Inka Health Selected by OneMedNet to Lead AI-Driven Oncology Project Using Real-World Data for External Control Arms
OneMedNet (NASDAQ:ONMD) has selected Inka Health, a subsidiary of Onco-Innovations, to spearhead an AI-driven oncology data analytics project focused on developing external control arms (ECAs) for clinical trials. The initiative aims to leverage OneMedNet's iRWD Real-World Data platform to create more efficient alternatives to traditional clinical trials.
The project will utilize Inka Health's SynoGraph platform, combining machine learning with causal inference methods, to validate an ECA for the Keynote-189 trial of pembrolizumab in non-small cell lung cancer. This collaboration targets the Real-World Evidence (RWE) market, projected to reach $4.6 billion by 2030, and aims to accelerate cancer therapy development while reducing costs.
OneMedNet (NASDAQ:ONMD) ha scelto Inka Health, una controllata di Onco-Innovations, per guidare un progetto di analisi dei dati oncologici basato sull'intelligenza artificiale, focalizzato sullo sviluppo di bracci di controllo esterni (ECA) per studi clinici. L'iniziativa mira a sfruttare la piattaforma iRWD Real-World Data di OneMedNet per creare alternative più efficienti ai tradizionali studi clinici.
Il progetto utilizzerà la piattaforma SynoGraph di Inka Health, che combina l'apprendimento automatico con metodi di inferenza causale, per validare un ECA per lo studio Keynote-189 sul pembrolizumab nel carcinoma polmonare non a piccole cellule. Questa collaborazione si rivolge al mercato della Real-World Evidence (RWE), previsto raggiungere 4,6 miliardi di dollari entro il 2030, con l'obiettivo di accelerare lo sviluppo delle terapie oncologiche riducendo i costi.
OneMedNet (NASDAQ:ONMD) ha seleccionado a Inka Health, una subsidiaria de Onco-Innovations, para liderar un proyecto de análisis de datos oncológicos impulsado por inteligencia artificial, enfocado en desarrollar brazos de control externos (ECA) para ensayos clínicos. La iniciativa busca aprovechar la plataforma iRWD Real-World Data de OneMedNet para crear alternativas más eficientes a los ensayos clínicos tradicionales.
El proyecto utilizará la plataforma SynoGraph de Inka Health, que combina aprendizaje automático con métodos de inferencia causal, para validar un ECA para el ensayo Keynote-189 de pembrolizumab en cáncer de pulmón no microcítico. Esta colaboración apunta al mercado de Evidencia del Mundo Real (RWE), que se proyecta alcance los
OneMedNet (NASDAQ:ONMD)는 Onco-Innovations의 자회사인 Inka Health를 AI 기반의 종양학 데이터 분석 프로젝트를 주도할 파트너로 선정했습니다. 이 프로젝트는 임상시험을 위한 외부 대조군(External Control Arms, ECA) 개발에 초점을 맞추고 있습니다. 이 이니셔티브는 OneMedNet의 iRWD Real-World Data 플랫폼을 활용하여 전통적인 임상시험보다 효율적인 대안을 만드는 것을 목표로 합니다.
프로젝트는 Inka Health의 SynoGraph 플랫폼을 사용하여 기계 학습과 인과 추론 방법을 결합, 비소세포 폐암에 대한 pembrolizumab의 Keynote-189 시험용 ECA를 검증할 예정입니다. 이 협력은 실제 증거(Real-World Evidence, RWE) 시장을 겨냥하며, 2030년까지 46억 달러에 이를 것으로 예상되며, 암 치료제 개발을 가속화하고 비용을 절감하는 데 목적이 있습니다.
OneMedNet (NASDAQ:ONMD) a choisi Inka Health, une filiale d'Onco-Innovations, pour diriger un projet d'analyse de données oncologiques piloté par l'IA, axé sur le développement de bras de contrôle externes (ECA) pour les essais cliniques. Cette initiative vise à exploiter la plateforme iRWD Real-World Data de OneMedNet afin de créer des alternatives plus efficaces aux essais cliniques traditionnels.
Le projet utilisera la plateforme SynoGraph d'Inka Health, combinant apprentissage automatique et méthodes d'inférence causale, pour valider un ECA pour l'essai Keynote-189 du pembrolizumab dans le cancer du poumon non à petites cellules. Cette collaboration cible le marché de la Real-World Evidence (RWE), qui devrait atteindre 4,6 milliards de dollars d'ici 2030, et vise à accélérer le développement des thérapies contre le cancer tout en réduisant les coûts.
