4BIO Capital Portfolio Company Ascend Acquires Florida-Based GMP Manufacturing Capacity

4BIO Capital recently announced its portfolio company, Ascend Advanced Therapies, has acquired the Contract, Manufacturing and Controls (CMC) team and site in Alachua, FL, from Beacon Therapeutics. 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.

Andrew Kozlov, Managing Partner of 4BIO Capital, said “The gene and cell therapy industry is evolving at speed and there remains a significant unmet need for highly sophisticated manufacturing companies that can act as partners and provide support to ensure patients get advanced therapies. This key acquisition brings Ascend its first US manufacturing site, a huge milestone for the company. We are proud to support Ascend as it takes the next steps toward achieving its vision.”

“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,” added Mike Stella, CEO at Ascend. “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,” commented David Fellows, CEO at Beacon Therapeutics. “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, optimization and forthcoming GMP QC release capabilities at the Munich, Germany, site and now the GMP facility in Alachua, FL, Ascend has the combined network and product experience to deliver total support for clients at all stages of development.

4BIO Capital is an international venture capital firm focused on investing in advanced therapies, including genomic medicines and other emerging technologies, to unlock the treatments of the future. 4BIO’s objective is to invest in, support, and grow early-stage companies developing treatments in areas of high unmet medical need, with the ultimate goal of ensuring access to these potentially curative therapies for all patients. Specifically, it looks for viable, high-quality opportunities in cell and gene therapy, RNA-based therapy, targeted therapies, and the microbiome. The 4BIO team comprises leading advanced therapy scientists and experienced life science investors who have collectively published over 250 scientific articles in prestigious academic journals including Nature, The Lancet, Cell, and the New England Journal of Medicine. 4BIO has both an unrivalled network within the advanced therapy sector and a unique understanding of the criteria that define a successful investment opportunity in this space. For more information,  visit www.4biocapital.com.

Ascend Advanced Therapies is a specialist adeno-associated virus (AAV) development partner working to bring next-generation gene therapy products to market. Using an acqui-building approach, Ascend hit the ground running in 2023 with operational facilities globally, and a team of experts that offer unparalleled insight and collaboration when delivering products from the bench through to commercialization. The flexible platform supports all AAV serotypes across scales with proprietary and partnered technologies and a world-class analytical toolkit. The team continuously aims higher for the long run when working with partners to balance yield and quality of accessible life-saving therapies. For more information, visit www.ascend-adv.com.

Beacon Therapeutics is an ophthalmic gene therapy company founded in 2023 to save and restore the vision of patients with a range of prevalent and rare retinal diseases that result in blindness. Beacon has an established scientific foundation that combines a late-stage development candidate to treat X-linked retinitis pigmentosa (XLRP), as well as two preclinical programs, one targeting dry age-related macular degeneration (AMD) and another targeting cone-rod dystrophy (CRD), an inherited retinal disease. The company is supported by funds from Syncona and additional investors including Oxford Science Enterprises. For more information, visit www.beacontx.com.