Novo Nordisk enters into research collaborations with Omega
Therapeutics and Cellarity on novel treatment approaches for
cardiometabolic diseases
- Omega collaboration will leverage
the company’s platform to develop an epigenomic controller as part
of a new approach to obesity management
- Cellarity collaboration will build
upon initial work and engage the company’s platform to develop a
small molecule therapy in metabolic dysfunction-associated
steatohepatitis (MASH)
- First two research programmes signed
under existing partnership between Novo Nordisk and Flagship
Pioneering
- Novo Nordisk will reimburse R&D
costs and each company and Flagship’s Pioneering Medicines are
eligible to receive up to 532 million US dollars in upfront and
milestone payments, as well as tiered royalties
Bagsværd, Denmark, Cambridge, Mass., and Somerville,
Mass. 4 January, 2024 – Novo Nordisk, Omega Therapeutics,
Inc. (Nasdaq: OMGA) (“Omega”) and Cellarity Inc. today announced
that Novo Nordisk has entered into separate research collaborations
with each company. The Omega collaboration will leverage its
proprietary platform technology to develop an epigenomic controller
designed to enhance metabolic activity as a part of a potential new
treatment approach for obesity management. The Cellarity
collaboration aims to unravel novel biological drivers of MASH and
will leverage Cellarity’s platform to develop a small molecule
therapy against this disease.
These are the first two programmes signed under the framework
collaboration between Flagship Pioneering and Novo Nordisk to
leverage Flagship’s bioplatform companies to develop novel
treatment approaches for cardiometabolic diseases.
“This is an important moment in our partnership with Flagship
Pioneering. We look forward to advancing these research programmes
with Omega and Cellarity in the coming years as we explore bold new
treatment strategies with the potential to make a significant
impact for people living with obesity or MASH,” said Marcus
Schindler, executive vice president and chief scientific officer at
Novo Nordisk. “Novo Nordisk is committed to advancing new treatment
options for people living with cardiometabolic diseases. To that
end, it is essential that we complement our internal research with
external innovation and work with partners who are bringing forward
cutting-edge technology. Both companies offer differentiated and
novel approaches, including Omega’s expertise in controlled
epigenomic modulation and Cellarity’s deep insights into applying
human data and artificial intelligence to the development of new
medicines.”
Harnessing epigenomic control as a new treatment
approach for obesity managementGlobally, there are more
than 800 million adults living with obesity1. Many of the existing
therapeutic interventions for weight management have focused on
appetite regulation. Thermogenesis, the production of heat within
tissues to raise body temperature, is a natural metabolic function
that critically regulates overall energy balance.
By harnessing the human body’s innate mechanisms to control
cellular identity and gene expression, Omega’s proprietary platform
has the potential to create an epigenomic controller designed to
enhance thermogenesis, and therefore metabolic activity.
“Precision epigenomic control is an emerging approach to
medicine that allows us to pre-transcriptionally modulate gene
expression with an unparalleled level of specificity,” said Mahesh
Karande, president and CEO of Omega Therapeutics. “By leveraging
Novo Nordisk’s deep expertise in the space and our OMEGA platform,
we have the opportunity to tap into the body’s natural processes
that control metabolic activity and potentially develop an
alternative, more durable approach to obesity management.”
Deciphering complex disease biology to develop a
transformative medicine for MASHMASH is a chronic and
progressive liver disease with high unmet patient need for which
there is currently no approved treatment. MASH is a leading cause
of chronic liver disease that can progress to liver failure or
require transplantation, and people living with MASH are at
increased risk of developing type 2 diabetes and cardiovascular
disease.
Cellarity has developed unique capabilities to link biology and
chemistry with high dimensional, transcriptomic data to generate
medicines against the cellular signatures of disease. Using
proprietary AI models, the Cellarity platform provides novel
insights into cellular dysfunction and enables the design of drugs
previously inaccessible with traditional methods of drug
discovery. In September 2022, Novo Nordisk engaged Cellarity
to identify novel cell behaviors implicated in MASH disease
progression. The research collaboration expands on this initial
work and will further leverage Cellarity’s platform to develop a
small molecule therapy.
