VIB leverages Belgian strengths to bring SARS-CoV-2 nanobody spin-off ExeVir Bio to life 

Four years ago, scientists from Xavier Saelens’ lab (VIB-UGent Center for Medical Biotechnology) developed an effective antibody – with the help of Winter the llama – to fight the SARS-CoV-1 virus. When COVID-19 exploded onto the global scene in January 2020, VIB raced against the clock to set up a spin-off company with an audacious ambition: to initiate clinic tests with a novel COVID-19 treatment based on this antibody by the end of 2020 and to start commercial production by mid-2021.

Part 1: 
Building the foundations of a legendary spin-off

Before the new spin-off saw the light of day, the tireless efforts of VIB personnel and innovative partners were crucial in paving the way and setting the record-breaking pace needed to move from molecule to manufacturing in a handful of months.

Joining forces across facilities, universities and functions
The first step was an intense collaboration between the antibody engineering group of Nico Callewaert’s lab (VIB-UGent Center for Medical Biotechnology) and VIB Discovery Sciences (Catelijne Stortelers and Bruno Dombrecht) to accelerate the development of a preclinical lead molecule.

With special financial support from the cabinet of Hilde Crevits, Flemish Minister for Science and Innovation, VIB successfully financed the necessary hamster efficacy studies with a contract research organization. These results provided crucial evidence that the antibody can effectively fight off COVID-19 and complemented the results of an academic collaboration with the lab of Johan Neyts at KU Leuven.

Achieving a patented world first
At the same time, colleagues from the VIB Innovation & Business team (Griet Den Herder and Jan Demolder) took the initiative to get the valorization part rolling.  As a first step, the IP team filed several patents claiming the innovation in a very proactive manner – only a few weeks after the release of the first SARS-CoV-2 sequence. Thanks to their tireless dedication, VIB was likely the first institute worldwide to patent an antibody to fight SARS-CoV-2.

“VIB was likely the first institute worldwide to patent an antibody to fight SARS-CoV-2.”
Jan Demolder (Head of IP)

Next, the Business Development team (Tim Van Acker and Jan Staelens) explored different routes to commercialization and formalized all the necessary underlying agreements with the different collaborating academic institutes. Third, the New Venture team (Katrien Swerts and Griet Vanpoucke) started drafting the business plan for a possible spin-off company, organized the fund-raising and due diligence process with venture capital investors and negotiated all the necessary financing agreements.

Even under ‘normal circumstances’, these tasks are already formidable challenges. But in the case of what would become ExeVir Bio, they were successfully performed during the first national lockdown in Belgium and at record-breaking speed!

Boosted by proactive advice from international regulators
An important stride was taken when Jérôme Van Biervliet, Managing Director of VIB, succeeded in convincing Dhaval Patel, CSO of UCB, and his management team to start a collaboration in which UCB colleagues initiated the necessary work to help design and to produce the lead antibody using the CMC (Chemistry, Manufacturing & Controls) process for biologicals. This is a highly engineered activity that is impossible in an academic setting and that requires top-notch expertise. UCB committed to delivering the first batch of the therapeutic antibody for the first clinical studies – a significant investment.

This collaboration was extremely productive and allowed VIB, for the first time ever, to compile a dossier aimed at receiving regulatory advice from authorities in Belgium and Germany. This advice was crucial in making decisions early on to accelerate development towards testing in patients.

Securing the dedicated support of specialized partners and funders

“It has been a great experience to be part of the team, along with Catelijne, Bruno, Xavier and Nico, that helped engineer, characterize and test this potential new therapy for COVID-19 as well as prepare for the journey to the regulators and then to the clinic,” asserts Alistair J. Henry, Senior Vice President & Head of Discovery Science at UCB. “This was a true collaboration right from the start, with ideas and expertise being shared by scientists from both UCB and VIB, driven by a real sense of purpose and urgency and focused on a tremendous goal.”

