CRVS Corvus Pharmaceuticals Inc

Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today announced that it will present new data for CPI-818, the Company’s ITK inhibitor, at the American Association for Cancer Research (AACR) Annual Meeting, which is taking place April 14-19, 2023 in Orlando, FL.

The data demonstrates that in a murine syngeneic CT26 colon cancer model, single-agent CPI-818 showed anti-tumor activity, and when CPI-818 was combined with suboptimal doses of anti-PD1 and anti-CTLA4 therapy, 100% of treated animals achieved complete tumor elimination. In addition, this triplet combination achieved durable anti-tumor immune memory demonstrated by the introduction and complete elimination of new CT26 tumor cells in already treated animals. Corvus believes these findings provide the foundation for potential future human clinical trials of CPI-818 for the treatment of solid tumors.      

“We have prioritized the development of CPI-818 given its broad potential across oncology and immune disease,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “Our strategy is similar to the development of BTK inhibitors, starting in lymphoma, where we have established CPI-818’s safety and activity profile with plans to explore other oncology and immune disease indications. The new data that will be presented at AACR we believe provides the foundation for CPI-818 to be studied as a treatment for solid tumors. It shows that selective ITK inhibition modulates the immune response to be more active against tumor cells, which may enable the next generation of tumor immunotherapy.”

CPI-818 is currently being studied in a Phase 1/1b clinical trial as a single agent therapy in patients with relapsed T cell lymphoma (TCL). Data from this study has shown that CPI-818 induces Th1 skewing, which is the maturation of T cells into mature effector T cells that are capable of eliminating cancer cells and viral infected cells. The data to be presented at AACR further explores the mechanisms behind these properties, demonstrating that anti-tumor activity required CD8+ T cells, and that treatment with CPI-818 increased CD8+ T effector cell tumor infiltration. In addition, levels of several exhaustion makers were down-regulated by treatment with CPI-818, suggesting that inhibition of ITK by CPI-818 produces favorable changes in the tumor microenvironment that could enhance anti-tumor immune system activity.

Details regarding the CPI-818 poster presentation at AACR, which will be available in the poster hall and the Corvus website, are as follows:

Date and Time: Monday, April 17, 2023, from 9:00 am – 12:30 PM ET

Title: Selective ITK blockade induces antitumor responses and enhances efficacy to immune checkpoint inhibitors in preclinical models

Abstract #: 1813

Presenter: Lih-Yun Hsu, Ph.D., Director of Immunology, Corvus Pharmaceuticals

About Corvus PharmaceuticalsCorvus Pharmaceuticals is a clinical-stage biopharmaceutical company. Corvus’ lead product candidate is CPI-818, an investigational, oral, small molecule drug that selectively inhibited ITK in preclinical studies and is in a multicenter Phase 1/1b clinical trial in patients with several types of T cell lymphomas. The Company’s second clinical program, ciforadenant (CPI-444), is an oral, small molecule inhibitor of the A2A receptor that is in an open-label Phase 1b/2 clinical trial. Its third clinical program, mupadolimab (CPI-006), is a humanized monoclonal antibody directed against CD73 that has exhibited immunomodulatory activity and activation of immune cells in preclinical and clinical studies. For more information, visit www.corvuspharma.com.

About CPI-818CPI-818 is an investigational small molecule drug given orally that has selectively inhibited ITK (interleukin-2-inducible T cell kinase) in preclinical studies. It was designed to block malignant T cell growth and to modulate immune responses. ITK, an enzyme, is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function. Recent clinical data in T cell lymphomas suggests that CPI-818 has the potential to control differentiation of T helper cells and enhance immune responses to tumors. Interference with ITK signaling also can modulate immune responses to various antigens. Optimal doses of CPI-818 have 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 Th2 related 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 immunologic effects of CPI-818 lead to what is known as Th1 skewing and is made possible by the high selectivity of CPI-818 for ITK. The Company believes the inhibition of specific molecular targets in T cells may be of therapeutic benefit for patients with T cell lymphomas and leukemias and in patients with autoimmune and allergic diseases. The Company is conducting a Phase 1/1b trial in patients with refractory T cell lymphomas that was designed to select the optimal dose of CPI-818 and evaluate its safety, PK, target occupancy, immunologic effects, biomarkers and efficacy. Interim data from the Phase 1/1b clinical trial of CPI-818 for T cell lymphoma demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies, and identified a dose that maximally affects T helper cell differentiation.

Forward-Looking StatementsThis press release contains forward-looking statements, including statements related to CPI-818’s broad potential across oncology and immune diseases; and the Company’s ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company’s Phase 1/1b clinical trial of CPI-818. 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 quarter ended September 30, 2022, filed with the Securities and Exchange Commission on November 3, 2022, 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 results of preclinical studies and interim data from clinical trials not being predictive of future results; the Company’s ability to demonstrate sufficient evidence of efficacy and safety in its clinical trials of CPI-818, ciforadenant and mupadolimab; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete preclinical studies and 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