RCS - Oxford BioDynamics - OBD's PSE test to be used in NCI trial

Oxford BiodynamicsAnnouncement

06/06/2024 07:00

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RNS Number : 3176R  Oxford BioDynamics PLC  06 June 2024

 

Oxford BioDynamics
("OBD" or the "Company" and, together with its subsidiaries, the "Group")

 

EpiSwitch® Prostate Screening (PSE) Blood Test to be used in correlative
studies of

NCI Trial for Prospective Monitoring of Biochemically Recurrent Prostate
Cancer

·    FDA registered trial (NCT05588128) organized and sponsored by the
National Cancer Institute (NCI), part of the US National Institutes of Health

·   Patients will be monitored over 5 years with regular blood collections
and prostate specific membrane antigen (PSMA) PET scans

·  EpiSwitch® Prostate Screening (PSE) test to be used in correlative
studies of the clinical trial to investigate early markers of prostate cancer
progression

 

Oxford, UK - 6 June 2024 - Oxford BioDynamics, Plc (AIM: OBD, the Company), a
biotechnology company developing precision medicine tests based on the
EpiSwitch® 3D genomics platform, announces that its EpiSwitch® Prostate
Screening (PSE) test will be utilized in correlative studies of a clinical
trial, NCT05588128
(https://url.avanan.click/v2/___https:/clinicaltrials.gov/study/NCT05588128___.YXAxZTpzaG9yZWNhcDphOm86ODUzMzRkZTNmZmE5OTVlYjM2MjI0OWEzNTFhYWU1NGQ6Njo0OGIzOjRkZWVlMjliODRjMTMzOTI0YTA4NGYwNmY1OTgwNjE0OTk0MDZjZTE5MjhjZDUzMzllOWI0MWU4MzUwNmU1YTg6cDpU)
, organized and sponsored by the National Cancer Institute (NCI) of the
National Institutes of Health, (Bethesda, MD, USA), to regularly monitor
prostate cancer  in patients with biochemically recurrent disease.

Prostate cancer is the most common malignancy and the second leading cause of
cancer-related deaths in American men. Each year in the US up to 50,000 men
whose early-stage cancer was treated, e.g. via definitive radiation or
surgery, unfortunately experience biochemical recurrence (BCR). At this
biochemically recurrent stage however, standard imaging techniques, such as
computed tomography (CT) and Tc99 bone scan, are often unable to detect the
disease.

One goal of the NCI clinical trial is to identify techniques, tools, and
biomarkers which can predict outcomes in patients with BCR. As part of this
clinical trial, NCI will follow ~250 patients with biochemically recurrent
prostate cancer for up to five years monitoring changes on prostate specific
membrane antigen (PSMA) PET imaging, collecting blood samples every three
months, as well as conducting annual or biannual bone or CT scans of the
chest, abdomen, and pelvis. The EpiSwitch® PSE test is one such tool being
evaluated and is being utilized in correlative studies under this clinical
trial to investigate early markers of prostate cancer progression.

"OBD's novel blood-based PSE test will be investigated while monitoring
patients in our prospective five-year trial with PSMA-PET recurrent prostate
cancer," said Dr Ravi Madan, M.D., the trial lead. "The multi-institutional
PROSTAGRAM trial
(https://url.avanan.click/v2/___https:/otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1666301___.YXAxZTpzaG9yZWNhcDphOm86ODUzMzRkZTNmZmE5OTVlYjM2MjI0OWEzNTFhYWU1NGQ6NjowODQ1OjdhYjcwYjExMTYxYjMzMzc1ZTFjYzZkMmU2ZTgxMTVjYTg3ZWViMTY2ODJmMjUyNDY3MWE3NDZhYzFmMjM4ZjQ6cDpU)
by OBD, Imperial College London, the University of East Anglia, and Imperial
College NHS Trust, highlighted the potential role of the PSE test in
supporting us in reaching the objectives of our new trial - to help us explore
the complex dynamics of recurrent prostate cancer and investigate how best to
monitor it using all available tools."

OBD and NCI are collaborating on the evaluation of samples and data collected
from NCI's clinical trial using the EpiSwitch® PSE test under a material
transfer agreement (MTA).

"We are delighted that we have been chosen to be part of this important and
far-reaching NCI trial," said Thomas Guiel, COO, OBD. "This natural history
study will allow all parties to study the evolution of recurrent prostate
cancer and validate new tools for managing patient care. We are pleased at how
quickly the utility of the PSE test has been recognized by prestigious
research organisations such as the NCI, with an eye to expanding the
application of our test into cancer monitoring applications."

For Patients Interested in Enrolling in NCT05588128:

For more information on this clinical trial, please call NCI's toll-free
number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), visit the
website https://trials.cancer.gov, and/or email NCIMO_referrals@mail.nih.gov
.

