Amarna Therapeutics Partners With NorthX Biologics to Advance Gene Therapy Development

Amarna Therapeutics recently announced its strategic collaboration with NorthX Biologics, a leading biologics manufacturing partner. This partnership represents a major step in advancing the clinical trial manufacturing of Nimvec™ AM510, Amarna’s groundbreaking 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. This critical step initiates 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 cutting-edge Nimvec platform with NorthX’s world-class 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.

This partnership embodies a shared vision to revolutionize gene therapy through scalable innovation. By uniting their expertise, Amarna Therapeutics and NorthX Biologics are set to advance transformative therapies that enhance patient outcomes while establishing new standards in therapeutic development and manufacturing excellence. Additionally, this collaboration enables the production of batches for future products, supporting the development of groundbreaking treatments yet to come.

T1D is a debilitating disease occurring in millions of patients globally, with rising incidences each year, where despite advancements in therapy the life expectancy remains lower than the general population. Diabetes is an autoimmune disease where self-reactive T lymphocytes selectively attack and destroy insulin-producing β cells lodged within the pancreas, leaving the patient unable to maintain glucose homeostasis. To date, T1D cannot be cured, and glucose homeostasis can only be maintained using daily insulin injections. In addition, secondary complications of the current therapy are considerable and can lead to significant morbidity and mortality. Using Nimvec AM510 Amarna intends to restore the immune tolerance to insulin and potentially cure the patients.
 
The development of AM510 is based on our proprietary Nimvec platform, which has demonstrated exceptional promise in preclinical studies. Unlike other gene therapies that induce a strong immune response, limiting the possibility for repeat dosing and efficacy, Nimvec does not trigger such immune responses. Instead, it moderates the immune system to induce tolerance, making it an ideal vehicle for our therapeutic approach. Our preclinical data with Nimvec AM510 showcases its protective effects in delaying the onset of hyperglycemia and preventing the development of T1DM in relevant animal models.

Amarna Therapeutics is at the forefront of developing groundbreaking immune-modulating gene therapies for rare and prevalent autoimmune diseases and genetic diseases. The company’s proprietary Nimvec platform is designed to deliver transformative treatments with exceptional promise in preclinical studies. Amarna is committed to pioneering treatments for Type 1 Diabetes Mellitus and enhancing patient outcomes.

NorthX Biologics, a leading biopharmaceutical contract development and manufacturing organization (CDMO), has expertise in producing cell and gene therapies, proteins, vaccines, other advanced biologics. With two sites in Sweden and headquartered in Matfors, the team has been manufacturing biologics to GMP standards since 1992. In 2021 NorthX was designated an innovation hub for advanced therapies and vaccines and has the ambition to become a leading cell and gene therapy manufacturer and partner for innovative drug development companies. For more information, visit www.amarnatherapeutics.com; www.nxbio.com.