Sanofi Pasteur, the vaccines global business unit of Sanofi and
Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA)
therapeutics company, have initiated a Phase 1 clinical trial
evaluating an mRNA-based investigational vaccine against seasonal
influenza.
The trial will evaluate the safety and
immunogenicity of a monovalent flu vaccine candidate coding for the
hemagglutinin protein of the A/H3N2 strain of the influenza virus.
Flu seasons that are dominated by A/H3N2 strain circulation
activity tend to be more severe, especially among those considered
at-risk such as older adults and younger children.
“The first clinical trial of a seasonal mRNA flu
vaccine candidate is an exciting milestone in our quest for the
next generation of influenza vaccines. We've all witnessed the
promise of mRNA technology during this pandemic and are now looking
to extend that promise to select annual vaccines,” said
Jean-François Toussaint, Global Head of Research and Development,
Sanofi Pasteur. “In line with our global leadership and our 70-year
history of protecting people with influenza vaccines, we will
always focus on developing products that demonstrate protection
beyond flu, as we believe it is critical to demonstrate protecting
patients from hospitalizations due to cardiovascular events and
pneumonia. We look forward to sharing initial results by
year-end.”
“We are pleased to have this second mRNA vaccine
program underway with our partner Sanofi Pasteur,” said Ronald
Renaud, chief executive officer, Translate Bio. “We believe that
mRNA technology could have several advantages for a seasonal flu
application including the potential ability to demonstrate robust
immune responses based on preclinical data to date, enable antigen
specificity within a short timeframe from seasonal virus strain
selection, and deploy agile manufacturing capacity. We look forward
to evaluating the potential of these mRNA influenza vaccine
candidates in this Phase 1 clinical trial.”
Sanofi and Translate Bio have developed and will
evaluate two formulations of the vaccine (MRT5400 and MRT5401) in
the Phase 1 influenza mRNA vaccine clinical trial. The two
formulations differ in the lipid nanoparticle (LNP) that contains
the mRNA.
The trial follows successful preclinical
research which demonstrated promising safety and immunogenicity.
Preclinical results were shared previously at the 8th annual mRNA
Healthcare Conference in November 2020.
About the Phase 1 trialThe
US-based Phase 1 clinical trial will assess the safety and
immunogenicity (immune response) of the monovalent (single-strain)
mRNA-based flu vaccine candidate in up to 280 participants. The
trial will evaluate several dose levels of both vaccine
formulations given to healthy adults 18 - 49 years of age.
About the Sanofi Pasteur and Translate
Bio collaborationIn June 2018, Translate Bio entered into
a collaboration and exclusive license agreement with Sanofi
Pasteur, the vaccines global business unit of Sanofi, to develop
mRNA vaccines for up to five infectious disease pathogens. The
agreement was first expanded in March 2020 to include development
of a novel mRNA vaccine for COVID-19. In June 2020, the two
companies built upon the existing agreement to pursue novel mRNA
vaccines to broadly address current and future infectious diseases.
There are two ongoing mRNA vaccine clinical trials under the
collaboration, one for COVID-19 and one for influenza.
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 infectious disease vaccine candidates and mRNA vaccine
platform development during a research term of at least four years
after the original signing in 2018.
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, or to prevent infectious
diseases by generating protective immunity. Translate Bio is
primarily focused on applying its technology to treat pulmonary
diseases with a lead pulmonary candidate being evaluated as an
inhaled treatment for cystic fibrosis (CF) in a Phase 1/2 clinical
trial. Additional pulmonary diseases are being evaluated in
discovery-stage research programs that utilize a proprietary lung
delivery platform. Translate Bio also believes its technology may
apply broadly to a wide 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
protein degradation. Translate Bio is also pursuing the development
of mRNA vaccines for infectious diseases under a collaboration with
Sanofi Pasteur.
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.
Translate Bio Cautionary Note Regarding
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: the
evaluation of the next generation of influenza vaccines; the
potential for MRT5400 and MRT5401 to be promising influenza vaccine
candidates; the plans to share interim clinical data from the trial
evaluating MRT5400 and MRT5401 by year-end 2021; the anticipated
enrollment of participants in the clinical trial of MRT5400 and
MRT5401; the extension of mRNA technology to influenza vaccines;
the role of Translate Bio’s platform in developing seasonal
influenza vaccines and the advantages of the application of its
technology for seasonal flu vaccine; the next steps of the broader
mRNA-based influenza vaccine program and strategy; the expected
benefits of Translate Bio’s collaboration with Sanofi; Translate
Bio’s beliefs regarding the broad applicability of its technology;
and Translate Bio’s plans, strategies and prospects for its
business, including its lead development programs and continued
development of mRNA vaccines for the treatment of infectious
diseases. 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 current and
potential future impacts of the COVID-19 pandemic on Translate
Bio’s business, financial condition, operations and liquidity;
Translate Bio’s ability to advance the development of its platform
and programs, including without limitation its vaccine development
program, 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
successful advancement of the collaboration agreement between
Translate Bio and Sanofi; uncertainties relating to the discovery
and development of vaccine candidates based on mRNA, and
specifically as it relates to influenza; the content and timing of
decisions made by the U.S. Food and Drug Administration (“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 Quarterly Report on
Form 10-Q for the three months ended March 31, 2021 filed with the
Securities and Exchange Commission (“SEC”) on May 6, 2021 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.
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, cost containment initiatives and
subsequent changes thereto, and the impact that COVID-19 will have
on us, our customers, suppliers, vendors, and other business
partners, and the financial condition of any one of them, as well
as on our employees and on the global economy as a whole. Any
material effect of COVID-19 on any of the foregoing could also
adversely impact us. This situation is changing rapidly and
additional impacts may arise of which we are not currently aware
and may exacerbate other previously identified risks. The risks and
uncertainties also include the uncertainties 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, 2020. 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 Investor Relations |
Translate Bio Media Relations |
Teri Dahlman |
Maura Gavaghan |
Tel: +1 (617) 817-8655 |
Tel: +1 (617) 233-1154 |
tdahlman@translate.bio |
mgavaghan@translate.bio |
|
|
Sanofi Investor Relations – Paris |
Sanofi Media Relations |
Eva Schaefer-Jansen |
Nicolas Kressmann |
Arnaud Delepine |
Tel.: +1 (732) 532 53-18 |
Nathalie Pham |
Nicolas.Kressmann@sanofi.com |
|
|
Sanofi Investor Relations – North America |
|
Felix Lauscher |
|
Fara Berkowitz |
|
Suzanne Greco |
|
|
|
Sanofi IR main line: |
|
Tel.: +33 (0)1 53 77 45 45 |
|
investor.relations@sanofi.com |
|
https://www.sanofi.com/en/investors/contact |
|
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