4D pharma plc (LON:DDDD) has said results of a trial using its Live Biotherapeutic in combination with an established cancer drug called a checkpoint inhibitor “far exceeded” the threshold for success set out before the study began.
MRx0518 was used alongside Merck & Co’s Keytruda to treat 12 ‘end of line’ patients with either advanced metastatic renal cell carcinoma or metastatic non-small cell lung cancer.
Five people, or 42% of the group, experienced a clinically meaningful benefit from the two drugs. This was well ahead of the success threshold of 10% agreed at the outset of the phase I/II trial.
Tumour shrinkage
Three patients enjoyed what’s called a partial response to the combination with tumour shrinkage of 30% or greater; in the other two the disease remained stable.
The median duration of treatment for the five patients experiencing the clinical benefit from the regimen is now 13.2 months.
The treatment itself was well tolerated with no serious adverse effects.
Professor Jaap Verweij, a leading cancer expert from the Netherlands and an advisor to 4D who has carried out more than 150 early-stage trials of this kind, called the results “extremely encouraging”.
Group B will widen the scope
This latest data came from the first group of a two-stage trial. Group B will recruit 30 people per tumour type.
Checkpoint inhibitors such as Merck’s Keytruda, which works to unmask cancer to the immune system, currently have their limitations. They work for probably only 30% of the population. When they do work, they work exceptionally well. Sadly, over time the effect can wane.
MRx0518 has been developed to work synergistically with Keytruda to reengage the immune system.
Human microbiome
4D’s work focuses on the emerging scientific area of the human microbiome (the bacteria that reside mainly in the gut) and how this complex ecosystem, tweaks it to impact the treatment of disease.
MRx0518 is a Live Biotherapeutic, meaning that it contains live organisms. The approach focuses on single bacteria strains to assess specific mechanisms of action targeting a defined disease pathway.
At the same time, it has been designed to be safe and well-tolerated, removing the side-effects of traditional pharmaceutical and biological drugs.
In a statement, 4D’s chief scientific officer, Dr Alex Stevenson, said of the trial results: “This is ground-breaking for the microbiome in immuno-oncology. Considering the advanced stage of disease of the patients in the study, end of line patients who have previously failed on a checkpoint inhibitor and have little to no remaining treatment options, these results are very promising."
He added: "We believe that, while this is a small study, these efficacy and safety results in such a difficult-to-treat population are notable. To achieve these results while maintaining a very clean safety profile is to our knowledge unparalleled, and particularly significant in oncology where there is all too often the unfortunate trade-off between treatment and quality of life, and patients often elect to interrupt or stop treatment completely due to adverse side effects."
