Centogene N.V. (Nasdaq: CNTG), a commercial-stage company focused
on generating data-driven insights to diagnose, understand, and
treat rare diseases, announced today that it has expanded its
partnership with Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a
leader in the field of cellular metabolism developing and
delivering innovative treatments for genetically defined diseases.
Under the terms of the new agreement, CENTOGENE will provide
genetic testing and clinical trial support for Agios’ three global,
pivotal trials in thalassemia and sickle cell disease. Under a
previous agreement, CENTOGENE provided support for Agios’ pyruvate
kinase (“PK”) deficiency clinical program.
The Companies signed a commercial three-year fee-for-service
agreement. Agios will be coordinating and bearing the costs for the
programs; further financial details were not disclosed. This
collaboration will offer patients access to genetic testing to help
identify causative mutations, including HBA1, HBA2, and HBB genes.
Agios’ global clinical trials will enroll patients in North
America, Europe, MENA, APAC, and LATAM. Samples will be collected
using CENTOGENE’s proprietary CentoCard® for dried blood spot
analysis.
A key asset to the partnership is CENTOGENE’s unique rare
disease-centric Bio/Databank, which is positioned to accelerate
precise diagnosis and continue to build novel insights into the
genetic factors causing rare diseases.
“With our globally leading Bio/Databank of rare diseases, we are
the partner of choice in discovery and development of rare disease
treatments. Our data-driven insights enable both acceleration and
de-risking of clinical trials,” said Andrin Oswald, M.D., Chief
Executive Officer at CENTOGENE. “Combining both CENTOGENE’s
expertise in genetics and unique global insights will lead to a
better understanding of the disease biology of those rare diseases.
This partnership will support the advancement of Agios’
first-in-class PK activator as a potential therapy for thalassemia
and sickle cell disease, two under-served patient communities in
need of new treatment options.”
“As we look ahead to initiating three global, pivotal trials in
thalassemia and sickle cell disease by the end of the year, we are
pleased to expand our partnership with CENTOGENE to better
understand the underlying genetics of patients in our studies and
the potential impact of our investigational medicine,” said Sarah
Gheuens, M.D., Ph.D., Chief Medical Officer at Agios. “At Agios, we
know that great science requires world-class teamwork. By working
with outstanding partners like CENTOGENE, we can together
accelerate innovations that make a positive difference in patients’
lives.”
This agreement represents another significant milestone for
CENTOGENE’s mission to enable the cure of 100 rare diseases within
the next 10 years. To learn more, visit:
https://www.centogene.com/virtual-investor-event
About Thalassemia
Thalassemia is an inherited blood disorder, affecting
approximately 18,000-23,000 people in the U.S. and France, Germany,
Italy, Spain, and the United Kingdom (“EU5”), with many more in
other parts of the world. The inherited mutations in hemoglobin
genes cause the body to produce less hemoglobin than normal, which
is essential in enabling red blood cells to carry oxygen, resulting
in severe anemia and related complications.
There are two types of thalassemia, beta and alpha. Both present
in an autosomal recessive manner, and approximately 5% of the
global population has a mutation in the beta or alpha globin genes.
Some patients require chronic transfusions which can be
associated with long-term complications such as iron overload
and associated organ damage. In patients who do not
require chronic transfusions, serious
complications can also occur,
including pulmonary hypertension and thrombosis.
There have been recent therapeutic advances for
beta-thalassemia; however, unmet needs remain, and further disease
understandings and additional treatment options are needed. There
are no approved treatments for alpha-thalassemia.
About Sickle Cell Disease
Sickle cell disease is an inherited red blood cell disorder,
with approximately 120,000-135,000 people in the U.S. and EU5
affected, with many more in other parts of the world. Sickle cell
disease is caused by the presence of a mutated form of hemoglobin,
which blocks off blood vessels. As a result, blood is unable to
properly flow, which can lead to severe pain and organ damage.
Sickle cell disease is associated with serious complications,
including infection, acute chest syndrome and stroke, and can
result in shortened life expectancy. Thanks to recent advances in
research and clinical progress, there are treatment options
available today; however, patients continue to suffer from acute
and chronic pain as well as serious complications, and further
therapeutic advances are needed.
