AGC Biologics, getting ready to enter the commercial stage, Inherited Retinal Disorders

Announcement

After getting near the end of the tunnel with the AAVantgarde closing of the Series B financing round, AGC Biologics is preparing for a new manufacturing agreement with the biotechnology company. This will be a symbol of AGC Biologics’ brand-new advancement in the adeno-based virus market.

According to this agreement, AGC Biologics will deliver Good Manufacturing Practice construction for AAVantgarde’s two novel candidates. These candidates are engineered to identify irreversible and progressive vision loss for which, as of now, there are no approved therapies in the healthcare market.

Therapies, yet to be approved

The first is AAVB-039 for Stargardt disease is a therapy that identifies the general, common inherited form of macular degeneration and a leading cause of vision loss in the young adult and children population that has been disrupted the health of approximately 1 in 6,500 people. The AAVB-039 is under a first-in-human Phase 1/2 clinical trial running in the background in the UK, US and Europe.

The second therapy is AAVB-081 for retinitis pigmentosa, which is caused by Usher syndrome type 1 B. The retinitis pigmentosa from Usher syndrome has affected 1 in 50,000 individuals, falling under the age of 10. This therapy, as of now, is in Phase 1/2 development and promotes the first dual AAV gene therapy clinically under a testing process in an ocular indication.

AGC Biologics benefit from this agreement

This forthcoming initiative will accelerate AGC Biologics’ BravoAAV™ suspension platform and can further use a creative dual AAV vector idea to challenge a basic hurdle in gene therapy (for those genes that are too long for an individual AAV vector). As observed, most of the therapeutic genes are very long to make space in a single AAV serving vector; this technique segregates the therapeutic gene into two halves. Both halves are then packed into their own different AAV vector.

When examined, both the vectors get into the target cell, where two parts are reassembled to create the entire functional gene. This allows the treatment of diseases that are currently not eligible for the standard single-vector idea because of the AAV vector’s low potential of 4.7 kilobases.

The CEO of AAVantgarde, Natalia Misciattelli, was seen as excited to partner with AGC Biologics, as they are the ideal best-in-class CDMO partner for this purpose-built agreement. With this agreement, AGC will get the opportunity to access the peak manufacturing capabilities.