A new program from ARPA-H has devoted funding to make individualized RNA-based genetic medicine more efficient to produce and improve accessibility.
The federal government’s Advanced Research Projects Agency for Health has committed up to $125 million of R&D funding for teams developing methods to manufacture RNA-based genetic medicine more quickly and in accessible locations.
The agency, known as ARPA-H, announced that the “new manufacturing paradigm” would result in an automated network for producing individualized RNA therapies, “replacing a slow, costly, centralized model with one created for speed, scale and reach,” according to a Wednesday release.
The Genetic Medicines and Individualized Manufacturing for Everyone, or GIVE, program seeks to make personalized medicines such as breakthrough CRISPR gene editing therapies available outside major treatment centers at more efficient cost and timelines. Early efforts will focus on cancer, rare genetic conditions and chronic diseases, and GIVE will work with the FDA to co-develop the regulatory framework needed to “to bring distributed, individualized genetic medicine manufacturing to scale.”
GIVE will engage the U.S. Food and Drug Administration (FDA) throughout the program to co-develop the regulatory framework needed to bring distributed, individualized genetic medicine manufacturing to scale.
To that end, the program has enlisted several teams within the biotech industry for development of a biomanufacturing network.
One of these biotechs is Centillion Biosciences, known for its “RNA manufacturing in a box” platform. Centillion will perform fill and finish with quality control testing and digital process management, according to the ARPA-H release. Joining Centillion in the manufacturing platform effort will be HDT Bio, which performs DNA synthesis and chip-based RNA production; Massachusetts General Hospital, offering continuous manufacturing and quality-control testing; and Waterfall Scientific, which will provide automation for RNA production.
For further quality control, a team from the University of Utah is developing a platform to test medications in as little as one day, according to the release.
ARPA-H did not specify the amount of funding that will be distributed to each organization. The boost to RNA-based research comes in the wake of federal cuts last year of approximately $500 million aimed at mRNA vaccines, which affected areas such as infectious disease and cancer, according to reports.
Threatened by the rise of the biotech industry in foreign nations, including a rapid ascent by China, the U.S. is looking for ways to fund medical innovation at home.
“Individualized domestic biomanufacturing will give the United States an advantage and ensure that all patients have access to the latest therapeutic capabilities, no matter where they live,” GIVE program manager John Schiel said in the release. “This investment will catalyze domestic innovation for distributed manufacturing of RNA-based genetic medicines — and these teams will deliver it in a matter of years, not decades.”
ARPA-H has also awarded other recent grants in the RNA space, including a $4.4 million pilot given this week to a team out of Harvard Medical School and MIT that includes the biotech RNAV8 Bio. This award is aimed at advancing research on programmable RNA for personalized treatments.
