Microbiome Therapeutics

Best-in-class microbiome program with a fully-integrated platform to deliver drug products across multiple indications and therapeutic categories

The human microbiome is the focus of widespread research interest for its potential utility in treating a number of important diseases. Assembly’s microbiome therapeutics program is based on three interlocking components:

(1) Our proprietary and scientifically rigorous bacteria strain selection methodologies, which include analyzing relevant strains using our bioinformatics expertise and testing candidate bacteria in preclinical models

(2) A robust inventory of well-characterized purebeneficial live bacteria strains produced under cGMP conditions

(3) A novel dual-release delivery technology designed to enable oral targeted delivery of biologics, including live bacteria, to the lower GI tract

Gemicel® platform technology enables targeted delivery to the colon of select strains of vegetative bacteria
  • Spores and
  • Non-Spores
  • Isolation
  • Development of appropriate culture media & cultivation conditions
Proprietary & scientifically rigorous strain selection methodologies, including:
  • Human FMT studies (for CDI indication)
  • Sequencing and analysis protocols
  • In vitro and in vivo models
  • GMP cell banking of pure strains
  • GMP production of bulk material
  • Scale-up

BACTERIA STRAIN LIBRARY & INVENTORY

Assembly is building a GMP bacteria strain inventory by isolating bacteria recovered from highly screened source donors and then identifying them by sequencing. In collaboration with academic experts, Assembly selects a subset of these bacterial strains based upon demonstrated correlations with health outcomes in individuals who have recovered from specific diseases or disease states, such as C. difficile infection. These selected bacteria are then manufactured reproducibly—they are grown in pure cultures under anaerobic conditions that are easily convertible to scalable GMP conditions. Assembly currently has dozens of strains in inventory and expects to have several hundred by the end of 2016.

Continued development of strain library and proprietary Gemicel® delivery system provide potential to rapidly expand into other microbiome-related conditions

  • Primary CDI
  • Additional infectious diseases
  • Inflammatory bowel disease (IBD)
  • Irritable bowel syndrome (IBS)
  • Metabolic diseases
  • Other indications