Adverum Biotechnologies Inc. (NASDAQ:ADVM) Announces Q3 2020 Results With FDA removing Partial Hold On ADVM-022 Development

Adverum Biotechnologies Inc. (NASDAQ:ADVM) has announced recent corporate updates and financial results for Q3 2020.

Adverum advancing DME and wet AMD programs

Laurent Fischer, the company’s CEO, said that Adverum is continuing with its execution and progress across the organization. Currently, preparations are underway for the Adverum to become a late-stage gene therapy company in 2021. Already two programs are underway for ADVM-022 in DME and wet AMD. Fischer said that ADVM-022 has the potential of reducing the treatment burden for patients across the world living with these chronic diseases with the possibility of a “one and done” therapy.

The company plans to meet regulators over development plans for ADVM-022 based on the encouraging data from OPTIC in wet AMD and progress with INFINITY in DME. This will expedite the development, manufacturing and plans for the commercial launch of the therapy. Fischer said that the company has also expanded its team of leaders to establish world-class capabilities across operational functions in readiness for future opportunities to bring proprietary gene therapies to patients.

Recently the FDA removed a partial clinical hold on ADVM-022 which is a huge milestone as the company moves to commence its pivotal ADVM-022 trial in wet AMD. The removal of the hold came after the company provided the FDA with requested information associated with CMC. Interestingly the hold didn’t affect the phase 2 INFINITY trial for DEM or the dose evaluation in OPTIC phase 1 study for wet AMD. Adverum will meet the FDA regarding plans for pivotal studies supporting Biologics License Application (BLA) filing for ADVM-022 in wet AMD.

Adverum makes leadership appointments

In August the company raised around $203.4 million from an underwritten public offering. Adverum also announced leadership appointment s with Thomas Kochy joined the company as the VP commercial and program strategy. Kochy brings leadership, sales and product marketing expertise to Adverum including over ten years’ experience in ophthalmology. Christopher Morrison also joined the company as the VP for process science. He is also bringing the pharmaceutical experience to the company in gene therapy, process development and recombinant adeno-associated viral vector (rAAV).