Up to 30 people per tumour type will participate in Part B of the company’s phase I/II trial to assess its live biotherapeutic, MRx0518, in combination with immune checkpoint inhibitor Keytruda.
The assessment will look for a meaningful clinical impact on cancer patients that have become resistant to this type of therapy.
Researchers are looking for a complete or partial response or stable disease for six months or longer.
Safety already assessed
Safety and tolerability will also be evaluated, although Part A of the study has already indicated there were no serious adverse events; no treatment-related drug discontinuations; and no increase of immune-related adverse events
Of the 12 people enrolled in Part A, five are still taking the combination therapy. They include two patients with a partial response to the regimen, one patient with ongoing stable disease for over six months, and two with ongoing stable disease for less than six months.
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.
The work on Keytruda addresses the fact that sadly, over time, the effect of this class of drug can wane.
Re-engaging the immune system
So, MRx0518 is being trialled to assess its potential to work synergistically with Keytruda to re-engage the immune system.
“Part A of our trial demonstrated that 4D pharma's candidate MRx0518 may provide benefit to this group of patients,” 4d chief executive Duncan Peyton said in a statement.
“Commencing Part B of the study and opening new sites in the US to accelerate recruitment will allow us to build quickly on the positive results of Part A. Continued positive results will support MRx0518 as a much-needed novel therapeutic for patients who currently have no alternative treatment options.
“This is another important step towards our aim to have the first approved Live Biotherapeutic in an oncology setting," he concluded.