Single Strain21 Oct 2021 11:44
I haven't watched the Tim Spector piece on diet and the microbiome but it is worth considering how 4Ds approach differs from that of using diet or probiotics to produce a healthy microbiome rather than an unhealthy one that can lead to various types of disease.
Faecal Microbiota Transplants, probiotic and the consortia approaches of Seres and Finch Therapeutics seek to correct dysbiosis by getting various species of healthy bacteria to become established in the gut so that they can start addressing illness.
These approaches can produce positive results but they involve a somewhat hit and hope approach whereby a collection of species and strains of bacteria are administered with no real understanding of which strain is having the greatest effect.
An example is the Seres consortia product SER 109. This has had some positive results in c difficil infections. However, in one of the trial studies you can see that they produced 3 different batches and only 59% of the bacterial strains identified were present in all 3.
4D has a completely different approach. They are not looking to produce a healthy microbiome to address dysbiosis caised disease by engrafting selected bacterial species in the gut.
They start with a theory about what causes a disease and how gut bacteria might effect the disease pathway in the same way that a traditional drug molecule would be expected to have a specific function produced by interaction with the host's body and the disease.
So you could have a species of bacteria or various similar species that are associated with anti inflammatory effects. So this could be SER 109 or particular fermented foods.
4D then explore their extensive library of donor samples for these species and start isolating single strains of bacteria using genomics and other screening techniques to find the strains with the most potent effects.
DP gave the example in the Jefferies presentation of looking at different strains of bifidobacterium-breve for the asthma drug. Some of these strains had minimal in Vitro effects compared to the selected one which was extremely potent in its function.
They can then use the platform to track the function of the selected strain in great detail, so that when an LBP has positive effects they can pinpoint exactly what the mechanism of the strain is. Furthermore, they don't need to ensure that the strain is engrafted in the gut. It can effectively be administered to exert its effect, e.g. tumour shrinkage and then washed out once its done its job, in the same way as say aspirin.
DP stressed the benefits of this approach both for demonstrating to regulators the effect of the LBP and also how it is so much easier to run quality control on the product when it's just the purity of one strain that needs to be ensured.
With the recent ESMO presentations on tumour biomarkers and genetic changes following dosing we are looking at drugs that fall firmly into the categories of precision medici
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