Category: News

Amarna Therapeutics, a privately held biotechnology company specializing in transformative gene therapies, is pleased to announce 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.

A shared vision for transformative gene therapy

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.

Looking ahead

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.

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. More information on www.amarnatherapeutics.com

Neogap Therapeutics, a Swedish clinical-stage biotechnology company, has entered a strategic collaboration with NorthX Biologics, a leading CDMO, to advance manufacturing strategies for Neogap’s personalised cancer cell therapy. Supported by ongoing funding from the European Innovation Council (EIC) Accelerator, the partnership aims to optimise and scale production for future clinical trials.

Neogap Therapeutics develops pTTL (personalised Tumour Trained Lymphocytes), a cell therapy designed to treat solid tumours by training the immune system to recognise and attack cancer cells through the patient’s unique neoantigens. Currently, pTTL is under evaluation in a Phase I/II clinical trial focused on assessing its safety and tolerability in patients with advanced colorectal cancer.

The collaboration, carried out within the framework of the EIC Accelerator program, aims to establish a robust, cost-effective production setup that enhances both productivity and scalability.

The project includes a comprehensive analysis of Neogap’s manufacturing protocols, with a focus on scale-out strategies and GMP process industrialisation to support large-scale clinical trials and eventual commercialisation. The goal is to implement streamlined production processes and logistics, increasing resilience and cost-effectiveness as Neogap progresses toward broader clinical applications and greater patient access.

Samuel Svensson, CEO of Neogap Therapeutics, comments: “Partnering with NorthX Biologics is an important step in preparing our therapy for future trials beyond the current Phase 1 study. Establishing a reliable and cost-effective manufacturing process is key to our clinical and commercial goals. We’re excited for our team to work closely with NorthX’s experts, combining our strengths to develop a scalable solution that will allow us to treat a larger patient population as we advance.”

Janet Hoogstraate, CEO of NorthX Biologics, comments: “At NorthX Biologics, we are proud to be ‘beyond CDMO’ – a proactive partner that actively contributes to the development of future medicines by collaborating with innovative companies like Neogap Therapeutics. Through our close partnership, we leverage our expertise and Innovation Hub to support at every stage, from initial concept to scalable production of pioneering cell therapies. Together, we are driving groundbreaking innovations forward to improve patients’ lives around the world.”

About Neogap Therapeutics
Neogap Therapeutics is a Swedish clinical-stage biotechnology company focused on developing personalised cancer immunotherapy using patient’s own cells. The therapy is based on the company’s two technologies PIOR® and EpiTCer®. PIOR® is sophisticated software that uses DNA sequencing data from the patient and machine learning algorithms to select tumour-specific mutations. EpiTCer® is used to multiply T cells that can recognise and attack the selected tumor-specific targets. Neogap is located at the Cancer Center Karolinska in Stockholm. To learn more about Neogap and its cutting-edge research, please visit the company’s website at neogap.se and follow Neogap on LinkedIn.

Project reference number: 190185439 – NEOpTTL

Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or EISMEA. Neither the European Union nor the granting authority can be held responsible for them.

Abera Bioscience AB (“Abera” or “the Company”) has been awarded a 1 million SEK grant from Vinnova to advance the development of its innovative pneumococcal vaccine, Ab-01.12, towards clinical trials. The vaccine, which is based on the Abera’s OMV platform, is administered as a nasal spray and designed to provide broad protection against all bacterial strains, preventing both disease and transmission.

Abera received the maximum grant under Vinnova’s call for proposals, “Utilize infrastructures to develop precision medicine.” Abera’s project, “Production development of a new nasal vaccine against pneumonia,” aims to ensure a verified GMP compatible production process for the vaccine and validate analysis methods for the material. These are critical final steps in the production development, resulting in the vaccine candidate being ready for GMP (Good Manufacturing Practices) production and use in clinical studies. The data generated in this project will be essential for the upcoming regulatory application to initiate clinical trials and will be crucial for advancing to the next stage of development.

“We are honored and grateful for the support from Vinnova, which takes us an important step closer to clinical Phase 1. As previously communicated, our goal is to finance the development of this candidate in a way that is favorable for our shareholders and to not initiate activities without secured funding. This grant moves us forward and reduces our funding needs for the next stage of development. This vaccine candidate has the potential to revolutionize the vaccine industry as it is administered as a nasal spray, providing protection where the bacteria first enter the body—at the nasal mucosa. Through this novel mechanism of action, it protects against both infection and transmission. Combined with broad protection against all bacterial variants and low production costs, this is a truly unique product that could save millions of lives,” says Maria Alriksson, CEO of Abera Bioscience.

Ab-01.12 is a universal vaccine candidate against pneumococcal infections, administered as a nasal spray. Pneumococci are bacteria that cause infections such as pneumonia, sepsis, meningitis, and ear infections. Severe pneumococcal infections primarily affect children and the elderly, causing approximately 1.5 million deaths annually and millions of hospitalizations, placing a significant burden on healthcare systems and society. The bacteria exist in about 100 variants, and current vaccines protect against only 13-23 specific variants. Ab-01.12 is based on a new technology, designed to protect against all bacterial variants.

The Vinnova grant will co-finance the project “Production development of a new nasal vaccine against pneumonia,” which starts in October 2024 and will be completed by April 2025 at the latest. The grant covers a maximum of 1 million SEK, with 800,000 SEK to be disbursed in 2024 and the remaining amount in 2025. The majority of the funding will be used for activities at NorthX Biologics and their Innovation Hub for vaccine development, while a smaller portion will be allocated to personnel costs at Abera. The project must follow the submitted project plan and report according to Vinnova’s regulations, which include a start report and a final report. The company must be able to demonstrate incurred costs according to the project plan. If the company does not meet the above requirements, Vinnova may demand repayment.

Biopharmaceutical contract development and manufacturing organization (CDMO) NorthX Biologics, is pleased to announce the appointment of Magnus Gustafsson as Chief Commercial Officer (CCO).

Magnus brings an exceptional wealth of experience from global roles across the pharma, biotech and CDMO industries. His proven expertise in building and leading commercial teams will be vital as NorthX expands its reach, particularly in new markets like North America.

Magnus holds an MSc in biotechnology from the Royal Institute of Technology, a PhD in Medical Biochemistry and Biophysics from Karolinska Institute and an MBA from Stockholm Business School.

Janet Hoogstraate, CEO NorthX Biologics comments: “I am delighted to welcome Magnus to the team as we continue our growth journey. His impressive credentials and experience will be invaluable to both the leadership team and the business.”

Magnus Gustafsson adds: “NorthX Biologics offers an impressive range of services, from microbial and mammalian recombinant proteins to viral products, mRNA, plasmids, cell therapy, and exosomes. The company’s reputation as a trusted partner, with satisfied clients and expert staff, makes it an exciting time to join. I look forward to working with the team to support our clients in delivering life-changing therapies to patients worldwide.”

Media inquiries 
Please contact Janet Hoogstraate, CEO, janet.hoogstraate@nxbio.com

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

Leiden, The Netherlands – February 19, 2024 – 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.

MATFORS, Sweden, Nov. 01, 2023 (GLOBE NEWSWIRE)

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.

Event summary: 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: