GlobeNewswire Inc | Mar 12, 2021 01:00AM EST

March 12, 2021

Sanofi and Translate Bio initiate Phase 1/2 clinical trial of mRNA COVID-19 vaccine candidate

-- Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels -- Expected to enroll 415 participants; interim results expected in Q3 2021 -- In parallel, preclinical studies are underway to evaluate additional mRNA candidates against emerging SARS-CoV-2 variants

PARIS and LEXINGTON, MASS. March 12, 2021 - 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 start of the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. The Companies expect interim results from this trial in the third quarter of 2021.

Our mRNA vaccine candidate is the result of our expertise in infectious diseases coupled with the innovative technologies of our partner, said Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur. Initiating the Phase 1/2 trial represents an important step forward in our goal of bringing another effective vaccine to the ongoing fight against the COVID-19 pandemic.

We have made important progress towards developing mRNA vaccine candidates for infectious diseases through our collaboration with our partner Sanofi Pasteur, said Ronald Renaud, Chief Executive Officer of Translate Bio. With the impact of mRNA vaccines demonstrated during the pandemic, our joint development team remains steadfast in our commitment to advancing MRT5500 as part of the collaborative effort to overcome this global health crisis.

Preclinical studies are ongoing and will continue over the next several months to evaluate whether MRT5500, as well as additional mRNA vaccine candidates, will induce neutralizing antibodies against the emerging SARS-CoV-2 variants, with the potential to inform current and future clinical development.

The joint development team is working on improving the temperature stability of the mRNA vaccine candidate and targeting a -20C storage temperature for late-stage clinical trials and at launch. Efforts are also underway to enable the product to be stable at routine refrigerator temperature (2-8C).

MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.

About the Phase 1/2 clinical trialThe Phase 1/2 clinical trial is a randomized, double blind and placebo-controlled trial designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of MRT5500, a COVID-19 vaccine candidate. A total of 415 healthy adults 18 years of age and older are expected to be enrolled in the trial across 13 investigational sites.

Clinical trial participants will receive one dose of MRT5500, or two doses 21 days apart. Three different dose levels will be investigated (15g, 45g or 135g).

About previously-published preclinical resultsPreclinical data showed that two immunizations of the mRNA vaccine induced high neutralizing antibody levels that are comparable to the upper range of those observed in infected humans.

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 Pasteurs leadership in vaccines and Translate Bios 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.

Shots on goal in the fight against COVID-19In addition to the mRNA vaccine candidate in collaboration with Translate Bio, Sanofi is collaborating with GSK on a COVID-19 vaccine candidate using the same recombinant protein-based manufacturing technology as one of Sanofis seasonal influenza vaccines, combined with GSKs established pandemic adjuvant platform. On February 22, 2021, GSK and Sanofi announced the beginning of a new Phase 2 study with an improved antigen formulation. Enrollment of total 720 participants was completed on March 8. This vaccine is expected to be available in Q4 2021 pending Phase 3 outcomes and regulatory authorizations.

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 Sanofi

Sanofi is dedicated to supporting people through their health challenges. Weare a global biopharmaceutical company focused on human health. We preventillness with vaccines, provide innovative treatments to fight pain and easesuffering. We stand by the few who suffer from rare diseases and the millionswith long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transformingscientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi Investor Relations - Paris Eva Schaefer-Jansen Arnaud Delepine Yvonne Naughton



Sanofi Investor Relations ? North America Felix LauscherSanofi Media Relations Fara BerkowitzNicolas Kressmann Suzanne GrecoTel.: +1 (732) 532 53-18Nicolas.Kressmann@sanofi.com

IR Main Line: Tel.: +33 (0)1 53 77 45 45Translate Bio Media Relations investor.relations@sanofi.comMaura GavaghanTel: +1 (617) 233-1154

mgavaghan@translate.bio https://www.sanofi.com/en/investors/contact



Translate Bio Investor Relations Teri Dahlman Tel: +1 (617) 817-8655 tdahlman@translate.bio

