Microbiotica, a microbiome-focused biotech based in Cambridge in the U.K., has achieved good Phase Ib results in a trial of its microbiome therapy for patients with advanced melanoma skin cancer.
The therapy, currently known as MB097, is designed to be given to patients who have not previously responded to immunotherapy in addition to a checkpoint inhibitor pembrolizumab. MB097 was developed to reverse the drug resistance seen in these patients and is based on research looking into the gut microbiome of melanoma patients who do respond to this kind of immunotherapy.
The primary endpoint of the trial, which included 41 patients from the U.K., France, Italy, and Spain, who had previously shown resistance to anti-PD-1 drugs, was safety and tolerability of MB097. Several secondary endpoints including response rate, duration of response, and overall survival were also included. The therapy, which contains nine beneficial strains of gut bacteria, met both its primary and secondary endpoints in the study, according to the company, although precise details will be released at a scientific conference later this year.
“There is increasing evidence that the microbiome plays a crucial role in patients’ response to immune checkpoint inhibitors. Clinical benefit has been reported with fecal microbiota transplantations, while MB097 capsules taken orally each day affords an easy and reproducible way of modifying the microbiome,” said the national coordinating investigator for the study, Pippa Corrie, MD, PhD, a clinician and researcher from Cambridge University Hospitals NHS Foundation Trust, in a press statement.
“The MELODY-1 study results show that MB097 is well tolerated, with encouraging early signs of efficacy in a very difficult to treat metastatic melanoma patient population with primary resistance to anti-PD-1 based immunotherapy, in whom there is a significant unmet need.”
Up to half of all advanced melanoma patients fail to respond to anti-PD-1 immunotherapy, leaving them with very few options. A growing body of research, including a 2021 study showing fecal transplant can overcome resistance to anti-PD-1 immunotherapy, shows that the gut microbiome plays an important role in whether a patient’s immune system mounts an effective anti-tumor response when given these therapies.
The make-up of MB097 is based on detailed research looking at strains of bacteria linked to effective response to immunotherapy. Preclinical work showed that the bacteria in the therapy directly activate cytotoxic T cells and counter immunosuppressive tumor macrophages. If larger controlled trials confirm these initial results MB097 could become a standard add-on to immunotherapy.
Microbiotica has another clinical program in ulcerative colitis, which also reported good results earlier this year in another Phase Ib trial. In total, 63% of those in the treatment group achieved clinical disease remission versus 30% in the placebo group and all were also taking standard therapy for the autoimmune disease.
The company now plans to move both its programs to larger controlled studies with a view to moving closer to market approval with both therapies.
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