Release Details

Horsholm, Denmark and Paris, France, December 12, 2016 – Today, ExpreS²ion Biotechnologies ApS (“ExpreS²ion”), a fully owned subsidiary of ExpreS²ion Biotech Holding AB, and ABIVAX S.A., (Euronext Paris: FR0012333284 – ABVX), an innovative biotechnology company targeting the immune system to eliminate viral disease, have entered into a service agreement and a term sheet for a commercial license agreement under which ExpreS²ion and ABIVAX collaborate in the development of their proprietary prophylactic and treatment for Ebola virus infection, ABX544. The financial terms of the agreement were not disclosed.

The Agreement

ExpreS²ion and ABIVAX have signed a Process Development Service Agreement (“the Service Agreement”), as well as a term sheet for a Commercial ExpreS²ion Platform License Agreement (“the License Agreement”) for ABX544, which specifies the terms and conditions for a commercial license to ExpreS²ion’s proprietary technology platform, ExpreS². According to the Service Agreement, ExpreS²ion will develop a process for the GMP production of an Ebola antigen, which is required for the production of ABX544. The overall preclinical work package is expected to be executed in 2017. The corresponding License Agreement is scheduled to be signed within three months. The financial terms of the agreement were not disclosed.

Ebola

Ebola virus disease (EVD), formerly known as Ebola haemorrhagic fever, is a severe and often fatal illness in humans. The virus is transmitted to humans from wild animals (fruit bats and monkeys) and following spread in the human population through human-to-human transmission. The average EVD case fatality rate is around 50%, but fatality rates have varied from 25% to 90% in past outbreaks. The first EVD outbreaks occurred in remote villages in Central Africa near tropical rainforests, but the most recent outbreak in West Africa has involved major urban as well as rural areas. This 2014/15 outbreak was particularly severe, causing the disease in >28.000 individuals of which >11.000 died. There are currently no licensed Ebola vaccines (but two potential candidates are undergoing evaluation) and no specific treatments (WHO Jan. 2016).

ABX544

The ABX544 program targets the generation of an Ebola hyperimmune anti-serum, containing neutralising antibodies produced from animals immunised with a specific Ebola antigen. In contrast to a vaccine that needs time to generate a protective response, ABX544 should have an immediate effect when administered. It can be applied either as treatment of infected persons or for protection of non-infected persons including health care workers, constituting a first line of defence during epidemic outbreaks. Following the formal preclinical evaluation including toxicology, ABIVAX aims to bring ABX544 into clinical trials.

Executive Management Comments

Prof. Hartmut Ehrlich, M.D., CEO of ABIVAX, said: “We are pleased to have entered into this agreement with ExpreS²ion, as this will be a major enabler for our ABX544 Ebola program. Ebola is a devastating disease with no licensed vaccines or therapeutics, and ABX544 has the potential to address the urgent need for immediate prophylaxis and treatment during future outbreaks.”

Dr. Steen Klysner, CEO, ExpreS²ion, commented: “We are pleased that ABIVAX has chosen our ExpreS² platform to produce the antigen required for their ABX544 Ebola programme. We see a good synergy between the ExpreS² platform’s capability for rapid production of high quality antigens and ABIVAX' approach for ABX544 and we look forward to support the development of this first-in-class product.”