Action required: Please refresh your browser
We have recently implemented some changes that require a hard refresh of your browser: Please hold down the CTRL-key and press the F5 key.
After a successful hard refresh, this message should not appear anymore.
More details about this topic are available here »
Mendus provides business update and outlook for vididencel program | ||
By: GlobeNewswire - 12 Mar 2024 | Back to overview list |
|
Press Release Stockholm, Sweden, March 12, 2024
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: About Mendus AB (publ)
Attachment |
||
|
||
Copyright 2024 GlobeNewswire | Back to overview list |