Litgenprostucel-L/GALGENPROSTUCEL-L

近日，RadNet宣布其两家子公司开发的两款AI诊断软件——DeepHealth Saige-DX乳腺X射线摄影（mammography）产品和Quantib前列腺2.0 MRI AI算法获美国FDA批准。 Saige-Dx是已获批的Saige-Q工作列表分类软件的升级版，是一种癌症检测工具，使放射科医生能够使用AI更有效地检测是否存在乳腺癌。DeepHealth强大的新AI技术可自动识别乳房X光照片中的可疑病变，并为每个可疑病变和整个病例分配可疑级别。它有助于及早发现和诊断乳腺癌。 Saige-Dx的获批是基于此前一项研究的数据，在该研究中18名放射科医生在使用Saige-Dx时取得更好的表现，体现在使用该软件时检测到的癌症百分比的增加和较低的假阳性率。“Saige-Dx建立在我们先进的深度学习算法之上。正如去年Nature Medicine的一篇文章中所述，我们高度准确的AI显示出比专业的乳腺成像放射科医生早一到两年发现癌症的能力。Saige-Dx的获批代表着在推进癌症护理方面又向前迈进了一步。使用我们的软件工具的医生给出了积极的反馈，该软件使他们在解释乳房X光检查图像时更加准确和高效，”DeepHealth首席执行官兼联合创始人Gregory Sorensen医学博士说。 Quantib Prostate是一种基于AI的软件解决方案，可推进MRI前列腺报告工作流程。该解决方案附带一套工具来提高报告质量和速度。Quantib Prostate的重大升级已获得FDA的510（K）认证。 RadNet总裁兼首席执行官Howard Berger博士说：“我们对两家子公司DeepHealth和Quantib的旗舰产品获批感到非常高兴。AI将对放射学和癌症产生变革性影响，我们致力于为患者和医疗保健提供者提供这些进步。在未来几十年，我们相信这些AI工具将在癌症的早期发现和诊断中发挥重要作用，从而提高生存率和改善治疗效果。” 参考资料： 1. RadNet Artificial Intelligence Subsidiaries, DeepHealth and Quantib, Obtain FDA Clearance for Mammography and Prostate AI Tools，Retrieved May 16, 2022, from https://www.globenewswire.com/news-release/2022/05/16/2443575/10985/en/RadNet-Artificial-Intelligence-Subsidiaries-DeepHealth-and-Quantib-Obtain-FDA-Clearance-for-Mammography-and-Prostate-AI-Tools.html 内容来源于网络，如有侵权，请联系删除，谢谢

- Combination Immunotherapeutic Regimen Designed to Enhance Cancer Fighting Competency of Immune Cells - BERKELEY, Calif.--(BUSINESS WIRE)--Aduro Biotech, Inc. today announced the initiation of an investigator-sponsored Phase 2 clinical trial of the company’s immuno-oncology product candidates GVAX Pancreas and CRS-207 in combination with Bristol-Myers Squibb’s Opdivo (nivolumab), a monoclonal antibody against programmed death-1 receptor (PD-1). The first patient has been enrolled in the trial that will be conducted at up to five U.S. clinical trial sites. “For some time, we have recognized and embraced the power of combination strategies for immuno-oncology and this trial will evaluate expanding our lead combination to include Opdivo, the first-in-class anti-PD-1” GVAX Pancreas and CRS-207 are designed to stimulate an immune response against a tumor, and nivolumab is designed to remove an immuno-suppressive mechanism that cancer cells have developed against the immune system. Aduro believes the combination of CRS-207 and GVAX Pancreas with nivolumab may improve clinical outcomes because of their complementary mechanisms of action. The randomized, controlled STELLAR trial (Safety and Therapeutic Efficacy of Live-attenuated Listeria/GVAX with Anti-PD1 Regimen) will enroll approximately 88 adults with metastatic pancreatic cancer who have had one prior chemotherapy regimen for metastatic disease. The trial will include two arms: Arm A with CRS-207/GVAX Pancreas vaccine and nivolumab and Arm B with CRS-207/GVAX Pancreas vaccine. The primary objective of this study is to compare the overall survival (OS) of patients in Arm A and Arm B. Secondary endpoints include evaluation of clinical and immune response and safety. For more information, please visit ClinicalTrials.gov (Identifier: NCT02243371). The trial is supported by Stand up to Cancer (SU2C)-Lustgarten Foundation Pancreatic Cancer Convergence Dream Team Translational Research; Pancreatic Cancer Action Network – AACR Research Acceleration Network Grant, supported by Fredman Family Foundation; and Bristol-Myers Squibb. SU2C is a program of the Entertainment Industry Foundation. “For some time, we have recognized and embraced the power of combination strategies for immuno-oncology and this trial will evaluate expanding our lead combination to include Opdivo, the first-in-class anti-PD-1,” said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. “While we continue our efforts to evaluate GVAX Pancreas and CRS-207 in our Phase 2b ECLIPSE trial as an effective treatment for pancreatic cancer, we look forward to generating data in yet another combination for potential future applications of our technologies.” “The Pancreatic Cancer Action Network is thrilled to have provided initial funding that has been leveraged for this important program,” said Julie Fleshman, president and CEO of the Pancreatic Cancer Action Network. “In an effort to double pancreatic cancer survival by 2020, we are investing in projects that have the potential to improve the treatment landscape of pancreatic cancer and ultimately increase survival.” “Stand Up To Cancer is excited not only that this immunotherapy clinical trial has begun patient enrollment, one of the 120 clinical trials we have launched or completed,” stated SU2C President and CEO Sung Poblete, R.N, Ph.D., “but that it involves collaboration by two distinct biotechnology firms to study the combination of two proprietary immunotherapies. Stand Up To Cancer is proud to have facilitated this level of multi-institutional