References

1.    Chromatin conformation changes in peripheral blood can
detect prostate cancer and stratify disease risk groups. Alshaker H, Mills R,
Hunter E, Salter M, Ramadass A, Skinner BM, Westra W, Green J, Akoulitchev A,
Winkler M, Pchejetski D. J Transl Med. 2021 Jan 28;19(1):46. doi:
10.1186/s12967-021-02710-y (https://pubmed.ncbi.nlm.nih.gov/33509203/) .

2.    Circulating Chromosome Conformation Signatures Significantly Enhance
PSA Positive Predicting Value and Overall Accuracy for Prostate Cancer
Detection. Pchejetski D, Hunter E, Dezfouli M, Salter M, Powell R, Green J,
Naithani T, Koutsothanasi C, Alshaker H, Jaipuria J, Connor MJ, Eldred-Evans
D, Fiorentino F, Ahmed H, Akoulitchev A, Winkler M. Cancers (Basel). 2023 Jan
29;15(3):821. doi: 10.3390/cancers15030821
(https://pubmed.ncbi.nlm.nih.gov/36765779/) .

- Ends -

For further details please contact:

 Oxford BioDynamics Plc                  +44 (0)1865 518910

 Jon Burrows, CEO

 Paul Stockdale, CFO

 Shore Capital                           +44 (0)20 7408 4090

(Nominated Adviser and Broker to OBD)

 Stephane Auton

 Lucy Bowden

 WG Partners                             +44 (0)20 3705 9330

 (Joint Broker to OBD)

 David Wilson / Claes Spång /

Sateesh Nadarajah / Erland Sternby

 Instinctif Partners                     Tel: +44 (0)20 7457 2020 OxfordBioDynamics@instinctif.com
 (Media / Analyst enquiries for OBD)

Melanie Toyne-Sewell / Katie Duffell

Notes for Editors

About Oxford BioDynamics Plc

Oxford BioDynamics Plc (AIM: OBD) is a global biotechnology company, advancing
personalized healthcare by developing and commercializing precision medicine
tests for life-changing diseases.

It has two commercially available products: the EpiSwitch® PSE
(https://url.avanan.click/v2/___http:/www.94percent.com/___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6NjphZTRmOjE1ZmE3ZTA1NmFmMzlmYjIzZmFhOGU1NTc5MWI0OTdiODZmMjVmOTFlOWQ2YjBiZTM3YmNmMTMxMGYxOTcxMjI6cDpU)
(EpiSwitch Prostate Screening test) and EpiSwitch® CiRT
(https://url.avanan.click/v2/___https:/www.mycirt.com/___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6NjpjZGI4OjQ3ZWJmMjU3YzNhNjYzYzNiYWVjZGNlMTJjZDM5ZGZkYzBlNmQyNTc0OTdlZWU4ZGI4ODFlYzU1OWZmN2JmMWE6cDpU)
(Checkpoint Inhibitor Response Test) blood tests. PSE is a blood test that
boosts the predictive accuracy of a PSA test from 55% to 94% when testing the
presence or absence of prostate cancer, launched in the US and UK in September
2023. CiRT is a predictive immune response profile for immuno-oncology (IO)
checkpoint inhibitor treatments, launched in February 2022.

The Company's product portfolio is based on a proprietary 3D genomic biomarker
platform, EpiSwitch®, which can build molecular diagnostic classifiers for
the prediction of response to therapy, patient prognosis, disease diagnosis
and subtyping, and residual disease monitoring, in a wide range of
indications, including oncology, neurology, inflammation, hepatology and
animal health.

In March 2021, the Company launched the first commercially available
microarray kit for high-resolution 3D genome profiling and biomarker
discovery, EpiSwitch® Explorer Array Kit
(https://url.avanan.click/v2/___http:/store.oxfordbiodynamics.com/___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6Njo0ZTU1OjIxYzYwYjMwMmY3Yzg3MzhlMTllY2IyNTRlYWQzMzk5ZWZmMzM2NjMyZTQyYmQwZmEyZDgwY2U0Yjg4M2JkOWU6cDpU)
, which is available for purchase by the life science research community.

Oxford BioDynamics has participated in more than 40 partnerships with big
pharma and leading institutions including Pfizer, EMD Serono, Genentech,
Roche, Biogen, Mayo Clinic, Massachusetts General Hospital and Mitsubishi
Tanabe Pharma.

The Company has created a valuable technology portfolio, including biomarker
arrays, molecular diagnostic tests, bioinformatic tools for 3D genomics and an
expertly curated 3D genome knowledgebase comprising hundreds of millions of
data points from over 15,000 samples in more than 30 human diseases.

OBD's group headquarters and research, product development and UK clinical
laboratories are in Oxford, UK. It also has a commercial office in
Gaithersburg and a clinical laboratory in Frederick, MD, USA, and a reference
laboratory in Penang, Malaysia.

