Dallas Gene Therapy Startup Closes $95M Series B to Bolster its Initial Clinical Studies

Taysha Gene Therapies, which was been operating in stealth with UT Southwestern until this April, plans to use the financing to advance its initial cohort of lead programs into its clinic. By the end of 2021, Taysha expects to file four Investigational New Drug applications.

R.A. Session II, president, CEO, and founder of Taysha Gene Therapies [Background image: Olena Yepifanova via iStock]

On the heels of Taysha Gene Therapies emerging from stealth with a $30 million Series A and a strategic partnership with UT Southwestern in April, the Dallas-based biotech has closed on a lot more money.

Taysha has closed on an oversubscribed $95 million Series B financing. A premier group of life science investors, led by Fidelity Management & Research Company LLC, contributed to the round. Founding investors PBM Capital and Nolan Capital participated.

New investors include funds and accounts managed by: BlackRock, GV (formerly Google Ventures), Invus, Casdin Capital, Franklin Templeton, Octagon Capital, Perceptive Advisors LLC, Sands Capital, ArrowMark Partners, and Venrock Healthcare Capital Partners.

According to the patient-centric gene therapy company, the funding will be used to advance its initial cohort of lead programs into its clinic. It will also accelerate progress on IND (Investigational New Drug) submissions, build a commercially scalable GMP manufacturing facility, and continue development of the company’s portfolio in partnership with the UT Southwestern Gene Therapy Program.

Taysha aims to end severe and life-threatening diseases of the central nervous system caused by variation in a single gene, also known as monogenic CNS diseases. According to R.A. Session II, Taysha’s president, CEO, and founder, the new significant investment will allow he and his team to advance that mission.

The work could help “thousands of patients who suffer from these devastating disorders.”

“We remain on track and expect to file four Investigational New Drug applications by the end of 2021, with TSHA-101 initiating clinical studies later this year for the treatment of GM2 Gangliosidosis,” he said.

The company initially launched with a pipeline of 15 adeno-associated virus gene therapy programs. Now, it has 17 gene therapy product candidates with exclusive options to acquire four additional programs across three distinct franchises.

The team has plans for human testing this year and expects to file four IND applications in 2021. In addition, Taysha is developing an improved treatment delivery platform that uses machine learning, DNA shuffling, and something it calls “directed evolution.” 

Sean Nolan, Taysha’s chairman of the Board, predicts the new financing will enable the company to rapidly translate programs from preclinical development into the clinic.

“We have brought together experts in gene therapy with leading healthcare and institutional investors to create a company that is uniquely positioned to advance the development of potentially curative gene therapies for CNS disease in rare and large patient populations,” he said.

The strategic partnership with UT Southwestern could help Taysha do so.

The UT Southwestern Gene Therapy Program—led by Steven Gray, director of the Viral Vector Core and Assistant Professor in the Department of Pediatrics, and Berge Minassian, division chief of Child Neurology—has the capacity to support Taysha’s wide range of preclinical and clinical development programs.

Together, Taysha and UTSW plan to merge cutting-edge translational research, hands-on clinical care, and expertise.

Under the partnership, UT Southwestern, which has developed a “state-of-the-art viral vector manufacturing facility,” will run discovery and preclinical research,  as well as lead studies, provide manufacturing, and execute natural history studies.

For its part, Taysha will lead all clinical development, regulatory strategy, commercial manufacturing, and commercialization activities.

A  joint steering committee of key leadership members from Taysha and UT Southwestern will govern the collaboration.

The story was updated on Sept. 25, 2020, at 4:53 p.m. Taysha launched with a $30 million in Series A funding.

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