Press Release
Stockholm, Sweden, March 12, 2024
- ADVANCE II Phase 2 trial data provide basis for late-stage development of lead product vididencel in acute myeloid leukemia
- Registration trial preparations are ongoing, following positive initial FDA feedback on main questions related to late-stage clinical development and large-scale manufacturing
- Manufacturing alliance with NorthX Biologics on track, with production facility installed and tech transfer process for large-scale GMP manufacturing of vididencel initiated
- Collaboration with ALLG to study vididencel in combination with oral azacitidine progressing according to earlier guidance, with AMLM22-CADENCE trial expected to start patient enrolment in April 2024
- Live Business Update event to be held today, March 12, 15.00-17.00 CET
Mendus AB ("Mendus" publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, announces a business update and outlook for the development of its lead product vididencel in acute myeloid leukemia (AML) during a live investor event to be held today, March 12, 15.00-17.00 CET.
Vididencel is developed as an AML maintenance therapy, addressing the high medical need to prolong disease-free and overall survival following initial chemotherapy. Mendus presented positive survival data from the ADVANCE II Phase 2 clinical trial at the annual meeting of the American Society for Hematology (ASH) in December 2023, demonstrating durable clinical remissions associated with broad immune responses following vididencel treatment in the majority of patients.
Mendus has entered into a collaboration with the Australian Leukemia and Lymphoma Group (ALLG), a world-leading group in clinical research for blood-borne tumors, to expand the clinical development of vididencel. The collaboration will support a multicenter, randomized controlled trial of vididencel in combination with oral azacitidine, currently the only approved AML maintenance drug. The collaboration is on track and recruitment for the AMLM22-CADENCE trial is expected to commence in April 2024.
Mendus is preparing for a global registration strategy of vididencel as a novel AML maintenance treatment. Mendus received positive feedback from the US FDA regarding the main topics related to late-stage clinical development of vididencel in AML, including the proposed steps towards large-scale manufacturing.
Mendus has secured a manufacturing alliance with NorthX Biologics, a specialized Nordic cell and gene therapy custom manufacturing organization. The alliance has successfully completed the installation of the vididencel production facility and has started the implementation phase of the technology transfer from Mendus to NorthX.
"The positive ADVANCE II data provide us with a unique opportunity to develop vididencel in AML," said Erik Manting, CEO of Mendus. "Initial big steps have been taken in the collaborations with ALLG and NorthX Biologics and we are encouraged by the positive FDA feedback on the main topics related to late-stage clinical development and large-scale manufacturing of vididencel. The potential large impact of vididencel as a novel maintenance treatment option for AML patients is what drives us in preparing for a global registration strategy."
In-person and live-streamed business update event in Stockholm on March 12, 15.00-17.00 CET
Mendus will host a business update event later today to present the next steps in the development of vididencel as a promising new maintenance treatment option for AML patients, together with its strategic partners ALLG and NorthX Biologics.
Venue: Inderes Event Studio (Västra Trädgårdsgatan 19, Stockholm)
Date and time: March 12 at 15.00-17.00 CET, registration is open from 14.30
Please register to attend via email to ir@mendus.com
Those unable to attend in person can listen to the presentation webcast: https://ir.financialhearings.com/mendus-business-update-march-2024
For more information, please contact:
Erik Manting
Chief Executive Officer
E-mail: ir@mendus.com
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. https://www.mendus.com/