Another important milestone was when Fund+, led by Philippe Monteyne, stepped in as a lead investor to raise the funds needed to take the ongoing trial to clinical testing as quickly as possible. Soon afterward, an ambitious investment syndicate made up of UCB Ventures, V Bio-Ventures, FPIM and several Belgian family offices successfully raised 23 million euros in the first A round. This achievement was essential in recruiting a top-notch management team for the spin-off in record time.

“This was a true collaboration right from the start, with ideas and expertise being shared by scientists from both UCB and UCB and VIB, driven by a real sense of purpose and urgency and focused on a tremendous goal.”
Alistair J. Henry, Senior Vice President & Head of Discovery Science at UCB

 

Part 2:  the leaders of the new company share their vision

Enter ExeVir Bio, led by Torsten Mummenbrauer (CEO), Dominique Tersago (CMO) and Fiona du Monceau (COO) – each with experience in critical domains for this new biotech player.

What led you to dive into a brand-new company at such short notice?
Torsten: “I was the pandemic lead at GlaxoSmithKline, and when VIB invited me to embark on another pandemic journey, I jumped at the chance to make a difference in the fight against SARS-CoV-2. But it was clear from the outset that this couldn’t be a one-man show. We immediately started searching for leadership team candidates and were fortunate to bring Dominique and Fiona on board.”

Fiona: “I came in from the investor side – one of the funds supporting ExeVir Bio is UCB Ventures. We were deeply passionate about this initiative to have an impact on the pandemic. I personally wanted to be more hands on involved to help build ExeVir, bringing me back to the initial reason I moved into this industry, a fascination with viruses, specifically Ebola at the time. It was a no brainer when I was approached to join.”

Dominique: “While we come from different backgrounds, we are defined by the drive to act rather than to observe in the face of this pandemic.”

“While we come from different backgrounds, we are all defined by the drive to act rather than to observe in the face of this pandemic.”
Dominique Tersago, CMO of ExeVir Bio

Torsten, you describe ExeVir Bio as an unusual spin-off. Why?
Torsten: “It’s unusual because it was set up within the context of an unfolding pandemic situation; things moved extremely quickly. A typical spin-off raises funds for six to nine months, which generally involves lots of travel and meetings with investors. Then, there’s the process of finding a strong leadership team, arranging the legalities, visiting the notary and getting everything stamped, etc. In our case, the entire setup process happened almost completely virtually and in a matter of weeks.”

Dominique: “Even though we met each other face to face for the first time at the beginning of July, we were already highly focused and engaged as a team. The speed at which we set up the company and established investors reflects our shared sense of responsibility: we all wanted to apply our expertise to make a real difference as quickly as possible. Anybody unsuited to this type of environment and this urgency would have dropped out early on in the process.”
“Also important was the strength of the Belgian biotech and pharma sectors – as well as the research – which was all in place and ready to accelerate the process.”

“Players from across Flanders and Belgium came together over handshake agreement to ensure not just a quick start-up, but also accelerated manufacturing and formulation. 
VIB played a key role here.”

Fiona du Monceau, COO of ExeVir Bio

Fiona: “Absolutely, players from across Flanders and Belgium came together to ensure not just a quick start-up, but also accelerated manufacturing and formulation. VIB played a key role here, as Xavier Saelens, Nico Callewaert, Catelijne Stortelers and Bruno Dombrecht performed all of the basic science and preclinical work needed to develop the SARS-CoV-2 nanobody® in preparation for manufacturing scale-up – which is now in the hands of UCB.”

How does the nanobody developed by ExeVir Bio act against the SARS-CoV-2 virus?
Torsten: “This nanobody targets larger proteins, just like antibodies do. But because of its miniscule size, it can reach into small clefts on the surface of the SARS-CoV-2 virus whereas human-derived antibodies cannot, blocking its ability to bind to human cells, replicate and cause the COVID-19 disease.”

“The nanobody® that we are developing is miniscule, enabling it to reach into tiny clefts on the surface of the SARS-CoV-2 virus that normal antibodies cannot, blocking its ability to bind to human cells.”
Torsten Mummenbrauer, CEO of ExeVir Bio

 

Dominique: “Our nanobody isn’t just tiny, though. It is also extremely specific, binding to a unique contact site on the surface of the virus that appears to be conserved by many SARS-CoV-2 mutations.”

