Ascend Acquires Beacon Gene Therapy Manufacturing Site

Ascend Advanced Therapies, a gene therapy development partner, has purchased Beacon Therapeutics’ contract, manufacturing, and controls team—along with the company's site located in Alachua, FL—a town considered to be a “biotech hub” in the state.¹ The acquisition introduces a good manufacturing practice (GMP) plant into the fold, along with process and analytical development capabilities.

Per the deal, Ascend also has a long-term agreement with Beacon which includes the production of its products for both clinical and commercial use, which allows for the ophthalmic gene therapy company to prioritize 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," said Mike Stella, Ascend’s CEO. "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."

Beacon’s current portfolio currently features three ocular gene therapy products that use AAV to provide gene constructs that help to tackle retinal disorders. The proteins that comprise the constructs are meant to help counteract any deficiencies in patients’ cells in an effort to potentially restore vision at the very least, stop the disease from getting worse.

"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 gene therapy company also announced results of its 12-month interim safety and efficacy results for its Phase II SKYLINE trial in patients with X-linked retinitis pigmentosa (XLRP).² The data from males with XLRP showed a response rate of 63% in study eyes that were treated with a high dose (6.8 E+11 vg/eye) of AGTC-501. Further, the response rates in study eyes treated with a low dose (7.5 E+10 vg/eye) of AGTC-501 were similar to the untreated fellow eyes in the high dose cohort (and 0% for both). Patients in the high dose cohort also demonstrated an improvement in visual function, including mean retinal sensitivity.

References

1. Ascend acquires GMP manufacturing capacity in Alachua, Florida from Beacon Therapeutics. Ascend Advanced Therapies. April 9, 2024. Accessed April 9, 2024. https://www.ascend-adv.com/news-and-insights/news/ascend-acquires-gmp-manufacturing-capacity-in-alachua-florida-from-beacon-therapeutics/

2. Beacon Therapeutics Announces Positive 12-Month Data from Phase 2 SKYLINE Trial of AGTC-501 in Patients with X-Linked Retinitis Pigmentosa. Beacon Therapeutics. February 8, 2024. Accessed April 9, 2024. https://www.beacontx.com/news-and-events/beacon-therapeutics-announces-positive-12-month-data-from-phase-2-skyline-trial-of-agtc-501-in-patients-with-x-linked-retinitis-pigmentosa/