ExeVir Bio Unveils Potent Neutralization of Variant-proof XVR013m Antibody Against SARS-CoV-2 Variant JN.1

ExeVir Bio, a biotechnology firm specializing in developing robust heavy chain-only antibody treatments for infectious diseases, has unveiled promising new data on its COVID-19 program. The company's antibodies have shown exceptional efficiency in neutralizing the SARS-CoV-2 variant JN.1, a prevalent strain circulating globally.

Focusing primarily on immunocompromised and elderly individuals, who constitute around 4% and 10% of the global population, respectively, ExeVir's initiative aims to address the urgent need for additional COVID-19 protection. Even though vaccines are available, these groups often struggle to mount an adequate immune response, making them more susceptible to severe illness, and thereby could greatly benefit from antibody therapeutics.

ExeVir’s leading clinical candidate, XVR013m, is a heavy chain-only antibody that targets a unique, conserved region in the S2 subunit of the spike protein. This specific binding site has not shown mutations across all known variants of concern and those under monitoring. XVR013m has demonstrated outstanding neutralization potency against the JN.1 variant, with an IC50 of 2.8 ng/mL in a pseudovirus neutralization assay, maintaining its efficacy against all previously tested variants. The company continues to test its activity against emerging variants.

Preparing for clinical development in 2025, ExeVir aims to offer XVR013m as a preventive solution for COVID-19, particularly for immunocompromised and elderly individuals. Jeanne Bolger, interim CEO of ExeVir, emphasized the persistent threat of COVID-19, noting it causes significantly more hospitalizations and fatalities than influenza and RSV. Unlike these diseases, COVID-19 does not display seasonality, underscoring the need for continuous protection.

The Chief Scientific Officer of ExeVir, Viki Bockstal, highlighted that XVR013m not only shows tremendous potency against all tested variants but is also likely to retain its effectiveness against future strains due to its unique epitope. She stressed the ongoing necessity for novel antibodies that can combat both current and future SARS-CoV-2 variants. The new data underscore XVR013m's potential to provide lasting protection for the most vulnerable populations.

ExeVir Bio, a clinical-stage biotechnology company, draws on its llama-derived antibody (VHH) technology to create multi-specific antibodies for the prevention and treatment of infectious diseases. The company's primary focus is on safeguarding immunocompromised patients, including those undergoing chemotherapy, on immunosuppressive drugs, organ transplant recipients, those with hematological cancers, AIDS patients, and the elderly. These populations often face high unmet medical needs due to the limitations of existing vaccines and treatments.

ExeVir has shown that it can advance its candidates from research to clinical trials within a year. The company's expertise includes executing Phase 1a and Phase 1b studies and conducting scale-up manufacturing. Leveraging this experience, ExeVir plans to initiate a First in Human clinical trial for XVR013m in 2025.

VHHs, being smaller than whole antibodies, can access hidden epitopes unreachable by traditional monoclonal antibodies, enabling deeper tissue penetration and more cost-effective manufacturing. VHHs can also be combined into single multi-specific molecules to target different epitopes or mechanisms simultaneously, addressing complex and evolving infectious diseases more effectively.

A spin-out from the Belgium-based life sciences research institute VIB, ExeVir is supported by strong investors, including Fund+ and an international consortium. The company has also received financial backing from VLAIO, SPW-Recherche, and the European Union, amounting to a total of EUR 18 million in non-dilutive funding. In 2023, ExeVir secured an option for a EUR 25 million venture debt financing from the European Investment Bank.

ExeVir Bio continues to progress in its mission to provide innovative antibody therapies for those most vulnerable to infectious diseases.