OneMedNet (NASDAQ:ONMD) hat Inka Health, eine Tochtergesellschaft von Onco-Innovations, ausgewählt, um ein KI-gesteuertes Projekt zur Onkologie-Datenanalyse zu leiten, das sich auf die Entwicklung von externen Kontrollarmen (ECAs) für klinische Studien konzentriert. Die Initiative zielt darauf ab, die iRWD Real-World Data Plattform von OneMedNet zu nutzen, um effizientere Alternativen zu traditionellen klinischen Studien zu schaffen.
Das Projekt wird die SynoGraph-Plattform von Inka Health verwenden, die maschinelles Lernen mit kausalen Inferenzmethoden kombiniert, um einen ECA für die Keynote-189-Studie mit Pembrolizumab bei nicht-kleinzelligem Lungenkrebs zu validieren. Diese Zusammenarbeit richtet sich an den Markt für Real-World Evidence (RWE), der bis 2030 voraussichtlich 4,6 Milliarden US-Dollar erreichen wird, und zielt darauf ab, die Entwicklung von Krebstherapien zu beschleunigen und gleichzeitig Kosten zu senken.
- Project aims to reduce clinical trial costs and accelerate cancer therapy development timelines
- Targets Real-World Evidence (RWE) market projected to reach $4.6 billion by 2030
- Partnership leverages regulatory-grade, diverse datasets through OneMedNet's iRWD platform
- Results will be submitted to ISPOR Europe 2025, potentially enhancing market visibility
- Success of external control arms approach still needs to be validated
- Initial focus limited to only non-small cell lung cancer (NSCLC)
Insights
OneMedNet's partnership with Inka Health positions both companies to transform oncology trials with AI-driven real-world evidence, potentially reducing drug development costs and timelines.
This partnership between OneMedNet and Inka Health represents a significant advancement in applying real-world data (RWD) to oncology drug development. The collaboration will leverage OneMedNet's regulatory-grade patient data to develop external control arms (ECAs) as alternatives to traditional randomized controlled trials. This approach has three major implications:
First, the economic impact could be substantial. Traditional oncology trials can cost upwards of
Second, the methodological approach is sophisticated. Inka Health's SynoGraph platform combines machine learning with causal inference - a critical advancement beyond simple correlative analytics. They're planning to validate their approach against the Keynote-189 trial for pembrolizumab in non-small cell lung cancer, which provides a robust benchmark for their methodology.
Third, the regulatory angle is well-considered. They're aligning with FDA, EMA, and NICE guidelines - essential for actual implementation. Regulatory acceptance of external control arms has been growing steadily, with the FDA increasingly open to RWE for supplemental approvals and label expansions.
The focus on non-small cell lung cancer is strategically sound as it's both prevalent and has established treatment protocols, making it ideal for initial validation. If successful, this methodology could be applied across oncology and potentially other therapeutic areas, representing significant scalability.
Reduce development timelines and costs, while improving access to life-saving treatments
VANCOUVER, British Columbia, July 31, 2025 (GLOBE NEWSWIRE) -- Onco-Innovations Limited (CBOE CA: ONCO) (OTCQB: ONNVF) (Frankfurt: W1H, WKN: A3EKSZ) ("Onco" or the "Company”) is pleased to announce that its wholly owned subsidiary, Inka Health Corp. ("Inka Health"), has been selected by OneMedNet Corporation (Nasdaq: ONMD) to lead a high-impact data analytics initiative focused on improving how cancer therapies are brought to market. The project focuses on leveraging OneMedNet’s regulatory-grade patient data including Radiology Imaging data to develop external control arms (ECAs), which has the potential to be a faster, more cost-effective alternative to traditional clinical trials. This approach offers a potentially smarter way to generate clinical evidence by leveraging existing patient data, thereby possibly accelerating treatment access and reducing the need for costly, time-consuming trials. The initiative also provides both organizations with exposure to the rapidly expanding Real-World Evidence (RWE) market is projected to exceed
This strategic project reflects growing momentum behind real-world data (RWD) as a critical component of next-generation evidence generation for cancer therapeutics2. OneMedNet’s iRWD Real-World Data platform and federated provider network offers regulatory-grade, diverse, and longitudinal datasets, making it uniquely suited to drive Real-World Evidence (RWE) studies and accelerate healthcare innovation.
The multi-phase project is intended to showcase how OneMedNet’s oncology dataset can be used to replicate the results of traditional clinical trials, without the same time, cost, and complexity as traditional trials. By offering a faster and more efficient path to generate the evidence needed for regulatory and reimbursement approvals, this initiative can potentially help accelerate market entry for new cancer therapies, particularly in areas of high unmet needs like colorectal cancer.
