- AGC Biologics has signed a manufacturing agreement to produce two of AAVantgarde’s gene therapy candidates targeting inherited eye diseases.
- The partnership will use AGC Biologics’ BravoAAV™ platform and dual AAV vector approach for early and late-phase clinical manufacturing.
AGC Biologics has entered a new manufacturing agreement with AAVantgarde to support the production of two investigational gene therapies for inherited eye conditions. The announcement follows AAVantgarde’s recent Series B financing and marks AGC Biologics’ latest expansion in the adeno-associated virus market.
The agreement covers Good Manufacturing Practice production for AAVB-039, a therapy for Stargardt disease, and AAVB-081, which targets retinitis pigmentosa caused by Usher syndrome type 1B. Both candidates are in Phase 1/2 clinical development across the U.S., the UK and Europe. The therapies address progressive and irreversible vision loss for which no approved treatments currently exist.
The work will be carried out at the company’s Milan Cell and Gene Center of Excellence, which supports early and late-stage clinical supply. The process will use the BravoAAV™ suspension platform and an innovative dual AAV vector method designed to address therapeutic genes too large for a single vector. This approach packages two halves of a gene separately before reassembly inside the target cell to enable delivery beyond the typical 4.7-kilobase vector capacity.
“We are delighted to partner with AGC Biologics, a world-class CDMO with deep expertise in viral vector manufacturing.”
AAVantgarde’s chief executive, Natalia Misciattelli
AGC Biologics stated that the collaboration will allow the company to apply its experience across multiple vector types and stages of clinical development. The Milan facility has a 30-year track record and ten product approvals from the European Medicines Agency and the U.S. Food and Drug Administration.
