Amarna Therapeutics and NorthX Biologics Collaborate on Nimvec™ AM510 Gene Therapy

Amarna Therapeutics has announced a strategic collaboration with NorthX Biologics to advance the clinical trial manufacturing of Nimvec™ AM510, a novel gene therapy platform developed by Amarna. This partnership is a significant milestone for Amarna, a private biotechnology company specializing in innovative gene therapies for immune-mediated diseases.

The collaboration involves transferring Amarna’s research-scale production process for Nimvec™ AM510 to NorthX Biologics. This critical step marks the beginning of the Chemistry, Manufacturing, and Controls (CMC) development process at NorthX, positioning the partnership to establish a cGMP-compliant manufacturing process. This will support the First-in-Human (FiH) clinical trials of Nimvec™ AM510, with the goal of optimizing and scaling up production processes to ensure the delivery of high-quality, safe, and effective therapies for clinical applications.

The partnership underscores the shared vision of Amarna Therapeutics and NorthX Biologics in advancing pioneering solutions in gene therapy. By integrating Amarna’s innovative Nimvec™ platform with NorthX’s expertise in biologics manufacturing, the collaboration aims to address unmet medical needs and set new benchmarks in therapeutic development.

"We are thrilled to collaborate with NorthX Biologics, whose excellence in biologics manufacturing aligns perfectly with our goal of delivering transformative gene therapies," said Henk Streefkerk, CEO of Amarna Therapeutics. "This collaboration is a significant step toward bringing Nimvec™ AM510 closer to clinical application."

Janet Hoogstraate, CEO of NorthX Biologics, expressed similar enthusiasm about the partnership. "We are excited to work with the Amarna team, utilizing NorthX Biologics’ expertise in viral vector manufacturing to support the development of this groundbreaking gene therapy platform. Together, we aim to expedite the journey of Nimvec™ AM510 toward providing life-changing treatments for patients in need," she stated.

Looking forward, this partnership is poised to revolutionize gene therapy through scalable innovation. By combining their expertise, Amarna Therapeutics and NorthX Biologics plan to advance transformative therapies that improve patient outcomes and establish new standards in therapeutic development and manufacturing excellence. The collaboration also paves the way for producing batches for future products, thereby supporting the development of groundbreaking treatments yet to come.

**About T1D**
Type 1 Diabetes (T1D) is a chronic condition affecting millions worldwide, with increasing incidences each year. Despite therapeutic advancements, life expectancy for T1D patients remains lower than the general population. T1D is an autoimmune disease where self-reactive T lymphocytes destroy insulin-producing β cells in the pancreas, leading to an inability to maintain glucose homeostasis. Currently, T1D can only be managed with daily insulin injections, and secondary complications from this treatment can lead to significant morbidity and mortality. Amarna aims to use Nimvec™ AM510 to restore immune tolerance to insulin and potentially cure T1D patients.

**About Nimvec™ AM510**
AM510 is developed using Amarna’s proprietary Nimvec™ platform, which has shown exceptional promise in preclinical studies. Unlike other gene therapies that trigger strong immune responses, Nimvec™ moderates the immune system to induce tolerance, making it suitable for repeat dosing and effective therapy. Preclinical data indicates that Nimvec™ AM510 has protective effects, delaying the onset of hyperglycemia and preventing the development of T1D in relevant animal models.

**About Amarna Therapeutics**
Amarna Therapeutics leads the development of innovative immune-modulating gene therapies for rare and common autoimmune and genetic diseases. The company’s Nimvec™ platform is designed to provide transformative treatments, demonstrating significant promise in preclinical studies. Amarna is dedicated to pioneering therapies for Type 1 Diabetes Mellitus and improving patient outcomes.

**About NorthX Biologics**
NorthX Biologics is a leading biopharmaceutical contract development and manufacturing organization (CDMO) with expertise in producing cell and gene therapies, proteins, vaccines, and other advanced biologics. With two locations in Sweden and headquartered in Matfors, the team has been manufacturing biologics to GMP standards since 1992. Designated an innovation hub for advanced therapies and vaccines in 2021, NorthX aims to become a leading cell and gene therapy manufacturer and partner for innovative drug development companies.