- Horizon’s Glutamine Synthetase-Knockout CHO K1 cell line has been used as part of a successful Investigational New Drug filing with the FDA
- Filing further validates the use of Horizon’s Bioproduction cell line platform for the manufacture of biotherapeutics
Cambridge, UK, 21 March 2018: Horizon Discovery Group plc (LSE: HZD) (“Horizon” or “the Group”), a global leader in the application of gene editing and gene modulation to deliver inspired cell solutions, today announces that one of the licensees to its Bioproduction cell line technology has used Horizon’s cell line as part of a successful Investigational New Drug (IND) filing with the United States Food and Drug Administration (USFDA). This successful filing enhances Horizon’s market opportunity by demonstrating that the cells and recombinant adeno-associated virus (rAAV) engineering technology used in their generation have been assessed as safe from a regulatory perspective for the manufacture of biotherapeutics for use in humans.
Industry adoption of Horizon’s CHO K1 GS knockout cell line has provided the Group with a strong source of repeatable revenue that has accelerated in recent months, with over 20 full commercial licenses in place and a strong pipeline of new licenses pending. These licenses have been secured as a result of Horizon’s unrivalled combination of high performance, transparent cell line history, and disruptive licensing terms. Now, as an important part of a successful IND filing by a licensee, Horizon’s Bioproduction cell line has been proven as a high-value platform upon which regulatory submissions can be based.
Horizon licenses its CHO K1 cell line broadly across the industry including to pharmaceutical, biotechnology, and biosimilar companies, as well as to Contract Manufacturing Organizations (CMO). By adopting this approach, Horizon intends to demonstrate its global leadership, empowering organizations of all sizes by providing access to the best biotherapeutic manufacturing technology available, driving efficiencies so that they, and ultimately patients, benefit.
Richard Vellacott, Interim CEO and CFO, Horizon Discovery, commented: "Next-generation biotherapeutics require next-generation manufacturing platforms. We are pleased that our highly specialized gene-edited cell line for bioproduction is not only being widely adopted by customers of all sizes but has now also been validated as a highly effective platform for regulatory submissions. Today’s announcement enables Horizon to access a wider customer base and represents a significant milestone in our goal of harnessing the power of the cell to empower customers across the life sciences.”