Fiona: “Our lead candidate is an antiviral treatment that is administered to people who are already infected, not a traditional vaccine. A vaccine works by exposing the immune system to the virus, ‘training’ it to effectively fight off the virus. As a first-line treatment, the ExeVir nanobody will be instrumental in safeguarding the 
health of people at high professional or medical risk 
of severe illness.”

Has the company’s status as a VIB spin-off led to advantages for ExeVir Bio’s growth plans

Torsten: “The value of our collaboration with VIB cannot be overestimated. Compared with my past experience with other research institutes, I find it very unique that VIB is so involved in the funding and development of a biotech product. They were responsible for identifying a manufacturing partner, coordinating plenty of steps along the road to commercialization. The VIB scientists are still 100% supportive.”

“VIB supported us on the manufacturing side – but also with trials, disease model studies, regulatory prep work – all of these aspects were coordinated by VIB scientists. They have shown exceptional dedication.”
Dominique Tersago, CMO of ExeVir Bio

Dominique: “And it’s not just on the manufacturing side that VIB supports us, but also on the nonclinical and clinical preparation side, the disease model studies, the regulatory prep work to ensure the quick, low-risk development of an antiviral treatment – all of these aspects have been coordinated by VIB scientists. They have shown exceptional dedication to making this a real, accessible product.”

Fiona: “VIB also has strong ties with partner institutes involved in the preclinical, in vitro and in vivo studies. 
This strong spirit of scientific collaboration is a huge benefit for ExeVir Bio. We already have our compound and we will kick off manufacturing this summer. We’re years ahead of where most biotech start-ups would be at this stage.”

How close are you to having the antiviral treatment on the global market?
Fiona: “The pandemic is unfolding now. It’s an unusual situation where we have to accomplish in a year and a half what, under normal circumstances, would take many years – and regulators are willing to help.”

Dominique: “On the assumption that we have our clinical data ready from a Phase II study next year, we anticipate an accelerated approval process. We need to be ready to provide the treatment globally – not just to the developed world.”

“We plan to start commerical production in the first half of 2021 and start shipping the antiviral treatment by the end of 2021.”
Torsten Mummenbrauer, CEO of ExeVir Bio

Torsten: “This means initiating commercial manufacturing activities as soon as possible. As soon as the manufacturing is fully developed by our partner UCB, we plan to start commercial production in the first half of 2021 and start shipping the treatment by the end of 2021, with the support of international partners and funders.”

What are your ambitions for ExeVir Bio beyond the COVID-19 pandemic?
Torsten: “The future of ExeVir Bio is closely linked to VIB, as we plan to establish a close R&D collaboration. In our first year, our focus will be on fighting the coronavirus, including developing a next-generation antibody that is even more specific.”Fiona: “Our long-term goal is to build these nanobody-based antiviral treatments out into a rapid-response platform – not just for COVID-19, but for other viral diseases as well. In order to move quickly, we will balance internal and external resources,

with the ambition of bringing more resources and talent in house over the next few years and establish a durable company in our Belgian ecosystem.”

And finally – how did you choose the name of the spin-off?
Torsten: “I’m not sure we want to get into this! (laughs) It was actually a pretty complex process. We held a vote among all scientists and personnel involved in the project based on a list of options that came up during a brainstorming session. This list was thinned out quite a bit by the trademark guys, though.”

Dominique: “The ‘Ex’ is for ‘excel’, ‘execute’, ‘exterminate’ – and the ‘Vir’ is pretty clear.”

Fiona: “We wanted something short, catchy, energetic, with a connection to what we do: excel at what we do and destroy viruses. Mission accomplished.”

“For the name of our company, we wanted something short, catchy, energetic, with a connection to what we do: excell at what we do and destroy viruses. Mission accomplished.
Fiona du Monceau, COO of ExeVir Bio

 

 

We wish the team every success in their virus-exterminating ambitions and look forward to future collaborations. Interested in the latest news on ExeVir Bio? Follow them on linkedin.com/company/exevir and visit their website at exevir.com