A subsidiary of Axovant Gene Therapies Ltd (NASDAQ:AXGT) entered a 3-year pact with Oxford BioMedica Plc (OTCMKTS:OXBDF) for the manufacture and supply of GMP batches. Axovant will use Oxford’s material to support the development of a clinical-stage gene therapy product – AXO-Lenti-PD for the treatment of patients with moderate to severe Parkinson’s disease.
Completes dosing in the second cohort
Phase 2 SUNRISE-PD clinical trial is underway at Axovant using AXO-Lenti-PD. The company completed the dosing of patients in the second cohort and expects 6-month efficacy and safety data in Q4 2020. Oxford will use its GMP manufacturing facilities for the manufacture of AXO-Lenti-PD. It will also use its OXB GMP facilities to ensure continued supply for the trial.
CEO of Axovant, Pavan Cheruvu, said the accord allows both the companies to advance AXO-Lenti-PD development jointly. The partnership with Oxford helps the company scale up the supply of clinical material to support its Phase 2 and Phase 3 clinical trials and commercialize it. It is another milestone for the company in its Parkinson’s disease program and expects to enroll the first patient in a sham-controlled and randomized clinical study next year.
Pavan said the company achieved significant progress in its three clinical-stage GTDP (gene therapy development programs) in Q1 2021 in Parkinson’s disease, Tay-Sachs/ Sandhoff diseases, and GM1 gangliosidosis. The company expects to announce the results of these programs by the end of this year.
In Q1 2021, Axovant enrolled Type II Juvenile patients for the low dose cohort of its AXO-AAV-GM1’s dose-escalation clinical trial. The company will initiate Type 1 (Infantile) GM1 treatment by the end of this year. Pavan further said the company will issue an update on its three clinical-stage programs soon.
To align with its governance and corporate structure, Axovant will continue corporate transformation with the existing and upcoming business activities. As part of this measure, the company will add more independent directors on its board besides incorporating a change in the company’s name by March 2021.
Axovant narrowed down its nets loss YoY to $8.6 million in Q1 2021. The company used $13.5 million for operational activities in Q1 2021. It holds cash equivalents and cash of $55.5 million by the end of Q1 2021.