IMA401 at Phase 1 RP2D showed 29% ORR, 64% DCR and median 8.8-month duration of response in 14 head and neck cancer patients, with 60-100% tumor reduction and no Grade ≥3 CRS or ICANS. Enrollment has begun for IMA401/IMA402 in sqNSCLC, targeting 40,000 patients, with first data due 2027.
IMA401 has shown encouraging anti-tumor activity at the recommended Phase 2 dose in a heavily pretreated head and neck cancer cohort. Of 14 patients, 29% achieved confirmed objective responses and 64% achieved disease control, with a median duration of response of 8.8 months and tumor reductions between 60% and 100%.
The safety profile at 1–2 mg RP2D was favorable, with only low-grade cytokine release syndrome in 38% of patients and no Grade ≥3 events or neurotoxicity. Transient neutropenia and lymphopenia were observed but were manageable, and combining IMA401 with pembrolizumab did not add significant toxicity.
Enrollment is underway for the first cohort combining IMA401 (MAGEA4/8 bispecific) with IMA402 (PRAME bispecific) in squamous cell non-small cell lung cancer. This dual targeting strategy aims to enhance patient coverage and potential synergistic activity by addressing two prevalent tumor antigens.
More than 90% of sqNSCLC patients express PRAME and/or MAGEA4/8, supporting an annual addressable population of approximately 40,000 in the US and EU5. First clinical data from the combination cohort are expected in 2027, informing further development plans.
