Mendus Expands Vididencel Clinical Strategy Across AML Risk Categories and Into Chronic Myeloid Leukemia
核心洞察
Mendus reports unprecedented long-term survival data from the ADVANCE II Phase 2a trial, with 13 of 20 high-risk AML patients remaining alive at 48 months median follow-up and five patients surpassing 5-year survival.
The company is accelerating recruitment in the randomized Phase 2b CADENCE trial combining vididencel with oral azacitidine and preparing a Phase 1b trial for AML patients unfit for intensive chemotherapy.
Mendus announces expansion into chronic myeloid leukemia (CML) with plans for Phase 1a/1b and Phase 2a trials aimed at improving treatment-free remission rates.
Mendus AB (搜索) has announced a significant expansion of its clinical development strategy for vididencel, its lead immunotherapy product, following continued positive data in acute myeloid leukemia (AML) and the recent appointment of Tariq Mughal as Chief Medical Officer. The Swedish biopharmaceutical company is broadening vididencel's development across all AML risk categories and entering chronic myeloid leukemia (CML) as a second blood cancer indication.
Unprecedented Long-Term Survival Data in High-Risk AML
The company continues to report exceptional survival outcomes from its pivotal Phase 2a ADVANCE II trial in high-risk AML patients with measurable residual disease (MRD). At a median follow-up of 48 months, 13 of 20 patients remain alive, with five patients having surpassed 5-year survival. These results demonstrate vididencel's mechanism as an active immunotherapy capable of inducing durable remissions.
"Rather than focusing on a limited patient population, our updated late-stage clinical development strategy in AML addresses the full spectrum of post-remission therapy in AML," said Chief Medical Officer Prof Tariq Mughal. "As an immunotherapy, vididencel acts across different subtypes of AML and independent of specific AML mutations."
The ADVANCE II data, presented at multiple conferences including the European Hematology Association Congress, confirms that vididencel functions as a mutation-agnostic immunotherapy, supporting broad positioning as post-clinical remission therapy regardless of specific mutations.
Accelerated Clinical Development Program
Mendus is actively recruiting patients in the randomized Phase 2b AMLM22-CADENCE trial, which combines vididencel with oral azacitidine in both MRD-positive and MRD-negative patients following high-intensity chemotherapy. The trial, supported by the Australasian Leukaemia and Lymphoma Group (搜索), has enrolled 12 patients since February 2025, with a goal of 20 patients by Q1 2026.
Additionally, the company has prepared a Phase 1b trial involving 24 patients to evaluate vididencel post-remission in AML patients unfit for intensive chemotherapy. This trial follows promising preclinical data showing synergy with azacitidine and venetoclax (aza+ven) presented at the ASH 2024 conference. The trial will be led by Prof Andrew Wei, who also serves as a lead investigator for the CADENCE study.
Initial topline data from both trials are expected mid-2026 and will guide the go-to-market strategy in AML. In the third quarter of 2025, Mendus entered into a preclinical research collaboration with an international biopharmaceutical company to study vididencel in combination with targeted therapy in AML.
Expansion into Chronic Myeloid Leukemia
Building on positive AML data and preclinical results presented at ASH 2024, Mendus is initiating clinical development of vididencel in chronic-phase CML patients receiving tyrosine kinase inhibitors (TKIs). While TKIs have transformed CML into a manageable chronic condition, most patients require life-long therapy, which carries risks of toxicity, serious adverse events, and expensive treatment costs.
The CML program aims to improve immune-mediated control and support durable TKI treatment-free remission (TFR). A Phase 1a/1b trial led by Prof Bjørn-Tore Gjertsen at the University of Bergen, Norway, will assess safety and feasibility, with first data expected mid-2026. If successful, a Phase 2a trial led by Prof Timothy Hughes at the University of Adelaide, Australia, will evaluate vididencel's role in improving TFR rates in patients who previously failed TFR attempts.
Ovarian Cancer Program Shows Promise
Mendus also reported positive data from the Phase 1 ALISON trial in ovarian cancer at ASCO 2025, demonstrating tumor-directed immune responses associated with improved progression-free survival. The data showed that stable disease is associated with successful induction of tumor-directed immune responses following vididencel treatment. The company secured a US patent for use of vididencel in ovarian cancer, further validating the product's potential in this indication.
Strategic Organizational Restructuring
To support the expanded clinical strategy while maintaining financial discipline, Mendus is implementing a corporate reorganization that will reduce staff from 28 to 19 employees. The executive management team will be adjusted from five to three members, with Chief Technology Officer Leopold Bertea and Chief Scientific Officer Alex Karlsson-Parra stepping down from their management roles.
Karlsson-Parra will continue as an adviser to Chief Medical Officer Tariq Mughal, who will assume the combined position of Chief Medical and Scientific Officer. CEO Erik Manting and CFO Lotta Ferm will remain in their current roles. The cost savings from this reorganization are estimated to offset the additional trial costs anticipated for 2026.
"The positive long-term follow-up data of the ADVANCE II trial and the momentum of the CADENCE trial underscore the potential of vididencel as a post-remission therapy following high-intensity chemotherapy in AML," commented CEO Erik Manting. "The goal of our clinical strategy is to further broaden the positioning of vididencel in the AML treatment landscape and in CML as a new indication."