Microbiotica announces clinical trial collaboration with MSD to evaluate MB097 in combination with KEYTRUDA® (pembrolizumab) in a Phase 1b Clinical Trial in melanoma

Microbiotica, a leader in discovering and developing microbiome-based therapeutics and biomarkers, today announces it has entered into a clinical trial collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA).

Under the terms of the agreement, 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.

Tim Sharpington, CEO of Microbiotica, said:

“We are delighted to be working with MSD, a world leader in immuno-oncology. The treatment of patients with advanced melanoma has been revolutionised by ICIs such as KEYTRUDA® and there is an opportunity to increase the number of patients who can benefit from these treatments. There is growing evidence that the gut microbiome plays a critical role in determining a patient’s response to ICIs and we believe that MB097, in combination with KEYTRUDA®, has the potential to enhance the benefit for patients with advanced melanoma and other difficult-to-treat cancers.”

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