ExeVir, which is developing single domain antibody therapies providing broad protection against viral infections, and Mithra Pharmaceuticals announce a new collaboration to utilize the fill and finish capabilities for ExeVir’s innovative therapies at Mithra’s integrated R&D and manufacturing platform, Mithra CDMO.
ExeVir launched less than one year ago and has made tremendous progress in building the company and an innovative pipeline. Following the final close of its $50 million Series A financing earlier this year, ExeVir is accelerating the development of XVR011 for the potential treatment and prevention of Covid-19. The Phase 1b/2 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) optimized for stability, safety, broad neutralizing capability and excellent manufacturability. It stops Covid-19 from entering human cells and demonstrates best-in-class potential offering breadth and potency against a range of Coronaviruses (pan-sarbecovirus neutralization) and is significantly differentiated from other antibody treatments. Preclinical data show XVR011 antibody to be effective against SARS-CoV-2, and importantly, its rapidly spreading variants of concern. ExeVir has recently generated data which demonstrate in vitro neutralization activity against SARS-CoV-2 variants of concern Gamma and Delta.
Mithra CDMO offers a complete spectrum of solutions from early drug development, clinical batches and commercial manufacturing of complex polymeric products (vaginal ring, implants) as well as hormonal tablets. Since July 2021, Mithra CDMO is operating a new manufacturing facility fully dedicated to fill & finish production of complex liquid injectables and biologicals in vials, pre-filled syringes or cartridges.
The selection of Mithra CDMO for the filling operations of ExeVir’s innovative Covid-19 therapeutic confirms its confidence in Mithra’s technological know-how and state-of-the-art infrastructure. 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 innovative Covid-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.”