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jondoeuk

07/27/25 8:18 PM

#13999 RE: axelvento #13994

MRNA's mRNA-4359 encodes immunogenic peptides for PD-L1 and IDO1.

Data (monotherapy dose-escalation) has already been shared from an ongoing PhI/II trial. Antigen-specific T-cell responses in the periphery, were detectable in 13/14 (93%) patients with evaluable samples. Antigen-specific T-cell responses post-treatment were observed. Induction of activated, cytotoxic, and memory T-cells, along with reduction in regulatory T-cells and myeloid-derived suppressor cells post-treatment were observed. In this population of patients with heavily pre-treated, advanced stage cancers, 8/16 response-evaluable patients achieved stable disease.

As a monotherapy, it was tolerable at all dose levels tested; most AEs were of low grade (Grade 1-2) and manageable. The trial is currently enrolling into disease-specific cohorts (melanoma and NSCLC), combining mRNA-4359 with Keytruda.