand what to expect of each patient." Dr Jyoti Nangalia, Group Leader at the Wellcome-MRC Stem Cell Institute and Wellcome Sanger Institute, said, "These disorders are an enigma and they are likely to have a unique genomic origin. Whilst we are aware that specific mutations are able to drive the disorders, we do not understand how such events result in a multitude of tissues being affected at different times in life, nor why clinical disease often follows distinct patterns across different patients. We hope that our genomics research at the Sanger Institute will shed light on the origin and trajectory of these diseases to help patients in the future." Newcastle University and its Principal Investigator, Prof. Matthew Collin, who have played a major role in establishing diagnostic and blood monitoring pipelines for LCH, (now adopted by the UK NHS Genomic Medicine Services), will also be part of this collaboration. Prof Matthew Collin said, "For patients with these disorders, it is tremendous that state-of-the-art approaches will be brought to bear on increasing our knowledge of how they arise. We are also very excited to extend the reach of research and training to new partners in other healthcare systems." Mr Davis Karedan, Vice Chairman & Trustee of SKAN said, "This collaboration is another step in SKAN's efforts to establish a robust inhouse stem cell research capability and comes on the back of its international collaboration with the Cambridge Stem Cell Institute". About SKAN Research Trust SKAN is a Bengaluru-based not-for-profit medical research trust that leverages transformational technologies to develop new therapies for ageing and neurological ailments, cardiovascular diseases, diabetes remission and lifestyle related disorders. SKAN applies its expertise in gut microbiome, genomics, stem cells, molecular biology, biomarkers, immunotherapies, nutrition, and alternate therapies to uncover kinder and gentler treatment protocols for ailments. Bioinformatics at SKAN vigorously pursues cutting edge artificial intelligence, machine learning and other advanced technologies to predict, pre-empt, diagnose, treat, and facilitate remission of medical disorders. The Mission statement of SKAN is "Transform the future of medicine. Impacting millions of lives". Media contact: [email protected] Careers: [email protected] About Wellcome Sanger Institute Founded to sequence the human genome, the Sanger Institute is a biomedical research centre recognized globally for undertaking large scale genome science that forms the foundations of knowledge in biology and medicine. In order to deliver on its mission to "apply and explore genomic technologies at scale to advance the understanding of biology and improve health", the Sanger Institute is committed to collaborating, leading, convening, engaging globally and providing world-class training to scientists and specialists in genomic research. The Sanger Institute strategically deploys its Wellcome core funding to enable faculty-driven genomic science, making discoveries not easily made elsewhere. About University of Newcastle As a member of the Russell Group, an association of 24 research-intensive institutions in the UK, Newcastle is delivering pioneering research that makes a positive impact in the world. From reversing Type 2 diabetes to protecting cultural property, Newcastle researchers are tackling international challenges to improve lives and influence policy around the world. Newcastle has one of the largest European Union research portfolios in the UK . Photo: Logo: SOURCE SKAN Research Trust

EpiSwitch® Specific Canine Blood (EpiSwitch® SCB) test is a new canine multi-cancer diagnostic test based on OBD’s non-invasive EpiSwitch® array platform Test developed in collaboration with leading US KOL Professor Jaime F Modiano, University of Minnesota, USA Test offers early blood-based detection and discrimination of six high-utility, frequently occuring cancer types: three sarcomas, two lymphomas, and malignant melanoma, each with balanced accuracy of >89% Real-world utility data with selected veterinary services will further validate the test OXFORD, England--(BUSINESS WIRE)-- Oxford BioDynamics Plc (AIM: OBD, the “Company”), a biotechnology company developing precision medicine tests based on the EpiSwitch® 3D genomics platform, announces development of a high-accuracy, discriminating multi-cancer canine diagnostic test for veterinary medicine. The test was developed in collaboration with Veterinary Referral Associates, Gaithersburg MD, USA; Animal Cancer Care and Research Program, University of Minnesota, St. Paul, MN, USA; Department of Veterinary Clinical