Moderna Inc ( MRNA ). announced on Sunday that its clinical, safety, and translational data from its Phase 1/2 study evaluating mRNA-4359 in combination with pembrolizumab in patients with checkpoint inhibitor-resistant/refractory (CPI-R/R) melanoma will be presented at the 2025 European Society for Medical Oncology Congress.

mRNA-4359 is an investigational immune-evasion targeted cancer antigen therapy (CAT) that encodes epitopes of two common immune escape pathways, PD-L1 and IDO1, to elicit antigen-specific T cell responses that may directly kill tumor cells and deplete tumor suppressor cells.

The presentation includes data from 29 participants who received the combination therapy at 400 µg (n=14) or 1,000 µg (n=15), administered intramuscularly every three weeks for up to nine doses.

Across all evaluable patients, the objective response rate (ORR) was 24%, and the disease control rate (DCR), which represents the combination of patients achieving tumor response and stable disease, was 60%.

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Among those with response-evaluable disease and PD-L1+ (TPS≥1%) tumors, the ORR was 67% (6 of 9 participants), with treatment inducing peripheral antigen-specific T cell responses and novel T cell receptor clones. The median duration of response (DOR) was not reached.

mRNA-4359 and pembrolizumab demonstrated a consistently manageable safety profile, with no new immune-related adverse events (AEs).

mRNA-4359 continues to be evaluated in an ongoing phase 1/2 study as a monotherapy and in combination with pembrolizumab in patients with advanced melanoma and non-small cell lung cancer (NSCLC).

In September, Moderna ( MRNA ) released preliminary immunogenicity data for the 2025-2026 formula of mNEXSPIKE (COVID-19 Vaccine, mRNA), which targets the LP.8.1 variant of SARS-CoV-2.

The data from an ongoing Phase 4 clinical trial evaluating the safety, tolerability, and immunogenicity of the 2025-2026 formula of mNEXSPIKE showed, on average, greater than a 16-fold increase in neutralizing antibodies against the LP.8.1 variant in individuals 12 through 64 years of age with at least one underlying condition and all adults 65 years of age and older.

Price Action: MRNA stock is up 3.54% at $27.78 at the last check on Monday.

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