Stockholm, Sweden, December 5, 2023
Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, today announced it will present the development of a robust, scaled up industrial process for vididencel supply at the Cell & Gene Therapy Manufacturing & Commercialization Conference held Dec 4-6 in Dublin.
Mendus Chief Technology Officer Leopold Bertea will chair the Cell Therapy Manufacturing & Analytics session on Dec 5 and present Mendus’ development work leading to an optimized manufacturing process suitable for large-scale production of vididencel, the Company’s lead product which is currently being developed as a novel cancer maintenance treatment in acute myeloid leukemia and ovarian cancer. Full implementation of the new process is the basis for the strategic vididencel manufacturing alliance with NorthX Biologics announced in June 2023, to provide the critical vididencel supplies required for late-stage clinical development and commercial launch readiness,
“The optimized manufacturing process for vididencel was developed thanks to Mendus’ strong in-house research and development capabilities. The cell line-based manufacturing process allows for scalable manufacturing of vididencel as an off-the-shelf product,” said Leopold Bertea, CTO at Mendus. “Establishing large-scale manufacturing, together with our partner NorthX Biologics is a key element to make vididencel available as a novel immunotherapy for cancer maintenance treatment to patients worldwide.”
Details of the conference
Cell & Gene Therapy Manufacturing & Commercialization Conference
Presentation title: Implementation of a Robust Industrial Manufacturing Process of an Allogeneic Cellular Immunotherapy for Cancer Maintenance Treatment
Date: December 5
Time: 11:40-12:15 CET
For more information, please contact:
Chief Executive Officer
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/
Vididencel is an off-the-shelf immunotherapy which is being developed as a cancer maintenance treatment, aimed at improving disease-free survival following first-line treatment. Vididencel is currently studied in a Phase 2 monotherapy trial in acute myeloid leukemia (AML) and a Phase 1 safety and feasibility trial in ovarian cancer. In December 2022, positive results from the ADVANCE II monotherapy Phase 2 trial in AML were presented at the American Society of Hematology (ASH) Annual Meeting. The analysis demonstrated the potential of vididencel to induce durable relapse-free survival in the majority of patients. Vididencel has received Orphan Drug Designation in Europe and the US and Fast Track Designation in the US for the treatment of AML. Mendus has secured a manufacturing alliance with NorthX Biologics for large-scale production of vididencel.