NorthX Biologics Innovation Hub supports Abera Bioscience with nasal pneumococcal vaccine

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.

BIO-Europe 2024

Join us at the upcoming event on November 4-6, 2024, in Stockholm, where NorthX Biologics will be actively participating with both a dedicated booth and as part of the prestigious Swedish Pavilion. This event is a prime opportunity to explore cutting-edge advancements in biotechnology and connect with industry leaders.

Don’t miss the chance to meet our team and discover how NorthX Biologics is driving the future of biopharmaceuticals. Visit our booth #170D for in-depth discussions and join us at the Swedish Pavilion to learn more about our groundbreaking projects. We look forward to seeing you there and forging new partnerships that will shape the future of healthcare.

Date: November 4-6, 2024
Location: Stockholmsmässan, Älvsjö, Sweden
Read more about the event here.

If you are interested in booking a meeting in advance, please fill out the form here.

NorthX Biologics strengthens leadership team with Magnus Gustafsson as Chief Commercial Officer

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 and NorthX Biologics enter into new strategic manufacturing alliance

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 and NorthX Biologics sign manufacturing alliance

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.

NorthX Biologics AB introduces proprietary AAV plasmids, bolstering comprehensive gene therapy support

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.

During 27-28 september over hundred frontrunners within advanced biologics were gathered at our first-class manufacturing site in Matfors.

More than a hundred advanced biologics frontrunners gathered at our first-class manufacturing site in Matfors

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.

During 27-28 september over hundred frontrunners within advanced biologics were gathered at our first-class manufacturing site in Matfors.
NorthX Biologics AB inviger Innovationshub vid tillverkningsenheten i Matfors

NorthX Biologics AB announces inauguration of Innovation Hub at Matfors facility

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.

NorthX Biologics Welcomes Dr Janet Hoogstraate as New CEO Following Merger with Valneva Clinical Trials Manufacturing Unit

NorthX Biologics welcomes Dr Janet Hoogstraate as new CEO following merger with Valneva Clinical Trials Manufacturing unit

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:

Come meet us at BioProcessing 2023!

We will be attending BioProcessing Summit 2023 and would love to meet. Contact us to book a meeting!

Celebrating its fifteenth year, The Bioprocessing Summit is a premier global forum for industry leaders to share the latest developments in bioprocess R&D, scale-up, quality and analytics. This year’s programming comprises more in-depth content than ever before, showcasing 8 topic-focused streams, 14 conference tracks, interactive sessions, panel discussions, training seminars, research posters, and so much more.