Category: News

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 (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, today announces that it has entered into a manufacturing alliance with NorthX Biologics AB (“NorthX”). 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!

We are proud to inform you that NorthX Biologics improved its score from bronze to silver in the International Sustainability Survey (EcoVadis) for the year 2022. We have also implemented more routines and policies at our company to continuously improve the way we operate.

EcoVadis provides holistic sustainability rating services of companies. The rating covers a broad range of non-financial management systems including environmental, labor & human rights, ethics, and sustainable procurement impacts. NorthX has been rated on the material issues that are relevant to our company’s size, location, and industry.

It is important as a company to manage sustainability risks, and the Pharma industry is no exception. Our goal is to provide sustainable process development and manufacturing services at our company.

If we look closer at the environmental area, we have improved our preventive work such as decreasing our impact on the environment and the municipality’s treatment plant. We now know more about the characteristics of our wastewater and how to handle our hazardous waste which gives us a better chance to improve and become more sustainable.

In the ethics area, we also have improved our preventative work such as implementing policies on information security, ethics issues and corruption. It is important to us that we also have a sustainable production and use raw materials that have been ethically made.

It is also important for us to have good work health and equality. At NorthX we have good diversity, equity, and inclusion of all employees. It is important that our employees stay safe and healthy for a sustainable workplace. We do preventive workthrough risk assessment, information sharing, and education.

We thank all of our employees for the work they have done for this rating and look forward to continuing our improvements in these areas in order to progress in the survey.

Conference “Advanced Biologics in Matfors and Beyond” at NorthX Bio went to a big success!

During a two day conference, a number of key stakeholders from the Swedish and Danish ecosystem visited the Matfors site of NorthX Biologics. The highlight of the tour being the walk about in our GMP licenced facility for ATMP manufacturing as well as the brand new innovation area, delegates also valued the discussions as such. How important it is not least for the government to know we have such capacity on Swedish territory. Yet, from a business perspective of NorthX, the importance to reach beyond the Nordics to showcase how biotechs can use this capacity.  

As the conference was such a success, with a waiting list for those that we could not fit, we are already planning for a follow up! Stay tuned.

Xintela and NorthX Biologics announce that they have signed a collaborative framework agreement to jointly accelerate the development of advanced therapeutics (ATMP) by leveraging the companies’ complementary skills and resources in ATMP development and GMP manufacturing. Projects to be initiated within the framework of the collaboration include, among other things, product and process development, quality control and increased expansion capacity for manufacturing ATMPs.

“This is a very interesting opportunity for us. Xintela has developed the unique stem cell product XSTEM, which is now in clinical development, and has strong expertise in process development and GMP manufacturing of stem cells and other ATMPs. Together with NorthX Biologics and their manufacturing capacity, we can further expand and also broaden our ATMP business”, says Evy Lundgren-Åkerlund, CEO of Xintela.
“This collaboration is another step in the right direction towards becoming a leading solution provider in the cell and gene therapy space, adding to the solid expertise NorthX has already gained from +30 years of advanced biological GMP manufacturing. I am happy to work with Xintela and look forward to our relationship going forward,” says Helena Strigård, CEO of NorthX Biologics.

What: Seminar
Where: Klara Strand, Klarabergsviadukten 90, Stockholm
When: 19th October

We are organizing a seminar on “Drug development of Today and the Future” in collaboration with Abera Biosciences AB, Testa Center, RISE Research Institutes of Sweden, STUNS Life science and Business Sweden on the 19^th of October 2022. 

We are using this opportunity to invite you to participate to this event.

Be present to hear our own Eva-karin Gidlund and other eminent speakers engaged in the development of drugs talking about opportunities, problems and practical examples of the field where innovative ways of collaboration and new acquired skills were essential to surmount hurdles associated with our branch’s new demands.

The future is coming in fast, with it new challenges arise for all of us who are active in our industry. This seminar is intendent to be a platform for networking, exchange of ideas, best practices and possible solutions.

We eagerly await your participation in the seminar!

Preliminary program:

15:00 – Introduction
15:05 – Jesper Hedberg (Testa Center)
15:15 – Matti Sällberg (pre – GMP facillity)
15:25 – Eva-karin Gidlund (NorthX Biologics)
15:35 – Anna Ridderstad Wollberg (RISE)
15:45 – Coffee break
16:00 – Maria Alriksson (Abera Biosciences)
16:15 – Angelica Loskog (Lokon Pharma)
16:30 – Charlotte af Klercker & Britta Stenson (Business Sweden, followed by Q&A and discussions)
17:00 -19:00 – Mingle with snacks

Click here to register!