US-based Vedanta Biosciences has started a phase I clinical study of its live biotherapeutic product (LBP) candidate VE202 to treat inflammatory bowel disease (IBD).
Janssen Research & Development is undertaking the study. Vedanta Biosciences had granted the licensing rights of VE202 in 2015 to Janssen Biotech.
The microbiome-derived product candidate is being assessed in healthy volunteers.
With VE202 reaching the clinical trial stage, Vedanta Biosciences will be paid $12m from Janssen in milestone payments. Overall, the clinical-stage company stands to earn up to a total of $339m in the form of development and commercialization milestone payments in addition to royalty payments.
Vedanta Biosciences co-founder and CEO Bernat Olle said: “There is significant evidence highlighting the role of the microbiome in the pathogenesis of IBD.
“Current treatments effectively block mediators of inflammation, but they do not address the underlying alterations in the gut microbiota that may be driving the inflammation in the first place, leaving a need for safe approaches that address this aspect of the disease.”
VE202 is produced from pure, clonal cell banks, which results in a standardized drug product in powder form. The LBP is made of a defined consortium of live bacteria designed to regulate the activity of regulatory T cells, thereby having a potential to treat IBD.
University of North Carolina medicine, microbiology & immunology professor Balfour Sartor said: “Randomized clinical trials of fecal microbiota transplants (FMT) have provided strong evidence for the microbiome’s involvement in inflammatory bowel diseases albeit with varying clinical success depending on the donor used and the frequency of instillations.
“The inconsistent composition of fecal donor material and the need for chronic administration make FMT a challenging modality for treating IBD.”
“I believe that a better, more consistent therapeutic approach is to use a well-characterized, rationally-defined, and orally-delivered LBP using bacterial species normally found in the intestine of healthy subjects.”
Earlier this month, Vedanta Biosciences released preclinical data for another LBP candidate VE800, which is being developed as an immuno-oncology.
The company said that VE800 evoked an anti-tumor immune response as a monotherapy and also improved effects of immune checkpoint inhibitors in the preclinical study.