Corvus Pharmaceuticals Announces Initiation of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis

Atopic dermatitis is the first immune disease indication being studied in the clinic for soquelitinib, the Company's selective ITK inhibitor

Corvus anticipates releasing initial clinical data from trial before year-end 2024

BURLINGAME, Calif., April 09, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced the initiation of the Company's randomized, double-blind, placebo-controlled Phase 1 clinical trial evaluating soquelitinib in patients with moderate to severe atopic dermatitis. The trial is expected to enroll 64 patients at 12 sites in the United States, with the potential for initial clinical data before year-end 2024.

"The initiation of our Phase 1 atopic dermatitis trial is an important step towards unlocking the broad potential of ITK inhibition for immune diseases," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Soquelitinib has the potential to improve the treatment landscape for atopic dermatitis by providing an oral medication designed to block multiple cytokines involved in the inflammatory process, compared to current injectable biologic therapies that only inhibit one or a limited number of cytokines. We look forward to ramping up enrollment with the potential to share initial data from the trial before year-end, while also working to initiate our soquelitinib registrational Phase 3 trial for PTCL."

Corvus previously published preclinical data describing soquelitinib's unique mechanism of action through ITK inhibition, supporting the rationale for its use in Th2-mediated diseases like atopic dermatitis. In addition, the Company has evaluated soquelitinib in companion dogs with naturally occurring, refractory atopic dermatitis. Results from this study demonstrated soquelitinib's potential activity in this disease.

About the Soquelitinib Atopic Dermatitis Phase 1 Clinical Trial

The randomized, double-blind, placebo-controlled Phase 1 clinical trial is planned to enroll 64 patients with moderate to severe atopic dermatitis that previously failed one prior topical or systemic therapy. Patients will be randomized in a 3:1 ratio to receive one of four 28-day dosing regimens (100 mg BID, 200 mg QD, 200 mg BID, or 400 mg QD) of soquelitinib or equivalent placebo. The primary endpoints include safety and tolerability, and efficacy, which will be measured by improvement in Eczema Area and Severity Index score, Investigator Global Assessment, reduction in itch and various cytokine biomarkers. Corvus and a data monitoring committee will be able to monitor the data from the trial.

About Atopic Dermatitis

Atopic dermatitis, also called eczema, is a chronic disease that can cause inflammation, redness, scaly patches, blisters and irritation of the skin. It affects up to 20% of children and up to 10% of adults, and treatments include topical therapies, oral therapies and systemic injectable biologic therapies. It is frequently associated with other allergic disorders such as food allergies and asthma. Atopic dermatitis, like asthma and allergy, involves the participation of Th2 lymphocytes which secrete cytokines that result in inflammation. Soquelitinib has been shown in preclinical studies to inhibit cytokine production from Th2 lymphocytes.

About Corvus Pharmaceuticals

Corvus 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 Soquelitinib

Soquelitinib (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. The immunologic effects of soquelitinib lead to what is known as Th1 skewing and is made possible by the high selectivity of soquelitinib for ITK. Research on soquelitinib's mechanism of action suggests that it has the potential to control differentiation of normal T helper cells and enhance immune responses to tumors by augmenting the generation of cytotoxic killer T cells and the production of cytokines that inhibit cancer cell survival. Soquelitinib has also been shown to prevent T cell exhaustion, a major limitation of current immunotherapy and CAR-T therapies. Optimal doses of soquelitinib 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 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.

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company's product candidates including soquelitinib; the potential use of soquelitinib to treat a variety of hematological cancers and autoimmune diseases; the Company's ability and its partners' ability, as well as the timing thereof, to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company's Phase 1 clinical trial for atopic dermatitis with soquelitinib; the timing of and the Company's ability to launch clinical trials, including the soquelitinib registrational Phase 3 clinical trial for PTCL; the design of clinical trials, including the timeline for initiation, target or expected number of patients to be enrolled, expected number of sites and certain other product development milestones, including in regards to the Phase 1 clinical trial for atopic dermatitis with soquelitinib; the availability and timing of clinical data announcements, including initial data from the Phase 1 clinical trial for atopic dermatitis with soquelitinib. 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 Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on March 19, 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 soquelitinib and its other 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 to fund its operations and continue as a going concern, of which substantial doubt exists. 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 Lea

Chief Financial Officer

Corvus Pharmaceuticals, Inc.

+1-650-900-4522

[email protected]

MEDIA CONTACT:

Sheryl Seapy

Real Chemistry

+1-949-903-4750

[email protected]