2021-08-19| Trials & Approvals

ExeVir Bio’s COVID-19 Neutralizing Antibody Derived From Llamas Advances to Phase 1 Trials

by Manju Bhaskar
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COVID-19 has been an unprecedented global threat, requiring a rapid and broad neutralizing response due to its tremendous impact on patients, healthcare systems, societies, and economies.

On August 18th, ExeVir Bio announced the entry of its lead asset, a COVID-neutralizing single domain antibody called XVR011, into Phase I clinical trial. The Belgium-based biotech is a clinical-stage company harnessing its VHH technology platform to bring antiviral treatments to help stop the pandemic and to protect the most vulnerable.

“This is a major milestone for ExeVir. Following the creation of ExeVir a year ago and our lead candidate XVR011 in accelerated development as a COVID-19 therapeutic, we are very pleased that our lead compound XVR011 is now in clinical development,” Dominique Tersago, Chief Medical Officer of ExeVir Bio.

He added that ExeVir is excited to bring a single-dose treatment for patients with COVID-19 to the clinic, first as an IV infusion, rapidly followed by a formulation of subcutaneous injection.

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


A Potent COVID-19 Neutralizing Antibody

XVR011 is a single domain-based anti-SARS-Cov-2 antibody optimized for stability, safety, broad neutralizing capability, and excellent manufacturability. The Ilama-derived antibodies are smaller than human antibodies and can attach to parts of the virus that are difficult to access for the human immune system. It also offers breadth and potency against a range of Sabecoviruses.

XVR011 inactivates SARS-C0V-2 spike proteins and sterically blocks spike protein binding to ACE2, preventing the virus from entering a human cell, stopping viral replication. This is expected to support the patient’s own immune response by reducing the viral load and dampening local and systemic inflammation.

This is particularly beneficial for those at increased risk of severe illness from COVID-19. Importantly, XVR011 was demonstrated to neutralize the Delta (B.1.617.2) and Gamma (P.1) variants of concern. These data were generated in the laboratory of Prof Johan Neyts at the Rega Institute (KU Leuven, Belgium).


Emerging Player in Anti-Viral Therapeutics

ExeVir, a single-domain antibody company, was launched less than a year ago. Since then, the company is making tremendous progress in building its innovative pipeline.

Following the close of its $50 million Series A financing earlier this year, ExeVir accelerated the development of XVR011 for the potential treatment and prevention of COVID-19. In addition, the company collaborates closely with the laboratories of Prof. Xavier Saelens and Prof. Nico Callewaert (VIB-Ghent University) to develop new antiviral VHH antibodies.

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 is supported by 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).

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