FLOWER is a completely virtual, nationwide, real-world observational study to collect, annotate, standardize, and report clinical data for rare diseases. Patients participate in the study by electronic consent (eConsent) and sign a medical records release to permit data collection. Medical records are accessed from institutions directly via eFax or paper fax, online from patient electronic medical record (EMR) portals, direct from DNA/RNA sequencing and molecular profiling vendors, and via electronic health information exchanges. Patients and their treating physicians may also optionally provide medical records. Medical records are received in or converted to electronic/digitized formats (CCDA, FHIR, PDF), sorted by medical record type (clinic visit, in-patient hospital, out-patient clinic, infusion and out-patient pharmacies, etc.) and made machine-readable to support data annotation, full text searches, and natural language processing (NLP) algorithms to further facilitate feature identification.

开始日期2024-06-10

申办/合作机构

xCures, Inc.初创企业

NCT06140719 / RecruitingN/A

A Retrospective and Prospective Observational Sub-Study for Diffuse Midline Glioma and Diffuse Intrinsic Pontine Glioma

This study will gather data from new and existing patients with patient medical records, and patient/family/caregiver reported information to establish a clear natural history of disease suitable to serve as an external, contemporary or historical control arm for future therapeutic development programs of drugs, devices, or biologic interventions in DMG or DIPG.

开始日期2023-11-01

申办/合作机构

xCures, Inc.初创企业

NCT05461430 / RecruitingN/A

Mass Response of Tumor Cells as a Biomarker for Rapid Therapy Guidance

The primary objective of this study, sponsored by Travera Inc. in Massachusetts, is to validate whether the mass response biomarker has potential to predict response of patients to specific therapies or therapeutic combinations using isolated tumor cells from various specimen formats including malignant fluids such as pleural effusions and ascites, core needle biopsies, fine needle aspirates, or resections.

开始日期2022-07-15

申办/合作机构

xCures, Inc.初创企业

100 项与 xCures, Inc. 相关的临床结果

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0 项与 xCures, Inc. 相关的专利（医药）

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项与 xCures, Inc. 相关的文献（医药）

2024-09-09·American journal of epidemiology

Emulations of Oncology Trials Using Real-World Data: A Systematic Literature Review.

Article

作者: Wasserman, Asher ; Slipski, Lukas ; Hodgkins, Priscilla ; Jiao, Xiaolong ; Quinn, Jameson ; Rider, Jennifer R ; Natanzon, Yanina ; Rodriguez-Watson, Carla ; Bruno, Amanda ; Harvey, Raymond ; Pinheiro, Simone ; Ovbiosa, Osayi E ; Merola, David ; McRoy, Lynn ; Eckert, Joy C ; Becnel, Lauren ; Jain, Purva ; Campbell, Ulka ; Carrigan, Gillis ; Pace, Nelson D

By evaluating published emulations of oncology RCTs studies in which both the active and comparator groups are sourced from RWD and target trial results are available for benchmarking, this systematic review aims to gain insight into factors related to emulation performance. Thirteen oncology emulation studies using various types of RWD were identified through an online database search of PubMed through 2022. Based on the ROBINS-I tool, most studies (N=8) had a serious risk of overall bias driven by risk of bias from confounding. Approximately half of the studies (N=6) fully proxied the RCT entry criteria. Of 11 RWD studies that provided sufficient detail to quantify emulation performance, the emulation HR estimate fell within the 95% CI of the trial estimate in 9 of the studies. There were no clear trends between risk of bias or degree to which the entry criteria were proxied and emulation performance. Findings may have been influenced by publication bias and researcher degrees of freedom, as only one emulation study pre-registered its protocol. Tools for comprehensively characterizing factors that affect emulation performance, including the real-world clinical context as it relates to the RCT research question, are needed to evaluate the feasibility of a RCT emulation.

2024-06-18·Neuro-Oncology

DIPG-71. XPEDITE: A STUDY TO EXPEDITE DIPG AND DMG RESEARCH

作者: Chuyka, Donald ; Federowicz, Bryan ; Ward, Lisa ; Lewis, Sarah ; Shapiro, Mark A ; Cole, Zachariah D ; Stuhlmiller, Timothy J ; Ginn, Sarah

