ExeVir and Mithra announce manufacturing collaboration

Published: 15-Jul-2021

Mithra CDMO will perform fill finish work for XVR011, ExeVir’s COVID-19 antibody therapy

ExeVir, a developer of single domain antibody therapies against viral infections, and Mithra Pharmaceuticals have announced a collaboration under which fill and finish for ExeVir’s therapies will be done at Mithra’s integrated CDMO platform.

Following the close of its $50m Series A financing earlier this year, ExeVir is accelerating the development of its candidate XVR011 for the potential treatment and prevention of COVID-19. The Phase Ib/II clinical study is designed as a registration trial targeting conditional or emergency approval.

XVR011 is a single domain-based anti-SARS-CoV-2 antibody (llama-derived VHH-Fc) which the company says is optimised for stability, safety, broad neutralising capability and manufacturability. Preclinical data reportedly show XVR011 antibody to be effective against SARS-CoV-2, and importantly, its rapidly spreading variants of concern.

Since July 2021, Mithra CDMO is operating a manufacturing facility dedicated to fill & finish production of complex liquid injectables and biologicals in vials, pre-filled syringes or cartridges. Under the terms of the collaboration, Mithra will be responsible for upscaling and manufacturing services for filling the drug substance in support of clinical and commercial supply.

Torsten Mummenbrauer, CEO of ExeVir Bio, said: “We are very pleased to collaborate with Mithra which has built a cutting-edge new fill and finish manufacturing facility. It has been a phenomenal year for ExeVir. Being able to collaborate with great partners in Europe such as Mithra and others are not only key to our success, but also helps the growth of the biotech ecosystem in Belgium and across Europe.”

Renaat Baes, Chief Manufacturing Officer of Mithra, commented: “We are absolutely thrilled to enter into this collaboration agreement with ExeVir, who is developing promising innovativeCovid-19 treatments. We will utilise both our team’s unique knowledge to accelerate clinical supply and ensure manufacturing capacity to bring relief to patients all over the world. Our collaboration will contribute to creating employment within the local biotech ecosystem across Belgium, Europe and support the increasing supply and manufacturing demands.”

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