SAN DIEGO and GERMANTOWN, Md. and HILDEN, Germany, Dec. 9,
2021 /PRNewswire/ -- Denovo Biopharma LLC and QIAGEN
(NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a
collaboration to develop a blood-based companion diagnostic (CDx)
test to identify patients expressing Denovo Genomic Marker 1
(DGM1™) who are likely to respond to Denovo's
investigational cancer drug DB102™ 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 (DGM1™) 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.
"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 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.
"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."
About DB102
DB102 (enzastaurin) is an orally available
first-in-class investigational small molecule, as a
serine/threonine kinase inhibitor of the PKC-beta, PI3K, and AKT
pathways, that has been studied in over 3,000 patients with a range
of solid and hematological tumor types. Enzastaurin was originally
developed by Eli Lilly & Co., and for which Denovo has acquired
worldwide rights. Denovo discovered the novel pharmacogenomic
biomarker DGM1 and is conducting a Phase 3 trial in patients
with newly-diagnosed DLBCL and another Phase 3 trial in
newly-diagnosed glioblastoma multiforme (GBM). Enzastaurin received
Fast Track Designation for GBM from the FDA, Orphan Drug
Designation for DLBCL and GBM from the FDA, and Orphan Medicinal
Product Designation for DLBCL and GBM from the EMA.
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.
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.
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).
Contacts:
Denovo Biopharma LLC
Michael
F. Haller, Ph.D.
Chief Business Officer and Head of US Finance
e-mail: mhaller@denovobiopharma.com
QIAGEN
Investor
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John
Gilardi
Phoebe Loh
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+49 2103 29
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+49 2103 29
11457
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Thomas
Theuringer
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+49 2103 29
11826
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e-mail:
ir@QIAGEN.com
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