New Developments in the Microbiome Research Progress Therapeutic Potential. How Executive Search Can Help in an unpredictable field

New developments in the continually evolving field of microbiome research have risen out of young startup Wild Biotech, a company whose focus is to turn genes from wild animal gut bacteria into therapeutic medicines capable of treating immunological, inflammatory, and gastrointestinal disorders (Mast, 2021).

Neta Raab and Ido Bachelet are the entrepreneurs behind Wild Biotech. For the last 4 years they have been examining the DNA of bacteria from fecal samples of land and sea animals from Hungary, Uganda, the Falkland Islands, Madagascar, Australia, and Israel (Mast, 2021). The animals and their habitats were chosen on the basis that, over thousands of years their habitats have been minimally impacted by human contact, and thus maintain gut microbiomes adapted to purely wild ecosystems.

The data compilation of their efforts is an extraordinary scientific breakthrough, yielding “the largest database ever assembled of the microbiome…inside different members of the animal kingdom” (Mast, 2021). Most of the 1,200 bacterial species found in the samples are novel discoveries.

Since the Human Microbiome Project (HMP) commenced in 2007, scientists now understand that the majority of bacteria using the human body as host work in harmony with the body. Many bacteria likely enhance immunity, and are beneficial for many of the body’s natural processes such as digestion, metabolism, and healthy neonatal development. Although harnessing the potential of the microbiome to treat human disease is still in its early stages, with mid-stage clinical trials underway in a few U.S.-based biotech companies.

Evelo Biosciences is a publicly traded, clinical stage microbiome biotech based in Boston. The company has developed a technology called SINTAX, which delivers oral microbiome drugs to the small intestine where they work to treat systemic inflammatory disease. In September, Evelo announced positive Phase 2 data results from its clinical trial for EDP1815, a drug used to treat mild to moderate psoriasis. The company is also working on oral biologics for a variety of inflammatory diseases, including atopic dermatitis and COVID-19.

Currently there is no therapy based on knowledge of the microbiome approved for disease treatment. However as of late last year, Boston-area biotech Seres Therapeutics’ stool-derived treatment for clostridium difficile infection cleared stage III clinical trials, and may become the first FDA-approved microbiome treatment (Garber, 2020).

In November this year, Seres announced it had enrolled its first patient in its Phase 1b SER-155 study – an investigational, oral microbiome therapeutic meant to reduce the incidence of gastrointestinal bacterial infections, bacteremia (a blood infection), and graft vs host disease (GvHD) in immunocompromised patients. Other potential applications in preclinical pipelines and early-stage clinical trials for Seres include treatments for ulcerative colitis and melanoma. Seres has rebounded from setbacks in their 2016 clinical trials, raising more than $260M in two stock offerings after announcing last year’s phase III results (Garber, 2020).

Several other companies have progressed their clinical trials in the treatment of clostridium difficile (C. difficile), including Vedanta Biosciences, Finch Therapeutics (another Boston-area biotech) and Rebiotix.

Vedanta is also developing microbiome-based drugs to treat irritable bowel disease (IBD), food allergies, and unspecified cancer (Garber, 2020). The company met its primary endpoints in Phase 2 clinical trials in October of this year, with a greater than 80% reduction in the odds of recurrence of c. difficile compared to placebo in patients with chronic infection. The positive results earned Vedanta a $23.8M contract option from the Biomedical Advanced Research and Development Authority (BARDA) to support Phase 3 clinical trials, which will begin in 2022.

A few of the mysteries that Raab and Bachalet were fascinated by, which prompted the founding of Wild Biotech and its microbiome project, have to do with understanding how animal microbiota may help develop treatments for infectious disease that spread across continents; and how “good” gut bacteria may contribute to a greater defense against toxic invaders (such as how birds have evolved to eat the rotting flesh of animal corpses and remain unscathed).

Raab and Bachelet hope that Wild Biotech will be able to contribute a “vast trove of genetic information that could be mined for new drugs on a long list of diseases” (Mast, 2021). Bachelet told Endpoints News’ Jason Mast that their focus is on “proteins and functions you can’t find in the human microbiome that might offer new routes of administration, or the ability to radically alter the immune system.” Their compiled data is essentially a platform that enables research on bacteria that have never been studied before. Whether or not that information is valuable in the development of new drugs remains to be seen.

“The growing enthusiasm for microbiome R&D has created much speculation from VCs and biotech industry leaders about the success of its application, although success has so far been limited in terms of developing viable therapeutics,” says Alex Ellis, Managing Director at BayBridge. He continues, “It’s exciting and challenging because discouraging results in early stage trials dampen investor activity, but then a team develops a breakthrough that may renew investor interest, turning everything around.”

He finishes, “The best executive search consultants should use a talent management approach to establish long term, invested relationships with biotech executive leaders and candidates working unfailingly in this space, because you never know when a company may explode with funding off the back of a successful step forward, and need to quickly expand.”

If you’re interested in learning more about BayBridge’s talent management approach to executive search, please reach out to alex.ellis@baybr.co.uk.

References

 Garber, K. (2020). First microbiome-based drug clears phase III, in clinical trial turnaround. Nature Reviews, 19, 655-656.

 Mast, J. (26 March 2021). Two Church lab vets, a secretive institute, and an Israeli billionaire hunt for drugs in the guts of wild animals. Endpoints News. https://endpts.com/two-church-lab-vets-a-secretive-institute-and-an-israeli-billionaire-hunt-for-drugs-in-the-guts-of-wild-animals/