Rockville, MD’s ABL has inked its second candidate manufacturing partnership in as many weeks, signing on with Regenxbio to produce the biotech’s lead adeno-associated virus gene therapy, RGX-501, for human trials.
Through the deal, CDMO ABL will continue its process development work for the candidate to treat homozygous familial hypercholesterolemial and begin manufacturing at its Rockville site. The facility specializes in gene therapies, vaccines and other biologics intended for human trials.
ABL will put to work its “established track record of cGMP virus vector manufacturing,” CEO Thomas VanCott said, and is “very excited to be applying our bulk production and fill/finish expertise to the RGX-501 program.”
Regenxbio’s candidate works by delivering human low-density lipoprotein receptor by way of the company’s proprietary NAV platform AAV8 vector. The therapy has an orphan drug designation and a Phase I/II IND active at the FDA; University of Pennsylvania is a development partner on RGX-501.
The agreement follows ABL’s deal last week with SillaJen to supply Pexa-Vec, a cancer vaccinia virus (which is used to vaccinate against the smallpox virus) candidate designed to help fight and kill cancer cells. That candidate is in a Phase III study in advanced liver cancer.
- here’s the release