4D Pharma Announces Positive Early Clinical Results of MRx0518 in Combination with Keytruda for Renal Cell Carcinoma

Today, 4D Pharma announced that MRx0518, its microbiome-based investigational therapy, in combination with MSD's anti-PD-1 therapy Keytruda, met the primary efficacy endpoint in a Phase 1/2 clinical trial for the treatment of renal cell carcinoma. These patients had previously been treated with immune checkpoint inhibitors and experienced disease progression.

4D Pharma is dedicated to developing Live Biotherapeutics, an emerging class of drugs that consists of a living organism (such as bacteria). The company’s Live Biotherapeutics products are derived from the healthy human gut and consist of bacterial strains administered orally.

This ongoing research is being conducted in patients with metastatic solid tumors who have received multiple prior treatments and whose disease has progressed after treatment with immune checkpoint inhibitors. The primary endpoint of Part B of this study is clinical benefit achieved in more than 3 out of 30 patients for each cancer type, defined as complete response, partial response, or stable disease for at least 6 months.

Currently, 20 patients with renal cell carcinoma have been enrolled in Part B of the trial. Among the first 16 evaluable patients, 4 achieved clinical benefit with stable disease for at least 6 months. This clinical trial has enrolled 47 patients, including those with renal cell carcinoma, non-small cell lung cancer, bladder cancer, and squamous cell carcinoma of the head and neck. MRx0518 demonstrated good safety and tolerability.

"Clinical outcomes in patients with renal cell carcinoma today have reached the pre-specified primary efficacy endpoint. This underscores the significance of the microbiome in cancer treatment," said Dr. Alex Stevenson, Chief Scientific Officer of 4D Pharma.

4D Pharma Plans to Discuss the Next Development Path of MRx0518 with Partners and the Company’s Genitourinary Cancer Advisory Board, Potentially Launching a Pivotal Clinical Trial in Patients with Immune Checkpoint Inhibitor-Refractory Renal Cell Carcinoma.

References:

[1] 4D pharma Announces Positive Interim Results from the Phase I/II Study of the Combination of MRx0518 and KEYTRUDA® (pembrolizumab) for the Treatment of Renal Cell Carcinoma. Retrieved March 23, 2022, from https://www.businesswire.com/news/home/20220323005207/en

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