“Cellarity is developing a new paradigm in drug creation by
harnessing the power of AI and multiomics data,” said Fabrice
Chouraqui, Pharm.D., CEO of Cellarity and a CEO-partner at Flagship
Pioneering. “Our partnership with Novo Nordisk, the world leader in
metabolic disease, creates a unique opportunity for application of
our platform to identify novel vantage points into the progression
of MASH and develop a transformative small molecule therapy against
this debilitating disease.”
First two programmes under Flagship framework
collaborationThe previously announced partnership brings
together Novo Nordisk’s Bio Innovation Hub, an R&D unit
designed to accelerate the development of therapeutics via
co-creative partnerships with academia, biotechs, and venture
capital groups, and Pioneering Medicines, Flagship’s drug
development initiative leveraging Flagship Pioneering’s unique
ecosystem of bioplatform capabilities.
“These collaboration agreements with Omega and Cellarity are an
exciting demonstration of how our partnership with Novo Nordisk is
leveraging the unique bioplatform technologies within the Flagship
ecosystem to develop potentially transformational medicines,” said
Paul Biondi, president, Pioneering Medicines, and executive
partner, Flagship Pioneering. “By bringing these innovative
platforms together with Novo Nordisk’s deep expertise in
cardiometabolic disease we have incredible potential to make a
bigger leap forward for patients.”
Each company, Novo Nordisk and Pioneering Medicines will jointly
advance these respective programmes through preclinical development
and conduct foundational activities, after which point Novo Nordisk
could advance the programmes into clinical studies. Under the terms
of the respective agreements, Novo Nordisk will reimburse R&D
costs. Additionally, each agreement may pay up to 532 million
dollars in upfront, development and commercial milestone payments,
as well as tiered royalties on annual net sales of a licensed
product, to be shared between the respective companies and
Flagship’s Pioneering Medicines.
About Novo NordiskNovo Nordisk is a leading
global healthcare company, founded in 1923 and headquartered in
Denmark. Our purpose is to drive change to defeat serious chronic
diseases, built upon our heritage in diabetes. We do so by
pioneering scientific breakthroughs, expanding access to our
medicines, and working to prevent and ultimately cure disease. Novo
Nordisk employs about 61,400 people in 80 countries and markets its
products in around 170 countries. For more information, visit
novonordisk.com, Facebook, Instagram, X, LinkedIn and YouTube.
About Omega TherapeuticsOmega Therapeutics is a
clinical-stage biotechnology company pioneering the development of
a new class of programmable epigenomic mRNA medicines to treat or
cure a broad range of diseases. By pre-transcriptionally modulating
gene expression, Omega’s approach enables controlled epigenomic
modulation of nearly all human genes, including historically
undruggable and difficult-to-treat targets, without altering native
nucleic acid sequences. Founded in 2017 by Flagship Pioneering
following breakthrough research by world-renowned experts in the
field of epigenetics, Omega is led by a seasoned and accomplished
leadership team with a track record of innovation and operational
excellence. The Company has a diverse pipeline of therapeutic
candidates derived from its OMEGA platform spanning oncology,
regenerative medicine, multigenic diseases including immunology,
and select monogenic diseases.
For more information, visit omegatherapeutics.com, or
follow us on X and LinkedIn.
About the OMEGA Platform The OMEGA
platform leverages the Company’s deep understanding of gene
regulation, genomic architecture and epigenetic mechanisms to
design programmable epigenomic mRNA medicines that precisely target
and modulate gene expression at the pre-transcriptional level.
Combining a biology-first approach and world-class data science
capabilities with rational drug design and customized delivery, the
OMEGA platform enables control of fundamental epigenetic processes
to correct the root cause of disease by returning aberrant gene
expression to a normal range. Omega’s modular and programmable mRNA
medicines, called epigenomic controllers, target specific genomic
loci within insulated genomic domains with high specificity to
durably tune single or multiple genes to treat and cure diseases
through unprecedented precision epigenomic control.
Omega Forward-Looking Statements This
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995.