AbstractBACKGROUNDDiffuse midline glioma (DMG), particularly the subtype known as diffuse intrinsic pontine glioma (DIPG), poses a significant challenge due to its aggressive nature and low survival rates, especially in children. Despite ongoing research and clinical trials, the survival rate remains alarmingly low. The scarcity of cases and siloed nature of current registry efforts have hindered the establishment of a reliable natural disease history for benchmarking studies and led to the need for randomization in clinical trials.METHODSxPedite (NCT06140719) is a fully virtual, patient-driven, nationwide, real-time observational study to collect, annotate, standardize, and report the critical data elements of DMG and DIPG in a regulatory-compliant framework. Patients of any age can join via electronic consent, with recruitment supported by provider referrals and patient advocacy organizations DDRFA and My DIPG Navigator. Medical records are accessed from institutions, sequencing vendors, and health information networks. Notably, data elements are annotated comprehensively and longitudinally in a 21 CFR Part 11-compliant clinical database by xCures remote study staff, eliminating the need for data entry by treating site staff or physicians. Data collected include anti-cancer interventions, non-cancer medications, biomarker results, radiological endpoints, steroid use, vitals, demographics, raw DICOM images, and genomics. In addition to clinical data, patient- and caregiver-reported outcome questionnaires (PROs) and video assessments of mobility and neurological status are collected for clinician review. The objective of the study is to collect these clinical, imaging, biomarker, and assessment data in a manner suitable to provide to health authorities to reduce randomization in future trials. In a commitment to scientific understanding and collaborative research, the data collected through the xPedite study is openly available to academic, government, and non-profit researchers. As of January 2024, 182 patients were enrolled in xPedite. Real-time enrollment and data statistics are available at https://xcures.com/dmgdashboard/.

2024-06-01·Journal of Clinical Oncology

Leveraging real-world data from multiple institutions to assess the rate of bilateral mastectomy after cancer genetics evaluations with genetic counselors.

作者: Caleshu, Colleen ; Stuhlmiller, Timothy Joseph ; Davies, Jill ; Daley, Ashley ; Kaufman, Zachary ; Russell, Callan

e22551 Background: Genetic counselors (GCs) assess patients’ risk of cancer and counsel them on cancer screening and preventative measures, based on national guidelines. Prior studies have found that adherence to guideline-based care is higher after genetic counseling. Thus care provided by GCs leads to a variety of imaging and surgical services that can both improve patient outcomes and generate revenue for health systems, which can in turn help financially support cancer genetics programs. Research that quantifies such downstream services and revenue is lacking. We aimed to address this gap by using real-world data from multiple institutions to quantify the rate of bilateral mastectomies occurring after cancer genetics evaluations performed by GCs. Methods: We studied consecutive patients from a nationwide telehealth practice who underwent genetic counseling and cancer risk assessment with a GC after having germline genetic testing. Structured data obtained from multiple care sites via health information networks and manual chart review of electronic medical records was utilized to determine whether patients had bilateral mastectomies after the GC appointment. Results: Of the 460 consecutive patients seen by a GC, 30 were advised to consider bilateral mastectomy, based on their genetic test results and national guidelines. Data was available from the health information networks for all (29/29 (100%)) of these patients who live in the United States, with a mean follow-up of 2.7 years (SD 0.23). These 29 patients had a mean age of 43.3 years (SD 15.3), were all female, and carried mutations in BRCA2 (18/29 (62%)), BRCA1 (6/29 (21%)), or PALB2 (5/30 (17%)). Clinical data was collected from 468 locations, a median of 23 unique locations per patient. At the time of the GC appointment, 7/29 (24%) had active breast cancer, 19/29 (66%) were unaffected, and 3/29 (10%) had a history of previously treated breast cancer. Two patients were diagnosed with breast cancer after the GC appointment. 15/29 (52%) patients underwent bilateral mastectomy after the GC appointment, including most patients with active breast cancer (7/9 (78%)), 8/17 (47%) unaffected patients, and none (0/3 (0%)) with a previously treated breast cancer. Among those without breast cancer, the mean time from the GC appointment to the bilateral risk-reducing mastectomy was 8.6 months (SD 4.4). Conclusions: Half of patients who had bilateral mastectomy indicated because of their genetic test results elected to have mastectomy done after discussion of this guideline-based care option with a GC. As evidenced in prior research, bilateral mastectomy markedly reduces risk of breast cancer. In addition to improved patient outcomes, the revenue a health system receives from these surgeries can also help to support cancer genetics services.

