Category: News

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:

NorthX Biologics, a leading Nordic development and manufacturing organisation announces acquisition of a biologics manufacturing unit from Valneva

MATFORS, Sweden, July 03, 2023 (GLOBE NEWSWIRE)

NorthX Biologics (‘NorthX’), a leading Nordic development and manufacturing organisation with a focus on advanced biologics, CGT (cell and gene therapy) and vaccines, announced today the successful acquisition of the Stockholm-based Clinical Trial Manufacturing unit from Valneva Sweden, significantly expanding capabilities.

The acquisition includes the transfer of a multi-purpose facility, situated in the Stockholm life science cluster, close to Karolinska University Hospital. In addition, 30 staff members who currently operate the facility will also join NorthX. The site and staff have a long history with extensive experience of serving both Valneva internally and also working with external customers on a contract development and manufacturing basis. With expertise in mammalian expression systems and viral vectors, the capabilities complement those of NorthX’s existing business of advanced microbial based manufacturing of proteins and plasmid DNA. The acquired unit excels in process development, scale up, GMP production, quality control analytics, and quality assurance/release and is capable of working with Biosafety Level (BSL) 2/2+ and BSL 3 organisms. With this expansion, NorthX enhances its capabilities and can offer comprehensive services to a wider range of clients globally.

Janet Hoogstraate, currently Managing Director of Valneva Sweden, will join the NorthX team. She commented, “I am very proud when looking back at what we have achieved within the unit over the past years and look forward with great enthusiasm to build on NorthX’s position as the go-to manufacturer of advanced biologics in Northern Europe.”

Helena Strigård, CEO of NorthX, said, “We are delighted to join forces with our new colleagues in Stockholm to bring new innovative treatments to tomorrow’s patients.”

Thomas Eldered, Chairman of NorthX, commented, “This strategic move marks a significant milestone in our growth journey and strengthens NorthX as Sweden’s Innovation Hub. We are now able to work with ATMPs and advanced biologics, including process development and manufacture for clinical trials and commercial requirements.”

A new DNA-based vaccine against covid-19 is being tested for the first time on healthy participants at Karolinska University Hospital. The vaccine has been developed at Karolinska Institutet and target multiple parts of the virus, making it less vulnerable to mutated strains and potentially effective against new variants.

“This vaccine makes the immune system’s reaction more similar to what it looks like in the event of a real infection compared to today’s vaccines. We hope that it will produce a broader immune response, which can be helpful for people who have difficulty forming antibodies due to, for example, being on dialysis or taking drugs that are immunosuppressive,” says Matti Sällberg, Professor in Biomedical Analysis at at Karolinska Institutet.

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Mendus AB, a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, today announces that it has entered into a manufacturing alliance with NorthX Biologics AB. NorthX is a Contract Development and Manufacturing Organization (CDMO) and serves as the National Swedish Innovation Hub for the GMP manufacture of biologics used in vaccines, gene therapy and other advanced therapy medicinal products (ATMPs). Mendus and NorthX will co-establish cell therapy manufacturing capabilities in Sweden, which will be used for late-stage development and commercial manufacturing of Mendus’ lead asset vididencel.

In conjunction with the NorthX collaboration, Mendus has entered into an agreement with Flerie Invest AB (“Flerie”), a leading Swedish investment firm. Flerie will initially invest SEK 90 million in Mendus to support the NorthX alliance. With the investment, Mendus and NorthX will collaborate to realize a cell therapy facility to be used for the large-scale manufacturing of Mendus’ lead program vididencel. The planned investment is scheduled to cover all necessary activities until Q2 2025, including adjustments to current NorthX facilities, tech transfer of the vididencel manufacturing process and manufacturing of vididencel batches for a pivotal-stage clinical trial. Following the successful completion of the financing transaction, Flerie will join Van Herk Investments and the Fourth Swedish National Pension Fund (AP4) as a major Mendus shareholder. Ted Fjällman, Chief Executive Officer at Flerie, is expected to join Mendus’ Board of Directors, subject to shareholder approval. The collaboration with NorthX and the investment by Flerie are part of a larger financing transaction of Mendus, which will be announced through a separate press release, and is conditional upon approval by an Extraordinary General Meeting, expected to be held on July 10, 2023.

