Taysha Gene Therapies has landed a $50 million investment to advance its streamlined pipeline of novel therapies aimed at rare diseases.

The Dallas-based biotech firm received the investment from Japanese pharmaceutical company Astellas Pharma in a move it says will address the unmet medical needs of patients with Rett syndrome and giant axonal neuropathy.

“We believe this investment not only further validates the potential of our technology platform, but also reinforces the therapeutic and market opportunity of our two lead clinical assets,” RA Sessions II, Taysha’s CEO, said in a statement.

Taysha’s pipeline includes the first-and-only gene therapy in clinical development for Rett syndrome and a Phase 1/2 development of a GAN treatment awaiting regulatory feedback, according to the startup.

Astellas takes 15% stake in Taysha

As part of the deal, Astellas will take a 15% stake in Taysha, along with an exclusive option to obtain the license to Taysha’s therapy development program to target genetic diseases in the central nervous system. According to the Dallas Morning News, $30 million of Astellas’ investment went into stock purchases, while the rest puts the Tokyo-based company at the front of the line to potentially purchase Taysha.

Astellas will also get a board observer seat on Taysha’s board of directors, allowing Taysha to leverage the firm’s expertise.

Initially launched as a UT Southwestern spinout with nearly 20 therapies in its pipeline, Taysha narrowed its focus to its therapies for Rett syndrome (TSHA-102) and giant axonal neuropathy (TSHA-120). The former is in clinical development and the latter is in Phase 1 and 2 development.

Each has received rare pediatric disease and orphan drug designations. The move came amid financial headwinds and a 35% staff reduction in an effort to extend Taysha’s runway.

Astellas acquired California’s Audentes Therapeutics for around $3 billion

Naoki Okamura, chief strategy officer at Astellas. [Photo: Astellas]

Astellas Chief Strategy Officer Naoki Okamura said his firm’s investment in Taysha aligns with its long-term focus of expanding its gene therapy capabilities. At the beginning of 2020, Astellas acquired California-based Audentes Therapeutics for around $3 billion, rebranding the company as Astellas Gene Therapies, California. The company also opened a “state-of-the-art” commercial manufacturing facility in North Carolina.

“Gene therapy is the cornerstone of Astellas’ primary focus, genetic regulation,” Okamura said in a statement. 

The CSO says Taysha is “an industry leader in CNS gene therapies,” making the partnership a strategic fit with the company’s long-term vision of “expanding Astellas’ gene therapy capabilities, allowing the company to impact the lives of a broader range of patients with urgent unmet medical needs.”

The CSO says the “goal is to bring new transformative treatment options to patients living with serious genetic diseases and limited treatment options.”

Taysha raised $181 million in 2020 IPO

Taysha launched in 2020, raising $125 million in Series A and B funding in a matter of months before debuting on the Nasdaq under the ticker TSHA. The IPO brought in around $181 million for the company, following underwriters exercising options to buy additional stock. After hitting a share price high of nearly $31 per share, Taysha’s stock was trading at $2.42 per share this morning.

“The way we’re thinking about 2022 is a year of focus,” Session said during a call with analysts earlier this year, the Dallas Business Journal reported.

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