Volition's Nu.Q® Discover Biomarkers to be utilized in Human Clinical Study Sponsored by Leading Pharmaceutical Company for the First Time

Rhea-AI Summary

VolitionRx (NYSE AMERICAN: VNRX) has signed an agreement with a leading pharmaceutical company to use its Nu.Q® Discover biomarkers in a longitudinal Phase 1/2b study. This marks the first human clinical study utilizing Volition's biomarkers with a pharmaceutical company sponsor.

The study will employ two Nu.Q® Discover assays to measure disease progression and treatment response, following a successful pilot study. The project is expected to span 12-18 months and generate significant revenue for Volition. The Nu.Q® Discover program offers drug developers rapid epigenetic profiling tools across various development stages.

Additional clinical studies are under discussion with this and other companies, potentially strengthening Volition's position in the pharmaco-epigenetics market. The biomarkers will be used to address an unmet medical need, though specific disease details were not disclosed.

Positive

• First pharmaceutical company partnership for human clinical trials
• Expected significant revenue generation from 12-18 month study
• Additional clinical studies under discussion with multiple companies
• Successful completion of pilot study leading to main trial

Negative

• None.

Nu.Q® Discover tools provide drug developers and scientists with a range of rapid epigenetic profiling assays across pre-clinical and clinical development pathways from discovery to market ready

HENDERSON, Nev., March 4, 2025 /PRNewswire/ -- VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, today announces that it has signed an agreement with a leading pharmaceutical company to utilize Volition's Nu.Q® Discover biomarkers in a longitudinal Phase 1/2b study. The Nu.Q® Discover program provides drug developers and scientists with a range of state-of-the-art assays for rapid epigenetic profiling in disease model development, preclinical testing, and clinical studies from discovery to market ready.

Following a successful pilot study, two of Volition's Nu.Q® Discover assays were selected for use in this study. It is expected to be completed over a 12-18 month period, generating significant revenue for Volition for this study alone, with further projects being discussed.

Dr. Andrew Retter, Chief Medical Officer at Volition, said:

"This is a significant milestone for our Nu.Q® Discover program: the first human clinical study with a pharmaceutical company sponsor, utilizing Volition's biomarkers to measure disease progression and response to treatment in a longitudinal phase 1/2b trial of an experimental drug.

We are delighted to support the pharmaceutical company's clinical efforts in developing new drugs for the treatment of a large, unmet medical need. The inclusion of our nucleosome-based biomarkers in this clinical trial demonstrates the growing recognition of their value in clinical development.

We are in further discussions with this and other companies, and anticipate additional clinical studies, which we believe will further validate the capabilities of our technology and strengthen our position in the pharmaco-epigenetics market."

About Nucleosome Expertise for Clinical Trial Enrichment

This collaboration represents an exciting opportunity for Volition to leverage its extensive experience with nucleosomes and scientific expertise in epigenetics to enhance research. By incorporating Nu.Q® Discover biomarkers into the sponsor's study design, Volition is enabling an enrichment strategy that can help identify patients most likely to respond to treatment or experience disease progression.

Clinical trial enrichment is the prospective use of patient characteristics to select a study population with a higher likelihood of demonstrating a treatment effect. This aligns perfectly with Volition's technological capabilities. The company's nucleosome quantification technology provides valuable biological insights that can be used to stratify patients, potentially increasing trial efficiency and improving the signal-to-noise ratio in treatment response assessment.

This approach represents a significant step toward Volition's long-term goal of enabling precision therapy for patients. By identifying specific epigenetic signatures associated with disease states and treatment responses, Volition aims to help clinicians match patients with the therapies most likely to benefit them, while sparing them from treatments unlikely to be effective.

The application of Nu.Q® Discover in this Phase 1b/2 trial demonstrates how Volition's nucleosome expertise is transitioning from research to clinical applications, creating value for pharmaceutical partners while advancing the field of personalized medicine. As this and future studies generate additional data about nucleosome based biomarkers' predictive and prognostic capabilities, Volition is well-positioned to expand its role in precision medicine and targeted therapeutic approaches.