Mendus has established a rich pipeline of innovative cell-based immunotherapy product candidates focused on delaying or preventing tumor recurrence, the main cause of death of cancer patients today. Vididencel is currently being evaluated in the ADVANCE II Phase 2 clinical study in Acute Myeloid Leukemia (AML) with patients in long-term follow up. Interim results on the primary and secondary endpoints of the study have demonstrated vididencel’s potential to treat minimal residual disease, improve the immune status of patients, and result in relapse-free and overall survival benefits. The company is preparing to advance vididencel into late-stage and pivotal-stage development with a second Phase II in AML maintenance, a combination study with standard of care, planned for H2 2023. In addition to hematological malignancies, Mendus is evaluating vididencel in ovarian cancer to translate the therapeutic strategy into the treatment of solid tumors.

“Establishing large-scale manufacturing is a key element of our development strategy for vididencel. The alliance with NorthX as Sweden’s emerging center of excellence for manufacturing of this drug class, supported by an investment by Flerie, is a major step for Mendus in this regard, as it brings together the required funding and the opportunity to establish a dedicated facility to manufacture vididencel for the next stage of clinical development and, eventually, commercialization,” commented Erik Manting, PhD, Chief Executive Officer of Mendus.

“Visiting the team on-site showed that NorthX uniquely combines innovation in process development and the industrial know-how to scale-up GMP manufacturing of ATMPs. This is key for the stage we are now entering for the large-scale manufacturing of vididencel. Additionally, Flerie’s active ownership model and their team’s operational experience having built Recipharm will be invaluable to us, as is the commitment and support from the Swedish government to build up world-class manufacturing expertise in the country,” said Leopold Bertea, PhD, Chief Technology Officer of Mendus.

“This strategic alliance not only paves Mendus’ path to commercializing vididencel for the benefit of cancer patients, but ensures NorthX strenghtens its positioning as the premier GMP manufacturing hub for advanced therapies in the Nordics, attracting regenerative medicine innovators worldwide. We are proud to be working with Mendus to hone both teams’ skills in this rapidly developing area of cell therapies,” said Helena Strigård, Chief Executive Officer of NorthX.

“Mendus’ approach to develop vididencel as a cancer maintenance therapy has the potential to prolong survival for many patients, based on an impressive doubling of median overall survival compared to the current standard of care in the most recent Phase 2 read-out in AML. The Mendus team has correctly focused on the science and good clinical trial design, and we are now happy to join very competent investors Van Herk and AP4 to help Mendus scale manufacturing together with NorthX and translate their cutting edge oncology, vaccine and cell therapy competence into products available to patients worldwide,” commented Ted Fjällman, Chief Executive Officer at Flerie.

ABOUT MENDUS AB (PUBL)

Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving survival outcomes for cancer patients, while preserving quality of life. We are leveraging our unparalleled expertise in allogeneic dendritic cell biology to develop an advanced clinical pipeline of novel, off-the-shelf, cell-based immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. http://www.mendus.com/

ABOUT FLERIE

Flerie is an active long-term global biotech and pharma investor based in Stockholm and London managing a portfolio of over 30 companies in Europe, Israel and the US. Flerie’s evergreen investment strategy, operational expertise and network enables pioneering technologies in the drug development and services space to advance on their path to treating patients and commercialisation. Flerie was founded in 2011 by Thomas Eldered, who also co-founded and built Recipharm to be one of the world’s top five pharmaceutical contract manufacturers. For more information, please visit www.flerie.com.

NorthX Biologics is proud to have the opportunity to support and be a part of AdBIOPRO. “It is a great infrastructure for ground breaking research and development aimed at finding solutions to some of the manufacturing challenges that need a resolution in order to bring advanced therapies to the patients at an affordable cost,” says Ola Tuvesson CTO at NorthX Biologics and member of the AdBIOPRO Centre Board.

Link to the press release: https://www.kth.se/adbiopro/news/adbiopro-competence-centre-for-advanced-bioproduction-secures-112-mkr-funding-1.1252385

Now you can read the exciting article about the innovation factory on Dagens Industri.

The digital link can be found here!