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Microbiotica to take precision live bacterial therapeutic in immuno-oncology into clinic in 2022



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The era of precision microbiome medicine is about to begin, with Microbiotica confirming that it plans clinical trials in 2022 of a live bacterial therapeutic in the field of immuno-oncology.

Preclinical data for MB097 - a consortium of bacteria - have been “hugely encouraging”, with potent anti-tumour efficacy in vitro and in a mouse model, according to the Chesterford Research Park company.

Microbiotica CEO and co-founder Dr Mike Romanos. Picture: Keith Heppell
Microbiotica CEO and co-founder Dr Mike Romanos. Picture: Keith Heppell

The gut microbiome is known to play a critical role in determining which cancer patients respond to immune checkpoint inhibitor (ICI) therapy.

These types of treatments - such as anti-PD1 therapy - are used where cancer cells are using the body’s own ‘checkpoints’ to avoid being attacked by the immune system, but only 10 to 40 per cent of patients respond.

There have been major inconsistencies in studies of the intestinal bacteria associated with anti-PD1 efficacy. Microbiotica’s unrivalled platform, however, has enabled it to identify the first microbiome signature that can predict patients’ response to ICI therapy across four melanoma studies. It follows analysis of MELRESIST, a melanoma study conducted in collaboration with Cambridge University Hospitals.

Trevor Lawley and Mike Romanos, co-founders of Microbiotica. Picture: Keith Heppell
Trevor Lawley and Mike Romanos, co-founders of Microbiotica. Picture: Keith Heppell

The company says this microbiome signature is a highly predictive clinical biomarker in advanced melanoma and is predictive in non-small cell lung cancer (NSCLC).

Patients that respond to anti-PD1 therapy all had elevated levels of certain bacteria, suggesting the gut microbes improve ICI efficacy by enhancing the anti-tumour immune response.

Microbiotica’s MB097 is a live bacterial therapeutic featuring nine key species from the signature, and is being developed as a co-therapy with ICI in advanced melanoma and NSCLC.

Mike Romanos, co-founder and CEO of Microbiotica, said: “Immune checkpoint inhibitors have had a major impact on the lives of many cancer patients. However, fewer than half respond to this type of immunotherapy. This has driven us to design a microbiome therapeutic to improve patient response rate.

Trevor Lawley and Mike Romanos, co-founders of Microbiotica. Picture: Keith Heppell
Trevor Lawley and Mike Romanos, co-founders of Microbiotica. Picture: Keith Heppell

“Through our MELRESIST study data and our platform, we have been able to identify a consistent bacterial signature predictive of drug response in advanced melanoma and NSCLC.

“The live bacterial therapeutic, MB097, arising from this signature, aims to tap into this predictive signature of ICI therapy response.

“Preclinical in vivo data and mechanistic in vitro human cell data generated thus far have been hugely encouraging.

“Coupled with our ongoing collaboration with Cancer Research UK and Cambridge University Hospitals, our IO program is now a significant focus for the company going forward. The aim is for us to enter the clinic in 2022 with this programme.”

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