TAAV’s synthetic DNA material approved for use in clinical trials

The dbDNA material will be used in the next approved Huntington’s disease study in France.

28.09.22

TAAV Biomanufacturing Solutions, announced the first planned use in a clinical trial of its doggybone DNA (dbDNA), a precision engineered synthetic DNA material.


The dsDNA produced by TAAV is a component of a gene therapy candidate from Asklepios BioPharmaceutical Inc. (AskBio) for the treatment of early-stage Huntington’s disease, which was recently cleared by the National Safety Agency medicine and health products (ANSM) for an upcoming phase I/II clinical trial.


TAAV dsDNA is produced using a synthetic manufacturing process that eliminates the use of fermenters and bacteria, which are required in more common plasmid DNA manufacturing. Synthetic manufacturing removes significant levels of bacterial contaminants, resulting in the production of a synthetic DNA product with an improved safety profile for the manufacture of recombinant adeno-associated virus (rAAV) gene therapy vectors.


“The success of this first clinical trial involving the dsDNA manufactured by TAAV would mark an important milestone for TAAV and bring us closer to the commercial validation of this revolutionary technology,” said Alfredo Martinez, COO of TAAV. “The clinical success of this first treatment would put us on the path to potentially increased access to this gene therapy with safer and more efficient DNA material that can be produced faster, in much higher volumes and at lower cost. We look forward to doing this and doing the same for others in the future.”


The synthetic manufacturing process consistently produces large quantities of dsDNA in reduced times, which can be measured in days compared to months that are typical when producing plasmid DNA. Additionally, since dbDNA does not contain a plasmid backbone, it significantly reduces the risk of introducing bacterial DNA sequences to patients, thereby improving the overall quality of gene therapy products.


“We knew early on that manufacturing at scale and at the lowest possible cost would be key to realizing all the promise of gene therapies,” said Sheila Mikhail, CEO and co-founder of AskBio, TAAV’s parent company. “Products like dbDNA could transform how AskBio and others effectively increase the availability of AAV therapies, creating a new industry standard for manufacturing transfection-based AAV therapies.”


TAAV produces dsDNA as a lower-cost, higher-yield alternative to plasmid DNA and makes it available to all biotech companies around the world that bring life-changing AAV gene therapies to the clinic.

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