VNRX: Breakthrough Cancer Detection Method Disclosed at ESMO and in a Webinar - preliminary proof of concept work indicates simple blood test should be able to detect several types of cancer, potentially at Stages I & II
NYSE:VNRX
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VolitionRx (NYSE:VNRX) announced a new breakthrough cancer detection method at ESMO 2023 (European Society for Medical Oncology), which was followed up by an informative webinar with an informative slide deck. Each is accessible through one of the following links:
Slide deck: https://ir.volition.com
ESMO Poster: https://volition.com/media/downloads/ESMO-POSTER-FPN-205P-FINAL.pdf
This novel method for detecting cancer through a blood test (liquid biopsy) is a step change advancement and was discovered through Volition’s research focus on fragments of chromosomes that circulate in the bloodstream. Volition recognized that particular combinations of DNA sequences that bind onto CTCF transcription factors only when cancer is present and devised a technique
1) to physically isolate these cancer-associated DNA fragments from blood plasma and
2) to detect these particular DNA sequences with a simple, low cost blood test (PCR liquid biopsy)
Volition’s commercial strategy continues to be to enter into technology licensing contracts (which include up-front & milestone payments and/or royalties) and then to secure arrangements for the sales of key components. The company is already in discussions with interested parties, and a number of meetings are scheduled for further discussions.
Expected Upcoming Events:
Thus far, the new method has been tested in a small, proof of concept studies. A paper on this method of isolating DNA sequences from CTCF transcription factors and testing for ctDNA cancer-associated DNA fragments is being prepared for peer review and publication.
Volition is in the process of optimizing the chemistry and developing specific biomarkers and panels for breast, prostate, lung, colorectal and liver cancers. These proof of concept studies for each type of cancer are expected to have sample sizes between 50 and 200. The results should be announced during 1Q 2024.
Therefore, cancer specific abstracts and posters are expected to be presented at conferences throughout the rest of 2024.
BREAKTHROUGH CANCER DETECTION METHOD
To explain the company’s breakthrough cancer detection method, an introductory discussion of Volition’s research focus, namely fragments of chromosomes that circulate in the bloodstream and particularly the components of chromatin fiber, nucleosomes, histones etc. The structure of chromatin is illustrated in the company’s image below with the addition of CTCF transcription factors, which also bind to DNA like nucleosomes but are proteins that regulate the transcription rate of genetic information from DNA to messenger RNA.
Since Volition’s core competencies are based on epigenetics, the company’s researchers discovered that CTCF-DNA fragments appear to hold a key to detecting cancer. Specifically, there are particular combinations of DNA sequences that bind onto CTCF transcription factors only when cancer is present. Overall, CTCF binds to between 60,000 and 100,000 places in the human genome; however, when a cell becomes cancerous, certain sequences bind to CTCF in places where in healthy people they do not.
Based on this discovery, Volition has created a novel method to analyze blood for ctDNA (circulating tumor DNA). Instead of extracting all the DNA and performing extensive and expensive liquid biopsy procedures (NGS/ctDNA assays), Volition extracts all the CTCF transcription factors and their associated DNA fragments and then conducts a simple blood test (aka PCR or Polymerase Chain Reaction test) in order to determine if certain CTCF proteins (with a particular sequence associated with cancer) are present.
The following images depict the hypothesis and method of the procedure to detect the presence of the DNA sequence on CTCF proteins that indicates cancer (depicted in yellow). It is important to note that the same targeted DNA sequence on nucleosomes is normal in healthy people.
The first slide depicts plasma (taken from a blood sample) containing nucleosomes and CTCF transcription factors, both with their associated DNA sequences. The yellow DNA sequences represent the cancer-associated sequence, but only when associated with a CTCF transcription factor.
The nucleosomes can be removed by adding a monoclonal anti-CTCF antibody, which pulls the CTCF transcription factors out of the plasma. Then, the nucleosomes are washed away, isolating the CTCF transcription factors bound to DNA sequences.
Subsequently, the DNA sequences are extracted, and a simple PCR blood assay tests for the presence of ctDNA cancer-associated DNA fragments (yellow). If only normal DNA sequences are detected, there would not be an indication of cancer; however, if cancer-associated DNA fragments are present, the test indicates the presence of cancer.
To test this discovery, blood samples from both healthy people (including some with other non-cancerous diseases) and people with cancer. After performing the procedure above, the CTCF-associated DNA fragments were sequenced for biomarker discovery. There were 29 sequences that were present in the cancer samples that were not present in the healthy samples. A preliminary proof of concept was conducted, and PCR tests were developed for 10 of the 29 sequences.
Two biomarkers were very effective for the identification of leukemia. A particular single PCR test detected 61% of leukemia cases with 98% specificity. By adding a second PCR, a panel of two PCR tests detected 74% of leukemia cases with 96% specificity.
Though this preliminary proof of concept was initially developed on a leukemia model, most of the ten biomarkers effectively identified a variety of common solid cancers. A panel of two PCR tests that detected 77% of colorectal cancer (CRC) cases with 92% specificity.
Notably, during this preliminary proof of concept work, another panel of two PCR tests detected multiple cancers, namely colorectal, breast, prostate and liver cancers. In the study, n=20 for each cancer type except n=13 for CRC.
Notably, 75% of Stage IV cancers were detected, but remarkably, 44% of Stage I were detected and 33% of Stage II cancers were detected. This aligns with one of Volition’s key goals: the identification of diseases with a simple, easy to use, low cost diagnostic test at the earliest stage possible in order to improve outcomes.
Expected Upcoming Events:
A paper on this method of isolating DNA sequences from CTCF transcription factors and testing for ctDNA cancer-associated DNA fragments is being prepared for peer review and publication.
In addition, Volition is in the process of optimizing the chemistry and developing specific biomarkers and panels for breast, prostate, lung, colorectal and liver cancers, the results of which should be announced over the next few months. Therefore, cancer specific abstracts and posters are expected to be presented at conferences throughout 2024.
The research leaders of the effort are optimistic, particularly in the potential to detect cancer early in Stages I & II.
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