Orasome™ and Other Technologies Platform for Oral Administration of Therapeutics

Our programs
Discovery
Preclinical
Phase 1
Phase 2
Phase 3
OrasomeTM and Other Technologies Platform

A versatile and programmable oral biotherapeutics platform being developed to enable administration of macromolecule therapeutic payloads, including antisense oligonucleotides, short interfering RNA, messenger RNA (mRNA), modular expression vector systems, peptides and nanoparticles that are otherwise administered exclusively by injection.

Phase completedPhase in progress
Programmable and scalable approach for oral administration of nucleic acids and other biologics
  • We are developing versatile and programmable oral biotherapeutics approaches, such as Orasome technology, to potentially enable the oral administration of macromolecule therapeutic payloads, including antisense oligonucleotides, short interfering RNA, mRNA, modular expression vector systems, peptides and nanoparticles that are otherwise administered exclusively by injection.
  • Our Orasome technology platform was inspired by the in vivo trafficking of ubiquitous, naturally occurring extracellular vesicles, which are often referred to as exosomes or ectosomes, and we have engineered them for transport through the gastrointestinal (GI) tract. We believe human cell-isolated exosomes/ectosomes have promise as vehicles for systemic drug administration due to their observed tolerability over synthetic polymer-based administration technologies. However, the fragile nature of exosomes/ectosomes from human cells limits their usage for oral administration and the type of post-isolation manipulations that can be applied in order to optimize such vesicles for exogenous drug cargo loading and storage.
  • Our Orasome technology platform, for example, utilizes both synthetic and naturally occurring components isolated from multiple sources to yield glycocalyx-stabilized vesicles (GVs). We have engineered and formulated these vesicles to remain stable following oral consumption and transit through the upper GI tract. Orasome GVs are readily amenable to manufacturing at scale and at relatively low cost based on the accessibility of the various components and simplicity of assembly.

 

  • Our Orasome GVs are being engineered to transport macromolecular medicines to selected mucosal cell types of the intestinal tract where the therapeutics act either directly in the GI tract, transit through the mucosa to the underlying lymphatic vascular network or, in the case of cargos that yield mRNAs, enable the body to produce its own therapeutic proteins and peptides, such as antibodies within mucosal cells that are secreted into the mucosal lymphatic vascular network for subsequent systemic distribution. Using our Orasome technology platform, we believe it may be possible for a patient to take an oral drug product that will permit their own GI tract cells to make virtually any type of therapeutic protein. We believe this approach also has the potential to provide a more convenient and significantly less expensive means to administer biological medicines.
  • In addition to Orasomes, we are also exploring the use of other approaches, such as certain exosomes isolated from milk as well as synthetic novel polymers and vesicles for delivering biotherapeutics.
  • Key Points of Innovation & Differentiation
    • Our proprietary oral administration technologies, including Orasome and Other Technologies Platform, have the potential to transform the treatment paradigm for diseases such as rheumatoid arthritis, diabetes, other autoimmune diseases and cancer for which the standard of care often requires intravenous infusion or subcutaneous injection of monoclonal antibodies (e.g., anti-PD-1, anti-tumor necrosis factor) or therapeutic proteins/peptides (e.g., glucagon-like peptide-1, insulin, granulocyte colony-stimulating factor GCSF, Factor VIII and IX, cytokines and erythropoietin), among others.

     

  • Program Discovery Process by the PureTech Team
    • We sought out different approaches to enable the oral administration of macromolecule therapeutic payloads that are otherwise administered exclusively by injection. We have independently developed our Orasome and Other Technologies Platform and have generated data and intellectual property supporting oral administration of macromolecule therapeutic payloads. We are also developing other oral administration technologies and intellectual property.
  • Milestones Achieved & Development Status
    • In 2021, we established preclinical proof-of-concept supporting the potential of our Orasome and Other Technologies Platform to achieve production of therapeutic proteins in the gut of an animal following simulated oral administration of expression systems and transport of these proteins from the gut into systemic circulation. Proof-of-concept was observed with multiple formulations involving Orasome and Other Technologies Platform, which are being further optimized to achieve a range of expression profiles for therapeutic proteins.
  • Expected Milestones
    • We continue to generate additional data in preclinical models to optimize and validate the Orasome and Other Technologies Platform. We intend to leverage our proprietary technology platforms, as well as our extensive network with major pharmaceutical companies and world-leading scientists in immunology and lymphatics, to generate additional novel therapeutic candidates.
  • Intellectual Property
    • We have broad intellectual property coverage for our Orasome technology platform. Our Orasome technology platform intellectual property portfolio covers compositions of matter, methods of use and methods of treatment spanning various platform-based technologies, as well as various broad classes of Orasome-formulated therapeutics, which include nucleic acid-based therapeutics (such as messenger RNA, short interfering RNA and antisense oligonucleotide-based approaches), small molecules, biologics (such as peptides, proteins and antibodies), expression systems for biologics and other therapeutics for use in the treatment of a wide range of diseases and disorders, including various immunological disorders, such as cancers and inflammatory diseases.
    • As of December 31, 2021, PureTech’s Orasome technology platform patent portfolio consists of four U.S. and nine foreign patent applications and one pending international PCT application in five patent families. Any patents to issue from these patent applications are expected to expire in 2037 through 2041, exclusive of possible patent term adjustments or extensions or other forms of exclusivity.
    • With regards to milk exosomes, we exclusively licensed a patent portfolio consisting of two patent families from 3P Biotechnologies, Inc., based on certain milk exosome technology originating from the University of Louisville. We also exclusively licensed a patent portfolio consisting of two patent families from NuTech Ventures, based on certain milk extracellular vesicle technology originating from the University of Nebraska.