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June 6, 2018

Genentech, Microbiotica to Develop Microbiome-Based IBD Treatments

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    Genentech and Roche Group agree to discover, develop, and commercialize microbiome-based biomarkers and therapies for inflammatory bowel disease.

    Genentech, a member of the Roche Group, will partner with Microbiotica to discover, develop, and commercialize microbiome-based biomarkers and therapies for inflammatory bowel disease (IBD), through a collaboration that the Wellcome Trust Sanger Institute spinout said today could generate for it up to $534 million-plus.

    Under its multiyear strategic collaboration with Genentech, Microbiotica agreed to use its precision metagenomics microbiome platform to analyze patient samples from clinical trials of Genentech’s IBD treatment candidates, with the goal of identifying microbiome biomarker signatures of drug response, novel IBD drug targets, and live bacterial therapeutic products.

    Microbiotica said its platform enables gut bacterial identification with unprecedented precision at clinical trial scale, by offering what it called the world’s leading microbiome culture collection and linked reference genome database.

    The physical culture collection aims to enable biological evaluation of bacteria in proprietary translational models, including humanized microbiome mouse models, while the database is growing “at a very rapid rate” through its industrial culturing and sequencing pipeline, intended to provide clinical trial samples for strain-level identification of bacteria, the Wellcome Sanger Institute spinout said.

    The resulting data from such studies is analyzed using artificial intelligence (AI) in order to discern microbiome signatures linked to phenotype, Microbiotica added.

    “This collaboration reflects Microbiotica’s strategy of utilizing its platform for medicines and biomarker discovery while simultaneously expanding platform capabilities,” Microbiotica CEO Mike Romanos, Ph.D., said in a statement. “The collaboration will enable Microbiotica to continue to rapidly expand its already leading Reference Genome Database and Culture Collection, further strengthening its value across all therapeutic areas.”

  • Second Microbiome-Based Collaboration

    The partnership marks Genentech’s second microbiome-related collaboration announced in as many months. On May 9, the biopharma giant launched an up-to-$969 million-plus partnership with Lodo Therapeutics to develop new microbiome-biosynthetic gene therapies that will apply Lodo’s metagenomics-based natural products drug discovery platform.

    Genentech and Lodo aim to genetically engineer bacteria in order to produce molecules that have the potential to treat certain disorders by altering human metabolism. The companies did not specify their targets or disease areas of interest—though according to its website, Lodo focuses on fighting drug-resistant microbial infections and cancers.

    In the latest collaboration, Genentech has agreed to pay Microbiotica an undisclosed up-front payment and up to $534 million tied to achieving research, development, and commercialization milestones. Genentech has also agreed to pay Microbiotica royalties on sales of products resulting from the collaboration.

    In return, Genentech holds an option to license assets that Microbiotica develops as a result of the research collaboration.

    “We believe the microbiome represents a new paradigm in biomedicine, both for understanding drug response and as a novel therapeutic modality,” James Sabry, M.D., Ph.D., SVP and global head of Genentech Partnering. “We have chosen to collaborate with Microbiotica because of its high-quality science and look forward to working together to potentially bring new medicines to people suffering from IBD.”

    Genentech’s pipeline includes one disclosed Phase III IBD candidate, etrolizumab, (rhuMAb Beta7, also called RG7413), a humanized Immunoglobulin G subclass 1 monoclonal antibody targeting the beta 7 integrin subunit.

    In October 2017, Genentech parent Roche trumpeted positive data from two ongoing Phase III trials, BERGAMOT (NCT02394028) and HICKORY (NCT02100696), indicating that patients treated with etrolizumab showed improvement in both patient-reported symptoms and endoscopic assessment of inflammation. Roche plans to file for regulatory approvals for etrolizumab in 2021.

    Two months later, Roche launched a partnership of undisclosed value with Boehringer Ingelheim to advance novel treatments for Crohn’s disease and ulcerative colitis by discovering and developing orally available novel locked nucleic acid (LNA) oligonucleotides. Boehringer Ingelheim said the companies agreed to share clinical development costs and responsibility for the commercialization of potential products.

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