Taysha, Catalent Partner to Advance Gene Therapies for Batten, Other Disorders

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by Forest Ray, PhD |

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Taysha Gene Therapies announced that it has joined with Catalent, a pharmaceutical services provider, to support production of its potential gene therapies for disorders that include CLN1 Batten disease and Rett syndrome.

“Through this partnership, we will be able to enhance our existing manufacturing capabilities to support Taysha’s broad gene therapy pipeline,” R.A. Session, the president, founder, and CEO of Taysha, said in a press release.

Taysha currently has over a dozen experimental therapies in various stages of development. The company focuses on disorders of the central nervous system (CNS) — the brain and spinal cord — that are caused by changes to single genes, so-called monogenic CNS disorders.

“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,” Session added.

Under the November agreement, Catalent will manufacture Taysha’s products at its gene therapy manufacturing facilities in Maryland.

“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.

Adeno-associated viruses (AAV) are harmless viruses often used to carry therapeutic genes to patient cells. AAV vectors form the backbone of Taysha’s gene therapy pipeline.

In addition to its agreement with Catalent, Taysha has partnered with UT Southwestern Medical Center, where Session also holds a position as entrepreneur-in-residence. This partnership grants Taysha access to the university’s 500-liter capacity CGMP-compliant manufacturing facility.

CGMP, meaning current good manufacturing practices, are a set of regulations governing quality care in drug manufacturing. CGMP regulations cover minimum requirements for the methods, facilities, and controls used to manufacture, process, and package drug products.

Taysha also plans to establish its own commercial-scale CGMP manufacturing facility to further support large-scale production of future gene therapies, including those for CLN1 and Rett.

“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, Taysha’s chief technical officer. “We believe that this partnership is critical to our strategy for future clinical and commercial supply of our gene therapy product candidates.”

Over the past year, Taysha has partnered with various pharmaceutical companies to support programs enabling rapid diagnoses for patients with lysosomal storage disorders and epileptic conditions, such as Batten disease, and to collaboratively advance potential gene therapies.