Corvus Pharmaceuticals, Inc. 8-K

What Happened

• Corvus Pharmaceuticals (CRVS) filed an 8-K on January 20, 2026 announcing positive results from cohort 4 of its randomized, blinded, placebo‑controlled Phase 1 trial of soquelitinib in moderate‑to‑severe atopic dermatitis. Cohort 4 patients were randomized 1:1 to soquelitinib 200 mg twice daily or placebo with a 56‑day treatment period (vs. 28 days in earlier cohorts). Enrollment in cohort 4 was completed as of January 15, 2026.
• Key efficacy: at Day 56, mean percent reduction in EASI was 70% (soquelitinib, n=12) vs 40% (placebo, n=10). Cohort 4 responder rates for soquelitinib were EASI‑75 = 75%, EASI‑90 = 25%, and IGA 0/1 = 33%, versus placebo 20%, 0%, and 0%, respectively. The Day 56 difference in mean EASI change reached statistical significance (p = 0.035).
• Safety: no new safety signals as of Jan 15, 2026. Adverse events were reported in 41.7% of soquelitinib patients and 50% of placebo patients, were Grade 1–2, and did not cause dose modifications; no severe or serious adverse events or significant lab abnormalities were reported.
• Next step: based on these results, Corvus plans to initiate a Phase 2 trial in Q1 2026 in patients with moderate‑to‑severe atopic dermatitis who failed at least one prior topical or systemic therapy.

Key Details

• Trial/cohort facts: cohort 4 randomized 1:1, soquelitinib 200 mg twice daily, 56‑day treatment, blinding maintained through an 86‑day period.
• Patient numbers & baseline: cohort 4 soquelitinib-treated n=12; placebo enrolled n=12 (10 evaluable at Day 56); mean baseline EASI = 25.7 (soquelitinib) vs 21.9 (placebo).
• Across all cohorts (1–4): total n=72; 35% (n=25) had prior systemic therapy (dupilumab n=11); soquelitinib activity was observed in patients with prior systemic therapy, including those previously treated with dupilumab and JAK inhibitors.
• Biomarkers: reductions reported in serum IL‑4, IL‑5, IL‑17 and TARC, decreased circulating Th2 cells, and increased circulating Treg cells (noted in cohort 3), consistent with the proposed ITK inhibition immune‑rebalancing mechanism.

Why It Matters

• These Phase 1 cohort results provide early clinical evidence of both efficacy (70% mean EASI reduction; meaningful EASI‑75/90 and IGA responses) and tolerability for soquelitinib at 200 mg BID, supporting advancement to a Phase 2 trial planned for Q1 2026.
• For investors, the data are material because they move the program from proof‑of‑concept toward a registrational pathway; biomarker changes also support the drug’s proposed mechanism (ITK inhibition).
• Caveats investors should note (from the filing): small cohort sizes, early‑phase data, and incomplete post‑treatment follow‑up for some patients—meaning additional, larger trials are needed to confirm clinical benefit and safety.