The research presented at CIMT confirms that vididencel can be combined with a broad range of TKIs used for the treatment of CML and that the immune-activating properties of vididencel are unaffected by asciminib. This supports the combination of vididencel with next-generation TKIs that belong to the class of allosteric inhibitors, also called STAMP (Specifically Targeting the ABL Myristoyl Pocket) inhibitors. This class of TKIs includes asciminib (sold under the brand name Scemblix) and several molecules in clinical development, such as TERN-701 and TGRX-678. The development of these and other potent next-generation TKIs is expected to result in more patients being positioned for treatment-free remission (TFR). Vididencel is developed as an active immunotherapy to prevent relapse caused by residual disease and improve TFR success.

“As a result of continued innovation in the treatment of CML, a growing number of patients will have the chance of reaching TFR eligibility,” said Prof. Tariq Mughal, Chief Medical and Scientific Officer of Mendus. “The preclinical data presented at CIMT indicate that vididencel is compatible with a broad range of TKIs including STAMP inhibitors, supporting our clinical strategy to support TFR attempts in combination with current and upcoming CML treatments.”

TFR, the ability to stop TKI treatment while maintaining disease control, is considered the ultimate therapeutic goal in CML but can only be achieved by a fraction of CML patients. Firstly, only patients with a sustained optimal response to TKI treatment, known as a deep molecular remission (DMR), are eligible for TFR attempts. Secondly, TFR outcomes are relatively unpredictable and limited by rising disease levels after discontinuation of TKI treatment, typically already within 6 months.

Mendus is currently advancing vididencel in chronic-phase CML patients with a suboptimal response to TKI therapy in the ongoing Phase 1b VITAL-CML trial, to establish safety, tolerability and the ability of vididencel to deepen molecular responses. Subject to positive initial data of the VITAL-CML trial, expected in the second half of 2026, the planned Phase 2a VITAL-TFR2 trial will assess the potential of vididencel to support TFR success in patients with a previously failed TFR attempt.