Sanofi Pasteur, the vaccines global business unit of Sanofi
(EURONEXT: SAN and NASDAQ: SNY), and Translate Bio (Nasdaq: TBIO),
a clinical-stage messenger RNA (mRNA) therapeutics company will
collaborate to develop a novel mRNA vaccine for COVID-19. This
collaboration leverages an existing agreement from 2018 between the
two companies to develop mRNA vaccines for infectious diseases.
Translate Bio has begun to produce multiple mRNA constructs and
will use its mRNA platform to discover, design and manufacture
SARS-CoV-2 vaccine candidates. Sanofi will provide deep vaccine
expertise and support from its external research networks to
advance vaccine candidates for potential further development.
Translate Bio has established 100 gram single-batch production with
its clinical-stage mRNA therapeutics platform. Build-out is
underway of dedicated manufacturing space through a contract
manufacturing partner to accommodate at least two 250 gram batches
per month. Depending on the final human dose, the mRNA
platform of Translate Bio has excellent promise to meet the future
demands for a pandemic response.
For Sanofi, this marks a second collaboration in its efforts to
develop a novel COVID-19 vaccine candidate. In February 2020,
Sanofi announced a collaboration with the Biomedical Advanced
Research and Development Authority (BARDA) to advance a novel
COVID-19 vaccine candidate. The agreement with BARDA calls for
Sanofi to initiate development of a recombinant, protein-based
vaccine candidate against COVID-19.
“We are committed to leveraging different ways to address the
COVID-19 public health crisis by testing treatments, as well as two
vaccines using different platforms. We believe the more approaches
we explore, the better our likelihood of success in achieving this
goal,” said David Loew, Global Head of Vaccines at Sanofi. “Having
sufficient installed capacity will be key to satisfy the strong
demand for vaccines we will probably see, and based on the
experience we’ve had under the collaboration to date, we believe
the Translate Bio mRNA platform could help us meet that need.”
“The Translate Bio and Sanofi Pasteur teams have generated
encouraging preclinical data across multiple infectious disease
targets as part of our ongoing mRNA vaccine collaboration. This
work will serve as a strong foundation as we direct joint research
efforts against COVID-19 to help address this public health
threat,” said Ronald Renaud, chief executive officer of Translate
Bio. “Our collaborative efforts to combat COVID-19 will leverage
Translate Bio’s innovative mRNA platform as well as Sanofi’s
vaccine expertise and ongoing COVID-19 research with the goal of
advancing a novel mRNA vaccine rapidly to the clinic.”
About mRNA Vaccines Vaccines work by
mimicking disease agents to stimulate the immune system; building
up a defense mechanism that remains active in the body to fight
future infections. mRNA vaccines offer an innovative approach by
delivering a nucleotide sequence encoding the antigen or antigens
selected for their high potential to induce a protective immune
response. mRNA vaccines also represent a potentially innovative
alternative to conventional vaccine approaches for several reasons
- their high potency, ability to initiate protein production
without the need for nuclear entry, capacity for rapid development
and potential for low-cost manufacture and safe administration
using non-viral delivery. This approach potentially enables the
development of vaccines for disease areas where vaccination is not
a viable option today. Additionally, a desired antigen or multiple
antigens can be expressed from mRNA without the need to adjust the
production process offering maximum flexibility and efficiency in
development.
Sanofi Conference Call InformationSanofi will
host a conference call and webcast today at 3:30 pm CET/10:30 am ET
to discuss this announcement, and Ronald Renaud, Translate Bio’s
chief executive officer, will be on the call for the question and
answer period. The live webcast can be accessed at
https://edge.media-server.com/mmc/p/rwbsdr83. Information about
accessing the webcast can be found on the Sanofi investor relations
website. A replay of the webcast will be available on Sanofi’s
website approximately one hour after the completion of the event
and will be archived for up to one year.
About the Sanofi Pasteur/Translate Bio
CollaborationIn 2018, Translate Bio entered into a
collaboration and exclusive licensing agreement with Sanofi Pasteur
Inc., the vaccines global business unit of Sanofi S.A., to develop
mRNA vaccines for up to five infectious disease pathogens. This
collaboration brings together Sanofi Pasteur’s leadership in
vaccines and Translate Bio’s mRNA research and development
expertise. Under the agreement, the companies are jointly
conducting research and development activities to advance mRNA
vaccines and mRNA vaccine platform development during a three-year
research term. Translate Bio and Sanofi Pasteur have advanced
the preclinical development vaccine programs including screening,
optimization and production of mRNA and LNP formulations across
multiple targets.
