4D pharma: A clinical stage innovator and pioneer of Live Biotherapeutics30 Jun 2020 19:29
https://www.proactiveinvestors.co.uk/companies/news/921377/4d-pharma-a-clinical-stage-innovator-and-pioneer-of-live-biotherapeutics-921377.html
15:14 Mon 08 Jun 2020
Working in the emerging area of the human microbiome, the company has developed candidates in cancer, gastrointestinal and respiratory ailments, and autoimmune disease
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4D has isolated bacteria from healthy human donors which are expected to have “highly attractive safety profiles”
To understand 4D pharma plc (LON:DDDD), it is first worth trying to get your head around the technology that has spawned drug candidates in cancer, gastrointestinal and respiratory ailments and autoimmune disease.
Working in the emerging area of the human microbiome (the bacteria that reside mainly in the gut), 4D has developed Live Biotherapeutics — products that contain live organisms such as human commensal bacteria.
The approach focuses on single strains to assess specific mechanisms of action targeting a defined disease pathway.
Even variations between different strains of bacteria of the same species are assessed and exploited.
4D’s chief executive, Duncan Peyton, says superficially identical bacteria can sometimes differ up to 20% in their gene content, and therefore may have highly different functional profiles.
Attractive safety profiles
Toxicity has always been a major impediment to the success of new drugs.
In developing its Live Biotherapeutics, 4D has isolated bacteria from healthy human donors which are expected to have “highly attractive safety profiles”.
“A lot of the safety issues encountered in novel drug development are due to the off-target effects,” explains Peyton.
“As bacteria derived from the human gut, and which are restricted to the gut following administration, we first approached Live Biotherapeutics from that angle – the potential to create safe and efficacious drugs.”
Early studies assessed the impact of these Live Biotherapeutics on the immune system.
While early programmes investigated ways to suppress the immune system, one strain, now known as MRx0518, was found to be a significant stimulator of it.
Important breakthrough
That was an important breakthrough, particularly in this era of immuno-oncology, where the body’s defences are used to battle and beat the disease.
Now in the early phase of clinical development, MRx0518 is being trialled as a single therapy for solid tumours and pancreatic cancer.
Sexier, to the lay investor at least, will be its collaboration with Merck & Co. trialling 4D’s breakthrough with the American giant’s blockbuster checkpoint inhibitor Keytruda.
Checkpoint inhibitors are big business. By 2022 sales are expected to be around US$25bn a year, while Keytruda alone generated revenues of US$11.1bn in 2019, up 55%........>>>>>>>>