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A novel technology enabling efficient delivery of personalized probiotics to prevent gut-related diseases and recover damaged gut microbiota

Periodic Reporting for period 1 - MBSelect (A novel technology enabling efficient delivery of personalized probiotics to prevent gut-related diseases and recover damaged gut microbiota)

Reporting period: 2020-06-01 to 2021-05-31

The importance of the gut-microbiome has long been recognized as an essential part of human health. Recently the importance of gut-bacteria-imbalance been recognized as a crucial factor in the development of therapeutics for many disease conditions.
According to the World Health Organization (WHO), probiotics are live microorganisms, which when administered in adequate amounts, confer a health benefit on the host. For centuries, the health benefits of consuming fermented food were known to humankind. The concept of administrating live microorganisms has been started over a century ago, and during the last two decades there has been growing interest both in basic and clinical science, resulting in more than 30,000 publications.
The effectiveness of traditional probiotics used today, aimed at restoring microbiome imbalance, is questionable – the main challenges is the ability to grow and produce most of them while whose who can, face the fact that many of the probiotic strains do no survive the body conditions and do not reach their target site, and even when they do many among them will not colonize or persist to achieve their desired affect.
MyBiotics Pharma is a clinical stage microbiome company which developed a unique culturing and delivery technologies integrated with computational and AI technologies which aim to close the probiotic clinical gap. MyBiotics designs and produce microbiome-based products which better survive body conditions, effectively delivered to their targets site and have potentially improved clinical effect due to the ability to colonize and persist. MyBiotics has entered several collaborations including a development collaboration with Ferring Pharmaceuticals announced in Feb 2021 following successful pilot projects.

In the Horizon2020 Next Generation Probiotics grant, MyBiotics is working on the development of MBselect. Three multi-strain probiotics products specially designed for:(a) Kids, (b) Adults, and (c) Elderly Using its proprietary technology “MyCrobe”
MBSelect overcomes the key challenges of culturing, delivery and colonization enabling the design and development of highly efficient segment-personalized probiotics, based on multi-strain collections of improved existing probiotics with human-originating beneficial commensal bacteria. The bacteria delivered using MBSelect will colonize easily, compete with the existent disease-promoting population, and shift the unbalanced bacterial communities to a healthy, balanced state.
The program successfully achieved its second milestone of optimization of the MyCrobe growth and powder formulation in small scale and preparation for scale up, entering several preclinical studies, to be followed by a clinical study planned for Q1 2022.
Regulatory landscape: MyBiotics address the three MBselect products as the first-generation line of products as dietary supplements with a well-defined product concept and strain composition rational.

Product characterization - clinical needs, bacterial strain: The products are based on MyBiotics propriety technologies and specifically the culturing and delivery system for single strain and the concept was to create a personalized probiotics by introducing a wide variety of strains, the body conditions will determine the strains that are best suitable for the consumer.
We focused on three types of custom probiotics, targeting the needs of three groups:
Kids (age 3-18) - Designed specifically for kids to enable fast recovery from antibiotic treatment and build rich and balanced microbiome community able to fight off pathogens and pathobionts.

Adults (18-65) - This product was designed to balance the specific population of microbes expected to be found in a healthy environment. Some of the indications and publications that led us in the design of the potential product were the following aspects: address adult population and specifically improve GI health and gastro related problems such as: IBD and IBS.

Elderly (65+) - During the definition of this product we have been focusing on the well documented loss of diversity and loss of specific taxonomic groups and the increased risk for infections such as CDI led us to design this group.

Lab scale growth protocol optimization using MyBiotics technology: After choosing the bacteria we developed protocols for growing each strain using MyBiotics technology, while using only food grade ingredients. First, we screened for the right growth media to establish high yelled of biomass. At the end of this step, we defined the most efficient growth conditions for each strain.

Next, we evaluated several fermentation protocols to grow each bacterium using MyBiotics technology. Each strain was examined in several conditions and manipulations based on MyBiotics knowhow, to improve their ability to survive the passage through the digestive tract. The increased acid resistance achieved by using MyBiotics technology in compare with conventional fermentations are presented in figure No 1.

Small-scale powder formulation & freeze dry process protocol after 3 months stability:
The dry powder has to meet probiotic and capsulation requirements, which are: free flowing powder - very important for tablet and capsules formulation and sachets, direct compression formulation for tablets, low water content to obtain long shelf life.
From product perspective all ingredients are food grade approved, allergen free, non-GMO, while preserving bacterial viability and stability over time. We decided to dry our powder using freeze drying process. Freeze drying is the common method for probiotics powder formulation
Following the small-scale optimization, the powder material shelf-life stability (bacteria viability over time) was tested periodically over three months at room temperature conditions (25°C with 60%RH) and at 4°C. most of the strains remained viable for 3 months at 4°C and room temperature. Additional and more specific optimization is and will be done as part of the scale up and preparation for product finalization.
The global population is becoming older, health and wellness is becoming a significant target in order to maintain high quality life.; this pattern will continue in the next couple of decades, as the medical infrastructure is improving and the post-war baby-boom generation completes its move into retirement.
Such developments are likely to have profound implications, not only for individuals, but also for governments, business and civil society, impacting, among others: health and social care systems, labor markets, public finances and pension entitlements3.
MyBiotics addresses this situation and would like to be able to contribute to these 3 sectors by specifically address potential problems. We believe that developing a line of products that one of them is for the Elderly population is of high relevance. the goal with this product and the others is to obtain wellness and wellbeing and leverage the power of the microbiome for this purpose.
By developing a functional product with strong clinical indication based on our proprietary technology, MyBiotics will be able to introduce a personalized wide range probiotics that actually works.
Acid resistance compared when applying MyBiotics with conventional fermentation