Oxford Biomedica notes Axovant's positive six-month follow-up from second cohort of SUNRISE-PD Phase 2 trial of AXO-Lenti-PD
10/06/2020 | 07:48am EST
Oxford Biomedica notes Axovant’s positive six-month follow-up from second cohort of SUNRISE-PD Phase 2 trial of AXO-Lenti-PD
Oxford, UK – 6 October, 2020: Oxford Biomedica plc (LSE:OXB) (“Oxford Biomedica” or “the Group”), a leading gene and cell therapy group, notes Axovant Gene Therapies’ (“Axovant”) positive six-month follow-up data from the second cohort of the SUNRISE-PD Phase 2 trial of AXO-Lenti-PD gene therapy in Parkinson’s disease.
Key highlights from the follow-up data were as follows:
AXO-Lenti-PD was well-tolerated with no treatment-related serious adverse events at 6 months
21-point mean improvement in UPDRS Part III “OFF” score, a 40% improvement from baseline based on the two evaluable patients in the study, exceeding predefined criteria for success
Greater than 2-hour improvement from baseline in both diary “good ON time” and diary OFF time assessments
EXPLORE-PD, a randomised, sham-controlled study of AXO-Lenti-PD is expected to begin dosing in 2021
To view the full announcement from Axovant, please follow this link: (LINK)
In June 2018, Oxford Biomedica out-licenced OXB-102 (later renamed AXO-Lenti-PD) to Axovant through a $842.5 million worldwide licence agreement (LINK). In July 2020 a three year clinical supply agreement was additionally signed with Axovant to manufacture GMP batches to support the ongoing and future clinical development of AXO-Lenti-PD (LINK).
Oxford Biomedica plc
John Dawson, Chief Executive Officer Stuart Paynter, Chief Financial Officer Catherine Isted, Head of Corporate Development & IR
About Oxford Biomedica Oxford Biomedica (LSE:OXB) is a leading, fully integrated, gene and cell therapy group focused on developing life changing treatments for serious diseases. Oxford Biomedica and its subsidiaries (the "Group") have built a sector leading lentiviral vector delivery platform (LentiVector®), which the Group leverages to develop in vivo and ex vivo products both in-house and with partners. The Group has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology, CNS disorders, liver diseases and respiratory disease. The Group has also entered into a number of partnerships, including with Novartis, Bristol Myers Squibb, Sanofi, Axovant Gene Therapies, Orchard Therapeutics, Santen, Beam Therapeutics, Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium and Imperial Innovations, through which it has long-term economic interests in other potential gene and cell therapy products. Additionally the group has signed a 3 year master supply and development agreement with AstraZeneca for large-scale manufacturing of the adenoviral based COVID-19 vaccine candidate, AZD1222. Oxford Biomedica is based across several locations in Oxfordshire, UK and employs more than 580 people. Further information is available at www.oxb.com
About Axovant Gene Therapies Axovant Gene Therapies is a clinical-stage gene therapy company focused on developing a pipeline of innovative product candidates for debilitating neurodegenerative diseases. Our current pipeline of gene therapy candidates targets GM1 gangliosidosis, GM2 gangliosidosis (also known as Tay-Sachs disease and Sandhoff disease), and Parkinson’s disease. Axovant is focused on accelerating product candidates into and through clinical trials with a team of experts in gene therapy development and through external partnerships with leading gene therapy organizations. For more information, visit www.axovant.com
About AXO-Lenti-PD AXO-Lenti-PD is an investigational gene therapy for the treatment of Parkinson’s disease that is designed to deliver three genes (tyrosine hydroxylase, cyclohydrolase 1, and aromatic L-amino acid decarboxylase) via a single lentiviral vector to encode a set of critical enzymes required for dopamine synthesis, with the goal of reducing variability and restoring steady levels of dopamine in the brain. The investigational gene therapy aims to provide patient benefit for years following a single administration. Axovant expects to dose the first patient in EXPLORE-PD, a randomized, sham controlled study in 2021.