Life Sciences

Ascend acquires GMP manufacturing capacity in Alachua, Florida; Enters long-term partnership with Beacon Therapeutics for clinical and commercial AAV production

Ascend Advanced Therapies (Ascend), a total solutions gene therapy development partner, has acquired the CMC team and site in Alachua, Florida from Beacon Therapeutics (Beacon). The transaction brings an operational good manufacturing practice (GMP) facility, process and analytical development capabilities, and additional experts to the Ascend team. It also includes a long-term partnership with Beacon to continue manufacturing its products for clinical and commercial use, securing product supply for Beacon and enabling it to focus on clinical development.

“Ascend was founded with a unique science and technology-driven strategy. As we continue building the most flexible adeno-associated virus (AAV) platform across serotypes on the market, we also understand the critical value of our highly experienced employees,” Mike Stella, CEO at Ascend offered. “This acquisition allows us to now support customers from research through to commercialization and adds to one of the most experienced gene therapy teams in the market. Every day we are working together to grow the company with a long-term mindset of quality first to appropriately balance quality and yield for the life of each product.”

“We are excited to enter this strategic arrangement with Ascend to advance our sight saving therapies toward approval. This alignment is critical to securing GMP drug product supply for our late-stage clinical asset AGTC-501 for the treatment of X-Linked Retinitis Pigmentosa,” David Fellows, CEO at Beacon Therapeutics offered. “The Ascend team brings significant experience in gene therapy manufacturing and a strong commitment to building capabilities to support future Beacon pipeline programs.”

The Beacon Therapeutics portfolio currently includes three ocular gene therapy products utilizing AAV to deliver gene constructs that address retinal disorders. The proteins expressed from the transduced constructs compensate for deficiencies in the patient cells, or otherwise intervene in pathological processes, potentially restoring vision or preventing disease progression.

Alachua is a leading biotech hub in Florida and continues to attract investments in advanced therapeutic programs. The facility is highly synergistic to a growing global network of Ascend sites that has been built via critical acquisitions. From early-stage R&D at the San Francisco Bay Area site, to process development, optimisation and forthcoming GMP QC release capabilities at the Munich, Germany site and now the GMP facility in Alachua Florida, Ascend has the combined network and product experience to deliver total support for clients at all stages of development.

The transaction was closed on 1st April 2024, and integration efforts began immediately.