Corvus Pharmaceuticals Highlights Soquelitinib Pipeline, Eyes Phase II Atopic Dermatitis Trial in 2026

Key Points

• Soquelitinib is Corvus’s lead program with a planned interim analysis in its phase III peripheral T‑cell lymphoma (PTCL) trial by year‑end 2026, plus proof‑of‑concept phase II studies in asthma and hidradenitis suppurativa planned this year and composition‑of‑matter protection through 2037.
• Early clinical data in atopic dermatitis showed strong activity and tolerability — an 8‑week cohort at 200 mg twice daily reported a mean EASI reduction of 72% vs 40% for placebo (p=0.035) with 75% achieving EASI‑75 and no new safety signals.
• Corvus plans an international phase II AD trial expected to open in Q1 2026 enrolling 200 moderate‑to‑severe patients across four arms (200 mg qd, 200 mg bid, 400 mg qd, and placebo) with a 12‑week primary endpoint of mean EASI reduction.

Corvus Pharmaceuticals NASDAQ: CRVS provided an update on its pipeline at Oppenheimer’s Annual Healthcare Conference, with Chief Business Officer Jeff Arcara focusing primarily on soquelitinib, the company’s lead program. Arcara described soquelitinib as a novel, potential first-in-class oral therapy designed to inhibit interleukin-2-inducible T-cell kinase (ITK), and he positioned the drug as a potential option across atopic dermatitis (AD) and other immune-mediated diseases, in addition to its development in oncology.

Pipeline focus: soquelitinib in lymphoma and inflammatory diseases

Arcara said Corvus is a clinical-stage company developing “first-in-class immune modulators” with potential in oncology and immune-mediated diseases. He noted that soquelitinib is in a phase III registrational trial for peripheral T-cell lymphoma (PTCL), with an interim analysis expected by year-end 2026.

In inflammatory diseases, Arcara said Corvus is “about to start” a phase II clinical trial in atopic dermatitis, described as a prospective, randomized, placebo-controlled trial in moderate-to-severe patients, with data expected in approximately 18 months. He also said the company plans to start two phase II proof-of-concept studies “this year” in asthma and hidradenitis suppurativa (HS).

Arcara also cited the program’s intellectual property position, stating that Corvus has issued composition-of-matter protection through 2037 (excluding any patent term extensions). He added that the company is developing next-generation ITK inhibitors to expand its ITK platform across additional diseases and indications.

Mechanism: selective ITK inhibition and immune “rebalancing”

Arcara outlined ITK’s role in T-cell receptor signaling and said genetic studies suggest that selectively knocking out ITK inhibits Th2 and Th17 cells and related cytokines. He highlighted cytokines he said are involved in autoimmune, inflammatory, fibrotic, and allergic diseases, including IL-4, IL-5, IL-13, and IL-17. At the same time, he said ITK inhibition permits Th1 differentiation, which he characterized as important for fighting cancer and viral-infected cells.

He emphasized the importance of selectivity, stating that blocking RLK (resting lymphocyte kinase) could cause immune dysfunction, and he described soquelitinib as highly specific for ITK while sparing other kinases such as RLK and BTK. He said ITK’s limited tissue distribution (on T-cells and NK cells) combined with target selectivity supports a favorable safety profile and therapeutic window.

Arcara also pointed to emerging scientific observations that ITK inhibition with soquelitinib may not only skew toward Th1 responses, but could also shift pro-inflammatory Th17 cells toward functional Foxp3 regulatory T cells (Tregs), which he suggested could potentially support lasting or remittive effects.

Atopic dermatitis: reported activity, durability, and safety in early cohorts

Arcara reviewed results from a phase I randomized, placebo-controlled, blinded study in moderate-to-severe AD that did not allow concomitant topical steroids. He said eligible patients had failed at least one prior topical or systemic therapy, including patients who had not responded to prior systemic therapies, a group he said is often excluded from other AD trials. The study was conducted across 17 U.S. centers and enrolled 72 patients across cohorts (48 active, 24 placebo).

He highlighted efficacy outcomes from an eight-week treatment cohort (Cohort 4) dosed at 200 mg twice daily. According to Arcara, at eight weeks the cohort showed a mean EASI reduction of 72% versus 40% for placebo (p=0.035). He reported that 75% of treated patients achieved EASI-75, 25% achieved EASI-90, and 33% achieved IGA 0/1. He also said 11 of 12 treated patients reached EASI-50 (92%). Arcara noted that two placebo patients achieved EASI-75, and he added that two placebo patients required rescue medications due to disease flare while none in the active group did.

Arcara said extending treatment from four to eight weeks deepened responses without compromising safety or tolerability. He also described durability observations, stating that EASI scores continued to decline after treatment stopped and that, following an extended follow-up protocol amendment for Cohort 3, responses were sustained and in some cases improved through day 118. He attributed potential durability mechanistically to induction of Treg cells and referenced observed increases in circulating Tregs in treated cohorts versus placebo.

For context, Arcara contrasted this with published follow-up data from a phase II trial of the JAK inhibitor abrocitinib, which he said showed a rapid rebound in disease activity after stopping therapy. He said Corvus has not observed a similar rebound effect with soquelitinib so far.

On safety, Arcara said no new safety signals were observed in Cohort 4 with eight-week dosing. He stated that adverse events were similar between placebo and active groups and that no significant laboratory abnormalities were observed. In adverse events of special interest, he said there were no hepatic abnormalities or LFT changes, and infections were similar and treated in the placebo group. He also noted the absence of injection-site reactions given soquelitinib is oral.

Prior therapy and refractory patients

Arcara emphasized that the study included treatment-experienced patients. He said 35% of patients overall had prior systemic therapy, rising to 50% in Cohort 4. He identified dupilumab (“DUPI”) as the most common prior agent, followed by JAK inhibitors, and said some patients had multiple prior therapies.

He also discussed a subset he described as resistant to their last systemic therapy at study entry, stating that at least six such patients were identified (four on active therapy, two on placebo). Arcara said both placebo patients experienced disease flares requiring rescue medication, while three of four soquelitinib-treated patients improved, including two achieving EASI-90; one patient had a 27% EASI reduction and one did not respond. He noted that the non-responder was the only patient out of 12 in Cohort 4 who did not reach EASI-50.

Next steps: phase II AD trial and upcoming milestones

Arcara said Corvus plans to begin a phase II AD trial “very shortly,” describing an international study planned to enroll 200 moderate-to-severe patients randomized into four cohorts: 200 mg once daily, 200 mg twice daily, 400 mg once daily, and placebo (50 patients per arm). Treatment duration is planned for 12 weeks followed by an off-treatment follow-up period, with the primary endpoint being mean reduction in EASI at 12 weeks. He said the study is expected to open in Q1 2026.

In addition to the AD trial, Arcara cited 2026 milestones including the start of proof-of-concept studies in asthma and HS, presentations of biomarker data at upcoming AAD and SID meetings, and progress in the ongoing PTCL phase III registrational trial with an interim analysis expected by year-end 2026.

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.

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