The firm’s Discovery platform also draws on microbiome bioinformatics and machine learning technology, that together forms the Personalised Bacterial Bank, a collection of all gut bacteria isolated from any one human.
“Checkpoint inhibitors have already impacted the lives of many cancer patients for the better but fewer than half of patients respond,” says Mike Romanos, co-founder and CEO of Microbiotica.
“There is strong evidence that response rates can be increased through manipulation of the microbiome and Microbiotica’s platform has already been able to identify consistent bacterial signatures predictive of drug response in melanoma for the first time.”
In collaboration with Cancer Research UK and Cambridge University Hospitals (CUH), the three organisations will combine well-powered data in patient efficacy and safety response, immunological and tumour biochemistry, with the microbiome classification and analysis.
Two clinical studies are involved: The MITRE, a landmark study in melanoma, lung and renal cancer, enrolled 1,800 patients, and was specifically designed for microbiome evaluation and other biomarker effects.
MITRE will look to examine the effects in different cancers, a range of immunotherapy regimens, as well as association with side-effects of immunotherapy as part of work co-led by Dr Trevor Lawley, Microbiotica co-founder and CSO, and Dr Pippa Corrie, consultant in medical oncology at CUH.
Microbiotica will undertake mass culturing of patient gut bacteria, microbiome sequencing and machine learning analysis.
MELRESIST study
Meanwhile MELRESIST, a completed melanoma study has used Microbiotica’s platform to analyse the study’s data to identify a common signature predictive of drug response across multiple melanoma studies, with Microbiotica continuing to work on this data.
“We have been applying our technology in other large-scale clinical studies to identify drug response signatures for biomarker and therapeutic discovery, such as our collaboration with Genentech in IBD, the most precise large-scale microbiome clinical study to date,” adds Romanos.
“We are delighted that Cancer Research UK and CUH have also recognised Microbiotica’s leadership in the microbiome and have chosen to partner with us in this landmark cancer microbiome study.”
Several previous studies in the past have shown the gut microbiome plays a critical and causative role in determining which patients respond to treatments targeting certain cancers.
However, researchers have been unable to identify a consistent gut bacterial signature associated with treatment response or resistance.
According to Microbiotica, the firm identified a gut bacterial signature 91% predictive of cancer immunotherapy response in melanoma in the MELRESIST study.
This signature is also predictive within three other melanoma studies and is the first microbiome signature predictive across multiple studies representing a potential biomarker for therapeutic classification and source of a potential live bacterial therapeutic.
Checkpoint inhibitors
Meanwhile, checkpoint inhibitors have transformed the management of cancer, due to the range of cancers that can be treated and their high levels of efficacy, including complete remission in some cases.
However, response rates are low, typically in the range 10-40% of patients. There is therefore a major unmet need for co-therapies to extend the number of responders and for biomarkers to classify patients for treatment.
“Cancer Research UK is always looking at the most promising new science to advance the treatment of patients, and we believe that the microbiome represents a very exciting new area that could play a major role in cancer therapy,” says Tony Hickson, chief business officer, Cancer Research UK.
“We believe this partnership is very well placed to do the quality of science required to identify the specific link between the gut microbiome and checkpoint inhibitors in multiple cancers.
“We look forward to working with the excellent teams in Microbiotica and Cambridge University Hospitals to progress new microbiome medicines and biomarkers toward the clinic.”
