TIDMOBD
RNS Number : 3371Z
Oxford BioDynamics PLC
15 May 2023
Oxford BioDynamics Plc
Peer-reviewed study results confirm and expand validation of
Oxford BioDynamics' EpiSwitch(R) CiRT blood test for checkpoint
inhibitor immunotherapies
-- Publication in high-impact journal Cancers describes the
development and validation of OBD's EpiSwitch CiRT blood test for
predicting individual cancer patient's therapeutic response to
checkpoint inhibitor immunotherapies
-- Results of the peer-reviewed studies document the expanded
validation of CiRT to five widely used checkpoint inhibitors across
280 patients and 14+ broad oncological indications
-- The first-in-class liquid biopsy test demonstrated high
accuracy ( 85%), sensitivity (93%), specificity (82%) to aid
physicians in identifying responders
-- CiRT continues to post record monthly orders in the US and is
available to physicians at mycirt.com
Oxford, UK - 15 May, 2023 - Oxford BioDynamics, Plc (AIM: OBD,
the Company), a biotechnology company developing precision medicine
tests based on the EpiSwitch(R) 3D genomics platform, announces the
publication in the journal Cancers of an expanded validation
supporting the use of its EpiSwitch CiRT (Checkpoint inhibitor
Response Test) test across the majority of widely used anti-PD-1/L1
checkpoint inhibitor monotherapies.
OBD's EpiSwitch CiRT is a first-of-its-kind blood test that
predicts an individual cancer patient's therapeutic response to
immune checkpoint inhibitors (ICIs), providing unique benefits for
physicians in treatment planning and navigating complex decisions
[1]. Despite pre-screening with currently approved tests, such as
tumor PD-L1 expression, typically only 1 in 5 patients see an
overall anti-cancer benefit to costly ICIs for most cancers, and
many face one or more adverse events [2].
In this peer-reviewed study, prospective clinical trials
representing 280 treatments with ICIs were used to develop, verify
and validate a predictive assay comprising the eight 3D genomic
biomarkers used in CiRT. The blood-based biomarker assay achieved
high accuracy (85%), sensitivity (93%), specificity (82%), and NPV
(97% negative predictive value ) across 14+ broad oncological
indications, including melanoma, head and neck, lung, pancreas,
prostate, liver, colon and breast cancer [3] .
The work builds on an earlier study published as a preprint in
medRxiv [4] . The validation results were extended to a total of
280 samples, using an additional collection exclusively from an
observational trial [3] . All of the observational samples were
evaluated with the EpiSwitch predictive biomarkers against a
clinical response assessment (using standard RECIST 1.1 guidelines)
performed for the same cycle of treatment as the sample collection.
Together, all the results expand CiRT utility to five of the most
widely used checkpoint inhibitor therapies: Pembrolizumab,
Atezolizumab, Durvalumab, Nivolumab and Avelumab.
The study demonstrates strong biomarker potential for systemic
readouts for the most challenging patient stratification problems -
prediction of response to cancer treatments. With these published
results, the power of liquid biopsy, as harnessed by the EpiSwitch
3D genomic platform, opens real possibilities in personalized
patient care, patient management and medical practice.
The publication, titled "Development and validation of
blood-based predictive biomarkers for response to PD-1/PD-L1
checkpoint inhibitors: evidence of a universal systemic core of 3D
immunogenetic profiling across multiple oncological indications,"
[3] is available online in Cancers here .
The study also shares important insights into the biological
relationship between 3D genomic architecture, exosome signaling and
biological mechanisms underlying systemic flow of epigenetic
synchronization that links a blood-based readout of 3D genomic
biomarkers with features of the tumor microenvironment.
The publication was a collaboration between OBD, Mount Miriam
Cancer Hospital (MMCH) and Island Hospital, Malaysia, and the
University of East Anglia, and was partly supported by one of two
concurrent awards granted to OBD by the Foundation for the National
Institutes of Health (FNIH) Partnership for Accelerating Cancer
Therapies (PACT) ( 2021 [5] & 2023 award [6]). PACT is a
collaboration between the US National Institutes of Health (NIH)
National Cancer Institute (NCI), US Food and Drug Administration
(US--FDA), and 12 leading pharmaceutical companies.
Launched in February 2022, the CiRT blood test continues to gain
traction in the US, posting record monthly orders in March [7] and
April 2023. EpiSwitch CiRT was launched in the US in February 2022
and made available in the UK in June 2022. A unique CPT PLA
reimbursement code for the test has been available for use by US
payors since October 2022.
Dr Alexandre Akoulitchev, Chief Scientific Officer of Oxford
BioDynamics , said: "This study publication is an important
validation of the expanded use of CiRT to five widely used
checkpoint inhibitors, demonstrating the potential for this test to
help more cancer patients.
"Personalised liquid biopsy tests promise to change the future
of medical practice. Most of those technologies remain in the
development stage. With the EpiSwitch CiRT test, we are delighted
to have already brought it to physicians and their patients without
delay. We are also determined to bring with it changes in medical
practice, to the mutual benefits of patients' and doctors'
communities."
Dr Joseph Menetski, Senior Vice President and Chief
Translational Sciences Officer of the FNIH, said: " The Foundation
for the NIH is pleased to see the results from Oxford BioDynamics'
PACT Novel Biomarker Award. It brings the field a more accurate and
deployable test for predicting responses to immune-oncology
interventions . By developing tools for personalized care like
CiRT, we can connect patients to the right treatment for them and
truly build bridges to innovative new therapies ."
