Pipeline

Coronavirus/COVID-19

Under the PREVENT-NCoV consortium, ExpreS2ion and its 34%-owned associate company AdaptVac have applied their unique Drosophila S2 insect cell protein production technology, ExpreS2™, and capsid virus-like particle (VLP) COVID-19 technology, respectively, to develop a novel next-generation COVID-19 vaccine, known as ABNCoV2. Bavarian Nordic has licensed the global commercialization rights to the ABNCoV2 COVID-19 vaccine and variants hereof.

ABNCoV2 has shown to be highly immunogenic in relevant preclinical models inducing durable and highly protective response from a COVID-19 challenge. Initial Phase I/II clinical study data from COUGH-1, the first-in-human trial of the vaccine, have confirmed its ability to induce strong and broad antibody levels, superior to those of the current approved vaccines, while also providing a favourable safety profile. In the Phase II trial,  ABNCoV2 was demonstrated to induce a significant boost to the neutralizing antibodies against all tested variants, including the Omicron variant.

In September 2022, Bavarian Nordic initiated a Phase III study with the aim to demonstrate non-inferiority of ABNCoV2 as a booster vaccine for individuals with previous COVID-19 disease or vaccination compared to the licensed mRNA vaccine Comirnaty®. Initial Phase III data readout is expected towards the end of 2022, which will allow for a rolling submission to the regulatory authorities, aiming to obtain approval of the vaccine in 2023.

Breast cancer

Breast cancer is a widespread oncology indication affecting more than 1.3 million people worldwide annually, resulting in more than 450,000 deaths, according to a study published in 2015. The most common treatment today is based on monoclonal antibodies, where the dominating therapy Herceptin (trastuzumab) generates annual global sales of USD 7 billion. The target product profile of the HER2-cVLP breast cancer vaccine candidate is tailored to be highly competitive both in terms of cost and efficacy, thus aiming at a significant market share.

In February 2021, ExpreS2ion signed a final patent license agreement with AdaptVac whereby ExpreS2ion exclusively licensed in AV001 (renamed ES2B-C001). This gives ExpreS2ion full control over and responsibility for driving this valuable asset forward, hereby realising the very significant value of this project.

In December 2021 and January 2022, positive preclinical proof-of-concept results were announced. In these studies, ES2B-C001 demonstrated a strong tumor-growth inhibiting effect in a mouse model and human cancer cells (December 2021), as well as in HER2-transgenic preventive and therapeutic tumor mice models (January 2022).

Further excellent preclinical results were announced in May 2022, based on a new study in which HER2-transgenic mice were injected with HER2-positive tumors followed by vaccination every two weeks one week after challenge. All control mice had lung nodules, whereas all mice vaccinated with ES2B-C001 formulated in an adjuvant were metastasis-free. Furthermore, 73% of mice vaccinated with ES2B-C001 without adjuvant were metastasis-free, the remaining had only 1-2 lung nodules.

Influenza

The international next-generation influenza vaccine consortium INDIGO, led by the University of Amsterdam with ExpreS2ion as a participating member, is developing a next-generation influenza vaccine in a large collaboration between public and private R&D organisations from the EU, India, and the United States. The project has been awarded a 10.0 MEUR Horizon 2020 grant from the EU, of which ExpreS2ion’s participation was directly awarded 0.6 MEUR.

The INDIGO consortium plans to carry out the preclinical and clinical development of the project, which contains two novel influenza vaccine concepts, including the application of a novel potent adjuvant by LiteVax BV, the Netherlands, as well as the use of the ExpreS2 platform for antigen production by ExpreS2ion. The aim is to create an influenza vaccine that meets the requirements of global vaccination, i.e. to achieve <10% instead of 60% non-responders, combined with a lower manufacturing cost and better accessibility.

 

Malaria Projects

Malaria I
Blood stage (RH5-1)
Jenner Institute of the University of Oxford is developing the blood-stage Plasmodium falciparum malaria antigen RH5.1 with ExpreS2ion as a collaboration partner. The RH5.1 antigen is produced in ExpreS2ion’s ExpreS2 platform.

 

Malaria II
Blood stage (RH5-2)
With the aim to further improve efficacy, Jenner Institute of the University of Oxford is developing a second-generation RH5 vaccine, RH5.2, in the ExpreS2 platform. RH5.2 has been engineered to retain regions important for red blood cell recognition, which are targeted by neutralising antibodies. Additionally, the RH5.2 protein will be displayed on the surface of a hepatitis B derived virus-like particle (VLP) in order to maximise the induction of high titre antibodies. The project is founded by the Wellcome Trust.

 

Malaria III
Transmission (Pfs48/45)
The goal for a transmission-blocking vaccine is to prevent the transfer to mosquitos feeding on persons infected with malaria, thus effectively hindering further spread of the disease. Thereby a transmission-blocking vaccine does not give direct protection from the disease, but it stops the disease from spreading and could therefore lead to eradication of malaria. During the last decade, the inability to produce the full-length Pfs48/45 antigen has been a major roadblock for researchers aiming to create a transmission-blocking malaria vaccine. However, this challenge was overcome by ExpreS2ion and Jenner Institute at the University of Oxford.

This vaccine is developed by the Horizon 2020-funded OptiMalVax grant consortium, led by Jenner Institute at the University of Oxford with ExpreS2ion as a member. The objective of the consortium is to create a combination malaria vaccine, and its clinical program will include trials to assess the pre-erythrocytic, blood-stage and mosquito-stage components of the combination vaccine, including this transmission vaccine.

 

Malaria IV
Placental (VAR2CSA)
ExpreS2ion is a part of the PlacMalVac project that started in 2013 as an international consortium project with the aim to develop a vaccine against placental malaria. The project is based on the antigen VAR2CSA, which enable parasite accumulation in the placenta and was discovered by Professor Ali Salanti and others at the University of Copenhagen.

 

Malaria V
Blood-stage (PfRipr complex)
An international research team, including scientists from ExpreS2ion and led by the Walter and Eliza Hall Institute of Medical Research (WEHI), is developing a next generation malaria vaccine that is targeting a recently discovered molecular ’key’ that the deadly malaria parasite uses to enter human blood cells. The malaria ‘key’ was first described in a Nature article, published December 2018 from the group. It is a complex of three parasite proteins called Rh5, CyRPA and Ripr, where the three proteins work together to unlock and enter the cell. This central role in the infection of human blood cells makes the complex a new and promising target for vaccine development. The vaccine is based on a patent co-owned by WEHI and ExpreS2ion.