Dallas-based biotech Taysha Gene Therapies has emerged out of stealth with a $30 million Series A and a new strategic partnership with UT Southwestern. The company 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.

Hitting the ground running, the company launches with a pipeline of 15 adeno-associated virus gene therapy programs, along with options to four others.

Taysha plans human testing this year and expects to file four Initial New Drug applications in 2021. In addition, the biotech is developing an improved treatment delivery platform that uses machine learning, DNA shuffling, and something it calls “directed evolution.” 

The gene therapy startup closed its round of seed financing in early March— just as the Dow “dropped a couple of thousand points,” according to a report in EndpointsNews.

“If you had to ask me, was I worried? Absolutely. I think I wouldn’t be human if I wasn’t,” RA Session II, president, CEO, and founder of Taysha, told the healthcare publication. 

“Session had a lot of certainty to balance out all the uncertainty of launching a new biotech during a pandemic,” noted Endpoints’ Amber Tong.

The experience of a proven management team, including some who previously led the development and commercialization of the first FDA-approved gene therapy for CNS disease, Zolgensma, is part of the equation. 

The startup intends to combine the speed, scale, and expertise of its partner’s UT Southwestern Gene Therapy Program with the experience of the Taysha team. 

Session says the launch reunites former investors and executives from AveXis. Taysha’s funding round was co-led by PBM Capital, the first institutional investor in AveXis, and Nolan Capital, the investment fund of former AveXis CEO Sean Nolan.

Taysha’s Board of Directors played a key role in the formation of the company, it said.  The board is comprised of Sean Nolan, Paul Manning of PBM Capital, Claire Aldridge, Ph.D., of UT Southwestern, and Taysha Founder Session.

Nolan, who serves as Chairman of the Board, sees promise in Taysha’s approach for patients suffering from many devastating CNS diseases.

“This is an exciting time for gene therapy,” he said.

Strategic alliance with UT Southwestern Gene Therapy Program

The strategic partnership with UT Southwestern could help Taysha to “rapidly and efficiently translate novel AAV gene therapies from bench to bedside,” the company said.

UTSW is home to “some of the brightest minds in gene therapy,” Sessions says. “By joining forces with UT Southwestern, Taysha can advance its potential cures with both speed and scale.”

The collaboration is “ultimately creating an engine for new cures,” said Claire Aldridge, Ph.D., a Taysha board member and associate vice president of commercialization and business development at UT Southwestern Medical Center.

Together, Taysha and UTSW will merge cutting-edge translational research, hands-on clinical care, and expertise—both regulatory and commercial, she said. 

Aldridge has already witnessed how quickly and efficiently the partners can leverage their collective expertise and resources. That means getting “new gene therapies to the patients who so desperately need them,” she said.

The UT Southwestern Gene Therapy Program, led by Steven Gray, Ph.D., Director of the Viral Vector Core and Assistant Professor in the Department of Pediatrics, and Berge Minassian, M.D., Division Chief of Child Neurology, has the capacity to support Taysha’s wide range of preclinical and clinical development programs, the company said.

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, according to the company.

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

This story was updated on Friday, Sept. 25 to clarify the details of Taysha’s funding.

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