Exagen Inc. and Queen Mary University of London Announce Exclusive License and Collaboration to Develop Novel Patented Molecular Signatures for Rheumatoid Arthritis Biologic Therapeutic Selection
January 09 2022 - 12:00PM
Exagen Inc. (Nasdaq: XGN), a leading provider of
autoimmune testing solutions, and Queen Mary University of London,
announced today the execution of a research collaboration and
exclusive license agreement. The collaboration will focus on
development and optimization of patent-pending precision medicine
approaches, based on RNA expression signatures, to personalize
therapeutic agent selection for rheumatoid arthritis (RA) patients.
Both parties will contribute to the development of the
patent-pending assays, leading to the commercialization of novel
molecular assays that segment patients according to gene expression
in their synovial tissue biopsies.
RA is estimated to affect approximately two million patients in
the United States and be twice as prevalent in women as in men and
can be difficult to manage due to the variability in treatment
response from patient to patient. Therapeutic agent selection for
RA patients remains a significant unmet need. RA patients often try
multiple therapies empirically before they find one that lowers
their disease activity. The placement of an RA patient on an
ineffective therapy risks progression and worsening of the disease,
further damage to the joints, and significant wasted spend on
expensive therapeutic agents. There are currently no reliable
assays for predicting positive patient response prior to the
selection of commonly prescribed biological therapeutic agents.
Building on Prof. Costantino Pitzalis and Dr. Myles Lewis’s
molecular pathology definition of disease evolution and treatment
response, Exagen has acquired an exclusive global license to a
family of patent-pending assays pertaining to RNA expression
patterns used in the prediction of patient response to commonly
prescribed csDMARD and biological therapeutics for RA. The assays
utilize minimally invasive synovial tissue biopsies as input, which
are then assessed for RNA expression data. These data are then run
through proprietary algorithms that provides actionable insights on
predicted csDMARD and biological therapeutic response for RA
patients based on an individual patient’s RNA expression
patterns.
Prof. Pitzalis, Versus Arthritis Professor of Rheumatology and
Deputy Director at the William Harvey Research Institute, Barts and
The London School of Medicine and Dentistry, Queen Mary University
of London stated, “I am excited to be part of this research
collaboration with Exagen and am very much looking forward to
contributing to the development of diagnostics aimed at bringing
molecular pathology into clinical algorithms to better define the
specific pathways driving disease diversity in individual patients.
This would better inform clinicians on patients’ prognosis and
enhance their ability to make informed decisions on drug
prescribing. Exagen’s track record in bringing diagnostics to the
market takes this opportunity to a completely new level, making the
promise of precision medicine closer to clinical
implementation.”
Prof. Pitzalis is a leading authority on rheumatoid arthritis.
He leads a team of 50 clinical researchers and is the author of
over 300 peer-reviewed publications in the field of inflammation,
immunity, and arthritis. Prof. Pitzalis formulated this
groundbreaking approach to gene expression patterns together with
Dr. Myles Lewis, head of the bioinformatics/biostatistics group at
the Centre for Experimental Medicine and Rheumatology. “We are
excited to work with Prof. Pitzalis and Dr. Lewis at Queen Mary
University of London to accelerate the development of their
highly-innovative RNA-based biomarker assays to better serve RA
patients. Prof. Pitzalis is a well-respected thought leader in the
field of arthritis research, and Exagen is enthusiastically looking
forward to collaborating with his group to bring exciting and
groundbreaking products forward to improve the care continuum for
rheumatoid arthritis patients,” said Ron Rocca, President and CEO
of Exagen Inc. “Exagen is committed to developing and
commercializing these assays to inform treatment decisions
throughout the RA patient journey. We intend to market the new
assays as AVISE® RADR (rheumatoid arthritis drug
response).”
For further information on AVISE® RADR please visit
https://exagen.com/tests/avise-radr/.
About Exagen Inc.
Exagen is dedicated to transforming the care continuum for
patients suffering from debilitating and chronic autoimmune
diseases by enabling timely differential diagnosis and optimizing
therapeutic intervention. Exagen has developed and is
commercializing a portfolio of innovative testing products under
its AVISE® brand, several of which are based on our proprietary
Cell-Bound Complement Activation Products, or CB-CAPs, technology.
Exagen’s goal is to enable providers to improve care for patients
through the differential diagnosis, prognosis and monitoring of
complex autoimmune and autoimmune-related diseases, including
rheumatoid arthritis and lupus. For further information please
visit www.exagen.com.
About Queen Mary University of London
and Queen Mary Innovation Ltd
Queen Mary University of London is a world-leading
research-intensive university with over 28,000 students
representing more than 160 nationalities.
A member of the prestigious Russell Group, we work across the
humanities and social sciences, medicine and dentistry, and science
and engineering, with inspirational teaching directly informed by
our research.
In the most recent Research Excellence Framework, we were ranked
5th in the country for the proportion of research outputs that were
world-leading or internationally excellent. We offer more than 240
degree programmes and our reputation for excellent teaching was
rewarded with a silver in the 2017 Teaching Excellence Framework
(TEF) awards.
Queen Mary Innovation Ltd (QMI) is Queen Mary’s
wholly-owned technology transfer company and is responsible for the
commercialisation and management of the University’s intellectual
property and portfolio of spinout companies. QMI protects and
exploits Queen Mary’s research-derived intellectual property and
helps to maximise the economic and societal impact of that
research. QMI’s Associate Commercialisation Director Biopharma, Dr.
Michele Hill-Perkins, led the negotiation and licence transaction
for QMUL.
For further information on QMI please visit
http://www.qminnovation.co.uk.
Forward Looking Statements
Exagen cautions you that statements in this press release
regarding matters that are not historical facts are forward-looking
statements. These statements are based on Exagen's current beliefs
and expectations. Such forward-looking statements include, but are
not limited to, statements regarding the expected benefits of the
collaboration with Queen Mary University of London and any
potential development and commercialization of novel patented
molecular signatures for diagnosis, prognosis and monitoring of
autoimmune diseases. The inclusion of forward-looking statements
should not be regarded as a representation by Exagen that any of
its plans will be achieved. Actual results may differ from those
set forth in this press release due to the risks and uncertainties
inherent in Exagen’s business, including, without limitation:
developing new molecular signatures involves a lengthy and complex
process, and the collaboration may not lead to novel patented
molecular signatures or generate significant commercial testing
products on a timely basis, or at all; the COVID-19 pandemic may
continue to adversely affect our business, financial condition and
results of operations, including our collaboration and development
activities; risks associated with maintaining the collaboration and
license agreement; and other risks described in the company’s prior
press releases and Exagen’s filings with the Securities and
Exchange Commission (SEC), including under the heading “Risk
Factors” in Exagen’s Annual Report on Form 10-K and any subsequent
filings with the SEC. You are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date hereof, and Exagen undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date hereof. All forward-looking statements are qualified
in their entirety by this cautionary statement, which is made under
the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995.
Investor RelationsExagen Inc. Ryan
Douglasrdouglas@exagen.com 760.560.1525
CompanyExagen Inc.Kamal Adawi, Chief Financial
Officerkadawi@exagen.com
760.477.5514
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