![]() ![]() The goal of the Part A phase of this study was to assess the safety, tolerability and initial efficacy enrolled a total of 12 heavily pre-treated metastatic renal cell carcinoma (RCC) and non-small cell lung cancer (NSCLC) patients refractory to immune checkpoint inhibitors. ![]() The ongoing Phase 1/2 open-label, two-part clinical trial is evaluating the safety and preliminary efficacy of MRx0518 in combination with pembrolizumab in heavily pre-treated metastatic patients with solid tumors refractory to immune checkpoint inhibitors. MRx0518 in Combination with Pembrolizumab – Part A Safety & Efficacy data MRx0518 monotherapy was generally well-tolerated with no SAEs or grades 3 or 4 toxicities reported. Gene expression analysis identified significant expression changes in 98 genes (p less than 0.05) in paired samples as a result of MRx0518 treatment, including upregulation of pathways associated with antigen presentation, costimulatory signaling, cytokine and chemokine signaling, known to promote anti-tumor immune activity. Upregulation of key immuno-stimulatory anti-tumor cytokines and chemokines, such as IL-12 and CXCL10, was observed in post-treatment plasma samples. Following MRx0518 treatment, relative increases in cytotoxic cells, CD8+ T cells and other immune subsets associated with anti-tumor activity were observed in paired tumor samples. The study is designed to generate paired patient samples at diagnostic biopsy and surgical resection, with an intervening period of MRx0518 monotherapy treatment of 2 to 4 weeks.Īs of data cut-off at October 10, 2020, 17 patients were evaluable for safety and biomarker analyses. The ongoing, two-part Phase 1 study is assessing the safety and tolerability of MRx0518 monotherapy in treatment-naïve subjects undergoing surgical resection of solid tumors. We look forward to advancing our MRx0518 program further into the clinic and we are already enrolling patients into Part B of our Keytruda combination study, including the addition of new tumor type cohorts.” The data generated from these trials provide us with huge confidence not only with moving forward with MRx0518 as a novel immunotherapy for the treatment of cancer, but also our MicroRx platform. “The data also furthers and clarifies our earlier work on the mechanism of action of MRx0518 and, importantly, the activity we are seeing in these patients mirrors the preclinical results, further validating our approach and the MicroRx platform. The strong immunological signals of biological activity shown in the monotherapy trial provides further clinical evidence of the role and contribution of MRx0518 to the impressive results we are seeing in combination with Keytruda in an incredibly difficult to treat patient population,” said Duncan Peyton, Chief Executive Officer of 4D pharma. “The data generated from both our trials of MRx0518 and presented this week at SITC, in monotherapy and combination with an immune checkpoint inhibitor settings, is further evidence of the potential of 4D’s LBPs in oncology. Two further presentations provide updates on the ongoing Phase 1/2 trial of MRx0518 in combination with Keytruda(R) (pembrolizumab) in patients refractory to checkpoint inhibitors. ![]() The results are from the completed Part A of a Phase 1 trial of MRx0518 in the neoadjuvant setting. The first poster includes the first data presented for MRx0518 as a monotherapy. The data was presented in three posters at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2020, November 9-14, 2020. ![]() 4D pharma plc recently announced new positive clinical data from two clinical trials of MRx0518, its lead immuno-oncology single strain Live Biotherapeutic candidate. ![]()
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