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

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– Acceleration of the clinical development of new antibody-based therapies derived from the ExeVir llama for the potential treatment and prevention of Covid-19

– Manufacture of the candidate product of ExeVir in the new injection plant of Mithra CDMO

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

GHENT, Belgium, July 15, 2021 / PRNewswire / – ExeVir, which develops single domain antibody therapies offering broad protection against viral infections, and Mithra Pharmaceuticals (Euronext Brussels: MITRA) announce new collaboration to use fill and finish capabilities for therapies innovations of ExeVir within Mithra’s integrated R&D and manufacturing platform, Mithra CDMO.

ExeVir was launched less than a year ago and has made huge strides in building the business and an innovative pipeline. After the final closure of its $ 50 million Series A funding earlier this year, ExeVir is accelerating the development of XVR011 for the potential treatment and prevention of Covid-19. The sentence 1b/ 2 is intended as a trial registration targeting conditional or emergency approval.

XVR011 is a single domain anti-SARS-CoV-2 antibody (llama-derived VHH-Fc) optimized for stability, safety, broad neutralization capacity, and excellent processability. It prevents Covid-19 from entering human cells and demonstrates best-in-class potential providing breadth and potency against a range of coronaviruses (pan-sarbecovirus neutralization) and significantly differentiates from other antibody treatments. Preclinical data shows that the XVR011 antibody is effective against SARS-CoV-2 and, most importantly, its rapidly spreading variants of concern. ExeVir recently generated data that demonstrates in vitro neutralizing activity against the SARS-CoV-2 variants of concern Gamma and Delta.

Mithra CDMO offers a full range of solutions ranging from early drug development, clinical batches and commercial manufacturing of complex polymer products (vaginal ring, implants) as well as hormone tablets. Since July 2021, Mithra CDMO operates a new manufacturing facility entirely dedicated to the production of filling and finishing of complex liquid injectables and biological products in vials, pre-filled syringes or cartridges.

The selection of Mithra CDMO for the filling operations of ExeVir’s innovative Covid-19 therapeutics confirms its confidence in Mithra’s technological know-how and cutting-edge infrastructure. Under the terms of the collaboration, Mithra will be responsible for the scale-up and manufacturing services for the filling of the drug substance in support of clinical and commercial supply.

Torsten Mummenbrauer, CEO of ExeVir Bio, said: “We are very pleased to work with Mithra who have built a new state-of-the-art fill and finish manufacturing facility. It has been a phenomenal year for ExeVir. Be able to collaborate with excellent partners in Europe like Mithras and others are not only the key to our success, but growth of the biotechnology ecosystem Belgium and through Europe. “

Renaat Baes, Chief Manufacturing Officer of Mithra, said:We are absolutely delighted to enter into this collaboration agreement with ExeVir, which is developing promising innovations Covid-19 treatments. We will use both the unique knowledge of our team to accelerate clinical supply and ensure manufacturing capacity to bring relief to patients around the world. Our collaboration will help create jobs within the local biotechnology ecosystem through Belgium, Europe and support the growing supply and manufacturing demands.

About ExeVir Bio

ExeVir Bio is a clinical stage company that leverages its VHH technology platform to generate robust antiviral therapies that provide broad protection against viral infections, including pan-coronaviruses. It’s a spin out of VIB, the world class Belgiumlife sciences research institute. The ExeVir platform is based on the work and collaboration of Professor Dr. Xavier Saelens and Professor Dr. Nico callewaert of the VIB. ExeVir Bio is led by a team of experts who combine international biotechnology and pharmacy experience with successful experience in product development and bringing to market. He has raised over € 42 million from leading 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 received funding from the Flemish Agency for Innovation and Entrepreneurship (VLAIO). www.exevir.com.

About Mithra Pharmaceuticals

Mithra (Euronext: MITRA) is a Belgian biotechnology 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 that offer greater efficiency, safety and convenience, meeting the needs of women throughout their lives. Mithra explores the potential of the unique native estrogen Estetrol in a wide range of applications for women’s health and beyond (Covid-19, neuroprotection…). Mithra also develops and manufactures complex therapies in the fields of contraception, menopause and hormone-dependent cancers. It offers its partners a full spectrum of research, development and specialized manufacturing on its Mithra CDMO technological platform in Flémalle, Belgium. With 15,000 m² of modern pilot and GMP pharmaceutical manufacturing facilities, Mithra CDMO provides specialized services covering complex therapeutic polymeric forms (vaginal rings and implants); filling and finishing the 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 employs around 350 people and is headquartered in Liège, Belgium. www.mithra.com www.mithradmo.com

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SOURCE ExeVir Bio


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