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Oxford BioDynamics PLC
02 May 2023
Oxford BioDynamics Plc
Oxford Biodynamics granted US Foundation of NIH PACT Award for
prognosis of cancer patients with IO-triggered Hyper-Progressive
Disease
-- Recipient of a PACT Award worth $963,000 to help reduce to
practice a blood-test for prognosis of patients with IO-triggered
Hyper-Progressive Disease (HPD)
-- HPD is an acute and highly adverse/potentially fatal reaction
to Immunotherapy with checkpoint inhibitors
-- This is the second Foundation of NIH PACT award for OBD in two years
-- OBD's EpiSwitch 3D genomics platform is well--recognized and
supported amongst the PACT consortium's pharmaceutical
stakeholders
Oxford, UK - 02 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
that it has been granted the FNIH Partnership for Accelerating
Cancer Therapies (PACT) Award to reduce to practice the EpiSwitch
test for prognosis of acute adverse response to immune checkpoint
inhibitor (ICI) therapy associated with IO-triggered
Hyper-Progressive disease (HPD).
The award worth $963,000 follows the Company's successful
execution of a $910,000 grant awarded in August 2021 [1]. The
prestigious award is executed by the Foundation for the National
Institutes of Health (FNIH), a US not--for--profit organization
managing the pre-competitive collaboration between the National
Institutes of Health (NIH), National Cancer Institute (NCI), US
Food and Drug Administration (US--FDA), and 12 leading
pharmaceutical companies comprising AbbVie, Amgen,
Boehringer--Ingelheim, Bristol--Myers Squibb, Celgene,
Genentech/Roche, Gilead, GlaxoSmithKline, Janssen, Novartis (NIBR),
Sanofi, and Pfizer, as part of the Beau Biden Cancer Moonshot(TM)
Initiative accelerating cancer research [2]. PACT's primary goal is
to provide a systematic approach to cancer biomarker investigation
in clinical trials by supporting the development of standardized
biomarkers and assays.
Immuno--oncology (IO) has offered a breakthrough in cancer
management, with some of the most efficacious examples of
treatment. Immune checkpoint inhibitors (ICIs) block checkpoint
proteins, such as the PD-1 receptor and its ligand PD-L1, from
binding with one another. This helps to reset a patient's immune
system, which in turn enables the host's system to effectively
fight cancer cells.
However, a subgroup of patients with a specific immune profile,
termed Hyper-Progressive Disease, react to ICIs treatment with
accelerated tumor growth rates and significantly reduced overall
survival. In an analysis of 24 studies and 3,109 patients, the
incidence of HPD averaged close to 12% [3]. To fully benefit from
the advantages of ICI cancer therapies, and to efficiently manage
cancer patients and clinical trials alike, an early prognosis of
HPD has been one of the long outstanding clinical needs. Since the
onset of the first ICI trials, there has been an acute shortage of
biomarker tools to help identify potential hyper-progressors. Now,
based on the results of the prototype Hyper-ICI Response Test
(HiRT), this PACT Award will support the reduction to practice of
the test, which will identify a common profile of the Hyper
Progressive Disease in blood, well before starting ICI therapy.
OBD's EpiSwitch 3D genomics platform is well--known amongst the
consortium's pharmaceutical companies and has been used for
practical patient stratification in prognostic, predictive and
early diagnostic applications across immuno--oncology, autoimmune
and neurodegenerative indications [6].
Dr Stacey Adam, Associate Vice President, Science Partnerships
at the FNIH, said: "Oxford BioDynamics has demonstrated its
expertise in end-to-end biomarker development with its first PACT
award. Today, the PACT partners are pleased to show their support
once again, this time to enable a non--invasive and more accurate
risk assessment of patients having a hyper-progressive disease
prognostic profile when being considered for immunotherapy."
Thomas Guiel, COO of Oxford BioDynamics, said: "The recognition
of the EpiSwitch(R) platform for a second time by the consortium of
US federal agencies and top pharmaceutical stakeholders is another
validation of OBD's ability to address the clinical challenges of
personalized medicine, cancer treatment, and immune health using
our 3D genomics technology and knowledgebase.
"Hyper-progressive response to immunotherapy has been, for too
long, a festering challenge on the side of the otherwise highly
successful IO field. Without any prognostic tools, it has become "a
bridge too far" for the biomarker industry. We are determined to
cross that bridge now for the benefit of the whole industry and
patient community."
-Ends-
References
[1] 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
[2] Foundation for the National Institutes of Health (last
accessed March 2023). Partnership for Accelerating Cancer Therapies
(PACT).
https://fnih.org/our-programs/partnership-accelerating-cancer-therapies-pact
[3] Park, H. J., et al. (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.
https://doi.org/10.1001/jamanetworkopen.2021.1136
[4] Oxford BioDynamics Plc. (2022). EpiSwitch CiRT.
https://www.mycirt.com
[5] 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
[6] Oxford BioDynamics plc. (last accessed March 2023).
Publications.
https://www.oxfordbiodynamics.com/media-center/publications
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 PACT
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, it is overseen by the Foundation for the National
Institutes of Health. The pharma 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 creates and
manages alliances with public and private institutions in support
of the mission of the NIH, the world's premier medical research
agency. The Foundation, also known as the FNIH, works with its
partners to accelerate biomedical research and strategies against
diseases and health concerns in the United States and across the
globe. The FNIH organizes and administers research projects;
supports education and training of new researchers; organizes
educational events and symposia; and administers a series of funds
supporting a wide range of health issues. Established by Congress,
the FNIH is a not--for--profit 501(c)(3) charitable organization.
For additional information about the FNIH, please visit fnih.org
.
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