Inka Health plans to deploy its proprietary SynoGraph platform, which combines machine learning with causal inference methods, to build and validate an ECA for the Keynote-189 trial3 of pembrolizumab in non-small cell lung cancer aligned with regulatory and Health Technology Assessment (HTA) best practices, including those from the FDA, European Medicines Agency (EMA), and National Institute for Health and Care Excellence (NICE). The initial focus will be on non-small cell lung cancer (NSCLC), a prevalent and clinically significant cancer type where real-world insights can meaningfully improve both patient access to therapies and regulatory confidence.
“We selected Inka Health for this initiative because their methodological approach aligns perfectly with our vision for high-quality evidence generation,” said Aaron Green, President & CEO of OneMedNet. “Their ability to apply rigorous, AI-driven analytics to our regulatory-grade, diverse datasets makes them the ideal partner to showcase how OneMedNet’s Real-World Data can be used as a trusted external control arm in oncology research—with the potential to help pharmaceutical companies realize a stronger ROI on clinical development and driving broader adoption among CROs and life sciences organizations looking for faster, more cost-effective trial alternatives.”
The collaboration is expected to result in a scientific abstract for submission to ISPOR Europe 2025, reinforcing Inka Health’s leadership in applying artificial intelligence and real-world data to oncology research. As ECAs become increasingly prominent in global drug development strategies, this project positions Onco and its subsidiary at the forefront of how industry brings new therapies to patients.
“This collaboration is about more than applying advanced analytics to oncology data. It's about reshaping how we generate credible evidence for regulatory and reimbursement decisions using real-world patients, not just trial participants. With SynoGraph, we’re aiming to set a new bar for how external control arms can be built and trusted,” said Paul Arora, Co-Founder of Inka Health.
About OneMedNet
OneMedNet is revolutionizing how the world unlocks Real-World Data (RWD), harnessing the untapped potential of over 1,750 healthcare sites through its iRWD™ platform. This isn’t just data, it’s the lifeblood of innovation, from de-identified medical imaging to electronic health records, fueling breakthroughs for drugmakers, medical device pioneers, and AI visionaries. With a network spanning rare diseases, oncology, cardiology, and beyond, OneMedNet delivers precision insights that redefine patient care and power the next wave of healthcare disruption.
Beyond healthcare OneMedNet’s proprietary AI anonymizes data for industries like finance, retail, and telecom, unlocking endless possibilities, rigorously testing production system upgrades, de-risking complex projects, and securely sharing sensitive data by stripping out personal information. Learn more at www.onemednet.com.
About Inka Health
Inka Health is an AI-driven analytics company revolutionizing oncology research and drug development through advanced causal AI. Its proprietary platform, SynoGraph, leverages AI-powered causal inference to identify which cancer patients are most likely to respond to specific treatments, advancing precision medicine. By integrating diverse multimodal medical data—including genomics, transcriptomics, and proteomics—SynoGraph uncovers hidden insights that can optimize treatment decisions and clinical trial design. With this cutting-edge technology, Inka Health aims to help pharmaceutical companies accelerate drug development, reduce trial failures, and bring life-saving therapies to market faster.
About Onco-Innovations Limited
Onco-Innovations is a Canadian-based company dedicated to cancer research and treatment, specializing in oncology. Onco’s mission is to pursue the prevention and treatment of cancer through pioneering research and innovative solutions. The company has secured an exclusive worldwide license to patented technology that targets solid tumours.
ON BEHALF OF ONCO-INNOVATIONS LIMITED,
“Thomas O’Shaughnessy”
Chief Executive Officer
For more information, please contact:
Thomas O’Shaughnessy
Chief Executive Officer
Tel: + 1 888 261 8055
investors@oncoinnovations.com
OneMedNet Contacts:
Michael Wong, VP Marketing
Email: michael.wong@onemednet.com
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1 Real World Evidence Solutions Market – https://www.grandviewresearch.com/industry-analysis/real-world-evidence-solutions-market-report
2 Wang X, Dormont F, Lorenzato C, et al. Current perspectives for external control arms in oncology clinical trials: Analysis of EMA approvals 2016–2021. J Cancer Policy. 2023;35:100403.
3 https://www.nejm.org/doi/full/10.1056/NEJMoa1801005
FAQ
What is the partnership between OneMedNet (NASDAQ:ONMD) and Inka Health?
How will OneMedNet's iRWD platform be used in the oncology project?
What is the market potential for the Real-World Evidence (RWE) initiative by OneMedNet?
Which specific cancer type will OneMedNet and Inka Health initially focus on?
How will Inka Health's SynoGraph platform contribute to the OneMedNet project?
