After early hiccups in manufacturing, Adverum outlines plans for commercial gene therapy plant in North Carolina hub
After some early hiccups in its manufacturing procedures for its gene therapy drug targeting wet age-related macular degeneration, California biotech Adverum has addressed those concerns and is priming the pump for a commercial launch.
The ocular and other rare disease-focused gene therapy company will invest $80 million in a new cGMP manufacturing facility in North Carolina’s bustling Research Triangle Park that by 2023 will be ready to manufacture commercial supply of ADVM-022, Adverum’s intravitreal therapeutic, the company said Thursday.
The 174,000 square-foot facility will include four 1,000-liter bioreactors, with space for future expansion, and will create more than 200 jobs. In addition to its $80 million investment, Adverum will gain up to $9 million in North Carolina state and local incentives.
“Our new in-house commercial manufacturing facility sets the foundation of our overall manufacturing strategy,” Angela Thedinga, Adverum’s chief technology officer, said in a statement. “Our new site will provide dedicated commercial supply, while we continue to leverage CMO partnerships for flexible clinical and additional commercial supply.”
In 2020, Phase I trial data from ADVM-022 started to turn a corner after some weak readouts in the past. Investigators in May reported that two of three cohorts continued to respond to treatment, with the majority still free of the need for rescue injections, while the third cohort experienced fewer side effects than other anti-VEGF therapeutics.
The year 2019 was more difficult for the biotech. In April of that year, the FDA imposed a clinical hold on the application to test ADVM-022 in humans, asking Adverum for more data on the chemistry, manufacturing and control process, Endpoints News reported. The hold was lifted shortly after.
Then in September, Adverum revealed data that indicated patients with AMD saw their vision deteriorate when treated with ADVM-022, despite signs that the treatment was improving retinal anatomy. Those patients who saw a vision deterioration lost visual acuity by two letters on average in a 90% confidence interval of -9.1 letters to +5.1 letters, the company reported from the 24-week OPTIC trial.
In late 2019, the biotech also abandoned development of its then-lead experimental drug, ADVM-043, for treating A1AT deficiency.
In a press release announcing Adverum’s new facility, CEO Laurent Fischer was downright bullish on the company’s future.
“We are building a team with exceptional AAV-gene therapy experience and we are thrilled to join the highly-skilled and diverse North Carolina biotech community,” he said. “This state-of-the-art facility will support our commercialization of ADVM-022, the potential first mass marketed gene therapy for wet AMD and DME.”