4D Pharma Announced Positive Interim Data From Phase I/II Study
Mar 23, 2022 By MarketDepth
4D pharma plc (NASDAQ: LBPS) today announced positive interim data from its Phase I/II study of MRx0518 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA®.
Shares of 4D pharma plc surged over 44% in premarket trading following the announcement.
Efficacy Endpoint Met
According to the announcement, patients with solid tumors that have progressed on a prior immune checkpoint inhibitor (ICI), the renal cell carcinoma (RCC) group has met its primary efficacy endpoint ahead of enrollment completion.
“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.”Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma
The ongoing study is being conducted in heavily pre-treated metastatic patients with solid tumors and is being conducted in collaboration with MSD. The primary efficacy endpoint for Part B of the study is more than three out of 30 patients per tumor group achieving clinical benefit, defined as complete response, partial response, or stable disease for at least six months.