Overview
- The first‑in‑human Phase Ia/Ib trial of IMA401 was reported on May 31 at ASCO and in Nature Medicine after enrolling 61 patients with treatment‑refractory solid tumours.
- IMA401 is a bispecific T‑cell engager that links the intracellular cancer antigen MAGE‑A4/8 to CD3 on T cells so the immune system can recognise and kill tumour cells.
- Safety findings showed treatment‑related immune activation that was mostly low grade, with cytokine release syndrome in 38% of patients, lymphopenia in 33%, and reversible neutropenia in 31%.
- The study recorded anti‑tumour activity across several tumour types and four of 14 head and neck cancer patients at the selected dose had marked shrinkage, with a median response duration of 8.8 months in responders.
- Investigators plan to test IMA401 in combination with other TCERs and checkpoint inhibitors and to expand early‑phase research, while stressing that these Phase 1 results require confirmation in larger, disease‑specific trials.