Novome Biotechnologies

Novome Biotechnologies, Inc. is a South San Francisco, California-based biotechnology company that engineers defined activities into the human gut microbiota to treat chronic diseases. Its platform produces what the company calls Genetically Engineered Microbial Medicines (GEMMs): proprietary commensal bacterial strains designed to colonize the gut at a controllable abundance and to express therapeutic transgenes or proteins. Colonization is sustained by a daily oral dose of a prebiotic polysaccharide on which the engineered strains are made metabolically dependent for survival, which the company describes as the first platform for controlled and robust colonization of the human gut with engineered therapeutic bacteria.

The lead program, NOV-001, is an investigational combination product consisting of NB1000S, a recombinant live biotherapeutic product, and NB2000P, a botanically derived polysaccharide. It is engineered to degrade oxalate in the gastrointestinal tract to reduce urinary oxalate and lower the risk of kidney stone formation and progressive kidney damage. Preclinical work showed reductions in urine oxalate across multiple animal disease models; the Phase 1 stage of a Phase 1/2a program showed the orally administered product was safe and well tolerated with dose-dependent strain engraftment in healthy volunteers and abundance controlled by once-daily porphyrin/prebiotic dosing. A Phase 2a stage evaluating safety, tolerability and early efficacy in patients with enteric hyperoxaluria was ongoing as of 2022. Beyond hyperoxaluria, Novome has advanced multiple preclinical GEMM candidates for inflammatory bowel disease, some wholly owned and some under a collaboration with Genentech, and has developed platform capability for oral GEMMs to secrete therapeutic proteins into the GI tract in a continuous, controlled manner.

Founding story

Novome was founded in 2016 by scientists from Stanford University and the University of California, Berkeley, based on research from the laboratory of scientific co-founder Dr. Justin Sonnenburg, Associate Professor at Stanford. The founding team consisted of Drs. Will DeLoache, Weston Whitaker, Zachary Russ and Liz Shepherd, combining synthetic biology and gut microbiota expertise. Co-founder Liz Shepherd developed a strategy for reliable engraftment of engineered bacteria in the gut microbiome during her PhD in the Sonnenburg lab, after earlier undergraduate work in David Baker's lab at the University of Washington on an engineered gluten-degrading enzyme. The founders' work produced peer-reviewed publications and a patent portfolio developed at Novome and licensed exclusively from Stanford.

Business model

Novome develops proprietary live biotherapeutic drug candidates on its GEMMs platform, retaining full control of development, manufacturing and commercialization for wholly owned programs while partnering the platform with larger pharmaceutical companies. In the Genentech collaboration, Novome engineers and develops bacterial strains expressing therapeutically relevant proteins for inflammatory bowel disease drug candidates, with Genentech assuming clinical development and commercialization.

As a clinical-stage drug developer, Novome's disclosed non-dilutive income comes from partnership economics: a $15 million upfront payment from Genentech plus eligibility for up to $590 million in additional milestone payments.

Traction

Reported positive Phase 1 results for NOV-001 in late 2021, demonstrating safe colonization of the human gut with a therapeutically engineered microbe and control of its abundance through once-daily prebiotic dosing, and initiated the Phase 2a portion of the enteric hyperoxaluria trial in 2022. The company also expanded platform capabilities to controlled, continuous secretion of therapeutic proteins in the GI tract and holds patent filings covering areas including recombinant fusion polypeptides for secreting soluble heterologous cargo, oral administration of genetically engineered bacteria, biologically contained bacteria, and compositions for treating bile-acid-associated disorders.

Latest developments

In September 2022 Novome closed a $43.5 million Series B round led by Tencent, to be used for the ongoing Phase 2a trial of NOV-001 and for multiple preclinical GEMM candidates in inflammatory bowel disease, both wholly owned and under the Genentech collaboration.