4D pharma PLC (AIM:DDDD, NASDAQ:LBPS) will deliver what is called a ‘trial in progress’ poster at a world-leading cancer conference, outlining the plans and aims of a phase II study of its cancer drug candidate used alongside an immune checkpoint inhibitor drug.
Delegates at the American Society of Clinical Oncology meeting in Chicago will be told that MRx0518 will be coupled with Bavencio to treat a common form of bladder cancer.
Specifically, the combination therapy will be available to people with unresectable locally advanced or metastatic urothelial carcinoma (an advanced form of the disease) who did not make progress on chemotherapy.
In all, 30 patients will be recruited, and researchers will assess the safety of using the 4D drug and Bavencio together as well as measuring progression-free survival rates over six months.
The secondary objectives of the clinical evaluation include other efficacy measures such as objective response rate, time to response, duration of response, disease control rate and overall survival.
Immunological changes in the microbiome and metabolome will also be looked at through biopsies and blood, stool and urine samples.
The trial is being carried out in collaboration with Merck KGaA and Pfizer.
"We are continuing to build a strong body of evidence to support MRx0518 as a novel immunotherapy with broad potential to address significant unmet need across multiple oncology indications," said 4D’s chief scientific officer, Dr Alex Stevenson.
"MRx0518 has previously demonstrated single-agent immuno-modulation of the tumour microenvironment, and this data supports the potential of this combination to significantly enhance and improve outcomes for patients beyond treatment with Bavencio alone.
“Not only are we able to evaluate MRx0518 with a leading immune checkpoint inhibitor, we are also able to assess its potential in earlier treatment settings.
“We are pleased to be sharing further details on the design of our first-line maintenance study with Bavencio for the treatment of locally advanced or metastatic urothelial carcinoma with the oncology medical community at ASCO."
The ASCO poster will be presented on 4 June 2022. For more information, click here.