RNS11 May 2020 08:15
RNS Number : 3688M
4d Pharma PLC
11 May 2020
4D pharma plc
(the "Company" or "4D")
Successful completion of immuno-oncology study safety phase
Leeds, UK, 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, today announces successful completion of Part A of a Phase I/II clinical trial of MRx0518 in combination with immune checkpoint inhibitor Keytruda® (pembrolizumab). Part A of the study evaluated the therapeutic combination in patients with advanced solid tumors who had previously shown an initial clinical benefit to PD-1/PD-L1 immune checkpoint inhibitors, but had subsequently developed secondary resistance and progressive disease.
The safety review committee for the study has evaluated data collected during the Dose Limiting Toxicity (DLT) period of the trial, the first cycle of treatment for the first 12 patients. The committee determined that it is safe to proceed to Part B of the study. Part B of the study has now commenced and will assess clinical benefit and safety, enrolling up to an additional 30 patients per tumor type cohort (up to a total of 120). Enrolment will be expanded to additional trial locations and sites. The study is open label and an update on progress is anticipated later in the year.
Dr. Alex Stevenson, Chief Scientific Officer, 4D pharma, commented:
"As with all of 4D pharma's Live Biotherapeutics targeting a range of conditions, a good safety profile for MRx0518 was expected. It is important that this has been confirmed in Part A of this study in combination with a PD-1 immune checkpoint inhibitor.
"Commencing Part B of the study and expanding enrolment will enable us to build on the very encouraging preliminary signals of efficacy we have seen. These initial results indicate the potential for MRx0518 to be a game-changing immunotherapy for this particularly difficult-to-treat patient population for which all other therapeutic options have been exhausted."
Dr. Jean-Pierre Bizzari, chair of the New Drug Advisory committee of the EORTC1, and formerly Executive Vice-President and Head of Clinical Oncology Development at Celgene, commented:
"The data from Part A of the study are very encouraging and quite promising, with the drug combination exhibiting an excellent safety profile and early signs of clinical benefit in heavily pre-treated patients with advanced metastatic disease. Further studies are warranted and I look forward to working with 4D in evaluating this treatment in a larger population of patients in Part B of the study".
4D pharma previously reported positive interim clinical observations from Part A, in which three of the first six patients enrolled achieved a clinical benefit (complete response, partial response, or stable disease for six months or more), evidence of increased tumor-infiltrating lymphocytes (TILs) following treatment, and no drug related serious adverse events. These patients continue to show
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