ExeVir and Mithra announce manufacturing collaboration for innovative Covid-19 treatments

- Accelerated clinical development of ExeVir's novel llama-derived antibody therapies for potential treatment and prevention of Covid-19

- Manufacturing of ExeVir's candidate product at Mithra CDMO's new Injectable Facility

- Joint unique expertise of two Belgian biotechs to provide global access to innovative therapies for a broad range of coronaviruses, including variants of concern

GHENT, Belgium, July 15, 2021 /PRNewswire/ -- ExeVir, which is developing single domain antibody therapies providing broad protection against viral infections, and Mithra Pharmaceuticals (Euronext Brussels: MITRA) 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."

About ExeVir Bio

ExeVir Bio is a clinical stage company harnessing its VHH technology platform to generate robust antiviral therapies providing broad protection against viral infections, including pan-coronaviruses. It is a spin out from VIB, the world class Belgium-based life sciences research institute. ExeVir's platform is based on the work of and collaboration with Professor Dr. Xavier Saelens and Professor Dr. Nico Callewaert from VIB. ExeVir Bio is led by a team of experts that combines international biotech and pharma experience with a successful track record of developing and bringing products to market. It has raised over €42M from blue chip investors led by Fund+, VIB, UCB Ventures, SFPI-FPIM, V-Bio Ventures, SRIW, Noshaq, Vives IUF, SambrInvest and several Belgian Family Offices.  ExeVir has also been awarded funding from the Flanders Agency for Innovation & Entrepreneurship (VLAIO). www.exevir.com.

About Mithra Pharmaceuticals

Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women's Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra's goal is to develop products offering better efficacy, safety and convenience, meeting women's needs throughout their life span. Mithra explores the potential of the unique native estrogen Estetrol in a wide range of applications in women health and beyond (Covid-19, neuroprotection…). Mithra also develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO in Flémalle, Belgium. With 15,000 m² of modern pharmaceutical pilot scale and GMP manufacturing facilities, Mithra CDMO provides specialized services covering complex therapeutic polymeric forms (vaginal rings and implants); fill & finish production of complex liquid injectables and biologicals in vials, pre-filled syringes or cartridges; a tablet manufacturing platform dedicated to Estetrol-based products. Active in more than 100 countries around the world, Mithra has an approximate headcount of 350 staff members and is headquartered in Liège, Belgium. www.mithra.com www.mithracdmo.com