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Restorative Medicine
Creating RNA for New Vaccines
License to manufacture GMP-grade RNA for gene therapy
In September 2018, Houston Methodist entered into an exclusive license with GeneOne Life Science and its subsidiary, VGXI, to produce clinical grade RNA.
Only 75 years ago, molecular biologists were just beginning to grasp the basics of genetic structure: DNA, found in the cell nucleus, establishes the genetic code, while RNA, found in the cytoplasm, is responsible for carrying it out, helping in the creation of basic proteins to build molecules and cells.
As recently as the 1960s, scientists were still struggling to understand RNA, due to its tendency to transmute so rapidly. But persistence paid off and today their understanding of RNA is crucial to the fields of gene therapy and epigenetics, as it focuses on changes in gene expression rather than altering the genetic code itself.
VGXI held a ribbon-cutting ceremony on November 2, 2018, to celebrate the opening of its Woodlands-based facility, including purpose-built GMP production areas for RNA synthesis. Shown left to right: Houston Methodist’s John Cooke, U.S. Congressman Kevin Brady, VGXI President and CEO Young Park, and VGXI COO Dorothy Peterson.
To be able to study—and ultimately implement—gene therapies, researchers and clinicians must have a steady source of RNA that is pure and stable. Houston Methodist's RNAcore has developed a process for producing RNA that is reliable and reproducible on a large scale. Directed by John Cooke, MD, PhD, the RNAcore has become a leader in RNA synthesis, generating RNA constructs including mRNA, modified mRNA, microRNA cassettes, and noncoding RNA for scientific and medical collaborators. In addition to its manufacturing methods, the RNAcore also has developed exceptional technologies for improved stability of RNA products and enhanced delivery of nucleic-acid-based therapies.
RNA based therapeutics and vaccines are developing rapidly, with an expected market value of $1.2 billion by 2020. The pairing of the RNAcore and VGXI fills a critical product development gap with a GMP manufacturing solution that enables biotechnology companies and academic consortia to drive novel mRNA therapies through FDA approval pathways to market.
John P. Cooke, MD, PhD
Joseph C. “Rusty” Walter and Carole Walter Looke
Presidential Distinguished Chair in Cardiovascular Disease Research
Houston Methodist
In September 2018, Houston Methodist entered into an exclusive license with GeneOne Life Science and its subsidiary, VGXI, to produce clinical grade RNA. The agreement will encourage development of new RNA vaccines and therapies by combining the design capabilities of the RNAcore with the manufacturing capabilities of VGXI, an industry leading plasmid DNA contract manufacturer, which has expanded its facility in The Woodlands, Texas, in anticipation of the collaboration.
VGXI has a successful track record of supplying preclinical through cGMP-grade DNA plasmids for vaccines, gene therapies and viral vector production. The addition of RNA manufacturing services will make it the world’s first dedicated contract manufacturing organization to encompass both DNA and RNA biopharmaceuticals.
The RNAcore received initial funding as a core group for the Progenitor Cell Biology Consortium of the National Heart, Lung, and Blood Institute; it now also receives support from the Cancer Prevention Research Institute of Texas to further the development of cutting-edge RNA technologies.
LaVonne Carlson, March 2019
