GENELUX Corp 8-K

What Happened

• Genelux Corporation filed an 8‑K on Jan 5, 2026, disclosing interim results from two ongoing systemic (intravenous) Olvi‑Vec trials: a Phase 1b/2 SCLC trial (NCT07136285) conducted in China with partner Newsoara HYK, and the Phase 2 VIRO‑25 NSCLC trial (NCT06463665) in the U.S.
• The company reported preliminary efficacy and tolerability data from dose‑escalation cohorts as of data cutoffs Dec 23, 2025 (SCLC) and Dec 31, 2025 (NSCLC).

Key Details

• SCLC (Phase 1b/2, 9 evaluable patients): Overall response rate (ORR) 33% (3/9) with three partial responses; disease control rate (DCR) 67% (6/9). Two PRs in the highest tested dose cohort (Cohort 4) showed ~55% and ~85% tumor shrinkage (Cohort 4 ORR 67% (2/3)). Tumor reductions among DCR patients ranged 24–85%.
• SCLC durability signals: one patient (1 prior line) had ongoing progression‑free survival (PFS) of 12.1 months; another (4 prior lines) had PFS 7.7 months vs 1.9 months on the immediately preceding line (improvement 5.8 months). The trial is primarily assessing safety; responders did not receive standard maintenance immunotherapy.
• NSCLC (Phase 2 VIRO‑25, 5 evaluable patients): DCR 60% (3/5). Tumor size changes among the 3 DCR patients were +8.9%, −18.9%, and −22.7%. Olvi‑Vec was reported as generally well tolerated in both trials.
• Near‑term milestones: additional interim dose‑finding readouts expected through 2026; topline Phase 3 ovarian cancer (OnPrime/GOG‑3076) data expected in H2 2026.

Why It Matters

• These interim clinical signals provide early evidence of activity and tolerability for systemic Olvi‑Vec in hard‑to‑treat, platinum‑relapsed lung cancers — information investors may use to track clinical progress and development risk.
• The results remain preliminary (small cohorts, early dose escalation) and Genelux notes forward‑looking statements and risks; upcoming dose‑finding updates and the Phase 3 ovarian topline readout in H2 2026 are key near‑term catalysts to watch.