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Will advance the clinical trial manufacturing of Nimvec AM510, Amarna’s gene therapy platform designed to transform the treatment of immune-mediated diseases.
December 4, 2024
By: Charlie Sternberg
Amarna Therapeutics, a privately held biotechnology company specializing in transformative gene therapies, has entered a strategic collaboration with NorthX Biologics, a biologics manufacturing partner, which aims to advance the clinical trial manufacturing of Nimvec AM510, Amarna’s gene therapy platform designed to transform the treatment of immune-mediated diseases. The collaboration will begin with the transfer of Amarna’s research-scale production process for Nimvec AM510 to NorthX Biologics, which will initiate the Chemistry, Manufacturing, and Controls (CMC) development process at NorthX, laying the groundwork for cGMP-compliant manufacturing to support First-in-Human (FiH) clinical trials. Together, the companies will focus on optimizing and scaling production processes to ensure high-quality, safe, and effective therapies for future clinical applications. This partnership highlights the shared commitment of Amarna Therapeutics and NorthX Biologics to advance innovative solutions in gene therapy. By combining Amarna’s Nimvec platform with NorthX’s expertise in biologics manufacturing, the collaboration aims to address unmet medical needs and set new standards for therapeutic development. “We are delighted to partner with NorthX Biologics, whose proven expertise in biologics manufacturing perfectly complements our vision of delivering transformative gene therapies,” said Henk Streefkerk, CEO of Amarna Therapeutics. “This collaboration is a pivotal milestone in bringing Nimvec AM510 closer to clinical application.” “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.
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