Inka Health Selected by OneMedNet to Lead AI-Driven Oncology Project Using Real-World Data for External Control Arms

Rhea-AI Summary

Onco-Innovations Limited (OTCQB:ONNVF) announced that its subsidiary Inka Health has been selected by OneMedNet (Nasdaq:ONMD) to lead an AI-driven oncology data analytics initiative. The project aims to develop external control arms (ECAs) using OneMedNet's regulatory-grade patient data to accelerate cancer therapy development.

The collaboration will utilize Inka Health's SynoGraph platform to validate an ECA for the Keynote-189 trial of pembrolizumab in non-small cell lung cancer. This initiative targets the Real-World Evidence (RWE) market, projected to reach $4.6 billion by 2030. The project aims to demonstrate how real-world data can replicate traditional clinical trial results more efficiently, potentially reducing development costs and timelines.

The companies plan to submit their findings to ISPOR Europe 2025, positioning themselves at the forefront of AI-driven oncology research and drug development.

Positive

• Partnership with Nasdaq-listed OneMedNet expands presence in $4.6B Real-World Evidence market
• Potential to reduce clinical trial costs and accelerate cancer therapy development through AI-driven analytics
• Access to regulatory-grade patient data for external control arm development
• Strategic positioning in emerging healthcare technology sector

Negative

• Project success and regulatory acceptance of external control arms not guaranteed
• Initial focus limited to single cancer type (non-small cell lung cancer)

Insights

Healthcare Data Scientist

Inka Health's AI partnership with OneMedNet could revolutionize cancer drug development by using real-world data instead of traditional control groups.

This partnership between Inka Health (owned by Onco-Innovations) and OneMedNet represents a potentially significant advancement in clinical trial methodology for oncology. The collaboration aims to leverage OneMedNet's regulatory-grade patient data to develop external control arms (ECAs) - an alternative to traditional randomized controlled trials that could substantially reduce both time and costs in cancer drug development.

What makes this particularly noteworthy is the application of Inka's SynoGraph platform, which combines machine learning with causal inference methods to build and validate ECAs. They're targeting the Keynote-189 trial of pembrolizumab in non-small cell lung cancer (NSCLC) as their initial proof-of-concept. This is methodologically sound as NSCLC has sufficient data volume and clinical significance to demonstrate value.

From a data science perspective, the regulatory alignment they're pursuing with FDA, EMA, and NICE guidelines is crucial - external control arms face significant validation hurdles and regulatory scrutiny. The real value proposition hinges on whether their approach can genuinely replicate traditional clinical trial results with sufficient rigor to satisfy regulatory requirements.

This partnership taps into the growing $4.6 billion real-world evidence (RWE) market. If successful, this approach could significantly accelerate cancer therapy approvals while reducing the ethical concerns of placing patients in control arms where they receive placebos or standard-of-care treatments rather than potentially life-saving experimental therapies. The planned scientific abstract submission to ISPOR Europe 2025 will be an important validation milestone for this methodology.

Pharmaceutical Industry Analyst

This partnership represents a strategic move in the rapidly evolving landscape of pharmaceutical R&D, where real-world data (RWD) is increasingly valued for regulatory submissions. The traditional clinical trial paradigm - randomizing patients to treatment or control arms - is often the most expensive and time-consuming aspect of drug development, particularly in oncology where patient recruitment is challenging.

Inka Health's approach using OneMedNet's data to create external control arms (ECAs) could potentially address several critical industry pain points:

• Reducing the $2.6 billion average cost of bringing a new drug to market
• Shortening the typical 7-10 year development timeline
• Allowing more patients to receive experimental treatments rather than control interventions
• Enabling trials in rare cancers where control arms are particularly difficult to populate

The decision to focus on replicating the Keynote-189 trial for pembrolizumab (Keytruda) in NSCLC is strategically sound. Keytruda is Merck's blockbuster immunotherapy with over $20 billion in annual sales, and this approach creates a visible proof-of-concept with a well-documented existing trial.

The regulatory landscape has been increasingly receptive to RWD/RWE approaches. The FDA's 2018 framework for RWE and the 21st Century Cures Act have opened doors for alternative evidence generation. However, the bar remains high for acceptance of external control arms as primary evidence.

If Inka and OneMedNet can demonstrate their approach meets regulatory standards, this could position both companies as leaders in a transformative approach to clinical development, potentially attracting partnerships with major pharmaceutical companies seeking to optimize their R&D investments.

Reduce development timelines and costs, while improving access to life-saving treatments

VANCOUVER, BC / ACCESS Newswire / July 30, 2025 / 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 $4.6 billion¹ globally by 2030.

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^TM 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.

Furthermore, the Company announces, further to its news releases dated May 26, 2025 and March 25, 2025, that it has extended the term of its engagement with MCS Market Communication Service GmbH (business address: Rheinpromenade 13, 40789 Monheim am Rhein, Nordrhein-Westfalen, Deutschland, email: info@mcsmarket.de; telephone: +491772481220; and website: www.mcsmarket.de) ("MCS") for the continued provision of a range of online marketing services, including campaign creation, production of marketing materials, as well as research and analytics (the "Services"). The Services are expected to run until October 30, or until budget exhaustion. The Company has paid MCS EUR 250,000 for the extended term. No securities have been provided to MCS or its principals as compensation. The Services will be executed via digital channels, including Google Ads and native advertising.

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

Forward-Looking Statements Caution. This news release contains forward-looking statements, including in relation to the Company's ability to collaborate successfully with OneMedNet, and the prospects of the Company, and the Company's business and plans generally, and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "potential", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including, but not limited to, the inability of Inka or the Company to collaborate successfully with OneMedNet. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

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.

³https://www.nejm.org/doi/full/10.1056/NEJMoa1801005

SOURCE: Onco-Innovations Limited

View the original press release on ACCESS Newswire

FAQ

What is the partnership between Inka Health and OneMedNet (ONNVF) about?

Inka Health will lead an AI-driven oncology project using OneMedNet's regulatory-grade patient data to develop external control arms (ECAs), aiming to reduce clinical trial costs and accelerate cancer therapy development.

How will ONNVF's SynoGraph platform be used in the OneMedNet collaboration?

SynoGraph will combine machine learning with causal inference methods to build and validate an external control arm for the Keynote-189 trial of pembrolizumab in non-small cell lung cancer, following FDA, EMA, and NICE guidelines.

What is the market potential for Real-World Evidence that ONNVF is targeting?

The Real-World Evidence (RWE) market is projected to exceed $4.6 billion globally by 2030, representing a significant opportunity for ONNVF's data analytics capabilities.

How does ONNVF's external control arm approach benefit cancer drug development?

The approach offers a potentially faster and more cost-effective alternative to traditional clinical trials by leveraging existing patient data, potentially accelerating treatment access and reducing development costs.

When will results from ONNVF's oncology data analytics project be presented?

The collaboration plans to submit a scientific abstract to ISPOR Europe 2025, showcasing their findings in AI-driven oncology research.