The company is listed on the London Stock Exchange's AIM, with ticker OBD. For
more information, please visit the Company's website,
www.oxfordbiodynamics.com
(https://url.avanan.click/v2/___http:/www.oxfordbiodynamics.com___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6Njo3YmRiOmUxODM2ZWZhYmIxNjdhMjFiNTMxOThjNjE0YzMwYzg5YzA1MjI2MmYxMGY0ZTU1MzdjYzdlYzg1NDA5ZTcyOWU6cDpU)
, or follow OBD on Twitter
(https://url.avanan.click/v2/___https:/x.com/OxBioDynamics___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6NjplZWUzOjc5NjFkZGM3Y2Y0ZDI5N2UxMmRlMWViM2UyODQwODYwZWNmMjNiMTM1NTMzMDQ1NDlhYmI3YTMwYjFlNTI3ZDk6cDpU)
(@OxBioDynamics) and LinkedIn
(https://url.avanan.click/v2/___https:/www.linkedin.com/company/oxford-biodynamics___.YXAxZTpzaG9yZWNhcDphOm86ZGFiYjhlY2EwMWM5YWYzYjdhZjZhZmExZGM4OTMyMDg6NjozM2I4OmVmNzdkN2M0NmYxZDg3ODc0MWQ1NDEyMGQ4MjAxOWVmMTg4ZTMzNWY4MTA5NGE3NTE5ZDdlNWIwNjI5MTRhMTM6cDpU)
.

 

About EpiSwitch®

The 3D configuration of the genome plays a crucial role in gene regulation. By
mapping this architecture and identifying abnormal configurations, EpiSwitch®
can be used to diagnose patients or determine how individuals might respond to
a disease or treatment.

Built on over 10 years of research, EpiSwitch® is Oxford Biodynamics'
award-winning, proprietary platform that enables screening, evaluation,
validation and monitoring of 3D genomic biomarkers. The technology is fully
developed, based on testing of over 15,000 samples in 30 disease areas, and
reduced to practice.

In addition to stratifying patients with respect to anticipated clinical
outcomes, EpiSwitch® data offer insights into systems biology and the
physiological manifestation of disease that are beyond the scope of other
molecular modalities. The technology has performed well in academic medical
research settings and has been validated through its integration in biomarker
discovery and clinical development with big pharma.

 

EpiSwitch® Prostate Screening test (PSE)

The current PSA blood screening test is only 55% accurate and is considered as
unreliable by many doctors, including the UK NHS(1). The EpiSwitch® PSE test
is the culmination of nearly ten years of collaboration between OBD, Imperial
College London, University of East Anglia, Imperial College NHS Trust, and the
UK's leading prostate cancer experts. The results of this multi-disciplinary
PROSTAGRAM study were published in the peer-reviewed publication, Cancers(2)
in February 2023.

The PSE test combines the PSA score with five additional proprietary
epigenetic biomarkers, to predict, with 94% accuracy, the presence (or
absence) of prostate cancer.(2) Those with a PSE result showing low likelihood
of cancer can be placed on active surveillance and retested later without
being referred for an invasive and often destructive biopsy. Meanwhile, a high
likelihood result would necessitate referral to a Urologist for further
investigation.

As well as very high accuracy, PSE has a high specificity, 97% (PSA: 53%), and
sensitivity, 86% (PSA: 64%), as well as high positive, 93% (PSA: 25%), and
high negative, 95% (PSA: 86%), predictive values to assess the risk of
prostate cancer in men.(2) The PSE test has been validated as a laboratory
developed test (LDT) in OBD's CLIA-certified testing laboratory in Frederick,
Maryland.

For more information on OBD's PSE test, please visit: www.94percent.com
(https://url.avanan.click/v2/___http:/www.94percent.com___.YXAxZTpzaG9yZWNhcDphOm86ODUzMzRkZTNmZmE5OTVlYjM2MjI0OWEzNTFhYWU1NGQ6Njo2ZmNhOjhjNWQ5ODU0ZTRmYmNlN2MyZDY1OWI0OGU5YmIzNzdiNjk4NmVlNmZlMWNhOTFiOGRiYTRlZWZlZDE4ODhhMWQ6cDpU)
.

References

1.    Chromatin conformation changes in peripheral blood can detect
prostate cancer and stratify disease risk groups. J Transl Med. 2021 Jan
28;19(1):46. Alshaker H, Mills R, Hunter E, Salter M, Ramadass A, Skinner BM,
Westra W, Green J, Akoulitchev A, Winkler M, Pchejetski D.

2.    NHS Health A to Z. Prostate cancer: PSA testing (2021).
https://www.nhs.uk/conditions/prostate-cancer/psa-testing
(https://url.avanan.click/v2/___https:/www.nhs.uk/conditions/prostate-cancer/psa-testing___.YXAxZTpzaG9yZWNhcDphOm86ODUzMzRkZTNmZmE5OTVlYjM2MjI0OWEzNTFhYWU1NGQ6Njo4MDEwOmE5MGQwNDU5ZjBlNWFhMTNjMWZkYTg5ZDBkMGM2MDViMWFiMDUxMjc4NzJhZTY5MjBjNmQ1ODJkZDFhYjFiMmE6cDpU)

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