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CHALFONT ST GILES, England--(BUSINESS WIRE)--GE HealthCare today announced an exclusive global licensing agreement with SOFIE Biosciences (SOFIE), a Virginia, U.S.-based company, to develop, manufacture and commercialize SOFIE’s Gallium-68 and Fluorine-18 labelled diagnostics targeting fibroblast activation protein (FAP).
英国CHALFONT ST GILES-(BUSINESS WIRE)-GE HealthCare今天宣布与美国弗吉尼亚州SOFIE Biosciences(SOFIE)签订独家全球许可协议,开发,制造和商业化SOFIE的镓-68和氟-18标记的靶向成纤维细胞活化蛋白(FAP)的诊断剂。
Financial terms were not disclosed. Based on this agreement, GE HealthCare will take on global rights for [68Ga]FAPI-46 and outside-US rights for [18F]FAPI-74, originally developed at Heidelberg University in Germany, and both currently in Phase II clinical trials in the U.S. ([68Ga]FAPI-46 (NCT05262855)2 and [18F]FAPI-74 (NCT05641896)3).
财务条款没有披露。根据该协议,GE HealthCare将承担[68Ga]FAPI-46的全球权利和[18F]FAPI-74的外部美国权利,最初由德国海德堡大学开发,目前均在美国进行II期临床试验([68Ga]FAPI-46(NCT05262855)2和[18F]FAPI-74(NCT05641896)3)。
SOFIE will continue its clinical development and commercialization program with [18F]FAPI-74 in the U.S..
SOFIE将在美国继续使用[18F]FAPI-74进行临床开发和商业化计划。。
FAP is an enzyme highly expressed in cancer associated fibroblasts (CAF), a key component of the tumor microenvironment which supports the growth and spread of cancerous cells. With CAF present in most tumor types including, for example, breast, pancreatic, colorectal, lung, liver and gastric, the development of FAP-targeted diagnostics holds great potential in oncology as well as other conditions including inflammation, fibrosis and arthritis4..
FAP是在癌症相关成纤维细胞(CAF)中高度表达的酶,CAF是支持癌细胞生长和扩散的肿瘤微环境的关键组分。由于CAF存在于大多数肿瘤类型中,包括例如乳腺癌,胰腺癌,结肠直肠癌,肺癌,肝癌和胃癌,因此FAP靶向诊断的发展在肿瘤学以及包括炎症,纤维化和关节炎在内的其他疾病中具有巨大潜力4。。
Building on the momentum created by SOFIE’s sponsored trials in the U.S. and FAPI Global Outreach Program which engages with 130 academic institutions in 39 countries to unlock FAPI’s clinical utility, GE HealthCare aims to develop FAP imaging products through clinical trials and towards regulatory submission, and potential commercialization in various regions.
基于SOFIE在美国赞助的试验和FAPI全球外展计划创造的动力,该计划与39个国家的130个学术机构合作,以解开FAPI的临床效用,GE HealthCare旨在通过临床试验和监管提交开发FAP成像产品,以及各地区的潜在商业化。
SOFIE and GE HealthCare will collaborate on both the development and commercialization processes through a joint steering committee..
SOFIE和GE HealthCare将通过联合指导委员会在开发和商业化流程方面进行合作。。
Usankar Thiru, Strategy & Evaluation Director with GE HealthCare’s Pharmaceutical Diagnostics segment said: “Working with SOFIE to add these FAPI assets to our next generation portfolio of investigational targets is a significant milestone and aligns with our vision to expand our innovation pipeline to enable precision care for personalized treatment decision making.
GE HealthCare制药诊断部门的战略与评估总监Usankar Thiru表示:“与SOFIE合作将这些FAPI资产添加到我们的下一代研究目标组合中是一个重要的里程碑,符合我们扩大创新渠道以实现精确护理的愿景。个性化治疗决策。
As a standalone company, we are keen to collaborate with companies like SOFIE in this way – bringing our size, scale and unique perspective as a developer, of both radiopharmaceuticals and the scanners needed to utilize them, to drive innovation in healthcare to benefit patients and clinicians.”.
作为一家独立公司,我们热衷于以这种方式与索菲等公司合作-作为开发者,为放射性药物和利用它们所需的扫描仪带来我们的规模,规模和独特的视角,推动医疗保健创新,使患者受益和临床医生“。
Sherly Mosessian, Ph.D, SOFIE’s Chief Scientific Officer, added: “The FAPI family of compounds have shown to have tremendous potential in diagnostic and companion diagnostic use in various oncologic and non-oncologic indications. I am very excited that we are collaborating with GE HealthCare, on a worldwide scale, to help jointly unlock the full promise of these products.”.
SOFIE首席科学官Sherly Mosessian博士补充说:“FAPI化合物家族在各种肿瘤学和非肿瘤学适应症的诊断和伴随诊断方面具有巨大潜力。我非常高兴我们正在合作与全球范围内的GE HealthCare合作,以帮助共同开启这些产品的全部承诺“。
GE HealthCare’s Pharmaceutical Diagnostics segment is a global leader in imaging agents used to support around 100 million procedures per year globally, equivalent to three patient procedures every second. Its Molecular Imaging portfolio combines established proprietary products across cardiology, neurology and oncology..
