The partnership allows Taysha to use Catalent’s gene therapy facilities in Maryland to expand the company’s manufacturing capacity.
The gene therapy for Rett, called TSHA-102, uses a modified, harmless adeno-associated virus (AAV), which is used commonly as a gene therapy delivery carrier. Taysha is developing 16 other gene therapies, all using AAVs.
“Through this partnership, we will be able to enhance our existing manufacturing capabilities to support Taysha’s broad gene therapy pipeline,” RA Session II, president, CEO, and founder of Taysha, said in a press release. “We are focused on ensuring that we can provide access to potentially curative gene therapies for thousands of patients by establishing this robust infrastructure early.”
Catalent’s gene therapy facilities in Maryland — five in total — are compliant with Good Manufacturing Practices (GMP).
“With our experience in process and analytical development and deep expertise in adeno-associated viral vectors, combined with our growing footprint, we are able to help companies manufacture patient material and reach the clinic faster,” said Manja Boerman, PhD, president of Catalent Cell & Gene Therapy.
The agreement with Catalent follows a collaboration between Taysha and the UT Southwestern Medical Center in Texas, intended to speed the development of gene therapies to be tested in preclinical and clinical development programs. The facility at UT Southwestern also is GMP-compliant.
Taysha is planning to build a GMP-compliant facility to produce AAV vectors on a commercial scale to continue development of its gene therapies along with UT Southwestern and Catalent. This year, the company received $95 million in funding to support the clinical development of its gene therapy programs. Taysha’s lead candidate, TSHA-101, is being developed for GM2-Gangliosidosis, a rare genetic disorder that progressively destroys nerve cells in the brain and spinal cord.
“Given Taysha’s large and growing pipeline of gene therapies, we wanted to plan for potential increased manufacturing needs above the GMP facility at UT Southwestern and our own planned manufacturing facility,” said Fred Porter, PhD, chief technical officer at Taysha.
“We believe that this partnership is critical to our strategy for future clinical and commercial supply of our gene therapy product candidates,” he said.
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