REG - Oxford BioDynamics - CiRT expanded validation for ICI immunotherapies

Oxford BiodynamicsAnnouncement

15/05/2023 07:00

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RNS Number : 3371Z  Oxford BioDynamics PLC  15 May 2023

Oxford BioDynamics Plc

 

Peer-reviewed study results confirm and expand validation of Oxford
BioDynamics' EpiSwitch® 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 (http://www.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® 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
(https://www.mdpi.com/2072-6694/15/10/2696) .

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
(https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1503717)
 5  & 2023
(https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1684666)
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
(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
(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
(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
(https://doi.org/10.1101/2021.12.21.21268094)

 5  Oxford BioDynamics Plc. (2021). Oxford BioDynamics awarded US FNIH Grant
to apply EpiSwitch® 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
(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
(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® test by end of 2023; sales progress for flagship
EpiSwitch® CiRT.
https://otp.tools.investis.com/clients/uk/oxford_biodynamics_plc/rns/regulatory-story.aspx?cid=2040&newsid=1679474
(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         +44 (0)1865 518910

 Jon Burrows, CEO

 Paul Stockdale, CFO

 Shore Capital                  +44 (0)20 7408 4090

 Nominated Adviser and Broker

 Stephane Auton

 John More

 Instinctif Partners

 Melanie Toyne-Sewell            +44 (0)20 7457 2020

 Rozi Morris                    OxfordBioDynamics@instinctif.com (mailto: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® CiRT (https://www.mycirt.com/) (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® CST (https://covidseveritytest.com/) (Covid Severity Test) and the
first commercially available microarray kit for high-resolution 3D genome
profiling and biomarker discovery, EpiSwitch® Explorer Array Kit
(https://store.oxfordbiodynamics.com/) .

The Company has developed a proprietary 3D genomic biomarker platform,
EpiSwitch®, 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 (http://www.oxfordbiodynamics.com) , or follow OBD
on Twitter (https://twitter.com/OxBioDynamics) (@OxBioDynamics) and LinkedIn
(https://www.linkedin.com/company/oxford-biodynamics) .

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 10,000 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.

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
(http://fnih.org/) .

 

 

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