Immuneering Corp 8-K

What Happened
Immuneering Corporation filed an 8-K on January 7, 2026 reporting updated interim data (cutoff December 15, 2025) from its ongoing Phase 1/2a trial of atebimetinib (IMM-1-104) plus modified gemcitabine/nab‑paclitaxel (mGnP) in first-line pancreatic cancer. In the intent-to-treat cohort of 34 patients dosed at 320 mg once daily, the company reported 64% overall survival (OS) at 12 months (median follow‑up 13.4 months); median OS was not reached and median progression‑free survival (PFS) was 8.5 months. By earlier timepoints the 320 mg cohort showed 94% OS at 6 months and 83% OS at 9 months. Safety remained generally tolerable: Grade ≥3 treatment‑emergent adverse events ≥10% were anemia (18%) and neutropenia (18%); no Grade 5 events were observed.

Key Details

• Filing date: January 7, 2026; data cutoff: December 15, 2025.
• Efficacy (320 mg ITT, N=34): 64% OS at 12 months; median follow‑up 13.4 months; median OS not reached; median PFS = 8.5 months.
• Comparative context: company cites MPACT trial (gemcitabine/nab‑paclitaxel) SOC rates of 35% OS at 12 months and 67% at 6 months; 9‑month SOC estimate (47%) was extrapolated by the company. Trial is non‑randomized and not a head‑to‑head comparison.
• Safety: Grade ≥3 TEAEs ≥10% — anemia 18%, neutropenia 18%; other Grade ≥3 TEAEs each ≤6%; no new safety signals.
• Near‑term milestones: ctDNA data at a major meeting (Q2 2026); updated survival data from >50 patients (H1 2026); first patient dosed in pivotal Phase 3 (mid‑2026); first patient dosed in atebimetinib + Libtayo NSCLC trial (H2 2026).

Why It Matters
For investors, these results are an early signal that atebimetinib plus mGnP may improve 12‑month survival versus historical gemcitabine/nab‑paclitaxel data, and the company plans key de‑risking steps (additional survival updates and a planned pivotal Phase 3 start in mid‑2026). However, the dataset is small (N=34), non‑randomized, and comparisons to historical controls involve extrapolation—so results should be interpreted cautiously. Upcoming data readouts and the Phase 3 start are material near‑term catalysts to watch; the filing also reiterates customary forward‑looking statement risks.