项与 xCures, Inc. 相关的新闻（医药）

2024-10-21

·PRNewswire

xCures Unveils Next-Generation AI-Powered Data Platform at HLTH Conference

The platform leverages AI to deliver real-time insights that will significantly reduce the time and effort needed to make informed clinical decisions. LAS VEGAS, Oct. 21, 2024 /PRNewswire/ -- xCures, a pioneer in AI-driven healthcare data solutions, announced today its latest innovation: a next-generation AI-powered platform designed to fundamentally change healthcare data access and patient care. Revealed during Mika Newton's (CEO) remarks at the HLTH 2024 conference in Las Vegas, Nevada, the new platform introduces a suite of tools to empower healthcare providers with faster, more efficient access to clinical insights to improve the quality and content of patient care. The cutting-edge platform produces specialty and encounter-specific checklists and natural language patient summaries, allowing healthcare professionals to gain immediate, actionable insights from vast amounts of patient data. Additionally, the platform features an innovative chat-based search functionality that enables users to engage with medical records as if in a conversation. This breakthrough will simplify the interrogation of complex health data and provide more efficient access to critical patient information. All of these capabilities retain source document linkages, giving certainty and the confidence needed to implement AI-powered solutions in the context of patient treatment. "We are thrilled to introduce this next-generation platform that will significantly accelerate how healthcare providers access and utilize medical data," said Mika Newton, CEO of xCures. "Our platform empowers providers to spend less time sifting through medical records and more time focusing on delivering high-quality care. This is a major step forward in making healthcare safer, faster, and more effective." The healthcare industry is often bogged down by inefficiencies in accessing and processing patient data. Providers traditionally spend hours manually extracting and organizing data from medical records, which can lead to delays in patient care. xCures' new platform addresses these challenges head-on by offering a faster, more efficient method to analyze and utilize health data. Organizations that implement the xCures platform will save valuable staff time, streamline operations, and increase revenue through improved efficiency, all while providing better, more timely care to patients. "Our goal with this platform is not only to provide healthcare professionals with faster access to data but to also transform how they interact with it," Newton added. "By incorporating natural language summaries and conversational search functionality, we're making it easier for providers to get the precise information they need, exactly when they need it. This is about more than efficiency—it's about fundamentally changing the relationship between providers and patient data." Since its inception in 2018, xCures has led the field of leveraging AI to extract and structure data from medical records. Their latest platform takes this capability to the next level, acting as an intelligent filter atop Health Information Exchanges (HIEs) and Qualified Health Information Networks (QHINs). This platform is accessible for Treatment or through Individual Access Services (IAS) as defined under TEFCA. The same solution can be seamlessly integrated with existing organization-owned medical records. By organizing medical records into a structured, searchable database, xCures empowers healthcare providers with rapid access to crucial clinical insights, enhancing patient care and streamlining workflows. By eliminating the need for manual data extraction, xCures helps providers offer safer and more accurate care. The faster providers can access accurate, actionable data, the quicker they can make informed decisions, improving patient outcomes and reducing administrative burdens. About xCures xCures Inc. operates an A.I.-assisted platform that can automatically retrieve medical records from any U.S. care site. The data is harmonized within 15 minutes to provide concise, contextual case summaries and dynamically assessed patient checklists. For more information, contact [email protected] or visit . SOURCE xCures WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2024-05-13

·GlobeNewswire-Health Care

MiNK Therapeutics Announces $5.8 Million Private Placement and Appointment of Board Observer

Financing of $5.8 Million at a 25% premium will help advance the clinical development of MiNK-215, an armored-FAP-CAR-iNKTGKCC, LLC joins as a new investor with Katie Chudnovsky appointed as a Board Observer NEW YORK, May 13, 2024 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic, off-the-shelf, invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases, today announced that it has entered into a stock purchase agreement to sell securities in a private placement financing (PIPE) for $5.8 million. This capital injection is earmarked for accelerating the clinical trials of MiNK-215, our leading allogeneic CAR-iNKT cell therapy targeting fibroblast activation protein (FAP) in solid tumors, which is planned to enter the clinic in early 2025. “This funding will help advance our unique armored iNKT therapy MiNK-215,” said Dr. Jennifer Buell, President and Chief Executive Officer at MiNK. “MiNK-215 is a novel cell therapeutic with the potential to overcome the limitations of traditional immune checkpoint inhibitors in solid tumors. Recent data highlighted MiNK-215’s activity to eradicate tumor cells in a model of MSS colorectal cancer with metastatic liver disease, a critical and growing area of unmet need. We are excited to partner with GKCC and committed to advancing our mission of reshaping the cell therapy landscape." In the PIPE, MiNK is selling 4,640,000 shares of its common stock at a price of $1.25 per share, a 25% premium. The PIPE is expected to close on May 14, 2024, subject to customary closing conditions. In addition, MiNK is pleased to announce the appointment of Yekaterina (“Katie”) Chudnovsky as Board Observer. An accomplished attorney and venture investor, Ms. Chudnovsky brings a wealth of experience as a dedicated patient advocate and supporter of medical research. She currently serves as the Chairperson of the GI Research Foundation (GIRF) at the University of Chicago Digestive Diseases Center, a role preceded by her 12-year tenure as President and Board Member. Additionally, Ms. Chudnovsky serves on the boards of Elicio Therapeutics, Immix Biopharma, XCures, and the Colorectal Cancer Alliance. She earned her BA from Northwestern University and a JD from DePaul University. About MiNK Therapeutics MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery, development, and commercialization of allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and other immune-mediated diseases. MiNK is advancing a pipeline of both native and next generation engineered iNKT programs, with a platform designed to facilitate scalable and reproducible manufacturing for off-the-shelf delivery. The company is headquartered in New York, NY. For more information, visit https://minktherapeutics.com/ or @MiNK_iNKT. Information that may be important to investors will be routinely posted on our website and social media channels. Forward Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic and curative potential of MiNK-215, including the mechanism of action, potency and safety, interim or top-line data, including statements regarding preclinical data, the anticipated benefits of MiNK-215 and clinical development plans and timelines. These forward-looking statements are subject to risks and uncertainties, including the factors described under the Risk Factors section of the most recent Form 10-K filed with the SEC. The securities described above have not been registered under the Securities Act of 1933, as amended. Accordingly, these securities may not be offered or sold in the United States, except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. MiNK cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and MiNK undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Investor Contact 917-362-1370 investor@minktherapeutics.com Media Contact 781-674-4428 communications@minktherapeutics.com

