Tao Bio is a stealth biotechnology company committed to pioneering novel genetic medicines. Our innovative strategy seeks to overcome the existing limitations of gene therapies through a non-viral technologies. We primarily develop treatments for metabolic and rare diseases.
Gene therapy DNA is traditionally delivered by viruses, such as adeno-associated virus. Patients experience symptoms in many tissues, but viruses cannot be used to treat multiple tissue types. Also, most viruses cannot carry large genes.
Patients are often immunosuppressed before treatment with a very high dose of virus. Yet, tissue damage and deaths occur from treatment.
The immune system develops strong antibodies to the virus that contains the gene therapy DNA. These antibodies render additional doses of virus ineffective, even if the patient is immunosuppressed.
Patients who have been exposed to the native virus develop antibodies and cannot receive gene therapy treatment.
Viral gene therapies persist in cells as non-replicating DNA bundles called episomes. As cells turn over, episomes are lost and the treatment becomes less effective over time. Some treatments are projected to become non-effective within 3-12 years of administration.
Producing viral vectors is expensive. Because they can only be delivered effectively once per patient, all costs are factored into a single dose. This can make critical medicines inaccessible.
Tao Bio has developed a non-viral approach to gene therapy that can be produced at a small fraction of the cost of viral therapies. Patients can receive repeat doses of the therapy without concern for immunogenicity or pre-existing immunity. The therapy may be delivered to multiple tissue types.
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Tao Bio uses a non-immunogenic vector to overcome the hurdles of traditional viral gene therapies. The lack of immune response from the body allows the treatment to be delivered multiple times.
The vector allows for treatment of diseases in two contexts in which viral therapies fail.
The first area is dividing tissues, such as skin or bone marrow. Viral vectors are often diluted very quickly in these tissues and treatment is rendered ineffective. Since our therapy is cost effective and re-dosable, it could be applied to such tissues.
The other application is diseases which require delivery of large genes, such as Usher syndrome. Viral vectors have strict limitations on the size of genes that can be inserted without disrupting viral assembly. Our system allows for flexibility in insert size, and this allows new treatments to be explored.
Most current-generation gene therapies are based on adeno-associated virus (AAV), which has many different serotypes. Many patients have been exposed to certain kinds of AAV before and so produce antibodies for AAV. About 20-30% of patients are ineligible to receive Roctavian, a Hemophilia A gene therapy using AAV-5, due to the presence of these AAV-5 antibodies that neutralize the treatment.
AAV and lentivirus gene therapies are single-dose, as patients develop strong antibodies from the large influx of virus. These antibodies are the same as those acquired from the native form of the virus, which bind to and neutralize the virus and treated cells. For this reason, there are no redosable AAV or lentiviral gene therapies to date.
Gene therapy viruses persist as non-replicative episomes, and so they are lost as cells turn over. The estimated half life for AAV treatments has been estimated to be about 2 years in some models. This means that in 4 years, the treatment will lose 75% of its efficacy.
Our treatments are designed with effectiveness, accessibility and broad applicability in mind. We aim primarily to treat rare diseases that cannot be addressed well by viral therapies, as well as to provide cost-effective alternatives to existing therapies.
Tao Bio is headquartered in X Factory, a startup incubator in the East End neighborhood of Pittsburgh.
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