Sanofi Pasteur, the vaccines global business unit of Sanofi, and
Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA)
therapeutics company, today announced the preclinical results for
MRT5500, a mRNA-based vaccine candidate against SARS-CoV-2, the
virus that causes COVID-19 disease.
Preclinical evaluation of MRT5500, importantly, demonstrated a
favorable immune response profile against SARS-CoV-2. These data
support the selection of MRT5500 for clinical development. A Phase
1/2 clinical trial is anticipated to begin in the fourth quarter of
2020. Full results are available here. MRT5500 is being developed
under a collaboration agreement between Sanofi Pasteur and
Translate Bio.
“To tackle this global pandemic, we must look to both the strong
knowledge we have from years of infectious disease expertise and
the promise of new, innovative technologies,” said Thomas Triomphe,
Executive Vice President and Global Head of Sanofi Pasteur.
“Today’s presentation of these positive results is another
development milestone for providing a safe and effective potential
vaccine against SARS-CoV2 and shows how promising this technology
is. We are looking forward to working on next steps with our
partner Translate Bio to bring this technology to people
worldwide.”
“The rapid development of effective vaccines to address the
COVID-19 pandemic continues to be an urgent global public health
need and I am encouraged by the progress we’ve made to date with
our partner Sanofi Pasteur toward the development of a promising
mRNA vaccine candidate,” said Ronald Renaud, Chief Executive
Officer at Translate Bio. “The preclinical results we report in
this paper demonstrate the ability of MRT5500 to elicit a favorable
immune response in both mice and non-human primates. Importantly,
these results provide additional support for using our mRNA
platform to potentially expedite the development of alternative
approaches to traditional vaccines.”
Key preclinical findingsThe main findings of
the preclinical studies demonstrate the potential of MRT5500 to
elicit neutralizing antibodies against SARS-CoV-2.
In mice, four dose levels were assessed at 0.2, 1, 5 and 10 µg
per dose using a two-dose vaccination schedule, administered three
weeks apart. MRT5500 induced dose-dependent levels of binding
antibodies and neutralizing antibodies specific to the SARS-CoV-2
spike protein. 100% seroconversion was observed at all dose levels
after one administration, and a further increase in titers was
observed following a second administration. Neutralizing antibody
titers were observed across all dose levels after receiving the
two-dose-administration regimen. In the higher dose groups (5 µg,
10 µg), titers were detected after one administration of MRT5500
and were more pronounced after the second administration.
In non-human primates (NHPs), three dose levels were assessed at
15, 45 and 135 µg per dose using a two-administration vaccination
schedule, three weeks apart. The potency of MRT5500 was assessed by
two types of neutralization assays: pseudovirus neutralization and
micro-neutralization. After the first administration, the majority
of NHPs developed neutralizing antibodies reactive to the
SARS-CoV-2 spike protein and those antibody titers were further
enhanced after a second administration with 100% of NHPs reaching
levels significantly higher than those from human convalescent sera
by day 35.
It was also demonstrated that MRT5500-immunized mice and
non-human primates exhibited a Th1-biased T cell response against
SARS-CoV-2.
The preprint publication, “Immunogenicity of novel mRNA COVID-19
vaccine MRT5500 in mice and non-human primates,” is available
here.
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.
About the Sanofi Pasteur and Translate Bio
collaborationIn 2018, Translate Bio entered into a
collaboration and exclusive license agreement with Sanofi Pasteur
Inc., 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 collaboration to pursue novel mRNA vaccines to
broadly address current and future infectious diseases.
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 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 caused by
insufficient protein production or where the reduction of proteins
can modify disease. Translate Bio’s lead pulmonary candidate is
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 believes that
mRNA can be delivered to target tissues via multiple routes of
administration and, consequently, its technology may apply broadly
to a wide range of diseases, including diseases that affect the
liver. 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.
Sanofi, Empowering Life
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, 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: the goal to initiate a Phase 1/2 clinical trial of
MRT5500 in the fourth quarter of 2020; the potential for MRT5500 to
be a promising candidate for clinical development; the development
of an mRNA vaccine candidate; the potential for MRT5500 to elicit a
robust immune response; 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 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 generally and MRT5500
specifically, 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 the novel coronavirus, COVID-19; the
content and timing of decisions made by the U.S. Food and Drug
Administration, 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 fiscal quarter ended June 30, 2020
filed with the Securities and Exchange Commission on August 6, 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
Sanofi Investor Relations - ParisEva
Schaefer-JansenArnaud DelepineYvonne Naughton
Sanofi Investor Relations – North AmericaFelix
LauscherFara BerkowitzSuzanne Greco
IR Main Line:Tél.: +33 (0)1 53 77 45 45ir@sanofi.com
Sanofi Media RelationsNicolas Kressmann Tel.:
+1 (732) 532 53-18Nicolas.Kressmann@sanofi.com
Contacts for Translate Bio
InvestorsTeri
Dahlmantdahlman@translate.bio617-817-8655
MediaMaura
Gavaghanmgavaghan@translate.bio617-233-1154
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