Biotech profile: Tom Evans, CEO, Vaccitech.

Vaccitech was launched in a spin-out from Oxford University in May 2016, with the aim of using its novel technology platform to develop a range of innovative new vaccines.

The company’s most advanced programme is a universal flu vaccine, VTP-100, which has just begun phase 2b trials.Vaccitech is also developing a clinical stage therapeutic vaccine for prostate cancer, and a number of further preclinical programmes.

Tom Evans

Pharma Market Europe talks to its chief executive Tom Evans, a veteran research and business leader in viral diseases, with experience across academia, big pharma and biotech.

What are the shortcomings of current influenza vaccines, and why are new products needed?

Current influenza vaccines fall short in their ability to protect against influenza illness year-on-year. This is because they induce antibodies against constantly evolving, surface antigens of the virus, so we are always playing catch up.

There’s a high risk the selected virus for the vaccine doesn’t match the most prevalent, infective strains each season and therefore must be updated annually. We’ve reached a state in which influenza peaks seasonally and leads to global health and economic costs through lost productivity and even death, while the risk of a global pandemic outbreak is ever present.

We need new flu vaccine products that enable long-term use and can increased efficacy in at-risk groups, such as the elderly and immunocompromised. Our VTP-100 vaccine has the potential to fulfil this target profile. It has been shown to boost human memory T-cell responses, rather than antibodies, to viral proteins that are highly conserved between different influenza A strains.

We have two recently initiated phase 2b clinical trials that will show if this type of immunity protects against illness, either when given alone, or in conjunction with seasonal influenza vaccine.

There are several major global R&D-based vaccine companies (of which you have experience) How does a small start-up compete with these bigger players?

We won’t compete directly with big vaccine companies, but may partner with them to support late phase product development and commercialisation. We have all the skills internally to oversee the regulatory, clinical and manufacturing aspects to take us through the large phase 2 trials that we are presently conducting.

The market is very competitive but we’re doing something different. Our vaccine generates a strong T-cell response that matches or exceed those found in persons who are naturally protected in each flu season.

US agencies like BARDA have a long history of supporting these innovative approaches to public health. Do you think EU institutions could do more on this front?

The EU also has some quite interesting approaches to universal vaccination, as evidenced by the EIB support of the BionDVax phase 3 study.

VACCITECH'S PIPELINE

VTP-100's clinical phase 2b trial is just getting underway, with analysis of the clinical and virologic data by Q1 2020.  If everything proceeds to plan, when could the vaccine reach the market?

We are pursuing a dual clinical development pathway that will differentiate VTP-100 in the marketplace. The first path establishes the vaccine’s suitability as a standalone vaccine desirable for pre-pandemic stockpiling. We are conducting a 134-person influenza challenge study, one of the largest ever conducted and co-funded by BARDA, to validate this approach.

The second development pathway is as an adjunct for seasonal vaccines to boost efficacy to levels higher than those achieved by the seasonal vaccine alone. On this front, we have initiated a 6,000-person influenza field study in Australia, in which our vaccine or placebo is administered in individuals who have received a seasonal vaccine

The outcome measurement is to decrease the amount of laboratory-confirmed influenza illness. These two settings are where we see the product having the most immediate patient and societal value. The challenge study results should be available in January of next year, with the Australia field study results available in late 2020.

As many of the safety and manufacturing issues surrounding our MVA-NP+M1 vaccine are already de-risked, a positive efficacy readout in the challenge study should allow us to take on a partner for development from phase 3 onwards. The positioning of the vaccine for use in multiple settings will allow us to engage a large pool of potential partners, including those both with and without an existing influenza vaccine franchise, which will be instrumental in driving the commercialisation process.

Vaccines can have an enormous impact on public health. Do you ever get frustrated that they don’t receive the acclaim and funding of other medicines, such as cancer treatments?

The preventive, and extremely effective nature of vaccines and the enormous benefit they provide to the global community is massively understated and underappreciated. Also, the present situation is that some of the diseases with greatest global need for new efficacious treatments, such as HIV, TB, Malaria, have been difficult to address using classical approaches that focus on antibody induction.

Vaccitech’s platform, which induces the cellular side of the immune system against disease targets, could be one approach in which a more powerful and durable T cell response is required. Success in our clinical programs for flu, HPV and HBV vaccines could help shine a light on vaccines: currently a therapeutic modality that saves more lives per year than almost any other medical intervention.

You have a broad pipeline of candidates, including therapeutic vaccines, such as your vaccine for prostate cancer in phase 1. How big a role do you think therapeutic vaccines will play in future cancer treatment?

This is hard to know. The value of T cell approaches, especially CD8+T cells, has been shown by the CAR-T field. We now need to show that we can induce similar effective responses using a vaccine approach. Once that Proof of Concept is achieved, the field will be open wide.

You took the helm of Vaccitech when it was spun out Oxford University Innovation in 2016. What was that process like, and would you do anything differently looking back?

We have had a good run so far, rapidly progressing into large-scale clinical trials for our lead product. There are minor issues that you would always do differently, but all in all, the approach would be the same. In the future we would like to raise more money from US investors and look to in-license a wider IP portfolio.

Dr Thomas G. Evans

Vaccitech’s CEO and board director, Dr Evans received his MD from the University of Virginia and trained in Internal Medicine at UCSF, and in Infectious Diseases  in Virginia.

He established a laboratory during his first position at the University of Utah and directed the HIV clinic. He moved to the University of Rochester as Associate Professor for 5 years, before becoming Infectious Diseases Division Chief and tenured full Professor at the University of California, Davis. His academic research centered on leishmania and HIV vaccine development and led to him joining Vical, a DNA vaccine developer as Chief Medical Officer in 2002.

In 2005, he joined the Novartis Institutes for Biomedical Research as Global Head of Infectious Diseases Translational Medicine and Research. In September 2008 he moved to Shanghai as VP for Translational Sciences in Asia for Novartis. In September 2010 he joined Aeras, a non-profit Product Development Partnership with a mission to develop global tuberculosis vaccines, as the Chief Scientific Officer, and became CEO in February 2013. He joined Vaccitech in the spring of 2016. He has over 140 authored publications.