GE HealthCare的药物诊断部门是全球成像代理商的全球领导者,每年在全球范围内支持约1亿个程序,相当于每秒三个患者程序。其分子成像产品组合结合了心脏病学,神经病学和肿瘤学方面的既定专有产品。。
About GE HealthCare Technologies Inc.
关于GE HealthCare Technologies Inc。
GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier.
GE HealthCare是领先的全球医疗技术,药物诊断和数字解决方案创新者,致力于提供综合解决方案,服务和数据分析,使医院更高效,临床医生更有效,治疗更精确,患者更健康,更快乐。
Serving patients and providers for more than 100 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring.
为患者和医疗服务提供者服务已有100多年,GE HealthCare正在推进个性化,互联和富有同情心的护理,同时简化患者在护理途径中的旅程。我们的成像,超声,患者护理解决方案和药物诊断业务共同帮助改善患者护理,从诊断,治疗到监测。
We are an $18.3 billion business with 50,000 employees working to create a world where healthcare has no limits..
我们是一家价值183亿美元的企业,有50000名员工致力于创造一个医疗保健没有限制的世界。。
Follow us on Facebook, LinkedIn, Twitter, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com/ for more information.
在Facebook,LinkedIn,Twitter,Instagram和最新新闻的见解上关注我们,或访问我们的网站https://www.gehealthcare.com/欲了解更多信息。
About SOFIE Biosciences (SOFIE)
关于SOFIE生物科学(SOFIE)
SOFIE’s vision is to improve patient outcomes by developing and delivering molecular diagnostics and therapeutics (theranostics). With its robust radiopharmaceutical production and distribution network, mature contract manufacturing services and high value theranostic intellectual property, SOFIE is poised to deliver on the promise of radiopharmaceuticals.
索菲的愿景是通过开发和提供分子诊断和治疗(theranostics)来改善患者预后。凭借其强大的放射性药物生产和分销网络,成熟的合同制造服务和高价值的治疗知识产权,索菲有望实现放射性药物的承诺。
For more information visit our website, https://sofie.com/ or contact us by email at info@sofie.com..
欲了解更多信息,请访问我们的网站,https://sofie.com/或通过电子邮件与我们联系info@sofie.com..
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1 Xing, F., Saidou, J. and Watabe, K. (2010) Cancer associated fibroblasts (cafs) in tumor microenvironment, Frontiers in bioscience (Landmark edition). Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2905156/ (Accessed: 28 July 2023).
1 Xing,F.,Saidou,J。和Watabe,K。(2010)肿瘤微环境中的癌症相关成纤维细胞(CAF),生物科学前沿(地标版)。可在:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2905156/(访问时间:2023年7月28日)。
2 Study of [68Ga]FAPI-46 PET in Patients With Pancreatic Ductal Carcinoma (FAPI-46 PDAC) - Full Text View - ClinicalTrials.gov. (n.d.). https://classic.clinicaltrials.gov/ct2/show/NCT05262855 (Accessed: October 4 2023).
2[68Ga]FAPI-46 PET在胰腺导管癌患者中的研究(FAPI-46 PDAC)-全文-ClinicalTrials.gov。(n.d.)。https://classic.clinicaltrials.gov/ct2/show/NCT05262855(访问时间:2023年10月4日)。
3 Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers - Full Text View - ClinicalTrials.gov. (n.d.). https://classic.clinicaltrials.gov/ct2/show/NCT05641896 (Accessed: October 4 2023).
3胃肠癌患者[18F]FAPI-74 PET的研究-全文-ClinicalTrials.gov。(n.d.)。https://classic.clinicaltrials.gov/ct2/show/NCT05641896(访问时间:2023年10月4日)。
4 Dendl, K., Koerber, S. A., Kratochwil, C., Cardinale, J., Finck, R., Dabir, M., Novruzov, E., Watabe, T., Kramer, V., Choyke, P. L., Haberkorn, U., & Giesel, F. L. (2021). FAP and FAPI-PET/CT in Malignant and Non-Malignant Diseases: A Perfect Symbiosis? Cancers, 13(19), 4946. https://doi.org/10.3390/cancers13194946.
4 Dendl,K.,Koerber,S.A.,Kratochwil,C.,Cardinale,J.,Finck,R.,Dabir,M.,Novruzov,E.,Watabe,T.,Kramer,V.,Choyke,P.L.,Haberkorn,U。,&Giesel,F.L。(2021)。FAP和FAPI-PET/CT在恶性和非恶性疾病中的完美共生?癌症,13(19),4946。https://doi.org/10.3390/cancers13194946.
Available at: https://www.mdpi.com/2072-6694/13/19/4946 (Accessed: October 4 2023)..
Available at: https://www.mdpi.com/2072-6694/13/19/4946 (Accessed: October 4 2023)..