Oncology (MRx0518)

4D pharma’s MRx0518 is the world's first Live Biotherapeutic to show positive signals of clinical activity in cancer. We are currently investigating the effects of MRx0518 in a wide range of solid tumor types and treatment settings.

Phase I/II Keytruda® combination study in ICI-refractory solid tumors

In collaboration with Merck & Co., known as MSD outside the United States and Canada, we are conducting a Phase I/II investigation of the combination of MRx0518 and Keytruda® (pembrolizumab) in patients with advanced or metastatic non-small cell lung cancer, kidney cancer, bladder cancer or melanoma who are refractory to prior anti-PD-1/PD-L1 therapy.

The trial is made up of two parts – Part A, an initial safety phase assessing dose-limiting toxicities after one three-week cycle of treatment in addition to clinical benefit, and the Part B cohort expansion phase. Part A was successfully completed in May 2020, and the safety review committee determined that it is safe to proceed to Part B of the study, which is ongoing. This study is being conducted at multiple sites in the United States.

Below is the clinical benefit analysis of all 12 patients enrolled in Part A (as of 21 August 2020):

RECIST 1.1 Response Criteria

Renal Cell Carcinoma

Non-Small Cell Lung Carcinoma

All Patients





Objective response rate (ORR)

2 (22%)

1 (33%) 1

3 (25%)

Stable disease (SD) ≥ 6 months

2 (22%)

0 (0%)

2 (17%)

Disease control rate

(response or SD ≥ 6 months)

4 (44%)

1 (33%)

5 (42%)

Progressive disease (PD)

5 (56%)

2 (67%)

7 (58%)

Details of the study can be found here.

Phase Ib neoadjuvant monotherapy study

A Phase Ib study for patients with solid tumors that have received no prior treatment and are due to undergo surgical removal of the tumor is enrolling. This study is being conducted in London, UK.

Details of the study can be found here.

Phase I study in combination with radiotherapy

A Phase I study to evaluate the safety and preliminary clinical efficacy of MRx0518 in combination with preoperative radiotherapy in patients with resectable pancreatic cancer. The study is being conducted at The University of Texas MD Anderson Cancer Center and is the second opened as part of our strategic collaboration.

Details of the study can be found here.

Asthma (MRx-4DP0004)

We are currently conducting a Phase I/II clinical study of MRx-4DP0004 in patients with poorly controlled asthma. The study is taking place in Europe and the USA.

Details of the study can be found here.

If you would like more information on any of these studies, please e-mail clinicaltrials@4dpharmaplc.com