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Mendus AB, a trailblazer in the development of immunotherapies for cancer recurrence, has announced a ground-breaking partnership with NorthX Biologics AB, a leading Contract Development and Manufacturing Organization (CDMO). This alliance aims to establish a cell therapy manufacturing hub in Sweden, which will be crucial for the advanced development and commercial production of Mendus' flagship asset, vididencel.
The Alliance
Mendus and NorthX are set to co-establish cell therapy manufacturing capabilities in Sweden, a move set to propel forward late-stage development and commercial manufacturing of Mendus' primary asset, vididencel.
NorthX Biologics is a CDMO and serves as the Swedish National Innovation Hub for the GMP manufacture of biologics used in vaccines, gene therapy, and other advanced therapy medicinal products (ATMPs). Their expertise will be crucial in the development and production of vididencel.
Investment by Flerie
In addition to the collaboration with NorthX, Mendus has procured a deal with Flerie Invest AB, a top-tier Swedish investment firm. Flerie will initially invest SEK 90 million in Mendus to bolster the NorthX alliance. This funding will enable the establishment of a cell therapy facility for the mass production of vididencel. The proposed investment is slated to cover all necessary activities until Q2 2025.
Following the successful completion of the financing transaction, Flerie will join ranks with Van Herk Investments and the Fourth Swedish National Pension Fund (AP4) as a significant Mendus shareholder. Ted Fjallman, Chief Executive Officer at Flerie, is expected to join Mendus' Board of Directors, subject to shareholder approval.
Vididencel: A Promising Asset
Mendus boasts a rich pipeline of innovative cell-based immunotherapy product candidates aimed at delaying or preventing tumor recurrence, the leading cause of death among cancer patients today. Vididencel is currently being evaluated in the ADVANCE II Phase 2 clinical study in Acute Myeloid Leukemia (AML). The interim results demonstrate vididencel's potential to treat minimal residual disease, enhance the immune status of patients, and result in relapse-free and overall survival benefits.
Furthermore, Mendus is preparing to advance vididencel into late-stage and pivotal-stage development with a second Phase II in AML maintenance. This combination study with the standard of care is planned for H2 2023. Additionally, Mendus is assessing vididencel in ovarian cancer to expand the therapeutic strategy to the treatment of solid tumors.
Future Prospects
The alliance with NorthX and the investment from Flerie are part of a larger financing transaction of Mendus which will be announced through a separate press release. The successful execution of these plans is conditional upon approval by an Extraordinary General Meeting, expected to be held on July 10, 2023.
Voices from the Leadership
Erik Manting, PhD, Chief Executive Officer of Mendus, said, "Establishing large-scale manufacturing is a key element of our development strategy for vididencel. The alliance with NorthX, supported by an investment by Flerie, is a major step for Mendus as it brings together the required funding and the opportunity to establish a dedicated facility to manufacture vididencel."
Leopold Bertea, PhD, Chief Technology Officer of Mendus, added, "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."
About Mendus AB
Mendus is committed to changing the course of cancer treatment by addressing tumor recurrence and improving survival outcomes for cancer patients, while preserving quality of life. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST.
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 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.
About NorthX Biologics
NorthX Biologics is a CDMO and Innovation Hub in Advanced Biologics, with +30 years of GMP production experience. The team provides process development and GMP manufacturing services with expertise in plasmid DNA, mRNA, proteins, cells, and other advanced biologics. NorthX has the ambition to become a leading cell and gene therapy manufacturer and partner of choice for innovative drug development companies.