SAHMRI is an Australian medical research institute, and home to internationally recognized experts in hematology and cancer research.

“Effective collaboration between researchers, clinicians and trial specialists is critical to advancing innovative therapies and delivering high-quality clinical research. We are delighted to support preparations for the VITAL-TFR2 trial alongside Mendus and the study team,” says Emma Heath, Head of the Clinical Trials Platform at SAHMRI.

VITAL-TFR2

VITAL-TFR2 is a Phase 2a trial to be led by Professor Timothy Hughes (SAHMRI and Adelaide University, Australia) and Associate Professor David Ross (SAHMRI and Royal Adelaide Hospital, Australia).

The development of tyrosine kinase inhibitors (TKIs) has transformed CML into a manageable chronic disease for most patients. As a result, focus has shifted toward quality of life and the attainment of treatment-free remission (TFR), which allows patients to safely stop taking daily TKIs. However, TFR remains elusive for many CML patients due to two key challenges. First, many patients do not achieve the deep and sustained molecular responses required to qualify for a TFR attempt. The ongoing VITAL-CML trial aims to address this by converting suboptimal responses into sustained deep molecular responses that enable TFR eligibility. Second, relapse after TKI discontinuation remains a major obstacle to durable TFR success. Approximately half of patients relapse after stopping treatment and must restart TKI therapy, with failure rates even higher for subsequent TFR attempts. VITAL-TFR2 will evaluate whether vididencel can support durable, immune-mediated remission and improve long-term TFR success in patients with a previous relapse following a TFR attempt.

As preparations for VITAL-TFR2 advance, Mendus will work with SAHMRI and the study team to support key trial planning and start-up activities.

Mendus recently announced completion of enrollment of the first safety and tolerability stage of the VITAL-CML trial in Bergen, Norway. Positive initial data from the VITAL-CML trial, expected in the second half of 2026, will lay the foundation for two parallel development paths with vididencel in CML. One path is focused on improving TFR eligibility for suboptimal TKI responders through the VITAL-CML trial, while the other seeks to support TFR success through the VITAL-TFR2 trial.