C3DNA — COVALENTLY CLOSED AND CIRCULAR DNA – IS INTERGALACTIC’S VERSATILE SYNTHETIC CARGO PLATFORM.
With C3DNA, Intergalactic scientists can design and deliver even the largest genes to target cells.
Intergalactic precisely engineers C3DNA, using synthetic biology tools to mine and assemble modular elements into a closed loop. This closed, circular construction allows C3DNA to be taken up by cells and expressed, without insertion into the host genome.
Moreover, C3DNA avoids triggering an immune response, because it is fully synthetic and does not contain viral or bacterial sequences. Therefore, the immune system does not “see” it, enabling C3DNA to act like an endogenous gene in the nucleus, with enhanced persistence of expression.
Our lead delivery modality for C3DNA therapies is COMET®: Cellular delivery of genetic Material by Electro-Transfer. COMET®, Intergalactic’s proprietary pulsed electric field focal gene therapy delivery system, combines custom wavelengths and algorithms, novel electrode design, and electrical field modeling in a simple yet sophisticated device design. COMET® devices are precisely engineered to work with different types of C3DNA therapeutic payloads. Given the versatile nature of C3DNA itself, it is also compatible with administration via other modalities such as nanoparticle-based nano transfer, and Intergalactic scientists are exploring these possibilities.
Our cell-free manufacturing process was created in-house to deliver a therapeutic product that is safer than AAV and other conventional gene therapy technologies.
Cell-free manufacturing is robust, well-controlled, faster, and less expensive than cell-based processes, enabling more patient doses to be made across more disease types.
Our comprehensive suite of analytical methods enables industry-leading product and process understanding that can streamline regulatory filings.
“Our manufacturing paradigm at Intergalactic starts with the goal of potentiating global access to safe and effective gene therapies by bringing down cost of goods and improving safety. Virus-based gene therapies—and some non-viral therapies—are manufactured in cells, which requires scaling up to very large volumes in bioreactors and then separating the vector from complex impurities. This manufacturing paradigm drives up cost, takes time, and can introduce factors such as empty capsids that compromise product purity. Our manufacturing process at Intergalactic is synthetic, enabling increased control of the process and allowing us to deliver a product with lower cost of goods and higher purity.”
Senior Vice President,
Head of Technical Operations
Intergalactic Therapeutics has entered into a strategic partnership with Resilience, a differentiated provider of manufacturing solutions for next-generation medicines, under which Resilience is providing cGMP capacity and resources to manufacture C3DNA products for Intergalactic’s first-in-human trials and process and analytical development support to advance Intergalactic’s novel cell-free manufacturing paradigm.