Oxford BioDynamics, Plc (AIM: OBD, the Company), a precision
clinical diagnostics company bringing specific and sensitive tests
to the practice of medicine based on the EpiSwitch® 3D genomics
platform [1], announces its key-note presentation at the 14th World
Summit for Clinical Biomarkers and Companion Diagnostics, taking
place on 3-6 September 2024 in Boston, MA, USA.
Oxford BioDynamics will discuss the diagnostic, predictive and
prognostic power of the EpiSwitch® platform as companion assays in
a keynote presentation. The Company will cover:
- EpiSwitch CiRT, a highly accurate (85%) Immune-Oncology
(IO) response test available today, predicts a patient’s response
to immune checkpoint inhibitor therapy, giving physicians a
powerful tool for patient care management.
- PROWES (Prospective Real-World Evidence Study); an application
of CiRT in an IRB-approved Registry Study currently enrolling up to
2,500 patients across up to a dozen oncology institutions,
evaluating CiRT performance and demonstrating the clinical utility
of the test.
- EpiSwitch® CiRT has been submitted to the New York State
Department of Health Clinical Laboratory Evaluation Program (CLEP)
for approval.
- EpiSwitch® HiRT, a prognostic test for IO-triggered
Hyperprogressive Disease, is a new test being validated by OBD to
address this most detrimental and life-threatening side effect of
immunotherapy.
- Application of a novel multiplexed Agilent® array
platform to deliver EpiSwitch® assays for early diagnosis and
prevention of immune related adverse events (irAEs) which affect up
to 70% of treated patients involving cutaneous, musculoskeletal,
gastrointestinal, renal, nervous system, endocrine, hematologic and
lung toxicities.
Oxford BioDynamics will present a keynote address at the 14th
Annual World Summit for Clinical Biomarkers and Companion
Diagnostics, a flagship meeting which takes place on September 3-6,
2024 in Boston, MA. OBD will discuss its products and pipelines of
clinical assays aimed at enhancing the benefits of, and navigating
the complexities of utilizing immunotherapy, by addressing low
response rates and predicting side effects – from the
life-threatening Hyper-Progressive Disease (manifested in c. 12% of
treated patients) to the normally-anticipated immune related
adverse events (affecting c. 70% of treated patients).
The EpiSwitch® Checkpoint Inhibitor Response Test (CiRT) is a
first-in-class, blood-based, accurate predictor of response to
immune checkpoint inhibitors (ICIs) [2-4]. The test is commercially
available through clinical diagnostic labs in both the US and
UK.
Today, EpiSwitch® CiRT is the focus of an observational registry
study in US: PROWES is a national IRB-approved study of the
concordance of CiRT response prediction to the clinically observed
response rate. It will further document the clinical application
and utility of the assay for the treatment of multiple oncological
indications. PROWES is projected to onboard up to dozen oncology
institutions and enroll up to 2,500 patients. The study is being
run under commercial terms through the CLIA labs in the US.
Dr Kashyap Patel, Oncologist and CEO at Carolina Blood and
Cancer Care Associates, said: “Episwitch CiRT is the unique
blood-based test that enables oncologists to identify patients with
advanced cancer likely to respond to Immunotherapy. This is truly
an unmet need and will likely improve outcomes, reduce toxicities
and with prospective HEOR studies will establish cost improvements
too.”
OBD has recently applied for a New York Department of Health
Clinical Laboratory Evaluation Program (CLEP) New York State (NYS)
CLIA license and, working with its partner lab NeXT Molecular
Analytics, has submitted EpiSwitch® CiRT for NYS DOH CLEP approval.
NYS CLEP requires that both the lab and the assay performed meet
the high standards expected for the care and management of
medically vulnerable populations.
The EpiSwitch® HiRT (Hyper-Immune Response Test), a unique
prognostic blood test developed with support from the Partnership
for Accelerating Cancer Therapies (PACT, USA), will demonstrate the
application of EpiSwitch as an important companion for patient
management. The test accurately predicts individuals who are most
likely to exhibit IO-triggered Hyper-Progressive Disease (HPD), a
response to immunotherapy which triggers life-threatening,
disease-accelerating side effects. An average of 12% of ICI-treated
patients exhibit HPD[5].
OBD will also introduce the EpiSwitch Data Knowledgebase, a
database of greater than 1 billion data points and a suite of
proprietary AI algorithms for in silico modelling of biomarkers and
assays. Application of the knowledgebase will facilitate
development of a multiplex assay for the early diagnosis of irAEs.