-Ends-
References
[1] Oxford BioDynamics Plc. (2022). EpiSwitch CiRT.
https://www.mycirt.com
[2] Zhao, B.; Zhao, H.; Zhao, J. (2020). Efficacy of PD-1/PD-L1
blockade monotherapy in clinical trials, Therapeutic Advances in
Medical Oncology, Vol. 12.
https://doi.org/10.1177/1758835920937612
[3] Hunter, E., et al. (2023). Development and validation of
blood--based predictive biomarkers for response to PD--1/PD-L1
checkpoint inhibitors: evidence of a universal systemic core of 3D
immunogenetic profiling across multiple oncological indications,
Cancers 15(10), 2696. https://www.mdpi.com/2072-6694/15/10/2696
[4] Hunter, E., et al. (2021). Development and validation of
blood--based predictive biomarkers for response to PD--(L)--1
checkpoint inhibitors: evidence of a universal systemic core of 3D
immunogenetic profiling across multiple oncological indications.
MedRxiv, 2021.12.21.21268094.
https://doi.org/10.1101/2021.12.21.21268094
[5] Oxford BioDynamics Plc. (2021). Oxford BioDynamics awarded
US FNIH Grant to apply EpiSwitch(R) Immune Health test for improved
prediction of patient response to Immune Checkpoint Inhibitor (ICI)
cancer therapies.
https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1503717
[6] Oxford BioDynamics Plc. (2023). Oxford Biodynamics granted
US Foundation of NIH PACT Award for prognosis of cancer patients
with IO-triggered Hyper-Progressive Disease.
https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1684666
[7] Oxford BioDynamics Plc. (2023). Business update - plan to
launch Prostate Screening EpiSwitch(R) test by end of 2023; sales
progress for flagship EpiSwitch(R) CiRT.
https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1679474
For further details please contact:
Oxford BioDynamics Plc
Jon Burrows, CEO
Paul Stockdale, CFO +44 (0)1865 518910
Shore Capital
Nominated Adviser and Broker
Stephane Auton
John More +44 (0)20 7408 4090
-----------------------------------
Instinctif Partners
Melanie Toyne-Sewell +44 (0)20 7457 2020
Rozi Morris OxfordBioDynamics@instinctif.com
Adam Loudon
-----------------------------------
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.
Its flagship product is EpiSwitch(R) CiRT (Checkpoint Inhibitor
Response Test) for cancer, a predictive immune response profile for
immuno-oncology (IO) checkpoint inhibitor treatments, launched in
February 2022.
In March 2021, the Company launched its first commercial
prognostic test, EpiSwitch(R) CST (Covid Severity Test) and the
first commercially available microarray kit for high-resolution 3D
genome profiling and biomarker discovery, EpiSwitch(R) Explorer
Array Kit .
The Company has developed a proprietary 3D genomic biomarker
platform, EpiSwitch(R), which can build molecular diagnostic
classifiers for prediction of response to therapy, patient
prognosis, disease diagnosis and subtyping, and residual disease
monitoring in a wide range of indications.
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 10,000 samples in more than 30 human diseases.
OBD is headquartered in Oxford, UK and is listed on AIM of the
London Stock Exchange. It also has a commercial office in
Gaithersburg, MD, USA and a reference laboratory in Penang,
Malaysia.
For more information, please visit the Company's website,
www.oxfordbiodynamics.com , or follow OBD on Twitter
(@OxBioDynamics) and LinkedIn .
About EpiSwitch(R)
The 3D configuration of the genome plays a crucial role in gene
regulation. By mapping this architecture and identifying abnormal
configurations, EpiSwitch(R) 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(R) 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 10,000 samples in 30 disease areas, and reduced to
practice.
In addition to stratifying patients with respect to anticipated
clinical outcomes, EpiSwitch(R) 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.
About the Partnership for Accelerating Cancer Therapies
The Partnership for Accelerating Cancer Therapies, or PACT, is a
five--year project meant to support research that seeks to
identify, develop and validate robust biomarkers -- standardized
biological markers of disease and treatment response -- to advance
new immunotherapy treatments that harness the immune system to
attack cancer. PACT is overseen by the Foundation for the National
Institutes of Health. The pharmaceutical companies participating
that have made this grant award possible are: AbbVie, Amgen,
Boehringer Ingelheim, Bristol--Myers Squibb, Celgene Corporation,
Genentech, Gilead, GlaxoSmithKline, Janssen/Johnson & Johnson,
Novartis, and Pfizer.
About The Foundation for the National Institutes of Health
The Foundation for the National Institutes of Health (FNIH)
connects the world's leading public and private organizations to
accelerate biomedical breakthroughs for patients, regardless of who
they are, where they live, or what disease they have. Together with
leading scientists and problem-solvers, and a successful track
record of navigating complex problems, the FNIH accelerates new
therapies, diagnostics, and potential cures; advances global health
and equity in care; and celebrates and trains the next generation
of scientists. Established by Congress in 1990 to support the
mission of the NIH, the FNIH is a not-for-profit 501(c)(3)
charitable organization. For more information about the FNIH,
please visit fnih.org .
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