Microbiotica’s Live Bacterial Therapeutic, MB097, in development to begin clinical trials in 2022 in immuno-oncology

Microbiotica, a leading player in microbiome-based therapeutics and biomarkers, today announces that MB097 is now in pre-clinical development for treatment of patients not responding to anti-PD1 therapy. Clinical trials are due to begin in 2022. MB097 is clinically designed and experimentally validated.

Studies have shown that the gut microbiome plays a critical and causative role in determining which cancer patients respond to Immune Checkpoint Inhibitor (ICI) therapy. However clinical translation of this ground-breaking discovery has been hampered by large inconsistencies between studies in the intestinal bacteria associated with anti-PD1 efficacy. The Microbiotica platform is unrivalled in the comprehensiveness and precision by which it can profile the microbiome of patients. It has enabled the Company to identify the first microbiome signature predictive of response to ICI therapy across four independent melanoma studies, by analysing MELRESIST, a melanoma study conducted in collaboration with Cambridge University Hospitals. This microbiome signature is a highly predictive clinical biomarker in advanced melanoma and is also predictive in non-small cell lung cancer (NSCLC).

The bacteria most significantly linked to outcome are all elevated in patients that respond to anti-PD1 based therapy, suggesting that gut microbes drive ICI efficacy by enhancing the anti-tumour immune response. MB097 is a Live Bacterial Therapeutic (LBT) comprising nine key species from the signature, and is being developed as a co-therapy with ICI in advanced melanoma and NSCLC. MB097 has shown potent anti-tumour efficacy in a mouse syngeneic tumour model. The bacteria also demonstrate multiple immuno-stimulatory mechanisms in primary human immune cell assays, leading to Cytotoxic T Lymphocyte activation and tumour cell killing in vitro.

Clinical testing of MB097, in combination with anti-PD1, will begin in 2022 with a Phase 1b study conducted in the same melanoma patient population that the microbiome signature was derived from. This is precision medicine enabled by the precise microbiome profiling of Microbiotica’s platform.

ICIs have transformed oncology, having increased the range of cancers that can be treated as well as improving levels of efficacy, including complete remission in some cases. However, response rates tend to be low, typically in the range 10%-40% of patients. Consequently, there is a major unmet need for co-therapies to increase the number of responders and for biomarkers to stratify patients for treatment.

Mike Romanos, Co-founder and CEO, 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. 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.”

Microbiotica’s platform comprises the world’s leading Reference Genome Database and Culture Collection of gut bacteria, and an unrivalled capability to culture and characterise all gut bacteria from patients at scale. This is complemented by a suite of bioinformatic and machine learning tools that enable the identification of previously undetectable gut bacterial signatures linked to patient phenotype.