Shares of Corvus Pharmaceuticals CRVS gained 13.9% on Sept. 10 after the company announced the initiation of a phase III registrational study of its lead product candidate, soquelitinib, to treat patients with relapsed/refractory peripheral T-cell lymphoma (PTCL).

Corvus’ soquelitinib is an investigational, oral, small-molecule drug that selectively inhibits interleukin-2 inducible T-cell kinase (ITK), a protein tyrosine kinase that plays a role in T-cell development and differentiation. The company believes that the candidate’s unique mechanism of action of ITK inhibition offers significant potential for treating lymphomas, solid tumors and autoimmune/allergic diseases.

Corvus’ Registrational Phase III Lymphoma Study Design

The phase III registrational study of soquelitinib will enroll approximately 150 patients with relapsed/refractory PTCL who have failed one to three prior lines of therapy. The enrolled patients will then be randomized equally into two groups to receive either a twice-daily, 200mg dose of soquelitinib or standard-of-care chemotherapy with either belinostat or pralatrexate.

The primary endpoint of the late-stage study is the progression-free survival (PFS) of the patients treated with the candidate. The secondary endpoints will include overall survival, objective response rate and duration of response.

Year to date, shares of Corvus have skyrocketed 163.4% against the industry’s 1.6% decline.

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PTCL is a rare and aggressive form of non-Hodgkin lymphoma that originates from mature T-cells in the peripheral lymphoid tissues, such as the lymph nodes, spleen or other organs. Standard-of-care treatment involves combination chemotherapy, but most patients either fail to respond or experience a relapse within the first two years. For those who relapse, different chemotherapy agents are used, though the outcomes remain poor. Median PFS is typically three to four months, with an overall median survival of six to 12 months. Currently, there are no approved drugs for relapsed PTCL.

Soquelitinib, on the other hand, has been well-tolerated while demonstrating durable anti-tumor activity in patients with very advanced, refractory, difficult-to-treat T-cell malignancies in earlier-stage studies. The candidate’s novel mechanism of action enhances the host’s anti-tumor response.

Corvus’ soquelitinib currently enjoys Orphan Drug designation and Fast Track designation in the United States for treating relapsed/refractory PTCL.

Corvus’ Other Clinical-Stage Pipeline Programs

Apart from the lymphoma indication, Corvus is also currently evaluating soquelitinib in an early-stage study to treat patients with moderate to severe atopic dermatitis.