About SanofiSanofi is dedicated to supporting
people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
About Translate BioTranslate Bio is a
clinical-stage mRNA therapeutics company developing a new class of
potentially transformative medicines to treat diseases caused by
protein or gene dysfunction. Translate Bio is primarily
focused on applying its technology to treat pulmonary diseases
caused by insufficient protein production or where the reduction of
proteins can modify disease. Translate Bio’s lead program is
being developed as a treatment for cystic fibrosis (CF) and is in
an ongoing Phase 1/2 clinical trial. The Company also believes its
technology is applicable to a broad range of diseases, including
diseases that affect the liver. Additionally, the platform may be
applied to various classes of treatments, such as therapeutic
antibodies or vaccines in areas such as infectious disease and
oncology. For more information about the Company, please visit
www.translate.bio or on Twitter at @TranslateBio.
Sanofi Forward-Looking StatementsThis press
release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates and their
underlying assumptions, statements regarding plans, objectives,
intentions and expectations with respect to future financial
results, events, operations, services, product development and
potential, and statements regarding future performance.
Forward-looking statements are generally identified by the words
“expects”, “anticipates”, “believes”, “intends”, “estimates”,
“plans” and similar expressions. Although Sanofi’s management
believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, the uncertainties inherent in research and development,
future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMA,
regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the fact that product candidates if
approved may not be commercially successful, the future approval
and commercial success of therapeutic alternatives, Sanofi’s
ability to benefit from external growth opportunities, to complete
related transactions and/or obtain regulatory clearances, risks
associated with intellectual property and any related pending or
future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest
rates, volatile economic and market conditions, the impact of
global disruptions, including pandemics, cost containment
initiatives and subsequent changes thereto, the average number of
shares outstanding as well as those discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under “Risk Factors” and “Cautionary Statement
Regarding Forward-Looking Statements” in Sanofi’s annual report on
Form 20-F for the year ended December 31, 2019. Other than as
required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
statements.
Translate Bio Forward-Looking StatementsThis
press release contains forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995.
Such forward-looking statements include, but are not limited to,
those regarding: Translate Bio’s expectations with respect to
its collaboration with Sanofi, including Translate Bio’s plans
to develop a novel mRNA vaccine for SARS-CoV-2 which could be
rapidly advanced by Sanofi into further development and the
parties’ ability to leverage existing preclinical data in their
joint research efforts against SARS-CoV-2; Translate Bio’s
expectations regarding its production capacity and its
ability scale its manufacturing to supply vaccine doses;Translate
Bio’s beliefs regarding the broad applicability of its MRT
platform; and Translate Bio’s plans, strategies and prospects for
its business, including its lead development programs. The words
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“forward,” “intend,” “may,” “plan,” “potential,” “predict,”
“project,” “should,” “target,” “would” and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Such
statements are subject to numerous important factors, risks and
uncertainties that may cause actual events or results to differ
materially from current expectations and beliefs, including but not
limited to: the successful advancement of the collaboration
agreement between Translate Bio and Sanofi; uncertainties relating
to the discovery and development of vaccine candidates based on
mRNA; uncertainties relating to preclinical and clinical vaccine
development, including delays and the risk of advancement into
clinical trials, and a failure to demonstrate safety and efficacy
of any vaccine candidate to the satisfaction of applicable
regulatory authorities. Other risks Translate Bio faces
include its ability to advance the development of its
platform and programs under the timelines it projects, demonstrate
the requisite safety and efficacy of its product candidates and
replicate in clinical trials any positive findings from preclinical
studies; the content and timing of decisions made by the FDA, other
regulatory authorities and investigational review boards at
clinical trial sites, including decisions as it relates to ongoing
and planned clinical trials; Translate Bio’s ability to obtain,
maintain and enforce necessary patent and other intellectual
property protection; the availability of significant cash required
to fund operations; competitive factors; general economic and
market conditions and other important risk factors set forth under
the caption “Risk Factors” in Translate Bio’s Annual Report
on Form 10-K for the fiscal year ended December 31, 2019 filed with
the Securities and Exchange Commission on March 12, 2020 and in any
other subsequent filings made by Translate Bio. Any forward-looking
statements contained in this press release speak only as of the
date hereof, and Translate Bio specifically disclaims any
obligation to update any forward-looking statement, whether as a
result of new information, future events or otherwise.
Contacts for Sanofi Pasteur |
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Investor Relations Felix Lausher Tel.: +33 (0)1 53
77 45 45ir@sanofi.com |
Media Ashleigh KossTel: +1 (908)
981-8745Ashleigh.Koss@sanofi.com |
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Contacts for Translate Bio |
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Investors Teri Dahlman
tdahlman@translate.bio 617-817-8655 |
MediaMaura
Gavaghanmgavaghan@translate.bio 617-233-1154 |
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