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Microbiotica ready to cross therapeutic threshold with clinical trials milestone

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Microbiotica is advancing steadily towards the goal of introducing microbiome-based therapeutics and biomarkers into the healthcare mix, with clinical studies – underpinned by additional investment earlier this year – starting soon.

Mike Romanos, chief executive of Microbiotica. Picture: Keith Heppell
Mike Romanos, chief executive of Microbiotica. Picture: Keith Heppell

The Chesterford Research Park-based company launched in 2016 identifies gut bacteria linked to patient outcome with unprecedented precision to discover and develop live bacterial therapeutics (LBTs) and biomarkers from big clinical datasets.

The £50million Series B financing round in March was the largest microbiome-related financing in Europe to date. The international investment syndicate was co-led by Flerie Invest, a major Swedish life science investor, and Tencent, a global technology company investing in innovations that help improve human life. New investors also included British Patient Capital, while existing investors Cambridge Innovation Capital, IP Group, and Seventure Partners, a world-leader in life science microbiome investment, all participated.

The capital will be mainly used to progress Microbiotica’s two lead LBTs, MB097 and MB310, to Phase 1b clinical studies.

Both products have been validated and mechanistically characterised through extensive laboratory testing in mice and in human cells. The LBTs comprise freeze-dried healthy gut bacteria in a capsule delivered orally and released into the lower intestine where they engraft. MB310 is a fully-defined LBT comprising a consortium of bacteria for the treatment of ulcerative colitis (UC) identified as driving disease remission in a UC faecal transplant clinical study. MB097 is also a fully-defined LBT comprising a consortium of bacteria at the core of Microbiotica’s clinical microbiome signature, predictive of patient response to immune checkpoint inhibitor cancer therapy. (Immune checkpoint inhibitors work by blocking checkpoint proteins from binding with their partner proteins, thereby preventing the ‘off’ signal from being sent and allowing T cells to kill cancer cells.)

Microbiotica has made huge progress in the labs
Microbiotica has made huge progress in the labs

“The funding is being directed largely towards MB097 and MB310,” says Mike Romanos, co-founder and chief executive of Microbiotica. “They’re very exciting medicines coming out of highly specific microbiome signatures predictive of successful checkpoint inhibitor therapy, which are then tested in the lab before going back into patients.

“We’ve completed the early phases of process development with external contractors and are proceeding towards scale-up and manufacture, ready for the clinical studies next year.”

The MB310 journey has already thrown up insights into therapeutic mechanisms of the 10 bacteria in the product from studies in human cell models – three specific mechanisms in fact, explains Mike. “One is the potent healing of damaged gut barrier, the other two are downregulation of the innate and adaptive immune systems to dampen gut inflammation.

“So from our clinic-first discovery approach we have identified a polypharmacy with the potential to both dampen down and provide long-term control in ulcerative colitis.”

Analysing bacteria at Microbiotica
Analysing bacteria at Microbiotica

The programme has been supported by the prestigious Crohn’s & Colitis Foundation, as part of its IBD Ventures programme. The Crohn’s & Colitis Foundation is the leading US charity for the development of therapies to treat inflammatory bowel disease. They are highly selective in what they fund, looking for innovation and benefit to patients, and do not often fund programmes outside the US.

The second live bacterial therapeutic is MB097. The goal – to convert patients with melanoma from being unresponsive to cancer immunotherapy to being responsive – has demonstrated its potential in laboratory pre-clinical studies.

“We were first to identify a highly predictive microbiome signature for checkpoint inhibitor drug response in melanoma across multiple clinical studies, including a clinical study that we undertook in collaboration with Addenbrooke’s Hospital,” Mike says.

“This shows that using our technology we can identify signatures not seen by others. MB097 was designed based on this work which led to the identification of the nine bacteria in the product, four hitherto unknown. It is effective in mouse tumour models, and it does exactly what we hoped it would do, which is to synergise and greatly stimulate the checkpoint inhibitor response in mice.

“We’ve also tested the bacteria in different cell models and identified a number of different immunological mechanisms that lead to increased tumour killing. With all this data we are of course hopeful that MB097 will convert human non-responders into responders in clinical trials.

Trevor Lawley, co-founder and CSO, left, with Mike Romanos, chief executive of Microbiotica
Trevor Lawley, co-founder and CSO, left, with Mike Romanos, chief executive of Microbiotica

“With MB097, we’ve also been able to expedite patent prosecution in the US. So we’ve filed separate biomarker patent and therapeutic patents, and already obtained grant for both in record time. The medical and commercial potential are great: the total checkpoint inhibitor market has predicted revenues of $55bn by 2025.

“If you can convert non-responders to responders, the impact on cancer treatment will be huge. And that’s what we’re aiming to do with MB097.”

Phase 1b of the clinical trials for MB097 and MB310 should be complete by the end of 2024.

Microbiotica – which was highly commended in the Life Science Company of the Year category at the Cambridge Independent 2022 Science & Technology Awards in May – has 52 people at its purpose-configured facilities at the Newnham Building on Chesterford Research Park. Given it is at the forefront of microbiome research, I ask Mike if the company’s microbiome insights have got anything to say about outcomes for Covid patients?

“There are suggestions that Covid disease severity is correlated with the gut microbiome,” replies Mike, “and that wouldn’t be unexpected because the gut microbiome regulates our immune system. Given the success of the vaccines, antibody therapeutics and antiviral drugs, this has become a less pressing problem and it is also harder to obtain large numbers of clinical samples from infected patients for microbiome analysis.

Rod-shaped Lactobacillus bacteria
Rod-shaped Lactobacillus bacteria

“However, the gut microbiome is relevant to a very large number of diseases and Microbiotica is using its technology to bring forward new programmes to address patient need in new disease areas.”

Microbiotica’s expertise in the understanding of gut microbiome is much in demand on the scientific networking circuit.

Last week CMO Dr Ron Carter contributed to a panel at the Microbiome Movement – Drug Development conference in Boston, US.

On July 7, Dr Ghaith Bakdash, director, cell biology, will present on the topic of ‘MB097: A clinically defined consortium of bacteria with potent anti-tumour activity’ at the two-day (July 6-7) Microbiome Connect Europe event in Amsterdam.

And on July 30, director, discovery microbiology Dr Anne Neville will present at Anaerobe 2022 in Seattle – which takes place July 28 to 31 – on the subject of ‘Anaerobic Cultivation and Strain-Banking from the Human Gastrointestinal Tract’.

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