The Novartis gene therapy business will contribute its technology and dedicated space at a facility run by CDMO Catalent to help produce a COVID-19 vaccine being developed by Massachusetts-based researchers.
Massachusetts Eye and Ear and Massachusetts General Hospital have teamed to develop a vaccine candidate that uses an adeno-associated virus (AAV) vector to deliver and express the Spike gene of the SARS-CoV-2 virus, which causes COVID-19, to elicit an immune response.
The developers have turned to AveXis, the gene therapy division of Swiss biopharma firm Novartis, to aid manufacture as the candidate moves towards the clinic.
“AveXis has entered into a manufacturing agreement with Massachusetts Eye and Ear and Massachusetts General Hospital to produce its novel genetic COVID-19 vaccine candidate called AAVCOVID,” AveXis spokesperson Samantha Schwarz told Bioprocess Insider.
“Through this strategic partnership, AveXis is contributing its technology, expertise and supply chain at no cost to supply the AAV vaccine for COVID clinical trials scheduled to begin in the second half of 2020.
“Once these early studies are completed, including the first clinical trials, the researchers aim to advance the study into later phases. AveXis has the option to manufacture the AAV vaccine for additional clinical development, registration and/or commercial activities.”
Dedicated CDMO space
AveXis has seen success with its product Zolgensma (onasemnogene abeparvovec), approved as a one-off gene for therapy spinal muscular atrophy (SMA) in the US in May 2019. The firm has built up its inhouse manufacturing network to support the product. It’s licensed site in Libertyville, Illinois exclusively makes Zolgensma, though the firm is scaling up two additional facilities in Durham, North Carolina and Longmont, Colorado, in preparation for a license in 2021.
But in July 2019, AveXis added third-party capacity, inking a deal with contract development and manufacturing organization (CDMO) Paragon Gene Therapy – owned by Catalent – to secure dedicated capacity at a site in Maryland to further assist in scale-up. The space is expected to be licensed to support commercial manufacturing in the second half of the year.
It is here where AAVCOVID will be manufactured, Schwarz confirmed.
“AAVCOVID will be manufactured utilizing capacity at our third-party clinical manufacturing site. AveXis’ manufacturing site in Libertyville, Illinois will continue to be exclusively dedicated to the production of Zolgensma to meet growing, global demand,” she told us.
“It is also important to note there are significant differences in the doses and amount of viral load needed for a vaccine of this nature vs. a gene therapy for SMA.”
Other parties involved in supporting the AAVCOVID vaccine program include Aldevron and Viralgen.
“Collaboration continues to be a huge priority in the context of this global pandemic and that is why are we honored to be a part of this effort among multiple stakeholders,” said Schwarz. “In addition to the capacity AveXis has for AAV production, there is a fair amount of capacity in the industry that could be redeployed if this effort is successful.”