CRVS Corvus Pharmaceuticals Inc

Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced the publication of preclinical data highlighting the potential of soquelitinib, the Company’s lead ITK inhibitor program, as a novel approach to modulate tumor immunity. The data was published in npj Drug Discovery (part of the Nature portfolio of journals), an open access, international, peer-reviewed journal dedicated to publishing the highest quality research relevant to all aspects of drug design and discovery.

The publication, entitled “Synthesis and characterization of soquelitinib a selective ITK inhibitor that modulates tumor immunity,” includes a detailed overview of soquelitinib’s mechanism of action – suppressing Th2 and Th17 cytokine production and sparing Th1 cytokines – that serves as a novel approach to cancer immunotherapy, both as a single agent and in combination with immune checkpoint inhibitors. The data also shows that soquelitinib increases effector function of cytotoxic CD8 positive T cells and leads to an increase in memory T cells with enhanced effector function.

“We continue to build awareness of the unique potential of soquelitinib and ITK inhibition as a novel therapy that modulates parallel signaling pathways in the immune system for the treatment of oncology and immune diseases,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “This publication in npj Drug Discovery highlights foundational work characterizing key properties and mechanisms of soquelitinib conducted at Corvus and with academic collaborators, and we are excited to now be in clinical development for PTCL and atopic dermatitis, along with a broad range of additional opportunities for soquelitinib and our next-generation ITK inhibitors.”

The published research was a result of collaborations between scientists at Corvus and researchers at the University of Michigan, The Ohio State University, Peking University, Stanford University and Angel Pharmaceuticals Co., Ltd.  The publication is available online at the Nature website and on the Publications and Presentations page of the Corvus website.

Corvus is currently developing soquelitinib and its next-generation ITK inhibitors for oncology and immune diseases. The Company is enrolling patients in a registrational Phase 3 clinical trial in patients with relapsed peripheral T cell lymphoma (PTCL) and a randomized, placebo-controlled Phase 1 clinical trial in patients with moderate to severe atopic dermatitis. The Company plans to initiate a Phase 1 clinical trial of soquelitinib in patients with solid tumors.

About Corvus PharmaceuticalsCorvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is soquelitinib, an investigational, oral, small molecule drug that selectively inhibits ITK. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com.

About SoquelitinibSoquelitinib (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. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with cancers, including solid tumors, and in patients with 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. 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 has initiated a registrational Phase 3 clinical trial (NCT06561048) of soquelitinib in patients with relapsed PTCL. Soquelitinib is also now being investigated in a randomized placebo-controlled phase 1 clinical trial in patients with atopic dermatitis.

Forward-Looking StatementsThis press release contains forward-looking statements, including statements related to the potential efficacy of the Company’s product candidates including soquelitinib; the potential use of soquelitinib to treat PTCL, solid tumors and a broad range of autoimmune diseases; and the conduct, enrollment in and timing of clinical trials, including the Company’s Phase 3 clinical trial for PTCL with soquelitinib and Phase 1 clinical trials in patients with moderate to severe atopic dermatitis and in patients with solid tumors. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to risks detailed in the Company’s Quarterly Report on Form 10-Q for the three months ended September 30, 2024, filed with the Securities and Exchange Commission on November 12, 2024, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of its product candidates; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and clinical trials and release data from such studies and clinical trials; the results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to enroll sufficient numbers of patients in its clinical trials; the unpredictability of the regulatory process; regulatory developments in the United States and other foreign countries; the costs of clinical trials may exceed expectations; and the Company’s ability to raise additional capital. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

INVESTOR CONTACT:Leiv LeaChief Financial OfficerCorvus Pharmaceuticals, Inc.+1-650-900-4522llea@corvuspharma.com

MEDIA CONTACT:Sheryl SeapyReal Chemistry+1-949-903-4750sseapy@realchemistry.com