Partnering

Microbiotica is assessing partnering opportunities to exploit the application of its unique platform in existing or emerging therapeutic areas. Strategic collaborations are established to bring the full microbiome dimension to analysis of a partner’s clinical program for discovery of stratification biomarkers, targets and Live Bacterial Therapeutics, for example in immuno-oncology with MSD. Partnerships are also established to build Microbiotica’s in-house pipeline, including ulcerative colitis with the University of Adelaide and in immuno-oncology with CRUK/CUH. Microbiotica is also able to establish drug screening of bioactives and metabolites from Microbiotica’s highly diverse culture collection.

MSD (Merck & Co., Inc)

Microbiotica has entered into a clinical trial collaboration with MSD (Merck & Co., Inc)
Microbiotica will conduct a phase 1b clinical trial to evaluate the safety and tolerability, and initial signs of clinical activity of its live biotherapeutic product, MB097, in combination with KEYTRUDA^® (pembrolizumab), MSD’s anti-PD-1 therapy, in melanoma patients with primary resistance to an anti-PD-1-containing immunotherapy. Microbiotica will be the study sponsor and MSD will supply KEYTRUDA^®.

MB097 is an orally administered live biotherapeutic product consisting of a defined consortium of nine bacterial strains designed to enhance the efficacy of immune checkpoint inhibitors (ICIs) such as KEYTRUDA^®.

The bacterial strains in MB097 were identified by analysing the microbiome of patients in multiple studies of ICIs in melanoma. Microbiotica’s discovery platform facilitates precise, strain-level identification of bacterial signatures associated with clinical response. Moreover, MB097 displayed potent anti-tumour efficacy in combination with ICIs in in vivo tumour models and demonstrated multiple immuno-stimulatory mechanisms in primary human immune cell assays including Cytotoxic T Lymphocyte activation and tumour cell killing in vitro.

(KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.)

Cancer Research UK and Cambridge University Hospitals

Immuno-oncology checkpoint inhibitors are broad-spectrum cancer therapies that are transforming prospects for patients, and whose market is expected to exceed $55 billion by 2025. This area is of intense interest in the microbiome field because only a minority of patients respond to checkpoint inhibitors, and it has become clear that response is controlled by immuno-modulatory gut bacteria. However, due to differences in study design, sample handing and microbiome analysis, the leading groups disagree about which bacteria are involved.

Microbiotica is collaborating with Cambridge University Hospitals and Cancer Research UK to address this issue and base novel therapeutics and biomarkers on robust predictive signatures for drug response. Based on the completed MELRESIST melanoma study, the company has identified a highly predictive bacterial signature, and for the first time shown it to be highly predictive against all published melanoma studies. From this a Live Bacterial Therapeutic and drug-response biomarker are being advanced.

MITRE is a landmark microbiome study in melanoma, Non-small cell lung cancer and renal carcinoma with 1800 patients that is being undertaken currently in a collaboration led by Dr Pippa Corrie and Dr Trevor Lawley. This study will enable validation of the predictive biomarker, evaluation across cancer types and with combination therapy and will be powered to investigate correlation with drug-induced side effects.

University of Adelaide

Microbiotica entered into an agreement with University of Adelaide as part of its programme to develop a defined bacterial product for ulcerative colitis (UC). Microbiotica is collaborating with Dr Sam Costello, Adelaide Medical School, University of Adelaide and Department of Gastroenterology at the Queen Elizabeth Hospital, to develop a new therapeutic to treat UC. Dr Costello led a faecal microbiota transplantation (FMT) study the results of which demonstrate the ability to induce remission in UC, without significant side-effects. This data is compelling evidence for a novel therapeutic approach based on resetting gut microbiota. Microbiotica has comprehensively analysed the study samples to define a bacterial signature highly predictive of remission in the FMT study and is progressing this as a Live Bacterial Therapeutic.