Amarna Therapeutics Partners with NorthX Biologics to Advance Gene Therapy Manufacturing

• Amarna Therapeutics has partnered with NorthX Biologics to advance the clinical trial manufacturing of its Nimvec AM510 gene therapy.

• The collaboration will focus on the transfer of Amarna’s research-scale production process to NorthX Biologics, aiming for cGMP-compliant manufacturing to support First-in-Human clinical trials.

Amarna Therapeutics, a biotechnology company focused on transformative gene therapies, has announced a strategic partnership with NorthX Biologics, a company focused on biologics manufacturing. The collaboration will facilitate the development of Nimvec AM510, a gene therapy designed to treat immune-mediated diseases, starting with transferring Amarna’s research-scale production process to NorthX.

The initial step will focus on initiating the Chemistry, Manufacturing, and Controls (CMC) development process at NorthX, ensuring the therapy’s production meets cGMP standards to support First-in-Human (FiH) clinical trials. Both companies will work closely to optimize the manufacturing process and scale production, ensuring high-quality and safe clinical supplies.

Henk Streefkerk, CEO of Amarna Therapeutics, commented, “We are delighted to partner with NorthX Biologics, whose proven expertise in biologics manufacturing perfectly complements our vision of delivering transformative gene therapies.”

Amarna’s Nimvec platform and NorthX’s world-class expertise in biologics manufacturing aim to offer a breakthrough in immune-mediated diseases, addressing unmet medical needs while setting new standards in therapeutic development.

”We are excited to collaborate with the Amarna team, allowing us to leverage NorthX Biologics’ expertise in viral vector manufacturing, to support the development of this pioneering gene therapy platform. Together, we aim to accelerate the journey of Nimvec™ AM510 toward providing life-changing treatments for patients in need,” said Janet Hoogstraate, CEO of NorthX Biologics.