Translate Bio Announces Strategic Manufacturing Agreement with AMRI in Support of Messenger RNA (mRNA) Manufacturing

--  Agreement provides Translate Bio with customized and dedicated manufacturing space for cGMP mRNA production for current and future programs --

LEXINGTON, Mass., Sept. 12, 2019 (GLOBE NEWSWIRE) -- Translate Bio (Nasdaq: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction, today announced that it has entered into a multi-year strategic manufacturing agreement with Albany Molecular Research, Inc. (AMRI), a best-in-class, global clinical development manufacturing organization, in support of the planned expansion of Translate Bio’s current Good Manufacturing Practices (cGMP) clinical mRNA manufacturing capabilities.

Under the five-year agreement, AMRI will build out new, dedicated cGMP clinical manufacturing suites that will support Translate Bio’s manufacturing needs. This allows for greater control and flexible access to AMRI’s purpose-built cGMP manufacturing capacity, experience and expertise to advance Translate Bio’s preclinical and clinical-stage programs.  Translate Bio’s lead program is an inhaled mRNA therapeutic in an ongoing Phase 1/2 clinical trial in patients with cystic fibrosis. Its preclinical programs are focused primarily on targets in additional pulmonary diseases and also include infectious disease targets for vaccine applications. Other discovery efforts include next-generation delivery programs for applications in diseases that affect the liver.

“At Translate Bio, we recognize the importance of developing scalable manufacturing processes in this innovative field and have made this a priority from the inception of our mRNA therapeutic (MRT) platform,” said Ronald Renaud, chief executive officer, Translate Bio. “We are excited to build upon our successful experience with AMRI, a demonstrated leader in drug manufacturing, with this agreement that supports the advancement of our manufacturing efforts as we work to develop first-in-class mRNA medicines for genetic diseases.”

"We are delighted to support Translate Bio in its goal of accelerating the development of its mRNA product pipeline across various stages of development," said Michael Mulhern, chief executive officer, AMRI. “Translate Bio’s technology platform has the potential to transform patients' lives and we are excited to partner with them as they advance medicines to treat unmet medical needs.”

About Translate Bio
Translate 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. The Company’s MRT platform is designed to develop product candidates that deliver mRNA carrying instructions to produce intracellular, transmembrane and secreted proteins for therapeutic benefit. Translate Bio is primarily focused on applying its MRT platform to pulmonary diseases caused by insufficient protein production or where production of proteins can modify disease. The Company also believes its technology is applicable to a broad range of diseases, including diseases that affect the liver, eye and central nervous system. Additionally, the MRT platform may be applied to various classes of treatments, such as therapeutic antibodies or vaccines in areas such as infectious disease and oncology. 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. For more information about the Company, please visit www.translate.bio or on Twitter at @TranslateBio.

About AMRI
AMRI, a global contract research and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, AMRI’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Discovery, Development, Analytical Services, API manufacturing and Drug Product. For more information about AMRI, visit www.amriglobal.com.

Cautionary Note Regarding Forward-Looking Statements
This 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 plans to expand its manufacturing capabilities; Translate Bio’s goal of accelerating the development of its mRNA product pipeline; Translate Bio’s expectations regarding the potential benefits and advantages of its technology; 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,” “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: Translate Bio’s 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 U.S. Food and Drug Administration, other regulatory authorities and investigational review boards at clinical trial sites, including 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 quarterly period ended June 30, 2019 and in any other subsequent filings made by Translate Bio with the Securities and Exchange Commission. 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.