The Phase lb trial will study MB097 in combination with KEYTRUDA to treat melanoma. Credit: Jensflorian / commons.wikimedia.org.

Microbiotica has formed a clinical trial alliance with Merck & Co (MSD) to commence a Phase lb trial of MB097 in combination with KEYTRUDA® (pembrolizumab) to treat melanoma patients with primary resistance to an anti-PD-1-containing immunotherapy.

As per the new deal, Microbiotica will sponsor the trial that will assess the safety and tolerability as well as initial signs of clinical activity of the combination therapy in the targeted patients. MSD will provide KEYTRUDA for the trial, under the deal.

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MB097 is an orally administered live biotherapeutic product developed by Microbiotica, while KEYTRUDA is MSD’s anti-PD-1 therapy.

MB097 comprises a defined group of nine bacterial strains that are capable of improving the efficacy of immune checkpoint inhibitors (ICIs), such as KEYTRUDA.

Its bacterial strains were determined by examining the microbiome of patients in various studies of ICIs in melanoma.

MB097 also showed significant anti-tumour efficacy along with ICIs in in vivo tumour models.

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It further exhibited diverse immuno-stimulatory mechanisms in primary human immune cell assays including tumour cell killing and Cytotoxic T Lymphocyte activation in vitro.

Microbiotica CEO Tim Sharpington said: “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.”