Corvus Pharmaceuticals Announces New Preclinical Data Highlighting Potential of Soquelitinib to Treat Systemic Sclerosis

Adds to growing body of evidence supporting the potential of ITK inhibition as a novel therapeutic for the treatment of a wide range of immune diseases

Data will be presented in a poster at ACR Convergence 2024, the annual meeting of the American College of Rheumatology

BURLINGAME, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced new preclinical data highlighting the potential of soquelitinib, the Company’s lead ITK inhibitor program, to prevent lung damage, inflammation and pulmonary hypertension caused by systemic sclerosis.

“We continue to build evidence that selective ITK inhibition can modulate immune responses for a wide range of immune diseases,” said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. “The preclinical findings reported at ACR confirm this potential for immune mediated fibrotic diseases such as systemic sclerosis. The data presented from these models provide a strong rationale for soquelitinib and our next-generation ITK inhibitors to be evaluated for these indications. While we may explore this potential in the future or via partnerships, we are currently focused on enrolling our soquelitinib registration Phase 3 trial in peripheral T cell lymphoma and Phase 1 trial in atopic dermatitis.”

Systemic sclerosis is an autoimmune disease characterized by inflammation, fibrosis, vascular damage and interstitial lung disease (ILD), with ILD and pulmonary hypertension being the major causes of death in these patients. The disease involves the activation of Th2 helper T cells and cytokines produced by these cells, including IL-4, IL-5 and IL-13.

The researchers utilized a Fra-2 transgenic mouse model that encompasses many of the features of systemic sclerosis in humans, including spontaneous systemic inflammation and fibrosis in the lungs, skin and heart, which leads to pulmonary hypertension and ILD. These mice also exhibit an accumulation of Th2 helper T cells.

The Fra-2 transgenenic mice were treated with oral soquelitinib for seven weeks, compared to control (untreated) Fra-2 transgenic mice. Compared to the control, the mice treated with soquelitinib showed:

• Significant reduction in lung infiltration and fibrosis, assessed by histology
• Significant improvement in clinical score, which measures disease severity
• Reduced vascular smooth muscle hypertrophy, assessed by histology
• Reduced right ventricular systolic blood pressure, consistent with improvement in pulmonary hypertension

These results were confirmed in a second model of pulmonary fibrosis using a bleomycin lung injury model. Treatment with soquelitinib showed reduced pulmonary fibrosis, and infiltration with Th2 helper T cells.

The data will be presented in a poster session on Sunday, November 17 at ACR Convergence 2024, the annual meeting of the American College of Rheumatology, taking place November 14-19, 2024 in Washington, D.C. The poster, which is titled, “Inhibition of Interleukin-2-Inducible T Cell Kinase with Soquelitinib Demonstrates Efficacy in Preventing Lung Damage in Murine Models of Systemic Sclerosis,” will be presented by Professor Yannick Allanore, M.D., Ph.D., Professor of Rheumatology, Université Paris Cité, Institut Cochin, Paris, France.

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 Systemic Sclerosis
Systemic sclerosis, also known as scleroderma, is a rare autoimmune disease that causes inflammation and fibrosis in the skin and multiple internal organ systems. It is estimated to affect approximately 125,000 people in the United States and 2.5 million people worldwide. Systemic sclerosis can lead to damage to blood vessels and internal organs, such as the heart, lungs and kidneys. Interstitial lung disease impacts approximately one-third to one-half of patients and is one of the leading causes of mortality in patients with the disease. There is no cure for systemic sclerosis, and current treatment options aim to relieve symptoms and stop disease progression.

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. 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. The immunologic effects of soquelitinib lead to what is known as Th1 skewing and inhibition of Th2 and Th17 cells. 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. 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.

Forward-Looking Statements
This 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 Company’s conduct of, enrollment in and timing of clinical trials, including the Company’s Phase 3 clinical trial in PTCL and Phase 1 clinical trial in atopic dermatitis. 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 Lea
Chief Financial Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4522
llea@corvuspharma.com

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