QIAGEN and Denovo Biopharma Partner to Develop Companion Diagnostic Test for the Treatment of Diffuse Large B-Cell Lymphoma (DLBCL)
09 December 2021 - 5:30PM
Business Wire
- QIAGEN’s blood-based test
will help to identify patients with Diffuse Large B-Cell Lymphoma
(DLBCL) likely to respond to Denovo’s new investigational cancer
treatment DB102TM
- The partners seek FDA
premarket approval (PMA) of the companion diagnostic test in tandem
with the new drug application (NDA) approval.
- New master collaboration
agreement adds to QIAGEN’s oncology testing portfolio, further
strengthening its leading position in precision
medicine
QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Denovo
Biopharma LLC today announced a collaboration to develop a
blood-based companion diagnostic (CDx) test to identify patients
expressing Denovo Genomic Marker 1 (DGM1TM) who are likely to
respond to Denovo’s investigational cancer drug DB102TM for
treatment of diffuse large B-cell lymphoma (DLBCL), one of the most
common lymphoid cancers.
Under the agreement, QIAGEN will develop a diagnostic assay that
can detect the Denovo Genomic Marker 1 (DGM1TM) in DLBCL patients,
a biomarker discovered by Denovo that predicts the responsiveness
to DB102. Also known as enzastaurin, Denovo’s drug is a
first-in-class investigational small molecule inhibitor of
PKC-beta, a protein whose presence has been compellingly linked to
DLBCL cases.
“We are proud to be at the cutting edge of precision medicine, a
quantum leap from traditional one-drug-fits all medicine,” said
Jonathan Arnold, Vice President, Head of Oncology and Precision
Diagnostics at QIAGEN. “Our molecular testing expertise will help
Denovo to develop the use of the DGM1 marker with the DB102 drug
for patients with DLBCL.”
QIAGEN will develop a real-time qualitative PCR companion
diagnostic for the QIAGEN Rotor-Gene Q MDx instrument and apply for
premarket approval (PMA) with the US-based Food and Drug
Administration (FDA). The goal is to get the PMA for the test
contemporaneously with Denovo receiving new drug application (NDA)
approval for its DB102. The drug and the DGM1 marker are currently
in a phase III trial, called ENGINE, on newly diagnosed, high-risk
DLBCL patients.
“As our ENGINE trial nears completion, we are pleased to be
working with QIAGEN on commercial development of our DB102 program
to enable patients and physicians to potentially benefit from DB102
treatment,” said Xiao-Xiong Lu, Denovo’s Chief Technology Officer.
“As a pioneer in precision medicine QIAGEN brings extensive
experience in companion diagnostics, including ten FDA-approved
tests.”
QIAGEN is 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. The company has an unmatched depth and breadth of
technologies from next-generation sequencing (NGS) to polymerase
chain reaction (PCR) for companion diagnostic development. Its ten
PCR-based CDx tests with FDA approval include therascreen EGFR for
non-small cell lung cancer, therascreen KRAS for colorectal cancer,
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 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.
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),
Applied Testing (primarily forensics), Pharma (pharma and biotech
companies) and Academia (life sciences research). As of September
30, 2021, QIAGEN employed approximately 6,000 people in over 35
locations worldwide. Further information can be found at
www.qiagen.com.
About Denovo Biopharma
Denovo Biopharma LLC is a clinical-stage biopharmaceutical
company that uses novel biomarker approaches to re-evaluate
medicines that have failed in broad patient populations. The
company seeks to discover genomic biomarkers correlated with
patients' responses to drug candidates retrospectively. Denovo then
designs and executes efficient clinical trials in targeted patient
populations to optimize the probability of a successful trial.
Denovo has completed enrollment of patients in the US and China
with DLBCL in a Phase 3 clinical trial and has an ongoing Phase 3
trial in GBM for its lead product candidate, DB102 (enzastaurin),
which was in-licensed from Eli Lilly & Co. The company has
seven additional late-stage programs targeting major unmet medical
needs: DB103 (pomaglumetad methionil) for schizophrenia, DB104
(liafensine) for depression, DB105 (ORM 12741) for Alzheimer’s
Disease, DB106 (vosaroxin) for acute myeloid leukemia (AML), DB107
(Toca 511/Toca FC) for recurrent high grade glioma, DB108
(endostatin) for non-small cell lung cancer (NSCLC), and DB109
(idalopirdine) for Alzheimer’s Disease. For additional information
please visit www.denovobiopharma.com.
Forward-Looking Statement QIAGEN
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).
Category: Corporate
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QIAGEN
Investor Relations John Gilardi +49 2103 29 11711 Phoebe
Loh +49 2103 29 11457 e-mail: ir@QIAGEN.com
Public Relations Thomas Theuringer +49 2103 29 11826
e-mail: pr@QIAGEN.com
Denovo
Michael F. Haller, Ph.D. Chief Business Officer and Head of US
Finance e-mail: mhaller@denovobiopharma.com
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