Finnish CDMO Biovian to make oncolytic virus candidate for Lokon

Lokon Pharma has selected CDMO Biovian to produce its oncolytic adenovirus candidate LOAd703 from its viral vector plant in Turku, Finland.

LOAd703 (delolimogene mupadenorepvec) is the first clinical candidate from Lokon Pharma’s platform expressing TMZ-CD40L and 4-1BBL, two potent stimulators of dendritic cells as well as of T and NK cells, which play key roles in the induction of immune response against cancer cells and supporting stroma.

To support various oncology clinical trials, the firm has inked a deal with contract development and manufacturing organization (CDMO) Biovian Oy, which will make the viral vector. The CDMO will also carry out aseptic filling, stability studies, and release for clinical use.

Image: iStock/naumoid

“This is a substantial deal for Biovian considering the mutual intent to continue the partnership during the possible commercial stage,” Biovian’s CEO Knut Ringbom told BioProcess Insider.

“Since 2004 Biovian has provided Viral Vector CDMO services to over 100 satisfied clients in the EU and the USA and we are happy that we can use our expertise in producing Lokon Pharma’s proprietary LOAd703.”

Financial details of the deal have not been disclosed.

Viral Vector manufacturing

Biovian’s offerings span from master cell and virus bank manufacturing to the qualified person-approved release of the final labeled drug product.

Its site in Turku, Finland, recently underwent a capacity expansion to feed the growing global demand for viral vectors.

“Multiple companies are performing more clinical trials and many companies have entered later clinical trials with viral vectors,” Ringbom said. “This has partly paved the way for earlier stage companies.”

He added another reason for the high demand is the transition from local administration to systemic delivery, which requires higher doses. “Also, patient populations are getting larger as gene therapy applications are no longer only targeting rare diseases. We are experiencing this at Biovian and have made strategic investments in response to the demand.”

The facility extension, completed last year, more than doubled Biovian’s capacity for viral vector manufacturing

“The new cleanroom facility is designed according to a ballroom concept with mobile equipment allowing for easy reconfiguring for each campaign. The equipment includes e.g. 200 L single-use bioreactor for suspension cell culture,” Ringbom told us.

“We also support adherent cell cultures in multilayer flasks, packed-bed bioreactor, and single-use bioreactors on microcarriers. For downstream processes, we provide e.g. Ultracentrifugation-based Downstream Processes, Chromatography-based Downstream Processes, and comprehensive purification solutions that include chromatography, membrane processes, and Tangential Flow Filtration processes (TFF).”