细胞疗法高管变更免疫疗法

2021-06-23

·BioSpace

xCures raises $12.69 million in Series A funding for their AI-powered precision oncology platform

OAKLAND, Calif., June 23, 2021 /PRNewswire/ -- xCures Inc., the leader in the patient-centric use of artificial intelligence (AI) and predictive modeling, announced today that it has raised $12.69 million in Series A funding. This investment, led by Boehringer Ingelheim Venture Fund and joined by Vanedge Capital, Harmonix Fund, Metaplanet, as well as other investors, will be used to accelerate adoption and further development of xCures' AI-Powered platform for precision oncology decision making. We're confident that xCures will continue to develop their platform and work to make a meaningful impact for patients The xCures platform transforms complex unstructured medical data directly from the patient's medical records into structured data suitable for analysis and machine learning. The AI engine then actively cross-references this data against a vast digital library of oncology data to match patients with potential treatments and predict outcomes, thereby empowering patients as well as their oncologists to make more informed and effective treatment decisions. "This new investment enables us to leverage our experience in helping over 1000 patients on our platform to dramatically increase both platform usage and the insights we are generating," stated Mika Newton, CEO of xCures. "Working with the Boehringer Ingelheim Venture Fund and our other investors, we are leading the field of patient-centric research, AI-powered clinical decision support, and prospectively generating regulatory-grade real-world evidence." xCures has developed the infrastructure and products to directly engage patients and access their raw unstructured medical records from anywhere in the United States. These records are then processed into structured data and stored in a HIPAA and CFR Part 11 compliant system. Patients and their physicians receive a crisp summary of their case in the form of a Cancer Journey. The platform then integrates knowledge and insights from this real-world evidence into xINFORM, providing powerful AI-driven clinical decision support tools. Also, the acquired real-world evidence is helpful for biopharmaceutical companies and payors to accelerate novel therapies and guide the optimization of precision medicine approaches to cancer treatment. "The Boehringer Ingelheim Venture Fund sees the potential of the xCures platform to provide valuable options for advanced cancer patients, while at the same time, generating real-world evidence that could lead to important therapeutic insights," said Mark Ralph, Executive Director of the Boehringer Ingelheim Venture Fund focused on Digital Health Investments, and who is joining the xCures Board of Directors. "We're confident that xCures will continue to develop their platform and work to make a meaningful impact for patients." About Boehringer Ingelheim Venture Fund The Boehringer Ingelheim Venture Fund is the strategic venture fund of the Boehringer Ingelheim Corporation. Since 2010, we invest in pioneering science that offers the potential to provide a significant benefit for our patients. Innovation is not restricted by geography; therefore, we invest worldwide. About xCures, Inc. xCures Inc. operates an AI-assisted platform that connects cancer patients and physicians with optimal investigational or approved therapies. The platform prospectively generates real-world evidence for clinical studies and decentralized trials. For more information, visit or contact info@xcures.com CONTACT: Patrick van der Valk, pvandervalk@xcures.com, (415) 6925258

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100 项与 xCures, Inc. 相关的转化医学

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