ExeVir Bio Announces Positive Virus Neutralization Data for XVR012 Against Emerging COVID-19 Omicron Variants

ExeVir Bio recently announced new data demonstrating that its antibodies are highly potent in neutralizing currently circulating COVID-19 Omicron variants. All authorized SARS-CoV-2 therapeutic antibodies that have been used in the clinic show severe to complete loss of virus neutralization potency against the currently circulating variants. ExeVir’s XVR012, a cocktail of XVR013m and XVR014, targets three distinct epitopes highly conserved across the broad sarbecovirus subgenus of Coronaviridae to minimize the risk for viral escape. XVR013m is a heavy chain-only antibody targeting a unique membrane-proximal epitope in the S2 subunit of the spike protein. XVR014 is a bispecific heavy chain-only antibody that, complementary to XVR013m, targets two epitopes in the receptor-binding domain of the S1 subunit of the spike protein. XVR013m and XVR014 neutralize both SARS-CoV-1 and SARS-CoV-2 viruses.

The cocktail of XVR012 demonstrates exceptional neutralization potency, with an IC50 range of 0.8 to 1.8 ng/mL (pseudovirus neutralization assay) against all SARS-CoV-2 variants evaluated so far, including the currently highly prevalent E.G.5.1, HV.1 and BA.2.86.1. The activity against new circulating variants under monitoring is continually being tested. ExeVir is currently gearing up to start the clinical development of both the combination XVR012, as well as its individual components XVR013m and XVR014.

Dr. Torsten Mummenbrauer, CEO of ExeVir, said “Whilst an end was declared to COVID-19 as a public health emergency by the WHO, the pandemic is still continuing, and COVID-19 has sadly not been conquered. It remains an ongoing life-threatening challenge for immunocompromised patients, and the elderly, who total around 4% and 10% respectively of the world population and remain at high risk of severe COVID-19 disease, despite the availability of current vaccines. Our unique and powerful approach of targeting three highly conserved epitopes in the SARS-CoV-2 spike protein with our cocktail XVR012 is anticipated to be highly potent against virtually all currently circulating variants under monitoring, including EG.5.1, HV.1, and BA.2.86.1. There is still a strong need for novel antibodies that work against the newest Omicron variants, and these new data demonstrate that ours can be part of the solution.”

ExeVir Bio is a clinical-stage biotechnology company developing single-domain antibody-based therapeutics focusing on infectious diseases. The company is harnessing its llama-derived antibody (VHH) technology platform to generate multi-specific antibodies for prophylaxis and treatment of infectious diseases. ExeVir’s initial focus is on prevention of COVID-19 for the immunocompromised patient population, including active chemotherapy, immunosuppressive drugs, solid organ transplantation, hematological malignancies, AIDS patients, and for the elderly, where there remains a high unmet need due to the limitations of current vaccines and therapeutic approaches.

ExeVir’s COVID-19 pipeline includes XVR012, a combination product of XVR013m and XVR014, a bi-specific single-domain-based antibody construct which targets two conserved epitopes in the S1 subunit. XVR013m is a modified form of XVR013. Together they target several S1 and S2 epitopes in one product. XVR021 is targeting dengue and XVR031 is for pandemic preparedness.

ExeVir has demonstrated it can progress its candidates from research to the clinic in under one year, execute on Phase 1a and Phase 1b studies, and conduct scale-up manufacturing. Leveraging this extensive experience, its XVR012 asset is being developed to start a First in Human clinical trial in 2024.

VHHs are smaller in size than whole antibodies, giving them access to hidden epitopes that traditional monoclonal antibodies are unable to reach with potential for deeper tissue penetration and simpler, more cost-effective manufacturing. VHHs can be linked together like building blocks into a single molecule to tackle different epitopes or act through different mechanisms of actions at once, to address the “arms race” in more complex and co-evolving infectious diseases.

ExeVir is a spin out of VIB, the leading Belgium-based life sciences research institute. It is backed by strong investors including Fund+, which led the series A of EUR 42 million, together with an international consortium including UCB Ventures, SFPIM, V-Bio Ventures, VIB, Wallonie Entreprendre, Noshaq, Vives IUF and SambrInvest. ExeVir has received support from VLAIO, the SPW-Recherche and the European Union, leading to a total of EUR 18 million in non-dilutive funding. In 2023, ExeVir secured an option for EUR 25 million venture debt financing from the European Investment Bank. For more information, visit ExeVir’s website.