About PK Deficiency
Pyruvate kinase (PK) deficiency is a rare, inherited disease
that presents as chronic hemolytic anemia, which is the accelerated
destruction of red blood cells. The inherited mutations in the PKLR
gene cause a deficit in cellular energy within the red blood cell,
as evidenced by lower PKR enzyme activity, a decline in adenosine
triphosphate (ATP) levels, and a build-up of upstream metabolites,
including 2,3-DPG (2,3-diphosphoglycerate).
PK deficiency affects approximately 3,000-8,000 people in the
U.S. and EU5. PK deficiency may result in serious complications,
such as pulmonary hypertension, extramedullary hematopoiesis, and
osteoporosis.
There are currently no approved disease-modifying therapies for
PK Deficiency.To learn more about ongoing clinical trials, please
visit:
https://www.agios.com/patients-caregivers/clinical-trials/
About Agios
Agios is focused on discovering and developing novel
investigational medicines to treat genetically defined diseases
through scientific leadership in the field of cellular metabolism.
The company’s most advanced drug candidate is a first-in-class
pyruvate kinase R (PKR) activator, mitapivat, that is currently
being evaluated for the treatment of three distinct hemolytic
anemias. In addition to its active late-stage clinical pipeline,
Agios has multiple novel, investigational therapies in clinical and
preclinical development. For more information, please visit the
company’s website at www.agios.com.
About CENTOGENE
CENTOGENE engages in diagnosis and research around rare diseases
transforming real-world clinical, genetic, and multiomic data to
diagnose, understand, and treat rare diseases. Our goal is to bring
rationality to treatment decisions and to accelerate the
development of new orphan drugs by using our extensive rare disease
knowledge and data. CENTOGENE has developed a global proprietary
rare disease platform based on our real-world data repository with
over 3.9 billion weighted data points from approximately 600,000
patients representing over 120 different countries.
The Company’s platform includes epidemiologic, phenotypic, and
genetic data that reflects a global population, as well as a
biobank of patients’ blood samples and cell cultures. CENTOGENE
believes this represents the only platform focused on comprehensive
analysis of multi-level data to improve the understanding of rare
hereditary diseases. It allows for better identification and
stratification of patients and their underlying diseases to enable
and accelerate discovery, development, and access to orphan drugs.
As of December 31, 2020, the Company collaborated with over 30
pharmaceutical partners.
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Forward-Looking Statement
This press release contains “forward-looking statements” within
the meaning of the U.S. federal securities laws. Statements
contained herein that are not clearly historical in nature are
forward-looking, and the words “anticipate,” “believe,”
“continues,” “expect,” “estimate,” “intend,” “project,” and similar
expressions and future or conditional verbs such as “will,”
“would,” “should,” “could,” “might,” “can,” and “may,” are
generally intended to identify forward-looking statements. Such
forward-looking statements involve known and unknown risks,
uncertainties, and other important factors that may cause
CENTOGENE’s actual results, performance, or achievements to be
materially different from any future results, performance, or
achievements expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others,
negative worldwide economic conditions and ongoing instability and
volatility in the worldwide financial markets, the effects of the
COVID-19 pandemic on our business and results of operations,
possible changes in current and proposed legislation, regulations
and governmental policies, pressures from increasing competition
and consolidation in our industry, the expense and uncertainty of
regulatory approval, including from the U.S. Food and Drug
Administration, our reliance on third parties and collaboration
partners, including our ability to manage growth and enter into new
client relationships, our dependency on the rare disease industry,
our ability to manage international expansion, our reliance on key
personnel, our reliance on intellectual property protection,
fluctuations of our operating results due to the effect of exchange
rates, or other factors. For further information on the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to CENTOGENE’s business in general, see CENTOGENE’s risk
factors set forth in CENTOGENE’s Form 20-F filed on April 15, 2021,
with the Securities and Exchange Commission (the “SEC”) and
subsequent filings with the SEC. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and CENTOGENE’s specifically disclaims any obligation to update any
forward-looking statement, whether as a result of new information,
future events, or otherwise.
Media Contact:
CENTOGENE
Ben Legg
Corporate Communications
Ben.Legg@centogene.com
Lennart Streibel
Investor Relations
Investor.Relations@centogene.com
FTI Consulting
Robert Stanislaro
robert.stanislaro@fticonsulting.com
Rachel Kleiman
rachel.kleiman@fticonsulting.com
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