NIH

Intravacc awarded $9,4M NIH contract to develop an enterovirus vaccine

We met with Dr. Dinja Oosterhoff, Program Director at Intravacc, to discuss their recent $9.4 million NIH contract win. Intravacc will use this funding to develop an enterovirus (EVD68) vaccine from vaccine candidate to completed phase I clinical trial, over a 3-year period.

Harvesting of EVD68 virus. (Image from Intravacc)

Before SARS-CoV-2, another virus topped the NIH’s watchlist

Of paramount importance to public health is the immunization of populations en-masse, in protection against viral (and other forms of) infectious agents. This is certainly clearer for us all today, during the ongoing COVID-19 pandemic. However, before the rapid emergence of SARS-CoV-2, a strain of non-polio enterovirus was one of the top priorities for the US’s National Institutes of Health (NIH). This virus – EVD68, was first identified in California, 1962, with regular infections reported from 1987. A concerning spike in numbers came in 2014, marking the first major outbreak with 1,153 confirmed infections across 49 states – although estimates suggest the actual number went into the millions. Infected individuals were identified through respiratory disease and increased reports of acute flaccid myelitis (AFM) – a serious condition affecting the nervous system, causing weakening of the muscles and reflexes. AFM has since been epidemiologically linked to EVD68 induced respiratory disease.

Broad US agency announcement for an EVD68 vaccine

Subsequent outbreaks have occurred biennially in the US between August and November and in other locations worldwide and AFM cases have also increased in-kind since 2014. This prompted the release of a broad agency announcement on 3 January 2020, by the National Institute of Allergy and Infectious Diseases (NIAID), NIH, of the Department of Health and Human Services (DHHS), for the advanced development of vaccine candidates for AFM associated with EVD68. Intravacc was an ideal candidate for this call, as Intravacc is uniquely active in the field of vaccines, including extensive experience in enteroviral vaccine development and the technology and expertise to bring vaccine candidates to phase I-II clinical studies. Intravacc has several well-established vaccine platforms, such as the Vero cell platform technology, which has an excellent safety record as a platform for human vaccines, demonstrated by its use in all three generations of the currently available poliovirus vaccines.

In their NIH grant they set out to use the Vero cell platform for the development of a prophylactic EVD68 vaccine, from development of a vaccine candidate, to completed phase I clinical trial. They received a 3-year, $9.4 million contract to conduct this work. With a tight submission deadline of 28 February 2020, Intravacc contacted Catalyze for support with their application, including our Revision Service.

Taking immediate action on EVD68

After the large 2014 EVD68 outbreak, the unprecedented increase in cases of EVD68 associated AFM caught the attention of Intravacc and Dinja Oosterhoff, who are experts in development of enteroviral vaccines. Outbreaks have continued to occur during the winter season, proving EVD68 is still there and replicating in the human population. Dr. Oosterhoff describes why this is cause for immediate action:
“You don’t want it to go to the point where the virus is spreading throughout the world and you do not have the vaccine. We must keep a close monitoring status, as all signals predict it will cause more problems in the future. Not at the level of COVID-19, but still a vaccine for this virus is needed.”

Ahead of the call, Intravacc was prepared for the task

As Dinja goes on to explain, they were well-equipped to take on this call, not only through the highly transferrable Vero cell platform that they will use for development of the EVD68 vaccine, but also thanks to their early conceptual studies on usage of this platform for the EVD68 virus.
“The advantage is we have this well-established Vero cell platform and a lot of knowledge on enteroviruses, allowing us to fast-track development of this vaccine candidate. After the 2014 outbreak we performed proof-of-concept studies to see if we could plug EVD68 into the Vero cell platform, with encouraging results. This gave us enough background information to apply for the NIH contract, as well as the confidence that we can succeed within 3 years.”

Announcement of the NIH call: all hands-on deck

While the six-week period from NIH announcement to submission deadline was already tight, Intravacc did not hear about the call immediately, which left them with even less time to prepare. Given the nature of the call, Intravacc was a great candidate for the demanding task of developing a vaccine from candidate to phase I clinical trial in only 3 years. Thus, it was crucial that they understood exactly what was needed for their application, which is why they contacted Catalyze.

Dinja explains, “Because we knew the complex nature of NIH contracts, we decided early to involve Catalyze. I think the most beneficial part was at the beginning. To submit your proposal, there was a 200-page guide describing everything that you need to include. For us to oversee the complete document while also writing the full proposal would have been very difficult. What Catalyze did was make the template, with all the parts laid out that we needed to fill in the text. That was really helpful to us and allowed us to start efficiently.”

Catalyze provided Intravacc with a Review Service, which entailed an in-text review of their grant application with explanation of the NIH program and recommendations for improvement.

“In the early phase we had two review rounds with Catalyze. That was helpful because when you are into writing a proposal you cannot see the outline so much, or it becomes hard to see where you might have missed certain things. The reviews from Catalyze were really an added value. After submission of the proposal, we went into a negotiation round with heavy scientific emphasis. Here again Catalyze provided us with the template. This was followed by a third round, which was more wrapping up and negotiating the contract with the NIH.”

Receiving an $9.4 million contract

Winning this contract has given Intravacc a truly exciting opportunity to implement their foundation of expertise for the generation of a vaccine that could be in-demand very soon. Indeed, EVD68 could become a much bigger problem in the years to come. Therefore, the ongoing work of Intravacc will serve to safeguard us in case of a major outbreak.

“For us it is a substantial amount, so we are really excited that it all worked out well and we were able to receive the contract. Presently there is no clear medical need for a vaccine, but I think it will become more evident over the coming years. It is great that we can already develop this vaccine to phase I clinical testing prior to the time when the disease is more serious and larger outbreaks will occur.”

Learn more about Intravacc: www.intravacc.nl
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