Mesoblast has sufficient capacity to launch Ryoncil for GVHD but will need to scale-up if the cell therapy works against COVID-19.

The Australian firm outlined its manufacturing plan for Ryoncil and other candidates last week during its Q4 call.

Ryoncil (remestemcel-L) is a candidate cell therapy for children with steroid-refractory acute graft versus host disease (SR-aGVHD).

Image: iStock/vshivkova

The product recently received the green light from the US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC), which recommended it be approved based on efficacy data.

The final decision is due in the next few weeks. According to CEO Silviu Itescu, “if approved, the launch for this product [Ryoncil] is planned in 2020.

“We have a PDUFA date for September 30, and we have industrial scale manufacturing in place to meet the commercial demand as we expect to move forward.”

Itescu added: “We have sufficient capacity to meet our Ryoncil GVHD launch plans, and we have the ability to increase and plans underway to increase our capacity requirements.”

Mesoblast’s products are made by Lonza under a 2019 agreement.

The deal grants Mesoblast access to the Swiss CDMO’s cell therapy manufacturing facility in Singapore.

The firm also has the option of asking Lonza to build a dedicated facility to meet its long-term commercial objectives.

COVID-19

Ryoncil is made from mesenchymal stem cells from healthy donors.

According to Mesoblast, it counteracts the inflammatory processes responsible for steroid-refractory aGVHD in people who have received prior stem cell transplants.

The product’s mechanisms of action include “down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.”

Ryoncil is also being tested as a therapy for children infected with COVID-19 who have acute respiratory distress syndrome, cardiovascular problems or other complications.

Itescu said: “For acute respiratory distress syndrome, recruitment of Phase III trial of remestemcel is ongoing. The trial completion is expected during the fourth quarter.

“And we assume that we will be establishing a strategic partnership for manufacturing commercialization for this indication.”