Author: Martina Ferneman

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.

Lipum AB (Publ), a clinical stage biopharmaceutical company specialized in discovery and development of a novel treatment for chronic inflammatory diseases today announces that
it has entered into a manufacturing alliance with NorthX Biologics AB, a Contract Development and Manufacturing Organisation (CDMO).

Under this agreement NorthX will manufacture Lipum´s lead asset, SOL-116, a humanized antibody, for use in a phase II clinical trial. SOL-116 is transferred from the current manufacturer to NorthX which will lead to cost and time savings with high quality.

Ola Sandborgh, CEO of Lipum said “We are delighted to be partnering with NorthX and it represents an important step as we move forward into our phase II trial. NorthX´s capabilities are a great fit and provide a cost effective one-stop-shop for both drug substance and sterile fill finish drug product. I am very much looking forward to the collaboration and bringing this therapy a step closer to patients”. Janet Hoogstraate, CEO of NorthX Biologics added “We are excited to be working on SOL-116 and look forward to adding our expertise and experience in the GMP manufacture of advanced biologics to the ultimate benefit of patients”.

Press Release Download here

Synerkine Pharma, a Dutch biopharmaceutical company creating innovative pain solutions, today announced a manufacturing alliance with NorthX Biologics AB, a leading biopharmaceutical company committed to pioneering solutions in gene therapy and biotechnology. The alliance will support Synerkine’s development portfolio, including its most advanced program SK-01, a cytokine-cytokine fusion protein combining the effects of IL-4 and IL-10 as a treatment option for chronic pain. SK-01 is progressing steadily toward clinical development with complex regional pain syndrome (CRPS), a severe chronic pain indication, as the lead indication.

An increased understanding of cytokine biology combined with new bioengineering approaches have unlocked a growing sector of engineered cytokine therapeutics, with cytokine-cytokine fusion being considered a new frontier. Synerkine’s cytokine fusion molecules retain the ability to activate the individual cytokine receptors and mediate the clustering of receptor complexes normally not interacting in proximity. The clustering activates unique gene transcription patterns and a fundamentally different, often increased, response compared to the one achieved via co-application of the respective individual cytokines.

“Establishing a robust manufacturing process is a crucial step in the development process of every biologic molecule. As we continue to advance SK-01 toward clinical trials, the timing is right to ramp up our process development and GMP manufacturing efforts. The alliance with NorthX Biologics allows us to combine our expertise in cytokine biology with NorthX extensive resources to get our first product candidate to an IND-ready stage,” commented Hans Preusting, PhD, Chief Executive Officer of Synerkine Pharma.

“Synerkine’s novel approach in pain medicine is crucially needed, and we are excited to partner with them on the important transition from preclinical to clinical development stage. We see huge potential in the programs that Synerkine aims to develop and are ideally positioned to support companies like them in this phase of the product development cycle due to our focus on the manufacturing of advanced biologics,” commented Janet Hoogstraate, Chief Executive Officer of NorthX Biologics.

About Synerkine Pharma

Synerkine Pharma B.V. focuses on the development of novel fusion proteins, called Synerkines, that combine the immunoregulatory activity of different cytokines. These fusion proteins have unique benefits over the individual cytokines and modulate a broad number of targets, including key elements in the pain pathway. This provides treatment options for chronic pain conditions with a clearly differentiated mechanism of action over current analgesic drugs and holds tremendous therapeutic and commercial potential. Synerkine Pharma B.V. was founded in 2018 as a spin-off of the University Medical Center Utrecht (UMCU), the Netherlands.

NorthX Biologics AB, a pioneer in biopharmaceutical innovation, is excited to announce the launch of its proprietary plasmids for the efficient manufacture of AAV (Adeno-Associated Virus) vectors for gene therapy. This strategic expansion complements NorthX’s existing GMP and non-GMP plasmid and viral vector production capabilities, allowing the company to offer end-to-end support to gene therapy companies, from sequence design to the final release of AAV gene therapy product.