All statements contained in this press release that do not relate
to matters of historical fact should be considered forward-looking
statements, including without limitation statements regarding the
research collaboration with Novo Nordisk and the development of a
programmable epigenomic mRNA candidate designed to increase
metabolic activity and support weight management; the potential of
the OMEGA platform to engineer programmable epigenomic mRNA
therapeutics that successfully regulate gene expression by
targeting insulated genomic domains; and expectations surrounding
the potential of Omega’s product candidates. These statements are
neither promises nor guarantees, but involve known and unknown
risks, uncertainties and other important factors that may cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements, including,
but not limited to, the following: the novel technology on which
our product candidates are based makes it difficult to predict the
time and cost of preclinical and clinical development and
subsequently obtaining regulatory approval, if at all; the
substantial development and regulatory risks associated with
epigenomic controllers due to the novel and unprecedented nature of
this new category of medicines; our limited operating history; the
incurrence of significant losses and the fact that we expect to
continue to incur significant additional losses for the foreseeable
future; our need for substantial additional financing; our
investments in research and development efforts that further
enhance the OMEGA platform, and their impact on our results;
uncertainty regarding preclinical development, especially for a new
class of medicines such as epigenomic controllers; potential delays
in and unforeseen costs arising from our clinical trials; the fact
that our product candidates may be associated with serious adverse
events, undesirable side effects or have other properties that
could halt their regulatory development, prevent their regulatory
approval, limit their commercial potential, or result in
significant negative consequences; the impact of increased demand
for the manufacture of mRNA and LNP based vaccines to treat
COVID-19 on our development plans; difficulties manufacturing the
novel technology on which our epigenomic controller candidates are
based; our ability to adapt to rapid and significant technological
change; our reliance on third parties for the manufacture of
materials; our ability to successfully acquire and establish our
own manufacturing facilities and infrastructure; our reliance on a
limited number of suppliers for lipid excipients used in our
product candidates; our ability to advance our product candidates
to clinical development; and our ability to obtain, maintain,
enforce and adequately protect our intellectual property rights.
These and other important factors discussed under the caption “Risk
Factors” in our Quarterly Report on Form 10-Q for the quarter ended
September 30, 2023, and our other filings with the SEC, could cause
actual results to differ materially from those indicated by the
forward-looking statements made in this press release. Any such
forward-looking statements represent management’s estimates as of
the date of this press release. While we may elect to update such
forward-looking statements at some point in the future, we disclaim
any obligation to do so, even if subsequent events cause our views
to change.
About CellarityCellarity is fundamentally
redesigning the way drugs are created. By shifting the focus from a
single target to the underlying cellular dysfunction, the company
unravels the complexity of disease biology to create medicines that
are out of reach with the target-based drug discovery approach.
Founded by Flagship Pioneering in 2017, Cellarity has developed a
platform that utilizes proprietary AI models trained on over 30
million single cell transcriptomes to uncover novel actionable
biology and create non-intuitive drug candidates in a vast array of
diseases. The company currently has programs ongoing in several
disease areas including those in metabolic disease, hematology, and
immuno-oncology. For more information, visit
www.cellarity.com.
Contacts for further information
Media: |
|
Ambre
James-Brown+45 3079 9289abmo@novonordisk.com |
Elizabeth
DeLuca (US)+1 609 580 9868edel@novonordisk.com |
Investors: |
|
Daniel
Muusmann Bohsen+45 3075 2175 dabo@novonordisk.com |
Jacob
Martin Wiborg Rode+45 3075 5956jrde@novonordisk.com |
David
Heiberg Landsted +45 3077 6915 dhel@novonordisk.com |
Mark
Joseph Root (US) +1 848 213 3219mjhr@novonordisk.com |
Sina
Meyer +45 3079 6656azey@novonordisk.com |
Frederik
Taylor Pitter +45 3075 8259fptr@novonordisk.com |
Omega
Therapeutics: Investors:Eva
Stroynowski+1 617 949 4370estroynowski@omegatx.com |
Media:Jason Braco, LifeSci
Communications+1 646 751 4361jbraco@lifescicomms.com |
Cellarity:Cellarity:
press@cellarity.com |
|
1 World_Obesity_Atlas_2023_Report.pdf (worldobesityday.org)
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