Mass General counts AveXis, James Wilson among partners as it readies to deploy gene therapy tools for COVID-19 vaccine
A Mass General program using gene therapy vectors to develop a COVID-19 vaccine has teed up the multilayered manufacturing capacity needed to get its AAV candidate into the clinic next half, highlighting the front-and-center role of manufacturers in COVID-19 countermeasures.
The AAVCOVID vaccine program, spearheaded by Massachusetts General Hospital and Massachusetts Eye and Ear, announced Thursday it formed manufacturing partnerships with the AveXis unit of Novartis AG (NYSE:NVS; SIX:NOVN) and CDMOs Aldevron LLC, Catalent Inc. (NYSE:CTLT) and Viralgen Vector Core, a Spain-based JV between Asklepios Bio Pharmaceutical Inc. (AskBio) and Columbus Venture Partners.
The program also announced that researchers at the University of Pennsylvania’s gene therapy program, led by AAV pioneer James Wilson, would participate by conducting IND-enabling studies for the AAVCOVID candidate.
AAVCOVID comprises a non-replicating AAV vector encoding the SARS-CoV-2 spike protein, and is delivered intramuscularly.
According to the Mass General team, the potency and speed with which the candidate induces antibody responses means a single, low dose will be sufficient to generate protective immunity. The team believes the vector used in AAVCOVID will also generate T cell responses.
AveXis will begin manufacturing the vaccine this month. It’s contributing its technology, expertise and supply chain at no cost to support the trials scheduled to start in 2H20.
The Mass General team said that once these early studies are completed, it plans to “hand the study off in later phases to AveXis for manufacturing and additional testing.”
The Viralgen, Aldevron and Catalent deals will also support the 2H20 studies.
Viralgen will use AskBio’s Pro10 cell suspension culture to rapidly manufacture AAV vectors at scale; the company said its facilities, supply chains and workflows can produce hundreds of trillions of viral particles per batch.
North Dakota-based Aldevron is supplying DNA plasmids that serve as payloads for AAVCOVID.
Catalent said it would assist with manufacturing and testing of the vaccine. The CDMO acquired gene therapy manufacturer Paragon Bioservices Inc. in 2019
The AAVCOVID program is supported by philanthropic funds and guided by a strategic advisory team that includes former Editas Medicine Inc. (NASDAQ:EDIT) CEO Katrine Bosley and Partners Innovation Fund’s Roger Kitterman.
SARS-CoV-2 S - SARS-CoV-2 spike protein