The 4d Pharma PLC (LON: DDDD) share price soared 36.8% after revealing the phase I/II clinical study of its MRx0518 combined with Merck’s KEYTRUDA® (pembrolizumab) anti-PD-1 therapy in patients with solid tumours had met its primary endpoints ahead of schedule.
The study was conducted on patients with different types of solid tumours before the renal cell carcinoma (RCC) group achieved its primary endpoint ahead of schedule while still enrolling patients.
4d Pharma’s study was focused on patients with metastatic tumours who had been heavily pre-treated with a prior immune checkpoint inhibitor (ICI) and shown clinical benefit before the disease progressed later.
The study aimed to have at least three patients of 30 in each group show clinical benefit in the form of complete or partial response or a stable disease condition for at least six months.
Investors were pleased to learn that the study had enrolled 20 patients with renal cell carcinoma. Four out of the first 16 patients evaluated met the primary endpoint by achieving the clinical benefit of a stable disease condition for six months.
The patients were part of the part B study that enrolled about 47 out of 120 patients with renal cell carcinoma, bladder cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma.
The study will continue enrolling new patients as 4d Pharma discusses the next steps with its Genitourinary Cancers Advisory Board and its partners regarding the potential development paths for MRx0518.
Investors cheered the results, which demonstrated the potential of live biotherapeutics and the importance of the microbiome in treating cancers, which is a novel approach to treating diseases.
Dr Alex Stevenson, 4D Pharma’s Chief Scientific Officer, commented: “Today’s results in renal cell carcinoma, meeting the predefined primary efficacy endpoint early in this difficult to treat population, marks another important step forward for MRx0518 and the increasing importance of the microbiome in cancer treatment,”
“Meeting the primary efficacy endpoint for this group is crucial for the future development of MRx0518, and these data are highly informative for our strategy going forward as we determine next steps in RCC.”
The last time I covered 4d Pharma, the company’s shares were down 50% for the year but have since reversed course and are now trading up 3.36% following recent developments, including today’s positive clinical trial results.
Given the recent rally, the company’s shares seem to be headed higher, but I would wait for a significant pullback before jumping in.
*This is not investment advice. Always do your due diligence before making investment decisions.
4d Pharma share price.
4d Pharma shares soared 36.83% to trade at 61.3p, rising from Tuesday’s closing price of 44.8p.
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