OBD has already pioneered the application of its EpiSwitch platform
and microarrays manufactured by Agilent Technologies, Inc to
develop a multi-choice/multiplex array for the early diagnosis of
multiple canine cancers (the EpiSwitch SCB test)[6]. Using a
similar approach and test design, OBD will develop a multiplex
Agilent array-based assay for prediction of the most prevalent side
effects in immunotherapy: cutaneous toxicity (inflammatory
dermatitis), musculoskeletal toxicities (inflammatory arthritis),
gastrointestinal toxicities (hepatitis), renal toxicities
nephritis), nervous system toxicity (peripheral neuropathy),
endocrine toxicities (hypophysis and primary hypothyroidism),
hematologic toxicities (haemolytic anemia) and lung toxicities
(pneumonitis).
These new efforts follow on the successful development of
prognostic and predictive biomarkers for prevention of rheumatoid
arthritis in collaboration with Prof. Andrew Cope, Kings College,
(APIPPRA trial)[7]. The EpiSwitch platform went beyond the
boundaries of disease diagnosis with samples from the APIPPRA trial
to prospectively identify patients who will respond, if treated
prophylactically, in the presymptomatic stage of rheumatoid
arthritis treatment with Abatacept thus minimizing or eliminating
irAEs.
Dr Alexandre Akoulitchev, CSO at OBD, said:
“Immunotherapy is bringing a revolution into the field of oncology.
Today, as the field has matured and the real-world data provides us
with better guidance on treatment utility, there is a strong
consensus emerging in the application of immunotherapy that we need
to do a better job on selecting biomarkers and developing strong
assays. The highest priority questions lie with biomarker selection
and the need for: 1) robust and accurate predictive biomarkers to
help identify potential responders among the majority of
non-responders; 2) prognostic biomarkers to identify patients most
likely to suffer IO-triggered Hyper-Progressive Disease and protect
them from harm, 3) diagnostic and prognostic biomarkers to help
correctly identify and manage the multitude of irAEs. The value of
such biomarker insights is recognized today by our industry
partners, clinical oncology clients and government programmes, such
as the Cancer Immunotherapy Response Research Platform (CIRRP) call
from the Office for Life Sciences, UK. Without good biomarkers, the
impact of side-effects and socio-economic aspects of the expensive
immunotherapy treatments will outweigh the great benefits from the
high efficacy that these new treatments can offer to the sub-group
of responsive patients. EpiSwitch biomarkers have the potential to
make a real difference in oncological practice. Early real-world
evidence from today’s US practice already attests to that.”
References
[1] Oxford BioDynamics Plc. (2023). Half-year report. HY results
link
[2] 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
[3] 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
[4] Oxford BioDynamics Plc. (2022). EpiSwitch CiRT.
https://www.mycirt.com
[5] Park, H. J.; Kim, K. W.; Won, S. E.; Yoon, S.; Chae, Y. K.;
Tirumani, S. H.; Ramaiya, N. H. (2021). Definition, Incidence, and
Challenges for Assessment of Hyperprogressive Disease during Cancer
Treatment with Immune Checkpoint Inhibitors: A Systematic Review
and Meta-analysis, JAMA Network Open, Vol. 4, No. 3.
doi:10.1001/jamanetworkopen.2021.1136
[6] Hunter, E.,, Salter, M., Powell, R., Dring, A., Naithani,
T., Vugrinec, D., Shliaiev, K., Issa, M., Weston, C., Hatton, A.,
Gebregzabhar, A., Green, J., Blum, A., Guiel, T., Fritz, S.,
Seelig, D., Modiano, J.F., Akoulitchev, A. (2024) Whole Genome 3D
Blood Biopsy Profiling of Canine Cancers: Development and
Validation of EpiSwitch Multi-Choice Array-Based Diagnostic Test
bioRxiv 2024.05.22.595358;
https://doi.org/10.1101/2024.05.22.595358
[7] Oxford BioDynamics Plc (2024). OBD and King’s College London
Collaborate on RA. LSE news link.
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
(EpiSwitch Prostate Screening test) and EpiSwitch® CiRT (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, 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, or follow OBD on Twitter
(@OxBioDynamics) and LinkedIn.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240725557683/en/
For more information:
Oxford BioDynamics Plc Jon Burrows, CEO Paul Stockdale,
CFO +44 (0)1865 518910
Shore Capital (Nominated Adviser and Broker to
OBD) Stephane Auton Lucy Bowden +44 (0)20 7408 4090
WG Partners (Joint Broker to OBD) David Wilson /
Claes Spång / Sateesh Nadarajah / Erland Sternby +44 (0)20 3705
9330
Vigo Consulting (Media / Analyst enquiries for
OBD) Rozi Morris Tel: +44 (0)20 7390 0230
obd@vigoconsulting.com
Oxford Biodynamics (LSE:OBD)
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Oxford Biodynamics (LSE:OBD)
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