Imagine a tiny, specialized key that can unlock and disable a virus's entry system. This project used llama-derived antibodies, which are much smaller than human ones, to reach hidden spots on the virus that normal antibodies miss. By blocking the virus from entering human cells, it stops the infection from spreading while the body's own immune system catches up.
Current antibodies and vaccines often fail to protect against rapidly mutating SARS-CoV-2 variants. There is a critical need for therapies that target conserved regions of the virus to prevent viral escape.
A nanobody-Fc fusion candidate (XVR011) and a validated commercial manufacturing process for consistency lots.
If you are a drug developer dealing with viral mutations that bypass current vaccines — this project developed XVR011 that binds to a highly conserved epitope to neutralize variants of concern. It provides a critical window of protection when the patient's immune system reacts too slowly.
If you are a CDMO dealing with the need for scalable, stable protein production — this project developed a nanobody-Fc fusion optimized for manufacturability. The process was successfully transferred to a commercial manufacturer to produce consistency lots for registration.
If you are a hospital network dealing with severe lung damage in COVID-19 patients — this project developed a therapy that minimized lung damage in challenged hamsters. It offers a way to stop viral replication before severe symptoms escalate.
Based on available project data, the specific price per dose or cost of the therapy is not mentioned; however, the EU contributed EUR 9,902,750 to the project.
Yes, the technology was transferred to Millipore/Merck to establish the process for commercial manufacturing and consistency lots, following initial production in a 2000 liters BioPlant.
A strong intellectual property rights portfolio was established early in the pandemic, with seven IP patents filed.
The project received approval from the Belgian regulators (FAHMP) and the Ethics Committee to move into Phase 1b/2 clinical trials.
The project period ran from 2021-12-01 to 2022-11-30, focusing on moving the candidate into a global Phase 2 trial.
The consortium is heavily industry-driven, with a 75% industry ratio consisting of 3 industrial partners and 1 research partner across Belgium, Germany, and France. This structure, featuring a mix of a lead SME (ExeVir Bio) and large-scale partners like UCB and Millipore/Merck, indicates a strong focus on commercialization and manufacturing scale-up rather than basic research.
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