Exosomes are membrane-bound nanoparticles naturally present in human and animal milks that contain microRNA (miRNA), or short chains of RNA that are associated with beneficial immune-related activity and anti-inflammatory properties.
“It is well known that breastfed babies are protected from a long list of diseases,” said Netta Granot, CEO and co-founder of the Israeli startup. “Research shows that many health benefits of mother’s milk are due to high concentration of natural nano-nutrients, called exosomes. Milk exosomes protect and contain short chains of RNA – microRNAs – which are proved to have health benefits, like anti-inflammatory activity.
“Obviously, mother’s milk isn’t commercially accessible or scalable. But our research team found that the same beneficial components exist also in raw cow’s milk, as we are all mammals. This realisation led us to develop our game-changing technology.”
According to laboratory analyses conducted by Exosomm, bovine milk exosomes and those found in human breast milk have a 90% similarity. The startup therefore worked to develop a proprietary chemical-free process to isolate these nano-nutrients from whey, a by-product of cheese manufacturing.
Thanks to this innovation, it has been invited as one of several food and nutrition startups to pitch before investors at Future Food-Tech this month, held in London on 28 and 29 September.
“We are creating a new ingredient. We are one of the first teams in the world to reveal this: to identify the exosome composition and understand the microRNA mechanism and connect it with a medical indication and benefit use,” said Granot.
While several companies have now started to develop products based on microRNA, Granot said Exosomm has a head start thanks to years of research led by Professor Shimon Reif and a team at the Israeli Hadassah University Medical Center in Jerusalem, and its numerous patents.
A solution for sufferers of IBD
Exosomm has decided to initially capture the medical food market with a product targeted towards sufferers of inflammatory bowel diseases (IBDs), including Crohn’s disease and ulcerative colitis.
“We decided to start first on the chronic colitis segment mainly due to their unmet needs,” Granot told Vitafoods Insights. “This is like a very good starting point to get recognition of the therapeutic benefits of our ingredient. As a startup you need to know where your entry point to the market [is] because you are very limited with resources, and you cannot conquer all the world at once.”
The number of people suffering from IBD, Crohn’s, or colitis also provides a more than adequate consumer base for Exosomm: there were around 4.9 million sufferers globally in 2019, according to a study published in the British Medical Journal, an increase of over 47% since 1990. Traditionally regarded as a Western disease, prevalence is also spreading to more recently industrialised countries in the Middle East, Asia, and Latin America.
In the long term, the startup also plans to target the much larger infant formula category and it has also conducted studies showing benefits of exosomes for managing type 2 diabetes and pre-diabetes.
Health benefits: Four distinct mechanisms of action
Exosomm, which is currently raising funds for a seed round, has published several pre-clinical studies that demonstrate how its milk exosomes improved inflammatory pathologies via four distinct mechanisms.
Firstly, milk exosomes promote cell proliferation to repair inflamed gut tissues, critical to ulcer healing; secondly, they increase the levels of anti-inflammatory cytokines; thirdly, they reduce the expression of pro-inflammatory cytokines; and, finally, they improve the gut microbiome.
Exosomm’s research on mice demonstrated that its exosomes reduce gut inflammation by 90%, results that are equivalent to the pre-clinical results of the drugs available today, it said.
It now plans to carry out clinical trials on humans suffering from Crohn’s and colitis, and has submitted a formal application to the Helsinki Committee at the Hadassah-Jerusalem Hospital.
Exosomm has already secured generally recognised as safe (GRAS) status from the US regulatory agency and is beginning to compile the data required for a novel food dossier in the EU.
A novel ingredient from a global waste product
One benefit of Exosomm’s production process is that it extracts exosomes from whey – both acid whey and sweet whey – without creating demand for additional milk production.
Whey is the liquid left over when milk has been curdled and the solids separated to make cheese. This huge side-stream of the dairy industry is generated worldwide at a rate of about 121 million tons per year.
“For one kilo of cheese, you need to have 10 litres of milk, so nine litres is whey cheese water,” Granot said. “You need to do something with it. It's a huge amount. [...] This is an opportunity for everyone.”
Upcycling whey is a win-win situation for cheesemakers because they can add value to a by-product that otherwise must be treated, she added.
Environmental regulations in many Western countries require whey to be disposed of properly. The acidity of acid whey – a by-product of making acid-coagulated dairy products such as ricotta, goat’s cheese, and Greek yoghurt – can be harmful to the environment. Nutrient-rich sweet whey can be used as crop fertiliser or animal feed but too much can also pollute waterways.
Exosomm’s ingredient comes in a shelf-stable, powdered format that can be added to food and drink products.
Strategic collaboration with Tnuva
The startup is already collaborating with Tnuva, Israel’s biggest dairy company, to produce its ingredients in Tnuva’s Ba’emek-Tech factory. Thanks to this collaboration, Exosomm has access to both a pilot facility and commercial-scale facility without having to invest in infrastructure itself – one of its biggest strategic advantages, Granot said.
However, it is looking for additional manufacturing partners to test various product applications, such as a ready-to-drink beverage, a milkshake-style powder, or food supplements, for example, and test its stability within these matrices.
“It’s like the art of finding the right application,” she said. “This is why we … want to collaborate with partners [as] this is their expertise.”
To register for Future Food-Tech in London, click here.