On September 6, 2023 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported that it has completed an End-of-Phase/Pre-Phase 3 meeting with FDA on its plans to initiate a Phase 3 registrational clinical trial of soquelitinib (formerly CPI-818), the Company’s ITK inhibitor product candidate, in relapsed peripheral T cell lymphoma (PTCL) (Press release, Corvus Pharmaceuticals, SEP 6, 2023, View Source [SID1234634938]).
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"We are pleased with the outcome of our End-of-Phase/Pre-Phase 3 meeting with FDA, allowing us to advance ITK inhibition with soquelitinib into a potentially registrational clinical trial for patients with relapsed peripheral T cell lymphoma," said Richard A. Miller, co-founder, president and chief executive officer of Corvus. "We appreciate the FDA’s input and their confirmation on the key aspects of the trial design, including sample size, dosing, eligibility, comparator arm and endpoints. We are now focused on finalizing the study protocol, qualifying trial sites and completing other standard steps required to initiate the trial. Based on current timelines, we anticipate that we can initiate the trial in the first quarter of 2024."
The soquelitinib Phase 3 potentially registrational clinical trial is designed to enroll a total of 150 patients with relapsed PTCL that have received three or fewer prior therapies. Patients will be randomized 1:1 to soquelitinib 200 mg two-times a day or standard of care chemotherapy. The primary endpoint will be progression-free survival. Secondary endpoints will include objective response rate and overall survival. The Company is recruiting U.S. and international investigators and anticipates that leading academic and private medical centers with significant experience in lymphoma research will participate in the trial, including a principal investigator who has conducted other Phase 3 clinical trials in T cell lymphoma and authored many peer-reviewed articles on lymphomas.
Dr. Miller added, "Soquelitinib’s proposed mechanism of action, based on selective ITK inhibition, represents a platform opportunity with the potential to address a wide range of indications beyond hematologic cancers, including solid tumors and autoimmune/allergic diseases."
Data highlighting the potential of selective inhibition of ITK to potentially enhance anti-tumor immune response to hematologic and solid tumors and provide a novel potential approach to cancer immunotherapy were recently published online as a preprint at bioRxiv.org. In addition, data demonstrating soquelitinib’s anti-tumor activity in patients with T cell lymphoma (TCL) and its therapeutic potential in Th2 and Th17-mediated autoimmune and allergic diseases was presented in a poster at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition, which took place in December 2022. The preprint and ASH (Free ASH Whitepaper) poster presentation are available on the Publications and Presentations page of the Corvus website.
Conference Call Details
Corvus will host a conference call and webcast tomorrow, Thursday, September 7, 2023, at 8:30 a.m. ET (5:30 a.m. PT), to discuss the soquelitinib Phase 3 clinical trial plan and other business updates. The conference call can be accessed by dialing 1-877-407-0784 (toll-free domestic) or 1-201-689-8560 (international) or by clicking on this link for instant telephone access to the event. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.