Corvus Pharmaceuticals (NASDAQ:CRVS) presented new Phase I results for oral soquelitinib in moderate-to-severe atopic dermatitis (AD), highlighting updated efficacy, durability, and safety findings from a blinded, placebo-controlled U.S. study that included patients with prior systemic therapy exposure.
Cohort 4 corroborates earlier signals with eight-week dosing
Chief Executive Officer Richard Miller said the company’s newly reported Cohort 4 data reinforce soquelitinib’s potential as a “first-in-class” selective ITK (interleukin-2 inducible T-cell kinase) inhibitor. Cohort 4 was designed to corroborate and extend results from earlier cohorts, with key design changes including 24 patients randomized 1:1 to active drug or placebo and an extended treatment period of eight weeks (versus four weeks in Cohorts 1–3). The dose in Cohort 4 was 200 mg twice daily, matching Cohort 3.
Durability and prior-treatment experience emphasized
Miller highlighted what he characterized as durable disease control, including continued reductions in EASI after treatment discontinuation. For Cohorts 1–3, the company had previously observed response persistence beyond the 28-day dosing period and said an amended protocol enabled longer blinded follow-up in Cohort 3, where responses were maintained or slightly improved out to 118 days without therapy.
The company also focused on outcomes among patients with prior systemic therapies, noting that 35% of patients across Cohorts 1–4 had prior systemic treatment and 50% did in Cohort 4. Dupixent and JAK inhibitors were described as the most common prior systemic agents. Corvus said soquelitinib’s efficacy appeared similar in systemic-therapy-naïve and experienced patients, while placebo patients with prior systemic therapy did worse, which management characterized as evidence that prior systemic therapy is an unfavorable baseline characteristic.
Management also discussed a small subgroup of patients said to be resistant to their last systemic therapy upon entering the trial. In that set (six patients total: four on active drug and two on placebo, all in Cohorts 3 and 4), the two placebo patients experienced flares requiring rescue medication, while three of four soquelitinib-treated patients improved, including two achieving EASI 90. One treated patient had a 27% reduction and one did not respond; Miller noted this was the only patient out of 12 treated in Cohort 4 who did not achieve EASI 50.
Safety profile described as clean in AD and lymphoma experience
Corvus reported no new safety signals in Cohort 4 despite the longer eight-week treatment duration. The company said adverse events were similar between placebo and active groups and that no significant laboratory abnormalities were observed. Management specifically noted no hepatic abnormalities and said infection rates were similar between treated and placebo patients. The company also contrasted its oral agent with injectable AD therapies by noting it does not have injection site reactions or conjunctivitis, which can affect both tolerability and trial blinding.
During Q&A, Miller cited broader safety experience from soquelitinib’s development in T-cell lymphoma, stating that hundreds of patients have been treated over months and years, and that in the lymphoma study no patient discontinued therapy due to toxicity. He also said the company has not seen liver function test abnormalities or hematologic suppression attributable to the drug, adding that some abnormalities observed in lymphoma patients reflect baseline disease status.
Mechanism and emerging biomarkers
Miller outlined the company’s mechanistic thesis that selective ITK inhibition reduces pro-inflammatory Th2 and Th17 signaling while sparing Th1 function due to redundancy via RLK, potentially avoiding broad immunosuppression. He also discussed research suggesting ITK influences a switch between Th17 and regulatory T cells (Tregs), and said the company observed an increase in circulating functional Tregs in Cohort 3 but not in Cohorts 1–2 or placebo, which Corvus believes could be related to durability of response.
Corvus previewed biomarker work it plans to present at upcoming American Academy of Dermatology and Society of Investigative Dermatology meetings. Management cited reductions in serum IL-4 in Cohorts 3 and 4, and reductions in serum IL-5 in Cohort 3 (with Cohort 4 IL-5 results still in process). The company also described early findings from single-cell RNA sequencing in a small set of patients from Cohorts 1 and 2 showing a trend toward reduced Th2 cells in treated patients compared with baseline, and said it is expanding these analyses in Cohorts 3 and 4.
Next steps: Phase II AD planned for Q1 2026 and broader pipeline ambitions
Corvus said it plans to initiate a Phase II randomized, placebo-controlled AD trial with 200 patients internationally, with four arms of 50 patients each. Planned dosing arms are 200 mg once daily, 200 mg twice daily, and 400 mg once daily, plus placebo, over 12 weeks with an off-treatment follow-up period. The primary endpoint is median reduction in EASI at 12 weeks. Management said the Phase II trial is expected to open “very soon” in Q1 2026 and will continue to allow prior systemic therapy, capped at 40% of enrollment.
In Q&A, Miller said once-daily dosing is “likely” feasible due to the drug’s covalent, irreversible binding and sustained pharmacodynamic effect. He also noted that a 400 mg once-daily regimen is being evaluated in China by partner Angel Pharmaceuticals, with data expected later in 2026, though he did not indicate it would alter the company’s near-term Phase II AD plan.
Beyond AD, Corvus said Phase II trials in hidradenitis suppurativa and asthma are planned to start in 2026, while a Phase III registration trial is ongoing in relapsed peripheral T-cell lymphoma, with an interim futility analysis expected later in 2026. The company also highlighted intellectual property it said provides composition-of-matter protection through 2042 and stated there are no royalty obligations tied to the drug’s IP.
On the financial front, management said the company’s reported runway into Q4 2026 includes the planned AD, asthma, and hidradenitis suppurativa studies, while also acknowledging it expects to raise additional capital.
About Corvus Pharmaceuticals (NASDAQ:CRVS)
Corvus Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on the discovery and development of next-generation immuno-oncology therapies. The company’s research efforts are centered on harnessing both the innate and adaptive immune systems to counteract tumor-driven immunosuppression. By targeting key pathways that regulate immune cell function, Corvus aims to create novel agents that can be combined with existing cancer treatments to improve patient outcomes.
Corvus’s lead pipeline candidates include small-molecule and antibody therapies designed to inhibit the adenosine pathway, a known mediator of tumor immune escape.
