(Alliance News) - Shares in 4D Pharma PLC surged on Wednesday after it said results of Part A of its Phase I/II trial of MRx0518 in combination with immune checkpoint inhibitor Keytruda were "extremely encouraging".
The stock was trading 33% higher at 104.13 pence each on Wednesday morning in London.
MRx0518 is single strain live biotherapeutic product in development for the treatment of cancer. It stimulates the body's immune system, directing it to produce cytokines and immune cells that are known to attack tumours
The pharmaceutical company said that in 12 patients with metastatic renal cell carcinoma and metastatic non-small cell lung cancer, the combination of MRx0518 with Keytruda achieved a disease control rate of 42%, with five of the 12 patients experiencing a clinically meaningful benefit from the combination. Three patients saw their tumours shrink by around 30%.
"Having been a clinical investigator on over 150 early stage trials with a wide variety of anti-cancer agents, I believe that these results are extremely encouraging, particularly given the novelty of the approach and the durability of clinical benefit observed," said Jaap Verweij, emeritus professor of medical oncology at Erasmus University Medical Center in Rotterdam, Netherlands.
4D Pharma Chief Scientific Officer Alex Stevenson added: "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. 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."
Following successful completion of the Part A safety phase, the Part B cohort expansion phase will assess the clinical benefit of the combination of MRx0518 and Keytruda in addition to safety, in up to 30 additional patients per tumour type.
By Ife Taiwo; ifetaiwo@alliancenews.com
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