Announcement • Aug 28

Corvus Pharmaceuticals Publishes Final Phase 1 Data from Soquelitinib Phase 1/1B T Cell Lymphoma Trial

Corvus Pharmaceuticals, Inc. announced the publication of peer-reviewed final data from its Phase 1/1b trial of soquelitinib in patients with T cell lymphoma. The publication in Blood, the journal of the American Society of Hematology, provides the medical and scientific community with clinical and immunologic data supporting the development of soquelitinib in oncology and immune and inflammatory diseases. In patients with advanced, aggressive and difficult-to-treat T cell lymphomas, soquelitinib demonstrated durable responses, including complete responses, maintained for more than two years in some patients and a median overall survival exceeding two years. This compares favorably to currently available therapies, providing the rationale for the ongoing registration Phase 3 trial in relapsed/refractory PTCL. The peer-reviewed data also detail soquelitinib’s mechanism of action, with selective ITK inhibition driving Th1 skewing and blocking of Th2 and Th17 differentiation. The Phase 1/1b trial enrolled 75 heavily pre-treated patients (27 in dose escalation portion and 48 in dose expansion portion) with various T cell lymphomas, including peripheral T cell lymphoma (PTCL), T follicular helper cell lymphoma (TFHC), natural killer cell T cell lymphoma (NKTCL), cutaneous T cell lymphoma (CTCL), anaplastic large cell lymphoma (ALCL) and adult T cell lymphoma/leukemia (ATLL). The median number of prior therapies was three (range 1-18), with only 31% achieving an objective response to their most recent prior therapy. In the dose escalation portion, patients received a twice-daily dose of soquelitinib of 100 mg, 200 mg, 400 mg or 600 mg, and the 200 mg twice-daily dose was selected for the dose expansion portion based on biomarker studies which demonstrated that doses of 200 mg or higher achieved complete occupancy of the ITK target with the drug. Soquelitinib was well tolerated across all dose cohorts up to 600 mg twice-daily, with no dose-limiting toxicities or significant adverse events and, notably, no myelosuppression or immunosuppression. In the 200 mg twice-daily cohort (N=36), there were objective and durable tumor responses, including six complete responses. Within this group, patients with one to three prior therapies were determined to be most likely to respond to therapy (N=24) and achieved the following results: objective responses in 9 of 24 patients (six complete and three partial), a median progression-free survival of 6.2 months with 30% of patients progression-free at 18 months, and a median overall survival of 28.1 months with 67% of patients alive at 24 months. The publication also characterizes soquelitinib’s mechanism of action. In vitro studies showed that appropriate doses resulted in Th1 skewing by blocking Th2 differentiation, and biomarker analyses of patient blood and tumor samples also demonstrated this effect in vivo, with increased Th1 cells and reduced serum IL-5. In six patients with paired tumor biopsies analyzed by RNA sequencing, treatment increased intratumoral Th1 cells by day 8, which Corvus believes reflects the direct linkage between the drug’s clinical activity and its underlying immunobiology. These findings are consistent with an anti-tumor mechanism of action involving both direct effects on the tumor (tumor intrinsic) as well as a tumor extrinsic effect on the tumor microenvironment leading to an enhanced host immune response against the tumor. Corvus is currently enrolling patients in a registration Phase 3 clinical trial of soquelitinib in patients with relapsed/refractory PTCL at multiple clinical sites. This randomized controlled trial is anticipated to enroll a total of 150 patients with relapsed/refractory PTCL and is evaluating soquelitinib versus physicians’ choice of either belinostat or pralatrexate. The primary endpoint of the trial is progression-free survival. There are no FDA fully approved agents for the treatment of relapsed/refractory PTCL, and the FDA has granted soquelitinib Orphan Drug Designation for the treatment of T cell lymphoma and Fast Track designation for treatment of adult patients with relapsed or refractory PTCL after at least 2 lines of systemic therapy. Soquelitinib (formerly CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. Soquelitinib has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of both Th2 and Th17 cells and production of their secreted cytokines. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. Recent studies have demonstrated that ITK controls a switch between the differentiation of Th17 proinflammatory cells and T regulatory suppressor cells. Inhibition of ITK leads to a shift toward T regulatory cell differentiation, which has the potential to suppress autoimmune and inflammatory reactions. The inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with autoimmune and allergic diseases and in cancers, including solid tumors. Based on interim results from a Phase 1/1b clinical trial in patients with refractory T cell lymphomas, which demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, the company is enrolling a registration Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed/refractory PTCL. Soquelitinib is also now being investigated in a randomized placebo-controlled Phase 2 clinical trial in patients with atopic dermatitis. A publication describing the chemistry, enzymology and biology of soquelitinib appeared in npj Drug Discovery in December 2024 and is available online at the Nature website and on the Publications and Presentations page of the Corvus website.

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