News: FDA

Elixirgen Therapeutics Concludes pre-IND Meeting with FDA for its COVID-19 Vaccine Candidate EXG-5003

BALTIMORE, June 4, 2020 /PRNewswire/ -- Elixirgen Therapeutics, Inc., a Baltimore-based biotechnology company focused on the discovery, development, and commercialization of therapies for genetic diseases and vaccines, announced that it concluded on May 18 its pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for the company's COVID-19 vaccine candidate, EXG-5003. EXG-5003 is a temperature-sensitive, intradermally-injected srRNA (self-replicating RNA) vaccine expressing the receptor binding domain (RBD) of the SARS-CoV-2 spike protein.

EXG-5003 was designed with unique features that have potential dose sparing and safety benefits. Using both intradermal injection and srRNA technology may result in improved immunogenicity, and may allow the vaccine candidate to be more dose sparing than mRNA (messenger RNA) alone. Additionally, EXG-5003's novel and proprietary temperature sensitivity may significantly enhance the vaccine's safety profile and establish it to be the third generation RNA vaccine for COVID-19, with mRNA vaccines being the first generation and self-replicating RNA vaccines being the second generation.

Elixirgen Therapeutics is continuing active development of EXG-5003 toward a planned Phase I clinical trial.

About Elixirgen Therapeutics, Inc.
Elixirgen Therapeutics, Inc. is a Baltimore-based biotechnology company co-founded by Akihiro Ko and Minoru Ko, MD, PhD, which is focused on curing humanity's ailments through innovations in stem cell biology. The company's experienced team of researchers has a wide variety of specialties, enabling it to use both basic and translational research approaches to developing therapies for genetic diseases and vaccines. For more information visit https://ElixirgenTherapeutics.com

Forward-Looking Statements
This press release may contain "forward-looking" statements, including statements regarding the potential to develop a COVID-19 vaccine. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in vaccine research and development. Any forward-looking statements in this press release speak only as of the date of this press release, and Elixirgen Therapeutics undertakes no obligation to update or revise the statements in the future, even if new information becomes available.

Contact:
Media Relations
Elixirgen Therapeutics, Inc.
(443) 869-5420
Media@ElixirgenTherapeutics.com

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