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 C
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. Forward-Looking Statements Contact: View original content:http://www.prnewswire.com/news-releases/elixirgen-therapeutics-concludes-pre-ind-meeting-with-fda-for-its-covid-19-vaccine-candidate-exg-5003-301070624.html SOURCE Elixirgen Therapeutics, Inc. |