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Big Year Ahead For New Vir CEO De Backer

2023 Could Be Transformational For US Biotech

Executive Summary

Having played a pivotal role in changing pharma strategy at Bayer, Marianne De Backer tells Scrip about her goal to turn Vir into an infectious disease powerhouse as the firm prepares for critical Phase II data readouts in hepatitis B and D, as well as flu.

Moving on after a stellar three years at Bayer AG, Marianne De Backer had plenty of CEO job offers but the lure of returning to the infectious disease space to lead Vir Biotechnology, Inc. proved too strong to resist.

At the end of January, De Backer was unveiled as the successor to biotech industry veteran George Scangos at Vir, joining from Bayer where she had been global head of pharma strategy, business development and licensing/open innovation. Her role in turning around the German group's innovation prospects after joining in February 2020 was considerable, cementing her reputation as an astute dealmaker.

Speaking to Scrip just a day after taking over the hot seat at Vir, De Backer reflected on her time at Bayer where "I focused on setting the strategy for growth of the pharma business and we decided there was a lack of diversification in modalities. We said, 'we're going to go to cell and gene therapy’ and that led to acquisitions that needed to happen, because the knowledge was just not there. It was a very logical process of seeing how can we get to grow and in what areas do we need to play." (Also see "Bayer Back In M&A Mode To Boost Pipeline" - Scrip, 12 Aug, 2020.) (Also see "Bayer Bids To Be A Winner In Cell & Gene Therapy" - Scrip, 8 Dec, 2020.)

De Backer oversaw five acquisitions and more than 60 alliances at Bayer but her extensive experience in the sector goes way beyond business development. "I have been in the industry for more than 30 years, I started working in October 1991 and the first 10 years of my career I was a scientist," she pointed out.

Much of her career was spent in various roles at Johnson & Johnson, "with a big chunk in R&D and a big chunk in commercial," launching both a neuroscience and an immunology drug in Europe, as well as leading promotion and co-marketing arrangements, corporate development and venture investing on both sides of the Atlantic. "This is now the third time I'm moved to the US and the fourth time I've returned to infectious diseases," she quipped.

Despite her successes at Bayer and J&J, De Backer said: "In the autumn of 2021, I decided that I wanted to be a CEO. It was coming up to my 30th anniversary in the industry and a lot of people were asking me, 'why aren't you CEO?', this came up all the time. I thought maybe this was actually the time to start looking so I informed people in my network, I saw a lot of opportunities and I said no to a lot of them."

Then came the approach from Vir, "which is exactly at the stage where we can grow it to the next level. It's not a start-up, right? It's a company that has already shown twice that it can go from an idea to a product on the market," De Backer said. Vir participated in the discovery of Ridgeback Biotherapeutics LP’s Ebola treatment Ebanga (ansuvimab), when it was known as MAb114 and the company, along with partner GSK plc, developed and launched a monoclonal antibody treatment for COVID-19, Xevudy (sotrovimab). (Also see "GSK Ends Pact with Vir For New COVID Treatments" - Scrip, 14 Feb, 2023.)

'Exceptional' Pipeline

Revenues from Xevudy have helped Vir compile "a very healthy balance sheet of more than $2bn in cash and equivalents," she noted, adding that it also has a number of products in Phase II. "For a company of this size, I think it's really exceptional to have such a rich clinical pipeline," De Backer added.

The second half of this year will reveal how rich that pipeline is with closely watched data readouts from three trials in hepatitis B and D, as well as influenza.

The firm has high hopes for VIR-2482 which is the Phase II PENINSULA trial that is looking at two potentially first-in-class intramuscularly administered doses of the monoclonal antibody in the prevention of influenza A. "More than a billion people get influenza every year, six million get hospitalized and 600,000 die across the world from influenza," De Backer said. "It's a serial killer, a predictable surprise that comes back every year, but there is an opportunity to do something about it."

There is also much excitement around Vir's hepatitis programs. Initial data from part B of the ongoing Phase II MARCH trial evaluating combinations of its siRNA drug VIR-2218, the monoclonal antibody VIR-3434 and pegylated interferon alpha for hepatitis B are expected in the second half of 2023.

De Backer noted that around 300 million people are living with hepatitis B and about 40% of them develop end-stage liver disease. "There's really nothing out there, it's a very similar situation to what we had in the past for hepatitis C," said De Backer who was involved with J&J's launch of Olysio/Sovriad (simeprevir), a NS3/4A protease inhibitor which sold very well before Gilead Sciences, Inc.’s Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) came to dominate the hepatitis C market.

Vir is hoping that the combo can stop the hepatitis B virus and clear the infection. "There's a huge unmet medical need and fingers crossed that the data will look good," De Backer said. She added: "In infectious diseases, you almost always need combination treatments because the viruses evolve, you get resistant variants and the more modalities you use to attack the virus or boost the immune system, the more chances you have to keep the pathogen in check."

Stressing that "the name of the game is combinations," De Backer said that Vir is looking at a number of them, including a combo of VIR-2218, Gilead’s investigational TLR-8 agonist selgantolimod and a marketed PD-1 antagonist. The VIR-2218/VIR-3434 combination is also being investigated in the Phase II SOLSTICE trial for hepatitis D, "another area of high unmet need where there's no treatments available so the second half of this year is going to be really exciting," she said.

De Backer noted that "I'm obviously a first-time CEO so I will be learning a lot and I look forward to that. Throughout my career, I've had that learning mindset which I think is required be a good leader." She will also be able to consult with Scangos, who is staying on as an advisor until June and will remain on Vir's "remarkable board," which includes chair Vicki Sato, former president at Vertex Pharmaceuticals Incorporated, Nobel Prize winner Phil Sharp and ex-Bristol Myers Squibb Company R&D chief Elliot Segal.

She concluded by saying that if one of the Phase II trials succeeds, "that's already great but if all three read out positively, that would be transformational for Vir and, more importantly, for patients."

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