With a gene therapy nearing the finish line and $3 billion in hand from its buyout by Astellas, biotech Audentes Therapeutics is ready to start work on its $109 million gene therapy manufacturing facility that will employ 200.
The 135,000-square-foot facility will be built in Sanford, North Carolina, Audentes announced today. The first phase is slated to take 18 months to build and be operational by 2021. The rest of the investment will play out over two more years.
“Our investment in large-scale manufacturing has always been a cornerstone of our strategy to develop and ultimately deliver our important genetic medicines to patients as rapidly as possible,” Audentes CEO Natalie Holles said in a statement.
San Francisco-based Audentes was already working on its manufacturing plans when it was snapped up by Japan-based Astellas in December. Analysts viewed the facility as a big draw for potential buyers.
Audentes is working on a portfolio of adeno-associated virus-based gene therapies aimed at targeting serious rare neuromuscular diseases.
The biotech is expected to seek approval in the U.S. and Europe this year for AT132, a candidate for improving the neuromuscular function and reducing ventilator dependence for patients with X-linked myotubular myopathy. The genetic condition affects about one in 40,000 to 50,000 live male births. It also is working toward gene therapies for Pompe disease, Duchenne muscular dystrophy and myotonic dystrophy.
Astellas is making Audentes and its technology the center of its move into gene therapies, which the Tokyo-based drugmaker is pursuing with vigor. Just weeks after announcing the Audentes deal, it made a $120 million down payment on Xyphos, an early-stage biotech that has engineered the NKG2D receptor to be inactive until it comes into contact with a bispecific, a trigger it intends to use in CAR-T therapies.
+info: biomédico-fiercepharma