Amarna Therapeutics and NorthX Biologics finalize agreement to advance Nimvec™ AM510 gene therapy toward clinical trials for type 1 diabetes

Amarna Therapeutics, a privately held biotechnology company pioneering transformative gene therapies, today announced the formalization of an agreement with NorthX Biologics, a leading biologics manufacturing partner, to accelerate the development of Nimvec™, Amarna’s next-generation gene therapy platform targeting immune-mediated diseases. This agreement builds on the strategic partnership announced last year, which initiated the transfer of Amarna’s research-scale production process for Nimvec™ AM510 to NorthX Biologics.

The initial focus remains on Type 1 Diabetes, where Nimvec™ AM510 is designed to restore immune tolerance to insulin-producing beta cells by targeting proinsulin. Proinsulin is the primary antigen that triggers the autoimmune attack on beta cells, so by restoring tolerance to it, the therapy aims to halt autoimmune destruction at its source. By combining Amarna’s proprietary Nimvec™ platform with NorthX Biologics’ world-class manufacturing expertise, the collaboration is laying the foundation for robust, scalable, and regulatory-compliant manufacturing processes to support future clinical trials.

Strengthening the path toward clinical readiness

Under the terms of the agreement, Amarna enables the transfer and optimization of Amarna’s research-scale production process for Nimvec™ AM510 to NorthX Biologics’ advanced development facilities. It includes a comprehensive analytical development package aimed at ensuring the identity, potency, and quality of the vector throughout its development lifecycle.

“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. “With this investment, we are accelerating our path to clinical trials and moving closer to providing a potential cure for Type 1 Diabetes. Collaborating with NorthX Biologics enables us to build a solid CMC foundation, ensuring we are well-prepared for the next phases of development. We’re eager to see our first clinical-grade batch produced.

A shared commitment to scalable innovation

This agreement underscores their shared mission to accelerate the development of scalable, high-quality gene therapies.
“We are proud to deepen our collaboration with Amarna and support the progression of Nimvec™ AM510,” said Dr. Janet Hoogstraate, CEO of NorthX Biologics. “Our combined expertise will help ensure the highest standards in process development and manufacturing as we advance this promising therapy.”

Looking ahead

This milestone paves the way for subsequent cGMP manufacturing activities to support First-in-Human (FiH) clinical studies, with Amarna targeting initiation of clinical trials in 2027. The partnership also establishes the framework to support the development and manufacturing of future Nimvec™-based therapies addressing other immune-mediated conditions including autoimmune diseases and chronic inflammatory disorders.

About T1D

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.

 About Nimvec™ AM510

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.

About Amarna Therapeutics

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.