Next in our series of conversations with experts at the World Vaccine Congress last month is founding CEO of Valneva, Thomas Lingelbach. Thomas joined us for a conversation about the many field-leading vaccines that his team is working on. We were glad to secure some of his time during a busy event, and hope that you enjoy the interview!
As Thomas mentions, he is founding CEO of Valneva, with “more than 30 years in the vaccine industry”. He led the Valneva team at the Congress to discuss their efforts against chikungunya and zika, which we heard a little more when we spoke to him.
The Chikungunya vaccine
A Biologic License Application is currently under review by the US FDA for the Company’s chikungunya vaccine candidate. If approved, it could become the first licensed vaccine available to address this unmet need. Thomas kindly explained a little more about the nature and significance of this vaccine.
“Valneva’s chikungunya vaccine is the most advanced chikungunya vaccine in the world.”
Having completed Phase III studies, the company expects the first approval this year, with regulatory preparations underway in several countries. It’s a live attenuated vaccine, targeting “long protection after a single shot”. The target populations are both both travelling to, and communities living in, areas affected by chikungunya.
“Chikungunya is a devastating disease.”
What about Lyme?
Another of Valneva’s vaccine candidates is a Lyme disease vaccine, which we previously explored as it progressed to Phase III trials last year. VLA15, an investigational multivalent subunit vaccine (which means it targets the outer surface protein of the disease-causing bacteria) is currently the only Lyme disease candidate in clinical development and is part of an ongoing partnership between Valneva and Pfizer. The current trial includes ~9000 total participants above 5 years of age at high risk of Lyme disease in the US, Canada, and Europe.
“We have quite a serious set of different clinical manifestations around Lyme disease, and with global warming, all those vector transmitted diseases are on the rise.”
Valneva is also considering re-activating its Zika vaccine programme, and led a roundtable at the Congress on the opportunities and challenges associated with the development of a Zika vaccine. We asked Thomas about some of these challenges. He states that it is a “very, very devastating disease” with “very severe consequences”. Therefore, the need for a vaccine “solution” is clear. However, Zika is an outbreak disease, meaning that “you need to find ways to prove the effectiveness of a vaccine”.
“Since you can’t predict when the outbreak is going to occur, you have to find other ways.”
Attention is then on an accelerated approval pathway, using animal models to “mimic” the immunological threshold. Another challenge is associated with the target population. The ideal vaccine would be appropriate for women of “childbearing age”, but also applicable to pregnant patients in an outbreak situation.
“Essentially this means that you need to have a vaccine technology that is considered safe, well-tolerated, and able to be given to pregnant women. Therefore, the choice of the vaccine technology that you’re actually going to pick, is critical.”
The current approach that Valneva is considering is an inactivated virus. Among other vaccine technologies this is considered the “best-tolerated” technology.
“We focus only on highly differentiated products and programmes that address high unmet medical needs. And all of our different programmes are characterised by either being first-in-class, best-in-class, or only-in-class.”
From this, Valneva is therefore in a strong position to continue “playing a pioneering role” in the fight against Zika.
Thomas also kindly took the time to give us a greater insight into Valneva’s travel vaccine portfolio. He explains that Valneva is not only focused on the development, but the “manufacturing and commercialisation” of vaccines in areas of “high unmet medical need”. For example, Valneva has a cholera vaccine and commercialises the “only vaccine licensed against Japanese Encephalitis in the United States and Europe”.
This area of the business generated “around 130 million Euros” in the last financial year and contributes to the continuation of Valneva’s investment in vaccine R&D.
Coming to the Congress
Our final question allows us to understand what brings Thomas and his team to the event. He describes the Congress as “one of the best networking events that we have in the vaccine industry”.
“It’s networking across all stakeholders; it’s not limited to a special group of stakeholders, and everyone is here.”
We are grateful to Thomas for his time and insights into the incredible work that Valneva is doing to target these diseases of high unmet medical need. We hope to be able to continue the conversation at future events! To get more information on the Congress download our post-event report and make sure you subscribe for the latest insights in your inbox.