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24 June, 2022 - 21:40 By Tony Quested

Microbiotica bang on the money as it pioneers global progress in microbiome science

The microbiome is transforming our knowledge of biology and promising novel therapies for a wide range of diseases based on live bacteria. 

Microbiotica is a global pioneer translating new rigour in microbiome science to enable it to fulfil its promise as a new therapeutic modality. 

Recognition of this has been demonstrated by collaborations with Cancer Research UK, University of Cambridge, University of Adelaide and Genentech, and by a recent £50 million Series B fundraise (the largest European microbiome financing to date). 

The fundraise, supported by an international syndicate of investors, enables the company to transition into the clinic and expand its discovery pipeline.

Within the last year Microbiotica has progressed two live bacterial therapeutics (for cancer and ulcerative colitis) into scale up development and towards the clinic; further strengthened its microbiome platform; built out its leadership team; and moved into its new purpose-built facility at Chesterford Research Park.

The company’s science was born of ground-breaking achievements over a period of 10 years in the laboratory of Trevor Lawley at the Wellcome Sanger Institute that addressed fundamental barriers in understanding the microbiome at the level of large-scale clinical data and then translating it into medicines based on therapeutic bacteria. 

Microbiotica has industrialised this technology and made it world-leading by development of the world’s largest database of gut microbial genomes and advanced bioinformatic and machine learning tools that can decipher the microbiome for discovery biomarkers and therapeutics.  

This technology has led to two best-in-class products in development heading to the clinic: MB097 designed to shift cancer immunotherapy non-responders to responders, and MB310 for long-term treatment of ulcerative colitis. 

These products have immense potential for patient benefit and value generation. Both the technology platform and the therapeutic assets are protected as part of a rich portfolio of proprietary know-how and patents. 

One of the most exciting microbiome areas is cancer immunotherapy, where there is strong evidence that the action of a key class of drugs, the immuno-oncology checkpoint inhibitors (transformational in cancer therapy and with predicted sales of $55bn in 2025), is controlled by gut bacteria. 

Though these drugs are efficacious across many cancers and can even be curative, only 10-40 per cent of patients respond to therapy. The gut microbiome offers a way to predict which patients will respond so they can be better managed, and to convert non-responders to responders. 

However due to limitations in the microbiome analysis, the specific gut bacteria driving the response had not been identified until now. 

Microbiotica has been able to use its platform to identify the first signature of gut bacteria that is highly predictive of response to checkpoint inhibitor drugs in cancer immunotherapy across multiple clinical cohorts. 

This signature was initially identified by analysing the gut bacteria that are highly associated with drug response in the MELRESIST melanoma study conducted in a collaboration initiated by Trevor Lawley and Addenbrooke’s Hospital. 
It has potential as a diagnostic to aid in management of cancer patients and also, in MB097, as a therapeutic cocktail of nine harmless live bacteria that can shift non-responding patients to be responders. 

Microbiotica has demonstrated that MB097 has a potent synergistic effect in tumour killing with checkpoint inhibitors in mouse models, just as in the human patients from which the bacteria are derived. 

The company has also showed that the bacteria have potent effects in inducing T cell killing of tumours and stimulating Natural Killer cells in human cell assays. 

As a result Microbiotica has progressed into manufacturing scale-up development of the product with a leading CDMO and are preparing for a Phase 1b clinical trial aimed at converting non-responding into responding melanoma patients. 

Furthermore, Microbiotica has initiated a new collaborative clinical study, MITRE, with Dr Pippa Corrie and colleagues at Addenbrooke’s Hospital, University of Cambridge, with Cancer Research UK and NHS funding and support. 

This landmark study of up to 1800 patients in multiple cancers, has sufficient powering to look at the effect of the microbiome on combination therapy and on side effects, and to develop a microbiome companion diagnostic assay predictive of therapeutic response. It will enable Microbiotica to strengthen its long-term position in the cancer microbiome field.

The company’s second advanced asset, MB310, is derived by reverse engineering from a successful Faecal Microbiota Transplant (FMT) clinical trial in ulcerative colitis conducted at University of Adelaide. 

Remarkably, several placebo controlled FMT trails have shown good efficacy without side-effects in inducing disease remission and FMT is widely used for treatment. In order to move a defined product that is not depended on donor stool, Microbiotica has used its technology to identify the bacteria engrafting in patients that correlate with remission. 

The resulting product, MB310, comprising 10 bacteria is being progressed towards the clinic. These bacteria are potent in mouse models; the company has identified the mechanism of action of the different bacteria in healing damaged gut epithelium and modulating the innate and adaptive immune systems in the gut.

With the recent Series B funding in place, Microbiotica is now prepared to complete the two key clinical trials, develop the immune-oncology biomarker, build out its microbiome platform further and grow its pipeline into new disease areas.

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