Regenxbio, AbbVie close license and collaboration deal to develop RGX-314

Biotechnology firm Regenxbio and AbbVie have closed the previously announced license and collaboration deal for the development and commercialisation of the former’s gene therapy, RGX-314.

The new gene therapy is being assessed as a one-time treatment for patients with wet age-related macular degeneration (wet AMD), diabetic retinopathy as well as other chronic retinal diseases.

It includes the NAV AAV8 vector that encodes a monoclonal antibody fragment, which is intended to inhibit vascular endothelial growth factor (VEGF).

As per the terms of the deal announced on 13 September this year, Regenxbio will receive $370m of upfront payment from AbbVie and will also be eligible to receive an additional $1.38bn in development, regulatory and commercial milestones.

Additionally, the company will receive the tiered royalties on net sales of RGX-314 outside the US.

Under the partnership, Regenxbio and AbbVie have agreed to share the costs of additional studies as well as equally share profits from net sales of the drug in the US.

Regenxbio will be responsible for the drug manufacturing for clinical development and commercial supply in the US, while AbbVie will lead the clinical development and commercialisation of RGX-314 outside the US.

The biotechnology firm is advancing research to administer RGX-314 in two different routes to the eye, through a standardised subretinal delivery, and the suprachoroidal delivery.

Certain exclusive rights to the SCS Microinjector have been licensed by the company from Clearside Biomedical to provide gene therapy treatments to the suprachoroidal space of the eye.