CRVS Corvus Pharmaceuticals Inc

Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, today announced the publication of preclinical data that demonstrated the potential of ITK inhibition as a novel approach to treat T cell-mediated inflammatory and immune diseases. Corvus’ ITK inhibitors include soquelitinib (formerly known as CPI-818), which was used in the preclinical studies and is currently in clinical trials for oncology indications, and several next-generation molecules that are being optimized for use in a variety of inflammatory and immune disease indications.

“Our research on soquelitinib and selective ITK inhibition is uncovering valuable new information about immune function and the role of ITK in different diseases,” said James Rosenbaum, M.D., senior vice president of research at Corvus. “The activity of soquelitinib in various inflammatory and immune disease models highlights the essential role of ITK in multiple T cell functions. Our publication demonstrates that soquelitinib can impact disease-associated cytokines by targeting the cellular sources, specifically Th2 and Th17 cells, which produce cytokines like IL-4, IL-5, IL-13 and IL-17. We believe that blocking the source of cytokine production upstream offers advantages over existing therapies that individually target specific cytokines.”

Professor Yannick Allanore, M.D., Ph.D., Professor of Rheumatology, Université Paris Cité, Institut Cochin, Paris, France, and a co-author of the publication, said, “Pulmonary fibrosis and systemic sclerosis are often fatal diseases for which current therapy is inadequate. Soquelitinib utilizes a novel mechanism and was effective in our model related to systemic sclerosis which is based on Fra2 gene overexpression, a model designed to represent human lung disease manifestations. Based on these data, we are eager to evaluate soquelitinib in a clinical trial for fibrotic diseases.”

The publication, entitled “Soquelitinib, A Selective Inhibitor of Interleukin- 2- Inducible T Cell Kinase (ITK), is Active in Several Murine Models of T Cell-Mediated Inflammatory Disease,” highlights data demonstrating that soquelitinib was active in six different models of T cell-mediated inflammatory and immune disease, including acute and chronic asthma, pulmonary fibrosis, systemic sclerosis (scleroderma), psoriasis, and acute graft versus host disease. The data also describe soquelitinib’s unique mechanism of action, providing rationale for the development of ITK inhibition in a range of additional Th2 and Th17 mediated diseases, including asthma, psoriasis, atopic dermatitis, chronic obstructive pulmonary disease (COPD), systemic sclerosis, lupus and other diseases. The published research was a result of collaborations between scientists at Corvus and researchers at both Memorial Sloan Kettering Cancer Center in New York and The National Institute of Health and Medical Research (INSERM) in France. The publication is now available online as a preprint at bioRxiv.org and on the Publications and Presentations page of the Corvus website.

“We are making significant progress with soquelitinib and believe that Corvus is firmly positioned as a leader in the scientific and clinical development of ITK inhibition as a platform opportunity across cancer, inflammation and immune disease,” said Richard A. Miller, M.D., co-founder, president, and CEO of Corvus. “Our primary focus is treating T cell lymphomas and cancer and we are actively preparing for a registrational Phase 3 trial of soquelitinib for peripheral T cell lymphoma. With this new publication, we further demonstrate the wide range of opportunities for ITK inhibition across specific indications with ongoing patient needs for new therapies. In addition, we have a robust pipeline of next generation ITK inhibitors and a portfolio of intellectual property that we believe provide attractive partnering opportunities for companies focused on various inflammatory and immune diseases.”

Key results from the preclinical studies described in the publication demonstrated that soquelitinib had the following observed effects in models of inflammatory disease:

• Acute and chronic asthma models:
  • Significant reductions in Th2 cytokines IL-4, IL-5 and IL-13 in both models, along with reductions in a validated disease activity score
  • Reduction in IL-6 signifying amelioration of inflammation
• Systemic sclerosis (Fra2 gene overexpression) model:
  • Improvement in clinical score and preservation of body weight
  • Improvement in lung histology, reduction of fibrosis and improvement in pulmonary vascular hypertension
  • Reduction of GATA3-expressing T cells, indicative of effect on Th2 cells
  • Reduction of ROR gammaT cells (RORγT), indicative of effects on Th17 cells
• Pulmonary fibrosis (bleomycin-induced) model:
  • More consistent reduction of pulmonary fibrosis compared to an FDA-approved medication (nintedanib)
  • Similar reduction in GATA3 as the systemic sclerosis model results
  • Reduction in MMP2 and TGF beta, two messenger RNAs associated with fibrosis
• Psoriasis (imiquimod (IMQ)-induced) model:
  • Improvement in epidermal thickness, erosion and inflammation
  • In vitro studies demonstrated a reduction in the expression of RORγT protein, a master transcription factor that is responsible for developing Th17 cells, and a corresponding dose-dependent reduction in IL-17 cytokine production
• Graft versus host disease (GVHD) model:
  • Improvement in survival rates and corresponding decrease in clinical GVHD score
  • No impact on engraftment or graft-versus-tumor effect

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. Corvus plans to initiate a Phase 3 registrational clinical trial for soquelitinib in patients with relapsed peripheral T cell lymphoma. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com.

About SoquelitinibSoquelitinib (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. 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 plans to initiate a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed peripheral T cell lymphoma (PTCL).

Forward-Looking StatementsThis press release contains forward-looking statements, including statements related to the potential safety and efficacy of the Company’s product candidates including soquelitinib, ciforadenant and mupadolimab; the potential use of soquelitinib to treat a variety of solid tumors and hematological cancers; the Company’s ability and its partners’ ability, as well as the timing thereof, to develop and advance product candidates through and successfully complete preclinical studies and clinical trials; the timing of and the Company’s ability to launch clinical trials including the potential registrational Phase 3 clinical trial for soquelitinib; and whether the Company is able to secure any partnerships or advance soquelitinib in any other indications. 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 June 30, 2023, filed with the Securities and Exchange Commission on August 8, 2023, 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 a sufficient number 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