- Amarna Therapeutics has formalised an agreement with NorthX Biologics to accelerate development of its Nimvec™ AM510 gene therapy platform.
- The collaboration will support the transfer, optimisation, and future cGMP manufacturing to enable clinical trials targeted for 2027.
Amarna Therapeutics has entered into a formal agreement with NorthX Biologics to support the continued development and manufacturing of Nimvec™ AM510, a gene therapy candidate aimed at treating Type 1 Diabetes (T1D). The agreement follows a previously announced strategic partnership between the two organisations, focused on advancing the Nimvec™ platform.
The agreement enables the transfer and optimisation of Amarna’s research-scale production process for Nimvec™ AM510 to NorthX Biologics’ advanced manufacturing facilities. This includes a comprehensive analytical development package to ensure vector identity, potency, and quality, forming a critical step in advancing the programme toward clinical readiness.
The lead therapeutic candidate, Nimvec™ AM510, is based on Amarna’s proprietary gene therapy platform. It is designed to restore immune tolerance to insulin-producing beta cells by targeting proinsulin, the antigen responsible for triggering the autoimmune response in T1D. By preventing beta cell destruction, the therapy aims to offer a potential cure for the disease.
“This agreement represents a major advancement in our partnership with NorthX Biologics and a critical step toward bringing Nimvec™ AM510 to patients,” said Dr. Henk Streefkerk, CEO of Amarna Therapeutics.
The agreement sets the foundation for cGMP manufacturing to support First-in-Human clinical trials, expected to begin in 2027. It also positions the partnership to expand the Nimvec™ platform for future therapies targeting other immune-mediated and chronic inflammatory conditions.
