Good bugs, bad bugs – who will win?  The Jlabs event “Bugs, Drugs, & Beyond: Translational Approaches to the Microbiome” on September 12 presented a realm of possibilities.  Approaches to translating microbiome explorations into real-world products ranged from profiling individuals’ diet and microbiome interactions to new routes for prevention and interception of disease with prebiotics and live microbiota.  A highlight of the day was the Quickfire challenge which showcased 6 start-ups in the microbiome area:  Lively Health, Epibiome, Siolta Therapeutics, SkinomiX, Dermala and OzStar.  Siolta came out the winner – presenting its plan to deliver live microbials for chronic inflammatory diseases including pediatric asthma.

Viewing the day as a whole triggered a number of observations.

Interesting questions remain as to the interaction between diet and the microbiome.   Studies have shown differences in microbiome profiles between industrialized and isolated populations.  Others have indicated that a change in daily diet, at least for the period of the switch, results in a shift of our microbiome profile.

One intriguing presentation came from Day Two, which showed that individuals respond differently when consuming the same foods.  Profiling the microbiome in each individual, using continuous glucose monitoring, tracking diet and applying predictive analytics could build a personalized nutrition plan tailored to each individual.  Lively Health also presented a nutrition based approach, using prebiotics and probiotics in functional foods to target IBS.  The functional foods approach provides a different and less arduous regulatory path to approval as compared to a prescription product.  This pathway was discussed in more detail by Colleen Cutcliffe, CEO and co-founder of Whole Biome, in an afternoon panel discussion.  Whole Biome is working on medical foods for treating metabolic syndrome and other diseases.

How are more traditional treatments with small molecule drugs affected by the microbiome?

In the Quickfire challenge, Epibiome presented the example of tenofovir for prevention of HIV transmission.  The drug varies in effectiveness in women dependent at least in part on whether the drug is metabolized by the vaginal microbiome and thus loses its effectiveness.  Epibiome is exploring phage that would eliminate the problematic bacteria. OzStar Therapeutics presented a probiotic approach to counteracting side effectives of sulfonylurea drugs used for type 2 diabetes.  These drugs can result in unwanted weight gain and also lose efficacy over time.

There are a wide range of applications of microbiome research and time will tell which have staying-power.  The day began with a presentation from Dirk Gevers from the Janssen Human Microbiome Institute (JHMI) on investments in microbiome applications ranging from neuroscience to metabolic conditions to auto-immune conditions.  Justin Sonnenberg presented research from his Stanford lab on gut microbiota distribution and carbohydrate interactions. At the end of the day, Dermala and SkinomiX presented on skincare products directed to interactions with the microbiota on the body’s outer surface in addition to the bugs in our gut.  Other applications not represented at the conference, but also in the news of late are microbiome interactions with agriculture. Indigo uses microbiome technology to boost crop yields and Gingko Bioworks has recently partners with Bayer to harness microbiome contributions to nitrogen fixation and plant nutrition.

The importance of IP protection for microbiome-related products and services.  Denise Kelley from Seventure joined a panel discussion to offer some guidance to newly developing companies.  She highlighted issues such as IP landscape analysis, determining freedom-to-operate, and assessing the robustness of the IP protection.

Microbiome products, including the microbes themselves and prebiotic treatments can be a challenge to protect. Once out on the market, products can be analyzed and reverse engineered by competitors.  Thus, trade secret protection at this point isn’t much, if any, help.  Patents are a challenge because natural products are difficult to patent if the same or similar substances or organisms are found in the natural world.  Novel combinations, formulations or methods of administration may be an avenue.  This was not discussed in the meeting, although it was the subject of several informal conversations during the networking breaks.

Based on the presentations and informal conversations, companies in this niche recognize the importance of IP protection.  Yet maybe because they are new to the scene or because of the challenges in securing patents, many appeared to have no published or granted patents at present.  This seems to be the case even for some companies that had publicly exhibited and sold their products.  Could this be true? Maybe not . . .. patent applications are often licensed, filed under other names, and generally take 18 months after filing to become public.  That said, given the number of companies starting in this area, and the overlap of their approaches, the lack of visible IP protection gave me pause.

Investment in microbiome-related companies is divided between a few repeat investors and many single players. Julie Betts from Silicon Valley Bank presented an overview of investments into the microbiome community.  A summary of the SVB analysis can be found here.  Interestingly, there are a few more active participants – J&J, Seventure, Illumina – but the remainder falls to 98 investors who made only a single investment in the area over the past 7 years.

In sum, translation of microbiome research to viable products and services remains a developing area with a lot of promise and a good dose of challenges.  May the best bugs win!