Collaboration combines leading expertise of
Neuron23 in drug discovery, data science, and machine learning with
QIAGEN's long-standing experience in companion diagnostic
development
SOUTH
SAN FRANCISCO, Calif. and GERMANTOWN, Md. and HILDEN, Germany, Sept. 14,
2022 /PRNewswire/ -- Neuron23™ Inc., an early stage
biotechnology company focused on developing precision medicines for
genetically defined neurological and immunological diseases, and
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced
a collaboration to develop a companion diagnostic for Neuron23's
LRRK2 inhibitor for Parkinson's disease.
Under the Master Collaboration Agreement, QIAGEN will develop
and validate a clinical trial assay that will detect a combination
of biomarkers discovered by Neuron23 that together predict the
responsiveness of Parkinson's disease patients to a LRRK2
inhibitor. The partnership will support the clinical development of
Neuron23's drug candidate that is currently in the late stages of
preclinical development. Subject to further clinical development,
the agreement also covers options for the future development of
additional companion diagnostics.
The assay for this collaboration will be integrated into a
next-generation sequencing (NGS) workflow that leverages QIAGEN's
Sample to Insight capabilities. Parallel development of the
diagnostic assay and the therapeutic will allow the companies to
submit the application to the U.S. Food and Drug Administration
(FDA) for premarket approval (PMA) of the NGS companion diagnostic
test in tandem with the new drug application (NDA) for Neuron23's
LRRK2 inhibitor.
"We are excited about this partnership as this is the first
companion diagnostic to be developed for Parkinson's disease. This
collaboration combines the leading expertise of Neuron23 in drug
discovery, data science, and machine learning with QIAGEN's
long-standing experience and global leadership in companion
diagnostic development," said Nancy
Stagliano, Ph.D., CEO of Neuron23. "QIAGEN's blood-based
test will help to identify patients with Parkinson's disease who
are likely to respond to Neuron23's LRRK2 inhibitor. The
development of a companion diagnostic identifying this
sub-population of Parkinson's disease patients will de-risk the
clinical development of Neuron23's LRRK2 inhibitor and help
identify individuals who may benefit from this disease-modifying
therapy. We are excited to be working with an industry leader on
the first companion diagnostic developed for Parkinson's
disease."
"The collaboration with Neuron23 shows the rapid momentum
precision medicine is gaining in disease areas outside oncology,"
said Jonathan Arnold, Vice
President, Head of Oncology and Precision Diagnostics at QIAGEN.
"Our expertise in blood- and NGS-based molecular testing from
Sample to Insight will enable Neuron23 to run a clinical trial for
a drug candidate that may have the potential to modify the course
of an inexorable neurodegenerative disease in a genetically defined
population."
LRRK2 is a complex, multidomain protein found in neurons and
many other tissues and cell types throughout the body. Mutations in
the LRRK2 gene are one of the most common causes of familial
Parkinson's disease and individuals who inherit gain of function
mutations in LRRK2 are clearly at higher risk to develop the
disease in later life. Additionally, there is emerging evidence
that LRRK2 activity may play a role in a subset of the larger
population of patients with non-familial Parkinson's disease.
Recent investigations have shown that small-molecule LRRK2
inhibitors can be neuroprotective, suggesting that therapies
targeting LRRK2 could be beneficial in a larger population of
patients.
No laboratory tests are currently available for the diagnosis of
non-genetic cases for Parkinson's disease. Usually, the disease is
diagnosed based on medical history and neurological
examination. Although no cure currently exists for Parkinson's
disease, therapies are used to alleviate some symptoms.
QIAGEN is a pioneer in Precision Medicine and the global leader
in collaborations with pharmaceutical and biotechnology companies
to co-develop companion diagnostics, which detect clinically
relevant genetic abnormalities to provide insights that guide
clinical decision-making in diseases such as cancer. QIAGEN has an
unmatched depth and breadth of technologies from NGS to polymerase
chain reaction (PCR) and digital PCR (dPCR) for companion
diagnostic development. QIAGEN has ten PCR based companion
diagnostic indications that are FDA approved, including
therascreen EGFR for non-small cell lung cancer (NSCLC),
therascreen KRAS for colorectal cancer and NSCLC,
therascreen FGFR for urothelial cancer, therascreen
PIK3CA for breast cancer based on tissue or plasma samples and the
therascreen BRAF kit for colorectal cancer.