Sciences, College of Veterinary Medicine, University of Minnesota, St. Paul, MN, USA; Masonic Cancer Center, University of Minnesota, Minneapolis, MN, USA; Center for Immunology, University of Minnesota, Minneapolis, MN; Stem Cell Institute, University of Minnesota, Minneapolis, MN; Department of Laboratory Medicine and Pathology, University of Minnesota Medical School, Minneapolis, MN; and Institute for Engineering in Medicine, University of Minnesota, Minneapolis, MN. OBD’s EpiSwitch® SCB (“Scooby”) test is a well balanced, highly accurate blood test to specifically diagnose canine diffuse large B-cell lymphoma (DLBCL), T-zone lymphoma (TZL), hemangiosarcoma (HSA), histiocytic sarcoma, osteosarcoma, and canine malignant melanoma, in a powerful single assay format. The test was validated using 3D whole-genome profiling in peripheral blood. It demonstrated high sensitivity and specificity for lymphomas and sarcomas as a class (accuracy >80%); and high sensitivity and specificity for specific individual indications, with an accuracy >89%. The validation results are published in BioRxiv (link here). There is a critical need in veterinary oncology for an accurate, specific, sensitive, non-invasive (blood) biomarker assay to assess canine oncological indications earlier, to better inform therapeutic interventions. Current alternatives for non-invasive canine cancer detection deliver only a “cancer/no cancer” outcome, with low specificity and no distinction between different cancer types. Effective therapeutic intervention requires a definitive identification of a specific cancer type – often a difficult task in current veterinary practice. OBD’s newly published study demonstrates a novel 3D genomic approach that can diagnose six canine cancers, as well as support continuing upgrade for additional diagnostic pro in a modular manner. The EpiSwitch® SCB test promises to help veterinary specialists to diagnose the disease, make more informed treatment decisions, minimize or avoid unnecessarily toxicity, and efficiently manage costs and resources. EpiSwitch SCB will be made available to a select group of vets who will generate real-world utility data that will further validate the test. It is expected that the commercialisation of the EpiSwitch ECB test will be through a partnership or outlicensing arrangement with an organisation with an existing presence in the pet healthcare market. Dr Sara Fritz, Veterinary Referral Associates, Gaithersburg MD, USA, said: “My first use of the EpiSwitch SCB test helped navigate a very complex case of canine cancer relapse in the absence of options from the current standards of care. This test opens possibilities for a quick and reliable diagnosis in the very cases where time is at premium.” Professor Jaime Modiano, College of Veterinary Medicine and Masonic Cancer Center, University of Minnesota, USA said: “The ability to detect the presence of common, life-threatening dog cancers with high accuracy using blood samples provides an improvement over current methods of diagnosis, reducing or eliminating the need for invasive biopsy procedures. I believe that the eventual implementation of these tests also has potential to enhance the precision and therefore improve the management and outcomes of canine cancer patients.” Dr Alexandre Akoulitchev, CSO, OBD said: “EpiSwitch SCB combines all the advantages of EpiSwitch blood based biomarkers with a novel proprietary multi-choice EpiSwitch array design. Once again, we were determined to translate to practice the full potential of our EpiSwitch technology, this time to tackle a prevalent veterinary challenge in support of our four legged friends.” Reference Ewan Hunter, Matthew Salter, Ryan Powell, Ann Dring, Tarun Naithani, Dominik Vugrinec, Kyrylo Shliaiev, Mutaz Issa, Cicely Weston, Abigail Hatton, Abel Gebregzabhar, Jayne Green, Anthony Blum, Thomas Guiel, Sara Fritz, Davis Seelig, Jaime F Modiano, Alexandre Akoulitchev bioRxiv 2024.05.22.595358; doi: Whole Genome 3D Blood Biopsy Profiling of Canine Cancers: Development and Validation of EpiSwitch Multi-Choice Array-Based Diagnostic Test. View source version on businesswire.com: Contacts Oxford BioDynamics Plc Jon Burrows, CEO Paul Stockdale, CFO +44 (0)1865 518910 Shore Capital (Nominated Adviser and Broker to OBD) Stephane Auton Lucy Bowden +44 (0)20 7408 4090 WG Partners (Joint Broker to OBD) David Wilson / Claes Spång / Sateesh Nadarajah / Erland Sternby +44 (0)20 3705 9330 Instinctif Partners (Media / Analyst enquiries for OBD) Melanie Toyne-Sewell / Katie Duffell Tel: +44 (0)20 7457 2020 OxfordBioDynamics@instinctif.com Source: Oxford BioDynamics Plc View this news release online at: