Microbiome to disrupt traditional drug discovery and development

November 4, 2015 ctheodoropulos

There is something intuitive about microbiomethe flora in our bodiesthat everyone understands.

“We have in our gut 10 times more bacteria than we have cells in our entire body,” said Eric de la Fortelle, a partner with Seventure, a venture capital firm. “Most of these bacteria play a very useful role in our digestion and they regulate interactions between the inside and the outside world that is equally full of microorganisms.”

From left, Joël Doré, Herve Affagard, Mark Offerhaus, Marie Lindner, and moderator Eric de la Fortelle.

From left, Joël Doré, Herve Affagard, Mark Offerhaus, Marie Lindner, and moderator Eric de la Fortelle.

When this homeostasis is disrupted or thrown out of balance the resulting dysbiosis can contribute to disease.

“This new field is bursting open our mental categories about drug discovery and development,” he said. “Some of this will be difficult for pharma companies, for example, having live biologic entities as drugs. Yet there will also be small molecule drugs targeting the microbiome, there will be protein-based drugs.”

According to Mark Offerhaus, a pioneering entrepreneur in the brave new world of drug discovery, early-stage investors have been comfortable in this uncharted landscape, helping him found the privately-held Micreos. Based in the Netherlands, the company has grown to more than 60 employees on the strength of an over-the-counter product used to date by 20,000 consumers for skin inflammations.

Now Micreos is seeking full-blown regulatory approval for an enzyme effective in killing the life-threatening methicillin-resistant staphylococcus aureus (MRSA). Raising the EUR 50 million runway Offerhaus estimates the company will require brings him to a new level of investment, and partners, who are proving more hesitant about entering this brave new world of microbiome therapeutics.

There is a pressure to look for alliances, he said, and he expects that traditional venture capitalists will find the courage to venture into the territory once the clinical trials reach Phase II results, “per their usual roadmap.”

For the moment, only Paris-based Seventure has boldly gone where no equity funds have dared to go. To date the venture partners have raised EUR 120 million for the Health for Life fund dedicated to microbiome drug development. By the end of November, 2015, Seventure will announce that a top-ten pharma company has joined the fund, according to de la Fortelle.

At BIO-Europe® in Munich, de la Fortelle gathered a panel of executives that included Offerhaus, Marie Lindner, MD, Head of Strategic Partnerships at Novartis, and Herve Affagard, CEO and co-founder of MaaT Pharma, which was incubated and launched with the help of Seventure, and Joël Doré, Research Director for France’s National Institute for Agronomic Research.

Over the past 10 years, the deep sequencing techniques of metagenomics have created new understandings of the complex community of organisms that inhabit the human body, enabling a transition from what was academic research into the world of diagnostics, therapeutics and nutriceutical approaches to human health.

According to Doré, “gut microbiota in its relation with the host as with any complex system has its own resilience, resistance, and robustness. If you disrupt this robustness, you may end up in a sterile condition that could be pathogenic and which would be difficult to move back.”

There is an exponential growth of microbiome research can be translated into powerful new diagnostic and therapeutic products. Direct correlations to modulating gut microbiota and effects have been established. Such correlations create a little value, said de la Fortelle, “where data that shows causation creates massive value, and every year we are seeing more value created.”

Herve Affagard is the CEO and co-founder of MaaT Pharma, which is working in the the autologous fecal microbiota transplant (FMT) arena where the primary focus is on preventing and treating infectious diseases in frail patients receiving antibiotics.

“What we are targeting is to restore the gut microbiotoma after the disequilibrium from taking antibiotics,” he said. “Our model is unique. Prior to an aggressive therapy planned for a patient, we collect the microbiota when it is healthy and stable, and we will restore the microbiota after the treatment to restore the balance.

“There is more and more clinical data and there are effects we are able to understand better and better thanks to the advent of the -omic technologies. This is going to help establish the science, and the claims,” he said.

MaaT Pharma will progressively shift from autologous to allogenic therapies, he said, and there is opportunity to make it industrially frozen, purified, filtered and delivered to patients.

“Our business model will be a product. We want it to fit with pharma, though the product will be very different from production of medicines,” said Affagard.

Marie Lindner said that among the potentials for microbiome, FMT is straightforward and it is clear. The challenges will come in addressing other diseases and conditions.

“Looking at it from an investor and pharma perspective,” she said, “we are asking if there are products there? Is the IP there? How do you protect it?”

“Some say you can’t protect products, that this is bacteria, not intellectual property. My answer is that we find IP here. It will not be the bacteria itself, but there is DNA, RNA, proteins and molecules, so there is a drug discovery component. That is the beginning,” she said.

“This is the forefront of new pathways that are opening thanks to new science, and for the people who are interested in investing in it, there is plenty of room,” she said.

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