ExeVir announces first subjects dosed in Phase I clinical study of potent COVID-19 neutralizing antibody

- Major milestone in development of "pan-coronavirus" nanobodies

- Now evaluating clinical safety and pharmacokinetics of XVR011, a potent COVID-19 neutralizing antibody – also against Delta variant

GHENT, Belgium, Aug. 18, 2021 /PRNewswire/ -- ExeVir, which is developing single domain antibody therapies providing broad protection against viral infections, today announces that the first subjects have been dosed in a Phase I clinical study of XVR011, its llama-derived antibody for the treatment and prevention of COVID-19.

The randomized, double-blinded, single-center, placebo-controlled Phase I clinical study will evaluate the safety profile and pharmacokinetics of XVR011 administered as an IV infusion in healthy subjects. The study will sequentially test three ascending doses of intravenously administered XVR011 in a maximum of three groups of 10 healthy adult subjects.

Dominique Tersago, Chief Medical Officer of ExeVir Bio, said: "This is a major milestone for ExeVir. Following the creation of ExeVir a year ago, we are very pleased that our lead compound XVR011 is now in clinical development. Importantly, XVR011 was recently demonstrated to neutralise the Delta variant, as well as all current COVID-19 variants of concern. We are excited by the prospect of bringing a single-dose treatment for patients with COVID-19 to the clinic, first as an IV infusion, which will be rapidly followed by a formulation for subcutaneous injection. We are making significant progress as we work to avert evolution and spread of existing and new coronaviral disease with next generation treatments. We would like to thank our investors, our team at ExeVir, VIB and our many collaborators for their exceptional work and steadfast support."

ExeVir recently announced that novel data generated in the laboratory of Professor Johan Neyts at the Rega institute (KU Leuven, Belgium) show that XVR011 demonstrated strong in vitro neutralization potency against the Variants of Concern Delta (B.1.617.2) and Gamma (P.1). Additionally, results from Professors Xavier Saelens and Nico Callewaert based on epitope sequencing indicate that the potency is not expected to be impacted by any currently circulating variant of concern or variant of interest. This is of particular relevance for the further clinical development and broad applicability.

The XVR011 molecule was developed by VIB-Ghent University (Belgium) scientists led by Professors Xavier Saelens and Nico Callewaert. The Belgian-based global biopharmaceutical company UCB helped design and optimize the therapeutic properties of XVR011 and manufactured the antibody at large scale for the clinical trial. The development work is presently undergoing peer review and was recently pre-printed in BioRxiv, demonstrating highly potent and broad neutralizing activity and infection protection in both hamster and mouse models against SARS-CoV-2.

About XVR011 (VHH72-Fc)

ExeVir's lead asset XVR011 is a single domain-based anti-SARS-CoV-2 antibody (VHH-Fc) optimized for stability, safety, broad neutralizing capability and excellent manufacturability. It demonstrates best-in-class potential offering breadth and potency against a range of Coronaviruses and is significantly differentiated from other antibody treatments.

• The single domain antibody (VHH) anti-coronavirus platform was developed by VIB- Ghent University scientists, Professor Xavier Saelens and Professor Nico Callewaert.
• The llama-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 SARS-CoV-2 spike proteins and sterically blocks spike binding to ACE2, preventing virus from entering a human cell, stopping viral replication; this is expected to support the patient's own immune response in a critical time window during which many patients' immune system reacts too slowly or inadequately.
• Epitope of XVR011 is much less susceptible to human antibody immune pressure that can lead to "viral escape", resulting in retained potency against such escape variants – No impact of any variants of concern on potency as of today.
• XVR011: Targets unique epitope in conserved region, leading to broad spectrum of binding to spike RBDs across numerous sarbecoviruses.

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 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 UCB

UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 8000 people operating in approximately 40 countries, the company generated revenue of € 5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news

For more information contact:

ExeVir Bio
Fiona du Monceau, COO
Email: info@exevir.com

Optimum Strategic Communications

Mary Clark, Stella Lempidaki, Zoe Bolt
Tel: +44 (0) 20 950 9144
Email:exevir@optimumcomms.com