Corvus Pharmaceuticals Receives Orphan Drug Designation for Soquelitinib in T Cell Lymphoma, Advances Towards Phase 3 Clinical Trial Subheadline: FDA Grants Orphan Drug Status to Soquelitinib, Signifying Critical Progress in Addressing Unmet Needs for T Cell Lymphoma Patients BURLINGAME, Calif., February 08, 2024 (GLOBE NEWSWIRE) - Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a distinguished player in the clinical-stage biopharmaceutical arena, has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting Orphan Drug Designation to soquelitinib for the treatment of T cell lymphoma. Soquelitinib, Corvus's leading ITK inhibitor candidate, is poised to enter a Phase 3 registrational clinical trial targeting patients with relapsed peripheral T cell lymphoma (PTCL) in the second quarter of 2024. Addressing Critical Medical Needs Richard A. Miller, M.D., Co-founder, President, and Chief Executive Officer of Corvus, emphasized the urgent necessity for innovative therapies in addressing T cell lymphoma. "Peripheral T cell lymphoma is an aggressive subset of non-Hodgkin’s lymphoma typically associated with a poor prognosis," stated Dr. Miller. "For these patients, there is significant need for new therapies given that existing drugs provide limited efficacy and are associated with significant toxicity. There are no FDA approved agents for relapsed PTCL. The orphan drug designation is an important milestone in the development of soquelitinib that reinforces the unmet need for patients with T cell lymphoma." Significance of Orphan Drug Designation FDA Orphan Drug Designation is a critical recognition granted to investigational therapies targeting rare medical diseases or conditions affecting fewer than 200,000 people in the United States. This designation provides several benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees, and seven years of post-approval marketing exclusivity. Driving Innovation in T Cell Lymphoma Treatment Corvus Pharmaceuticals' receipt of Orphan Drug Designation for soquelitinib underscores the company's commitment to driving innovation in the treatment landscape of T cell lymphoma. By advancing into Phase 3 clinical trials, Corvus aims to accelerate the development of soquelitinib, potentially offering a novel therapeutic option for patients with relapsed PTCL