and corporate collaboration, which is at the core of SU2C’s research model and its mission to benefit cancer patients faster.” Last year, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Aduro’s pancreatic cancer combination treatment consisting of CRS-207 and GVAX Pancreas. According to the FDA, a Breakthrough Therapy designation is for a drug candidate that treats a serious or life-threatening condition and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint over available therapies. Separately, Aduro is currently conducting a 240 patient Phase 2b clinical trial (ECLIPSE; identifier NCT02004262) in metastatic pancreatic cancer patients who have received at least one line of therapy. The randomized, controlled 3-arm trial will involve approximately 20 clinical trial sites in the United States and Canada and will evaluate the safety, immune response and efficacy of the combination immunotherapy of GVAX Pancreas in combination with CRS-207 compared to chemotherapy or to CRS-207 as a monotherapy. The primary endpoint of the trial is overall survival. About CRS-207 CRS-207 is one of a family of product candidates based on Aduro’s live-attenuated, double-deleted (LADD) Listeria monocytogenes immuno-oncology platform that are designed to induce potent innate and adaptive immune responses. CRS-207 has been engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including mesothelioma and pancreatic, non-small cell lung, ovarian and gastric cancers. About GVAX Pancreas GVAX Pancreas is one of a family of GVAX vaccines derived from human cancer cell lines that are genetically modified to express granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune system-stimulating cytokine. GVAX Pancreas is derived from human pancreatic cancer cell lines and is designed to activate specific T cell immunity to pancreatic cancer antigens, including mesothelin. About the Stand Up To Cancer Initiative Stand Up To Cancer (SU2C) raises funds to accelerate the pace of research to get new therapies to patients quickly and save lives now. SU2C, a program of the Entertainment Industry Foundation (EIF), a 501(c)(3) charitable organization, was established in 2008 by film and media leaders who utilize the industry’s resources to engage the public in supporting a new, collaborative model of cancer research, and to increase awareness about cancer prevention as well as progress being made in the fight against the disease. As SU2C’s scientific partner, the American Association for Cancer Research (AACR) and a Scientific Advisory Committee led by Nobel Laureate Phillip A. Sharp, PhD, conduct rigorous, competitive review processes to identify the best research proposals to recommend for funding, oversee grants administration, and provide expert review of research progress. About the Pancreatic Cancer Action Network The Pancreatic Cancer Action Network is the national organization creating hope in a comprehensive way through research, patient support, community outreach and advocacy for a cure. The organization is leading the way to increase survival for people diagnosed with this devastating disease through a bold initiative — The Vision of Progress: Double Pancreatic Cancer Survival by 2020. Together, we can Wage Hope in the fight against pancreatic cancer by intensifying our efforts to heighten awareness, raise funds for comprehensive private research, and advocate for dedicated federal research to advance early diagnostics and better treatments and increase chances of survival. For more information, go to . About Aduro Aduro Biotech, Inc. is a private, clinical-stage immuno-oncology company focused on the development of technology platforms to stimulate an immune response against cancer. Aduro’s lead platform is based on proprietary strains of live-attenuated, double-deleted (LADD) Listeria monocytogenes that induce a potent innate immune response and have been engineered to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity. Aduro has received Breakthrough Therapy designation from the FDA for its lead LADD regimen, CRS-207 in combination with GVAX Pancreas in pancreatic cancer. The company is evaluating the proprietary immuno-oncology combination in the ongoing Phase 2b ECLIPSE clinical trial and has additional ongoing clinical trials with its LADD platform in mesothelioma and glioblastoma. The company is also developing clinical candidates using synthetic small molecule immune modulators that are designed to activate the intracellular STING receptor, a central mediator of the innate immune response. For more information, please visit . Contacts Aduro Biotech, Inc.Sylvia Wheeler, 510-809-9264SVP, Corporate AffairsorMedia Contact:Angela Bitting, 925-202-6211a.bitting@comcast.net Help employers find you! Check out all the jobs and post your resume.