About Nu.Q® Discover

Volition's Nu.Q® Discover program enables drug developers and scientists access to a range of state-of-the-art assays for rapid epigenetic profiling in disease model development, preclinical testing, and clinical studies from discovery to market ready.

Nu.Q® Discover is built on proprietary nucleosome quantification technology. It is a valuable research tool for R&D professionals working within the field of pharmaco-epigenetics, studying the epigenetic basis for variation in response to drugs.

About Volition

Volition is a multi-national epigenetics company focused on advancing the science of epigenetics. Volition is dedicated to saving lives and improving outcomes for people and animals with life-altering diseases through earlier detection, as well as disease and treatment monitoring.

Through its subsidiaries, Volition is developing and commercializing simple, easy to use, cost-effective blood tests to help diagnose and monitor a range of diseases, including some cancers and diseases associated with NETosis, such as sepsis. Early diagnosis and monitoring have the potential not only to prolong the life of patients but also improve their quality of life.

Volition's research and development activities are centered in Belgium, with an innovation laboratory and office in the U.S. and London. 

The contents found at Volition's website address are not incorporated by reference into this document and should not be considered part of this document. Such website address is included in this document as an inactive textual reference only.

Media Enquiries:
Louise Batchelor, Volition, mediarelations@volition.com +44 (0)7557 774620

Investor Relations
Jeremy Feffer, LifeSci Advisors, jfeffer@lifesciadvisors.com, +1-212-915-2568

Safe Harbor Statement

Statements in this press release may be "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as "expects," "anticipates," "intends," "plans," "aims," "targets," "believes," "seeks," "estimates," "optimizing," "potential," "goal," "suggests," "could," "would," "should," "may," "will" and similar expressions identify forward-looking statements. These forward-looking statements relate to, among other topics, Volition's expectations related to revenue opportunities and growth, the timing, completion, success and delivery of data from clinical studies, the timing of publications, , the effectiveness and availability of Volition's blood-based diagnostic, prognostic and disease monitoring tests, Volition's ability to develop and successfully commercialize such test platforms for early detection of cancer and other diseases as well as serving as a diagnostic, prognostic or disease monitoring tools for such diseases, and Volition's success in securing licensing and/or distribution agreements with third parties for its products. Volition's actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties, including, without limitation, results of studies testing the efficacy of its tests. For instance, if Volition fails to develop and commercialize diagnostic, prognostic or disease monitoring products, it may be unable to execute its plan of operations. Other risks and uncertainties include Volition's failure to obtain necessary regulatory clearances or approvals to distribute and market future products; a failure by the marketplace to accept the products in Volition's development pipeline or any other diagnostic, prognostic or disease monitoring products Volition might develop; Volition's failure to secure adequate intellectual property protection; Volition will face fierce competition and Volition's intended products may become obsolete due to the highly competitive nature of the diagnostics and disease monitoring market and its rapid technological change; downturns in domestic and foreign economies; and other risks, including those identified in Volition's most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that Volition files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about Volition's business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this press release, and, except as required by law, Volition does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.

Nucleosomics™, Capture-PCR™ and Nu.Q® and their respective logos are trademarks and/or service marks of VolitionRx Limited and its subsidiaries. All other trademarks, service marks and trade names referred to in this press release are the property of their respective owners.

 

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SOURCE VolitionRx Limited

FAQ

What is the timeline for VNRX's Phase 1/2b study with the pharmaceutical company?

The study is expected to be completed over a 12-18 month period.

How many Nu.Q® Discover assays will be used in VNRX's pharmaceutical partnership study?

Two Nu.Q® Discover assays were selected for use in the study following a successful pilot.

What will VNRX's Nu.Q® Discover biomarkers measure in the clinical trial?

The biomarkers will measure disease progression and response to treatment in the Phase 1/2b trial.

What is the significance of this pharmaceutical partnership for VNRX?

It's the first human clinical study with a pharmaceutical company sponsor using Volition's biomarkers, marking a significant milestone for the Nu.Q® Discover program.