Translate Bio Granted U.S. Patent Relating to Messenger RNA (mRNA) Delivery

LEXINGTON, Mass., March 26, 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 the United States Patent and Trademark Office (USPTO) has issued U.S. Patent 10,238,754.  This patent, titled “Lipid Nanoparticle Compositions and Methods for mRNA Delivery,” enhances the Company’s current intellectual property by providing coverage for lipid-nanoparticle delivery of encapsulated mRNA where the encoded protein or peptide is secreted and the lipid nanoparticle contains a polyethylene glycol (PEG)-modified lipid. The patent coverage extends to mRNA that is modified or unmodified and to various routes of administration including by intravenous injection, intramuscular injection, or pulmonary delivery. This patent is owned by Translate Bio and expires in November 2031.

“This patent recognizes the discoveries and innovations developed by Translate Bio researchers that have played a critical role in advancing our work in mRNA therapeutics,” said Ronald Renaud, chief executive officer of Translate Bio. “Today’s patent issuance is a milestone in the development of our growing IP portfolio, but more importantly, it supports our goal of developing innovative therapies for patients with life-limiting genetic diseases.”

This newly granted patent is part of an expanding and comprehensive portfolio of patent applications and other intellectual property supporting Translate Bio’s messenger RNA therapeutics (MRT^TM) platform.  The Company’s intellectual property portfolio is comprised of significant patents and patent applications covering mRNA and mRNA delivery systems, as well as various methods for the manufacture and delivery of mRNA, and treatments using mRNA, which the Company believes are important for the development and commercialization of a wide range of mRNA therapeutics. In aggregate, Translate Bio owns or has exclusively in-licensed over 300 active patent cases, with over 110 granted or allowed patents worldwide of which over 60 have been granted or allowed in the U.S. or Europe. 

About the MRT^TM Platform
Translate Bio’s MRT platform is designed to develop product candidates that deliver mRNA that can carry instructions to produce intracellular, transmembrane and secreted proteins. The MRT platform is also designed to be flexible and scalable by allowing for the development of MRT product candidates that may vary only in the mRNA coding sequence and/or the tissue-specific delivery system. This modular nature of the MRT platform may allow for rapid advancement into new indications that are amenable to our established delivery systems. Currently, the Company is utilizing its MRT platform to identify and rapidly develop new product candidates designed to address the underlying causes of diseases beyond our initial efforts in the lung, to treat cystic fibrosis, and in the liver, to treat OTC deficiency.

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 believes that its MRT platform is applicable to a broad range of diseases caused by insufficient protein production or where production of proteins can modify disease, including diseases that affect the lung, liver, eye, central nervous system and lymphatic system. The Company also believes its 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 two lead programs are being developed as treatments for cystic fibrosis (CF) and ornithine transcarbamylase (OTC) deficiency. For more information about the Company, please visit www.translate.bio or on Twitter at @TranslateBio.

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 expectations regarding the potential for its patent portfolio to protect its intellectual property; the benefits and broad applicability of the Company’s MRT^TM 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 (for example, two of our patents issued in Europe are under opposition); 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 year ended December 31, 2018 filed with the Securities and Exchange Commission on March 21, 2019 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.

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