MILAN, Italy — AGC Biologics has entered into a new manufacturing agreement with AAVantgarde following the biotech company’s recent Series B financing close. The partnership marks AGC Biologics’ latest expansion in the adeno-associated virus sector and will support production of AAVantgarde’s two clinical-stage dual-vector gene therapy candidates targeting severe inherited retinal disorders for which no approved treatments currently exist.
The agreement covers Good Manufacturing Practice production for two programs:
AAVB-039 for Stargardt disease, the most common inherited form of macular degeneration and a leading cause of childhood and young adult vision loss, affecting roughly 1 in 6,500 people. The therapy is being evaluated in a first-in-human Phase 1/2 trial in the U.S., the U.K. and Europe.
AAVB-081 for retinitis pigmentosa caused by Usher syndrome type 1B, a condition affecting approximately 1 in 50,000 individuals, typically before age 10. The program is in Phase 1/2 development and represents the first dual AAV gene therapy tested clinically for an ocular condition.
Both therapies rely on a dual adeno-associated viral vector approach to address a longstanding limitation in gene therapy: delivering genes that are too large to fit inside a single AAV vector. The method splits an oversized gene into two segments, each loaded into its own vector. Once delivered, both vectors enter the target cell and the gene reassembles into a full, functional sequence, enabling treatment of diseases that cannot be addressed by traditional single-vector methods due to the AAV’s approximately 4.7-kilobase capacity.
“We are delighted to partner with AGC Biologics, a world-class CDMO with deep expertise in viral vector manufacturing. This partnership marks an important milestone for AAVantgarde as we continue to advance our innovative gene therapy pipeline in the clinic,” said Natalia Misciattelli, CEO of AAVantgarde. “Working with AGC will ensure that we have access to the highest quality manufacturing capabilities, enabling us to deliver transformative therapies for patients.”
AGC Biologics will manufacture both programs at its Milan Cell and Gene Center of Excellence, which supports early- and late-phase clinical supply. The facility has three decades of experience and ten EMA and FDA approvals and is recognized for its leadership in complex cell and gene therapy projects. The therapies will use the company’s BravoAAV suspension platform, a high-yield process designed to move programs from gene to clinic in as little as nine months.
“This collaboration with AAVantgarde allows us to contribute to the noble mission of addressing this significant unmet medical need and showcase our technical precision across many vector types as well as various stages of clinical development,” said Luca Alberici, Executive Vice President of AGC Biologics’ Global Cell & Gene Technologies Division. “As a dedicated team with a focus on reliability and stability, we are honored to develop, manufacture, and optimize lenti-, retro- and adeno-associated viral vectors for developers with complex, cutting-edge projects.”
