Microbiotica, Cancer Research UK and Cambridge University Hospitals Collaborate in Landmark Cancer Microbiome Study

• Collaboration in immuno-oncology microbiome therapeutic and biomarker development
• Partnership based on class-leading MELRESIST melanoma study and new MITRE landmark study in 1,800 patients in multiple cancers
• Uses Microbiotica’s unrivalled microbiome platform

CAMBRIDGE, England--(BUSINESS WIRE)-- Microbiotica, a leading player in microbiome-based therapeutics and biomarkers, Cancer Research UK and Cambridge University Hospitals NHS Foundation Trust (“CUH”), today announce a collaboration to identify and develop microbiome co-therapeutics and biomarkers for cancer patients receiving immune checkpoint inhibitor therapy.

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The collaboration is based on clinical studies conducted by CUH that evaluate immune checkpoint inhibitor drug response in cancer patients, combined with Microbiotica’s unrivalled microbiome profiling and analysis capability.

Two clinical studies are involved: MELRESIST, a completed class-leading melanoma study, and MITRE, a major landmark study in melanoma, lung and renal cancer, involving 1,800 patients, specifically designed for evaluation of microbiome and other biomarker effects.

The MITRE study will be co-led by Dr Trevor Lawley, Microbiotica’s co-founder and CSO, and Dr Pippa Corrie, Consultant in Medical Oncology at CUH, and will involve comprehensive patient sample collection, data collection and biochemical analysis, with medicines provided by the NHS. Microbiotica will undertake mass culturing of patient gut bacteria, microbiome sequencing and machine learning analysis.

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 stratify patients for treatment.

Several studies have shown that the gut microbiome plays a critical and causative role in determining which patients respond to these medicines. However thus far they have failed to identify a consistent gut bacterial signature associated with treatment response or resistance. Microbiotica has used its unique microbiome profiling platform with MELRESIST data to identify for the first time a common signature predictive of drug response across multiple melanoma studies, and this is being progressed within the Company. MITRE will take this further by examining the effects in different cancers, a range of immunotherapy regimens, as well as association with side-effects of immunotherapy.

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. The Company also has capabilities to develop and take such products to the clinic.

The collaboration will identify specific gut bacterial signatures correlated with drug efficacy and side effects in patients under treatment for melanoma, non-small cell lung cancer and renal cancer. From these signatures, Microbiotica will progress live bacterial products as co-therapies and microbiome biomarkers predictive of immunotherapy response and toxicity into the clinic.

Mike Romanos, Co-founder and CEO, Microbiotica, said:

“Checkpoint inhibitors have already impacted the lives of many cancer patients for the better but fewer than half of patients respond. 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.

“The collaboration enables us to base our therapeutic and biomarker programs on two exceptional studies, MELRESIST and MITRE, bringing together well-powered data in patient efficacy and safety response, immunological and tumour biochemistry, with the most comprehensive microbiome classification and analysis.

“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. We are delighted that Cancer Research UK and CUH have also recognized Microbiotica’s leadership in the microbiome and have chosen to partner with us in this landmark cancer microbiome study.”

Tony Hickson, Chief Business Officer, Cancer Research UK, said:

“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. 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.”

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NOTES TO EDITORS

About Microbiotica

Microbiotica is a leading player in the field of microbiome-based therapeutics, biomarkers and targets. The Company is building a growing pipeline of best-in-class differentiated products based on high quality clinical datasets and unique bacterial signatures that drive biology, identified by its proprietary platform.

Consisting of the world’s leading microbiome Reference Genome Database, Culture Collection, mass culturing technology (Personalised Bacterial Bank) and proprietary AI tools, Microbiotica’s platform enables unrivalled strain-level microbiome analysis linked to patient phenotypes. The Company’s current therapeutic areas of focus are immuno-oncology and IBD, and it has established major clinical and academic partnerships, including a $534m collaboration with Genentech.

Spun out of the Sanger Institute in 2016 by Dr Mike Romanos, Dr Trevor Lawley and Professor Gordon Dougan, the Company is based at the Wellcome Genome Campus in Cambridge, UK, with offices in the Biodata Innovation Centre and laboratories in the Sanger Institute. Microbiotica’s investor syndicate includes Cambridge Innovation Capital, IP Group plc and Seventure Partners.

For more information, please visit www.microbiotica.com, LinkedIn and Twitter.

About Cancer Research UK’s Commercial Partnerships Team

Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research. Cancer Research UK’s specialist Commercial Partnerships Team works closely with leading international cancer scientists and their institutes to protect intellectual property arising from their research and to establish links with commercial partners. Cancer Research UK’s commercial activity operates through Cancer Research Technology Ltd., a wholly owned subsidiary of Cancer Research UK. It is the legal entity which pursues drug discovery research in themed alliance partnerships and delivers varied commercial partnering arrangements.

About Cancer Research UK

• Cancer Research UK is the world’s leading cancer charity dedicated to saving lives through research.
• Cancer Research UK’s pioneering work into the prevention, diagnosis and treatment of cancer has helped save millions of lives.
• Cancer Research UK has been at the heart of the progress that has already seen survival in the UK double in the last 40 years.
• Today, 2 in 4 people survive their cancer for at least 10 years. Cancer Research UK’s ambition is to accelerate progress so that by 2034, 3 in 4 people will survive their cancer for at least 10 years.
• Cancer Research UK supports research into all aspects of cancer through the work of over 4,000 scientists, doctors and nurses.
• Together with its partners and supporters, Cancer Research UK’s vision is to bring forward the day when all cancers are cured.

For further information about Cancer Research UK’s work or to find out how to support the charity, please call 0300 123 1022 or visit www.cancerresearchuk.org. Follow us on Twitter and Facebook.

About Cambridge University Hospitals Trust

Cambridge University Hospitals NHS Foundation Trust (CUH) is one of the largest and best known trusts in the country, delivering high-quality patient care through Addenbrooke’s and the Rosie Hospitals. CUH is a leading national centre for specialist treatment for rare or complex conditions and a university teaching hospital with a worldwide reputation.

CUH is a key partner in Cambridge University Health Partners (CUHP), one of only six academic health science centres in the UK, and is at the heart of the development of the Cambridge Biomedical Campus (CBC), which brings together on one site world-class biomedical research, patient care and education. As part of the Campus development, Papworth Hospital has created a bespoke, purpose-built hospital, and AstraZeneca is building a new global R&D centre and corporate headquarters. The Campus is one of the government’s National Institute for Health Research (NIHR) biomedical research centres.

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