ExeVir and Mithra Announce Manufacturing Collaboration for Innovative Covid-19 Treatments

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– Accelerated clinical development of ExeVir’s novel antibody therapies from llamas for the potential treatment and prevention of Covid-19

– Manufacture of ExeVir’s product candidate in Mithra CDMO’s new injectable facility

– Joint unique know-how of two Belgian biotech companies to enable global access to innovative therapies for a wide range of coronaviruses, including worrying variants

GENT, Belgium, July 15, 2021 / PRNewswire / – ExeVir, developing single domain antibody therapies that provide comprehensive protection against viral infection, and Mithra Pharmaceuticals (Euronext Brussels: MITRA) announce a new collaboration to expand the filling and finishing capabilities of ExeVir’s innovative therapies at Mithra’s integrated R&D to use and production platform, Mithra CDMO.

ExeVir was launched less than a year ago and has made tremendous strides in building the company and an innovative pipeline. After the final completion of his $ 50 million Series A funding earlier this year will accelerate ExeVir’s development of XVR011 for the potential treatment and prevention of Covid-19. The phase 1bThe clinical study / 2 is designed as a registration study aimed at conditional or emergency authorization.

XVR011 is a single domain-based anti-SARS-CoV-2 antibody (VHH-Fc from llamas) that is optimized for stability, safety, broad neutralization capabilities, and excellent manufacturability. It prevents Covid-19 from entering human cells and shows prime potential that offers breadth and effectiveness against a range of coronaviruses (Pan-Sarbecovirus neutralization) and is significantly different from other antibody treatments. Preclinical data show that the XVR011 antibody is effective against SARS-CoV-2 and especially its rapidly spreading worrying variants. ExeVir recently generated data to prove it in vitro Neutralizing activity against the worrying SARS-CoV-2 variants Gamma and Delta.

Mithra CDMO offers a complete range of solutions from early drug development through clinical batches to the commercial manufacture of complex polymeric products (vaginal ring, implants) and hormone tablets. Since July 2021, Mithra CDMO operates a new production facility that is exclusively dedicated to the fill & finish production of complex liquid injection and biologics in vials, prefilled syringes or cartridges.

The choice of Mithra CDMO to fill the innovative Covid-19 therapeutic from ExeVir confirms the trust 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 to fill the compound in support of clinical and commercial supply.

Torsten Mummenbrauer, CEO of ExeVir Bio, said: “We are very excited to be working with Mithra, who have built a state-of-the-art new fill-and-finish manufacturing facility. It’s been a phenomenal year for ExeVir. Working with great partners in Europe like Mithra and others are not only the key to our success, but also help Growth of the biotech ecosystem in Belgium and across Europe. “

Renaat Baes, Mithra’s Chief Manufacturing Officer, commented:We are total hyped to enter into this cooperation agreement with ExeVir, the promising innovative Covid-19 treatments. We will use the unique knowledge of our team to accelerates clinical care and ensures production capacity to bring relief to patients around the world. Our collaboration will help create jobs within the local biotech ecosystem across the region Belgium, Europe and support the increasing delivery and manufacturing requirements

About ExeVir Bio

ExeVir Bio is a clinical stage company leveraging its VHH technology platform to develop robust antiviral therapies that provide comprehensive protection against viral infections, including pan-coronaviruses. It’s a spin-out from VIB, the world class Belgium-Research Institute for Life Sciences. ExeVir’s platform is based on the work and collaboration with Professor Dr. Xavier Saelens and Professor Dr. Nico Callewaert by VIB. ExeVir Bio is led by a team of experts that combine international biotech and pharmaceutical experience with a successful track record in developing and bringing products to market. It has over 42 million. ExeVir was also funded by 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 delivering new opportunities through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products that offer greater efficacy, safety and convenience, and meet the needs of women throughout their lifespan. Mithra explores the potential of the unique native estrogen Estetrol in a variety of applications in women’s health and beyond (Covid-19, neuroprotection …). Mithra also develops and produces complex therapeutics in the fields of contraception, menopause and hormone-dependent cancers. On its Mithra CDMO technology platform in Flémalle, it offers partners a complete range of research, development and special production, Belgium. With 15,000 m² of modern pilot-scale pharmaceutical and GMP production facilities, Mithra CDMO offers specialized services for complex therapeutic polymer forms (vaginal rings and implants); Fill & Finish Production of complex liquid injectables and biologics in vials, pre-filled syringes or cartridges; a tablet production platform for Estetrol-based products. Mithra is active in more than 100 countries around the world, employs around 350 people and is headquartered in Liège, Belgium. www.mithra.com www.mithracdmo.com

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SOURCE ExeVir Bio



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