6 July 2020
4D pharma treats first cancer patients in Part B of Phase I/II trial of MRx0518 in combination with Keytruda®
Leeds, UK, 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, today announces it has commenced treatment of the first patients in Part B of its Phase I/II clinical trial of MRx0518 in combination with immune checkpoint inhibitor Keytruda® (pembrolizumab) in patients with acquired resistance to prior immune checkpoint therapy.
Part B of the Phase I/II study will evaluate clinical benefit of MRx0518 and Keytruda®, defined as a complete response or partial response or stable disease for six months or longer. Safety and tolerability will also be evaluated. Part B of the study will assess up to an additional 30 patients per tumour type cohort.
To rapidly build on the proof of concept data previously reported from Part A of the study, 4D pharma is opening four additional trial sites in the US throughout July and August to support accelerated patient recruitment for Part B of the trial.The study is open label and an interim update is anticipated later in the year.
The Part A safety phase of the study has been successfully completed, as reported in May 2020. In Part A there were no treatment-related serious adverse events, no treatment-related drug discontinuations and no increase of immune-related adverse events as seen with immune checkpoint inhibitors.Of the 12 patients enrolled in Part A, five remain on study including two patients with best response of partial response, one patient with ongoing stable disease for over six months, and two patients with ongoing stable disease currently for less than six months.These represent first-in-class proof of concept clinical data for a Live Biotherapeutic in cancer.
Duncan Peyton, CEO, 4D pharma, commented “Immune checkpoint inhibitor therapies have provided a significant step forward in the toolbox in the fight against cancer.Unfortunately however, they do not work in all patients, and in those patients that do benefit that response can be lost over time.This results in a substantial group of patients who are extremely ill and, due to the stage of their disease and failure of previous lines of therapy, have no approved treatment options. Part A of our trial demonstrated that 4D pharma’s candidate MRx0518 may provide benefit to this group of patients. Commencing Part B of the study and opening new sites in the US to accelerate recruitment will allow us to build quickly on the positive results of Part A. Continued positive results will support MRx0518 as a much needed novel therapeutic for patients who currently have no alternative treatment options. This is another important step towards our aim to have the first approved Live Biotherapeutic in an oncology setting”
MRx0518 is single strain Live Biotherapeutic product in development for the treatment of cancer. It is delivered as an oral capsule and stimulates the body’s immune system, directing it to produce cytokines and immune cells that are known to attack tumours. It is currently being evaluated in three clinical trials in cancer patients. MRx0518-I-001 is a neoadjuvant monotherapy study in a variety of solid tumours and is being conducted at Imperial College (London, UK). MRx0518-I-002 is in combination with KEYTRUDA® (pembrolizumab) in patients who have previously progressed on anti PD-1 therapies. This study is being carried out at The University of Texas MD Anderson Cancer Center, Houston, USA, in collaboration with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA.MRx0518-I-003 is in combination with preoperative radiotherapy in resectable pancreatic cancer.
About MRx0518-I-002 clinical trial
MRx0518-I-002 (NCT03637803) is a Phase I/II open-label, safety and preliminary efficacy study of MRx0518 in combination with KEYTRUDA® (pembrolizumab) in patients with solid tumours (non-small cell lung cancer, renal cell carcinoma, bladder cancer or melanoma) who have previously progressed on anti PD-1/PD-L1 therapy. Subjects are treated with intravenous KEYTRUDA® every three weeks and one capsule twice daily of MRx0518. Treatment continues as long as clinically relevant, until disease progression, unacceptable AEs or withdrawal of consent up to a maximum of 35 cycles of KEYTRUDA.
Part A was conducted in 12 patients and Part B will be conducted in up to 30 patients of each tumour type.
This study is being carried out at The University of Texas MD Anderson Cancer Center, Houston, USA, in collaboration with MSD, the tradename of Merck & Co., Inc., Kenilworth, NJ, USA. Additional US sites are being opened to supported accelerated enrolment.
For more information on the trial, see https://clinicaltrials.gov/ct2/show/NCT03637803
Founded in February 2014, 4D pharma is a world leader in the development of Live Biotherapeutics, a novel and emerging class of drugs, defined by the FDA as biological products that contain a live organism, such as a bacterium, that is applicable to the prevention, treatment or cure of a disease. 4D has developed a proprietary platform, MicroRx®, that rationally identifies Live Biotherapeutics based on a deep understanding of function and mechanism.
4D's Live Biotherapeutic Products are orally delivered single strains of bacteria that are naturally found in the healthy human gut. The Company has six clinical studies in progress, namely a Phase II clinical study of BLAUTIX® in Irritable Bowel Syndrome (IBS), a Phase I/II study of MRx0518 in combination with KEYTRUDA® (pembrolizumab) in solid tumours, a Phase I study of MRx0518 in a neoadjuvant setting for patients with solid tumours, a Phase I study of MRx0518 in patients with pancreatic cancer, a Phase I/II study of MRx-4DP0004 in asthma, and a Phase II study of MRx-4DP0004 in patients hospitalised with COVID-19. Preclinical-stage programs include candidates for CNS disease such as Parkinson's disease and other neurodegenerative conditions. The Company has a research collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to discover and develop Live Biotherapeutics for vaccines.
For more information, refer to https://www.4dpharmaplc.com.
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