Sanofi Forward-Looking StatementsThis press release contains forward-looking statements as defined in thePrivate Securities Litigation Reform Act of 1995, as amended. Forward-lookingstatements are statements that are not historical facts. These statementsinclude projections and estimates and their underlying assumptions, statementsregarding plans, objectives, intentions and expectations with respect to futurefinancial results, events, operations, services, product development andpotential, and statements regarding future performance. Forward-lookingstatements are generally identified by the words ?expects?, ?anticipates?,?believes?, ?intends?, ?estimates?, ?plans? and similar expressions. AlthoughSanofi?s management believes that the expectations reflected in suchforward-looking statements are reasonable, investors are cautioned thatforward-looking information and statements are subject to various risks anduncertainties, many of which are difficult to predict and generally beyond thecontrol of Sanofi, that could cause actual results and developments to differmaterially from those expressed in, or implied or projected by, theforward-looking information and statements. These risks and uncertaintiesinclude among other things, the uncertainties inherent in research anddevelopment, future clinical data and analysis, including post marketing,decisions by regulatory authorities, such as the FDA or the EMA, regardingwhether and when to approve any drug, device or biological application that maybe filed for any such product candidates as well as their decisions regardinglabelling and other matters that could affect the availability or commercialpotential of such product candidates, the fact that product candidates ifapproved may not be commercially successful, the future approval and commercialsuccess of therapeutic alternatives, Sanofi?s ability to benefit from externalgrowth opportunities, to complete related transactions and/or obtain regulatoryclearances, risks associated with intellectual property and any related pendingor future litigation and the ultimate outcome of such litigation, trends inexchange rates and prevailing interest rates, volatile economic and marketconditions, cost containment initiatives and subsequent changes thereto, andthe 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, aswell as on our employees and on the global economy as a whole. Any materialeffect of COVID-19 on any of the foregoing could also adversely impact us. Thissituation is changing rapidly and additional impacts may arise of which we arenot currently aware and may exacerbate other previously identified risks. Therisks and uncertainties also include the uncertainties discussed or identifiedin the public filings with the SEC and the AMF made by Sanofi, including thoselisted under ?Risk Factors? and ?Cautionary Statement Regarding Forward-LookingStatements? in Sanofi?s annual report on Form 20-F for the year ended December31, 2020. Other than as required by applicable law, Sanofi does not undertakeany obligation to update or revise any forward-looking information orstatements.

Translate Bio Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning ofThe Private Securities Litigation Reform Act of 1995. Such forward-lookingstatements include, but are not limited to, those regarding: the expectednumber of participants to be enrolled in the Phase 1/2 clinical trial ofMRT5500; the plans to report interim results from the Phase 1/2 clinical trialof MRT5500 in the third quarter of 2021; plans and strategies to furtheradvance MRT5500, including improvements to the temperature stability; thepotential for MRT5500 to be a promising COVID-19 vaccine candidate; thepotential for mRNA vaccine approaches to effectively address COVID-19 and anynew SARS-CoV-2 variants; the expected benefits of Translate Bio?s collaborationwith Sanofi; Translate Bio?s beliefs regarding the broad applicability of itstechnology; and Translate Bio?s plans, strategies and prospects for itsbusiness, including its lead development programs and continued development ofmRNA 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 anduncertainties that may cause actual events or results to differ materially fromcurrent expectations and beliefs, including but not limited to: the current andpotential future impacts of the COVID-19 pandemic on Translate Bio?s business,financial condition, operations and liquidity; Translate Bio?s ability toadvance the development of its platform and programs, including withoutlimitation its vaccine development program generally and MRT5500 specifically,under the timelines it projects, demonstrate the requisite safety and efficacyof its product candidates and replicate in clinical trials any positivefindings from preclinical studies; the successful advancement of thecollaboration agreement between Translate Bio and Sanofi; uncertaintiesrelating to the discovery and development of vaccine candidates based on mRNA,and specifically as it relates to COVID-19; the content and timing of decisionsmade by the U.S. Food and Drug Administration (?FDA?), other regulatoryauthorities 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 andother intellectual property protection; the availability of significant cashrequired to fund operations; competitive factors; general economic and marketconditions and other important risk factors set forth under the caption ?RiskFactors? in Translate Bio?s Annual Report on Form 10-K for the full year endedDecember 31, 2020 filed with the Securities and Exchange Commission (?SEC?) onMarch 1, 2021 and in any other subsequent filings made by Translate Bio. Anyforward-looking statements contained in this press release speak only as of thedate hereof, and Translate Bio specifically disclaims any obligation to updateany forward-looking statement, whether as a result of new information, futureevents or otherwise.





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