Currently, QIAGEN is working under master collaboration
agreements with more than 25 leading pharmaceutical and
biotechnology companies to develop and commercialize companion
diagnostic tests for their drug candidates – a deep pipeline of
potential future products to advance Precision Medicine for the
benefit of patients.
Financial terms of the agreement were not disclosed.
About Neuron23™
Neuron23™ Inc. is an early stage
biotechnology company focused on developing precision medicines for
genetically defined neurological and immunological diseases.
Neuron23 combines recent advances in human genetics with a
state-of-the-art artificial intelligence (AI)-enabled drug
discovery and biomarker platform to advance therapeutics for
devastating diseases. The Company's focus areas are
neurodegenerative diseases, neuroinflammatory
diseases, and systemic autoimmune and
inflammatory diseases. Founded in 2018, Neuron23 has assembled a
world-class team of experts and entrepreneurs located in
South San Francisco, CA. For more
information, please visit www.neuron23.com.
About QIAGEN
QIAGEN N.V., a
Netherlands-based holding company,
is the leading global provider of Sample to Insight solutions that
enable customers to gain valuable molecular insights from samples
containing the building blocks of life. Our sample technologies
isolate and process DNA, RNA and proteins from blood, tissue and
other materials. Assay technologies make these biomolecules
visible and ready for analysis. Bioinformatics
software and knowledge bases interpret data to report
relevant, actionable insights. Automation solutions tie these
together in seamless and cost-effective workflows. QIAGEN
provides solutions to more than 500,000 customers around the
world in Molecular Diagnostics (human healthcare) and Life Sciences
(academia, pharma R&D and industrial applications,
primarily forensics). As of June 30,
2022, QIAGEN employed more than 6,100 people in
over 35 locations worldwide. Further information can be found at
http://www.qiagen.com.
QIAGEN Forward-Looking Statement
Certain statements
contained in this press release may be considered forward-looking
statements within the meaning of Section 27A of the U.S. Securities
Act of 1933, as amended, and Section 21E of the U.S. Securities
Exchange Act of 1934, as amended. To the extent that any of the
statements contained herein relating to QIAGEN's products,
collaborations markets, strategy or operating results, including
without limitation its expected adjusted net sales and adjusted
diluted earnings results, are forward-looking, such statements are
based on current expectations and assumptions that involve a number
of uncertainties and risks. Such uncertainties and risks include,
but are not limited to, risks associated with management of growth
and international operations (including the effects of currency
fluctuations, regulatory processes and dependence on logistics),
variability of operating results and allocations between customer
classes, the commercial development of markets for our products to
customers in academia, pharma, applied testing and molecular
diagnostics; changing relationships with customers, suppliers and
strategic partners; competition; rapid or unexpected changes in
technologies; fluctuations in demand for QIAGEN's products
(including fluctuations due to general economic conditions, the
level and timing of customers' funding, budgets and other factors);
our ability to obtain regulatory approval of our products;
difficulties in successfully adapting QIAGEN's products to
integrated solutions and producing such products; the ability of
QIAGEN to identify and develop new products and to differentiate
and protect our products from competitors' products; market
acceptance of QIAGEN's new products and the integration of acquired
technologies and businesses. For further information, please refer
to the discussions in reports that QIAGEN has filed with, or
furnished to, the U.S. Securities and Exchange Commission
(SEC).
View original content to download
multimedia:https://www.prnewswire.com/news-releases/neuron23-and-qiagen-announce-collaboration-to-develop-the-first-next-generation-sequencing-companion-diagnostic-for-novel-parkinsons-disease-drug-301623586.html
SOURCE Neuron23