Corvus Pharmaceuticals Provides Business Update and Reports Third Quarter 2023 Financial Results
Protocol finalized for soquelitinib (CPI-818) Phase 3 registrational clinical trial in peripheral T cell lymphoma (PTCL); multiple sites preparing to initiate trial enrollment
New data from soquelitinib Phase 1 T cell lymphoma trial accepted for presentation at the 65th ASH Annual Meeting and Exposition
New publications highlight therapeutic potential of ITK inhibition in solid tumors and multiple autoimmune and allergic conditions
Conference call today at
“We continue to make progress towards initiating our Phase 3 registrational clinical trial for soquelitinib, including finalizing the study protocol and submitting it to the FDA,” said
Business Update and Strategy
Prioritized Program: Soquelitinib (formerly CPI-818, Corvus’ selective ITK inhibitor)
Soquelitinib for T Cell Lymphoma
- Corvus continues to enroll patients with relapsed PTCL in a Phase 1/1b clinical trial evaluating single agent therapy with soquelitinib. The latest data from the trial was reported at the
International Conference on Malignant Lymphoma, which took place June 13-17, 2023in Lugano, Switzerland. As of the May 18, 2023cut-off date, the data showed that a majority of the patients treated with the optimal dose of 200 mg twice per day of soquelitinib experienced tumor regression.
- New interim data from the Phase 1/1b clinical trial, along with complementary preclinical data, will be presented in a poster presentation at the 65th
American Society of Hematology(ASH) Annual Meeting and Exposition in December 2023.
Soquelitinib Preclinical Data in Hematologic and Solid Tumors
July 2023, Corvus announced the publication of preclinical data on soquelitinib as a preprint at bioRxiv, which highlighted the selective inhibition of ITK being able to potentially enhance anti-tumor immune response to hematologic and solid tumors, indicating its potential as a novel approach to cancer immunotherapy.
September 2023, a paper was published by an independent academic group in Scientific Reports validating the potential of ITK inhibition for treatment of solid tumors. The preclinical data demonstrated a reduction and reversal of T cell exhaustion markers and an increase in the infiltration of killer T cells into tumors, consistent with soquelitinib’s proposed mechanism of action. The paper highlights the potential of selective ITK inhibition for the treatment of cancers and helps to confirm preclinical and clinical results generated by Corvus.
Soquelitinib Preclinical Data in Autoimmune/Allergy
November 1, 2023, 2023, Corvus announced the publication of preclinical data on soquelitinib as a preprint at bioRxiv that demonstrated ITK’s selective inhibition which produced therapeutic benefits in several autoimmune and allergy preclinical models including psoriasis, asthma, pulmonary fibrosis, scleroderma and graft versus host disease. The mechanism of action involves the inhibition of Th2 and Th17 cells and the subsequent production of cytokines such as IL-17, IL-4, IL-5 and other cytokines involved in these diseases. The novel mechanism is a result of ITK inhibition and blockade of formation of Th2 and Th17 cells.
Partner Led Programs: Ciforadenant (adenosine 2a receptor inhibitor) and Mupadolimab (anti-CD73)
The Kidney Cancer Research Consortiumis enrolling a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The Phase 1b portion of this trial has been completed and patients are now being enrolled in the Phase 2 portion. The clinical trial is expected to enroll up to 60 patients and initial data is anticipated in early 2024. Angel Pharmaceuticals, Corvus’ partner in China, is enrolling patients in a Phase 1/1b clinical trial of mupadolimab in patients with non-small cell lung cancer (NSCLC) and head and neck squamous cell cancers. In this clinical trial, patients will receive mupadolimab monotherapy or in combination with pembrolizumab.
Research and development expenses for the three months ended
The net loss for the three months ended
Conference Call Details
Corvus will host a conference call and webcast today, Tuesday, November 7, 2023, at 4:30 p.m. ET (
About Corvus Pharmaceuticals
Soquelitinib (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).
About Peripheral T Cell Lymphoma
Peripheral T cell lymphoma is a heterogeneous group of malignancies accounting for about 10% of non-Hodgkin’s lymphomas (NHL) in Western populations, reaching 20% to 25% of NHL in some parts of
PTCL is a disease of mature helper T cells that express ITK, often containing numerous genetic mutations and frequently associated with viral infection. Most often the malignant cells of PTCL express a Th2 phenotype.
Ciforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine to immune cells present in the tumor microenvironment. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. Ciforadenant has been shown to block the immunosuppressive effects of myeloid cells present in tumors and preclinical studies published in 2018 demonstrated synergy with combinations of anti PD1 and anti-CTLA4 antibodies.
Mupadolimab (CPI-006) is an investigational, potent humanized monoclonal antibody that is designed to react with a specific site on CD73. In preclinical studies, it has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. While there are other anti-CD73 antibodies and small molecules in development for treatment of cancer, such agents react with a different region of CD73. Mupadolimab is designed to react with a region of the molecule that acts to stimulate B cells and block production of immunosuppressive adenosine. Mupadolimab is being studied in combination with pembrolizumab in a Phase 1b/2 clinical trial in patients with advanced head and neck cancers and in patients with NSCLC that have failed chemotherapy and anti-PD(L)1 therapy. It is postulated that the activation of B cells will enhance immunity within the tumors of these patients, leading to improved clinical outcomes.
This 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 into and successfully complete preclinical studies and clinical trials, including the Company’s Phase 1/1b clinical trial of soquelitinib and its Phase 1b/2 clinical trial of ciforadenant; the timing of and the Company’s ability to launch clinical trials including the potentially registrational Phase 3 clinical trial for soquelitinib; the timing of initial data from the Phase 1b/2 clinical trial with ciforadenant; the timing of and the Company’s ability to secure institutional review board approvals for its Phase 3 trial for soquelitinib; and the estimated amount of net cash used in operating activities for 2023 and its ability to fund operations into late 2024. 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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
|Three Months Ended
||Nine Months Ended
|Research and development||$||3,965||$||10,365||$||12,527||$||20,388|
|General and administrative||1,595||2,108||5,229||6,511|
|Total operating expenses||5,560||12,473||17,756||26,899|
|Loss from operations||(5,560||)||(12,473||)||(17,756||)||(26,899||)|
|Interest income and other expense, net||425||225||1,204||336|
|Sublease income - related party||—||147||56||439|
|Loss from equity method investment||(865||)||(2,730||)||(3,880||)||(5,367||)|
|Net loss per share, basic and diluted||$||(0.12||)||$||(0.32||)||$||(0.43||)||$||(0.68||)|
|Shares used to compute net loss per share, basic and diluted||48,971,246||46,553,511||47,683,792||46,553,511|
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash, cash equivalents and marketable securities||$||32,168||$||42,303|
|Operating lease right-of-use asset||1,423||2,217|
|Liabilities and stockholders' equity|
|Accounts payable and accrued liabilities and other liabilities||$||5,963||$||9,524|
|Operating lease liability||1,690||2,601|
|Total liabilities and stockholders' equity||$||51,942||$||68,240|
Chief Financial Officer
Source: Corvus Pharmaceuticals, Inc.