NorthX’s new proprietary AAV plasmids represent a significant extension of NorthX service offering within gene therapy. The company’s commitment to innovation and excellence is evident in this new offering, which is designed to streamline the production process and accelerate the development of life-changing therapies.

In addition to the proprietary AAV plasmids, NorthX Biologics AB has recently acquired a viral vector manufacturing site in Stockholm, further enhancing its capabilities in the gene therapy space. This acquisition allows NorthX to provide a seamless offering, from sequence design to the final fill of gene therapy products utilizing AAV technology, all under one roof.

“At NorthX Biologics AB, we are dedicated to the development of more efficient and cost-effective manufacturing options for advanced therapies,” said Ola Tuvesson, Chief Technology Officer at NorthX Biologics AB. “The launch of our proprietary AAV plasmids and the acquisition of the viral vector manufacturing site in Stockholm represent significant milestones in our mission to support the development of transformative gene therapies. We are excited to partner with gene therapy companies on their journey from concept to commercialization.”

NorthX Biologics AB is committed to driving innovation in biopharmaceuticals, and this latest development underscores the company’s dedication to advancing gene therapy solutions. The proprietary AAV plasmids will play a crucial role in accelerating the development of AAV-based gene therapies and addressing unmet medical needs.

The future of advanced biologics

On 26-28 September NorthX successfully arranged the conference ”the future of advanced biologics” where over 100 front-runners from the life science field were invited to participate in workshops, dinners, networking, talks and panel-sessions. Some the most prominent attendees were representatives from BioNtech, Moderna and Cytiva (to name a few).

During the conference minster Ebba Busch inaugurated our new innovation hub which have taken over 20 months to build. The hub partly funded by Swedish Vinnova will be a huge step forward in our mission to drive innovation and novel type of research to ultimately bring life saving therapies to patients.

Matfors, Sweden (September 28 2023)

NorthX Biologics AB (“NorthX”) is proud to announce the official inauguration of its state-of-the-art Innovation Hub at the Matfors facility. This significant milestone marks a major step forward in NorthX’s commitment to the field of advanced therapies in Sweden. The Innovation Hub, co-funded by the Swedish Government, is poised to enhance the country’s infrastructure for cutting-edge therapies and accelerate innovation in the biopharmaceutical sector.

The Innovation Hub represents NorthX’s dedication to pushing the boundaries of biotechnology by fostering collaboration, research, and development in advanced therapies. With a focus on manufacturing of advanced biologics including Vaccine, Cell and Gene therapies, the Innovation Hub is set to become a catalyst for breakthroughs in medical science. This facility supplements NorthX’s existing expertise in Plasmid and Protein manufacturing by adding mRNA services, reinforcing the company’s position as a comprehensive solution provider in the biopharmaceutical industry.

NorthX has experienced rapid growth, expanding its portfolio to encompass a wide range of services that cater to the evolving needs of the industry. The addition of the Matfors Innovation Hub, combined with the recent acquisition of a site in Stockholm, with state-of-the-art facilities and expertise for GMP biomanufacturing through mammalian cell culture processes, further solidifies NorthX’s commitment to advancing life-changing therapies.

“We are thrilled to unveil the Innovation Hub at our Matfors facility and it represents our dedication to driving innovation and progress in the field of biopharmaceuticals” said Janet Hoogstraate, CEO of NorthX Biologics AB. “This hub stands as a testament to the collaborative efforts of NorthX and the Swedish Government, as well as our ongoing commitment to providing cutting-edge solutions to our partners and clients for bringing new therapies to patients.”

NorthX Biologics AB extends its gratitude to all stakeholders, partners, and employees who have contributed to the realization of the Innovation Hub. The facility represents a shared vision of advancing science and medicine to improve the lives of patients worldwide.

We are announcing the appointment of a new CEO Dr. Janet Hoogstraate. Janet is a distinguished leader within the biopharmaceutical sector and this move follows the company’s strategic merger with Valneva Sweden’s Clinical Trial Manufacturing Unit.

Janet will succeed Helena Strigård who in a short time navigated NorthX through several important milestones, including global promotion of NorthX’ services and the recent merger.

Press release here: