XVR011 Phase 2 · ExeVir's XVR011, a best in class nanobody-based biology that broadly neutralizes SARS-COV-1 and SARS-COV-2

XVR011, ExeVir's clinical lead candidate has emerged from scientific research from labs of highly regarded virologist Xavier Saelens and biochemist Nico Callewaert. Nonclinical data has recently been published in Cell and a preprint on BiorxIV. XVR011 is a nanobody-Fc fusion, has best-in-class potential, neutralizes SARS-CoV-2 and minimizes the development of lung damage in hamsters. The lama-derived single-domain antibodies are smaller than human antibodies and can attach to parts of a virus that are difficult to access for the human immune system. XVR011 inactivates spike proteins and sterically blocks spike binding to ACE2, preventing virus from entering a human cell, stopping viral replication; this supplements the patient's own immune response in a critical time window during which many COVID-19 patient's immune system reacts too slowly, giving it more time to do its job and eliminate the virus. It binds to a unique highly conserved epitope in the viral receptor-binding domain. Its epitope is much less susceptible to human antibody immunity pressure that can lead to viral escape, resulting in retained potency against such escape variants. It thus neutralises the rapidly spreading SARS-CoV-2 variants, and exhibits a unique, wide scope binding across the Sarbecovirus clades. Furthermore, XVR011 has been optimized for stability, safety and manufacturability. XVR011 received approval from the Belgium regulators to move into its Phase 1b. Seven IP patents were filed early on during the pandemic. ExeVir has surrounded itself with both a team of experienced entrepreneurs and is backed by a mix of private and public experienced partners and has a strong board of directors bringing with expertise across the whole value chain. The objectives of this proposal is to demonstrate XVR011 safety and efficacy in a global Phase 2; to strengthen its nonclinical package including neutralising variants data, set-up its manufacturing process and progress its regulatory pathway.