4D pharma (AIM: DDDD) has hailed positive results of a trial using its Live Biotherapeutic with a cancer drug, “far exceeding” the threshold of success set out before the study began.
The trial used 4D’s Live Biotherapeutic candidate MRx0518 alongside an immune checkpoint inhibitor, which is marketed by Merck & Co as Keytruda®, to treat 12 patients with either advanced metastatic renal cell carcinoma or metastatic non-small cell lung cancer.
MRx0518 is a single strain product in development by 4D pharma for the treatment of cancer. It is delivered as an oral capsule and stimulates the body's immune system, directing it to produce cytokines and immune cells that are known to attack tumours.
The pharmaceutical group said that five patients - or 42% of the group - experienced a clinically meaningful benefit from the combination of the two drugs. The company said this was ‘well ahead’ of the success threshold of 10% agreed at the outset of the phase I/II trial.
Three patients experienced partial responses to the treatment with a tumour shrinkage of 30% or greater, while the disease remained stable in an additional two patients.
The median duration of treatment for the five patients experiencing clinical benefit is now 13.2 months, with four of these currently ongoing, 4D pharma told investors this morning.
4D said the trial has demonstrated that MRx0518 shows a ‘highly favourable safety profile, with no treatment-related serious adverse events or drug discontinuations and no increase of immune-related adverse events (irAEs) commonly associated with ICI therapy.’
Shares in DDDD jumped 30% following the news
Professor Jaap Verweij, Emeritus Professor of Medical Oncology, at Erasmus University Medical Center in Rotterdam, described the results of the trial as “extremely encouraging”.
Dr Alex Stevenson, Chief Scientific Officer of 4D pharma, said the fact that Part A of the trial study has far exceeded the threshold for success agreed upon with its partner MSD for the cohort expansion phase bodes well for the outcome of the ongoing Part B of the study.
The Part B of the trial is enrolling at multiple sites and will assess the clinical benefit of the combination drugs in addition to safety, in up to 30 additional patients per tumour type.
“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,” added Dr Stevenson.
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