Corvus Pharmaceuticals Provides Business Update and Reports Third Quarter 2022 Financial Results
Data From CPI-818 T Cell Lymphoma Study Accepted for Presentation at the 64th ASH Annual Meeting and Exposition; Advancing CPI-818 Development for Autoimmune and Allergic Diseases
Initiation of a Phase 1b/2 Clinical Trial of Ciforadenant in First Line Renal Cell Cancer (RCC) in Partnership with
IND approved in
Conference Call Today at
"We anticipate several important milestones for all three of our clinical programs in the near-term, headlined by the continued advancement of CPI-818 for T cell lymphoma and the initiation of studies for CPI-818 in autoimmune disease,” said
“We also continue to advance ciforadenant, our adenosine 2a receptor inhibitor, with the recent initiation of a Phase 1b/2 clinical trial in first line renal cell cancer. This study is partnered with the
Business Update and Strategy
CPI-818 (selective ITK inhibitor)
- Monitoring of immune modulation of normal T cells as well as safety and anti-tumor activity are being assessed in the clinical trial, with new data to be presented at the 64th
American Society of Hematology(ASH) Annual Meeting and Exposition in December 2022.
- As of
July 22, 2022, 12 patients were enrolled in the 200 mg cohort and eight were evaluable for response. In this group, there was one complete response (CR) lasting 25 months; one nodal CR lasting 16 months; one partial response (PR) ongoing at two months follow up. Five patients had stable disease (SD), two of the patients with SD had been on treatment for approximately 12 weeks and continued on study. Two additional patients were on treatment and had not yet had their disease monitoring assessments. An additional patient in the 600 mg cohort also had a PR.
- Analysis of blood in four of four patients treated in the 200 mg cohort showed increases in Th1 cells compared to baseline and increases in terminally differentiated T effector memory cells; these are T cells that are antigen primed and capable of destroying tumor cells. Tumor biopsy from one patient taken during response demonstrated an increase in these cells in the tumor.
- Three of three patients in the 200 mg cohort with high baseline, pretreatment eosinophil counts demonstrated reductions in circulating eosinophils during treatment with CPI-818. Eosinophils are white blood cells that play a key role in allergic and autoimmune diseases, and they are often elevated in patients with TCL.
Corvus is also developing CPI-818 for autoimmune and allergic diseases and is preparing to initiate clinical trials for certain autoimmune diseases in the near term.
- CPI-818 has demonstrated activity in various animal models of autoimmunity including models of systemic lupus erythematosus, psoriasis, inflammatory bowel disease, lung fibrosis and graft versus host disease. Some of this research was presented at the annual meetings of the
American Society of Hematologyin 2020 and 2021.
- Corvus’ research and development team has been working to prioritize and prepare protocols for new CPI-818 clinical studies in autoimmune diseases, with the announcement of next clinical program anticipated in the near-term.
Ciforadenant (adenosine 2a receptor inhibitor) for first line renal cell cancer
- Corvus is collaborating with the KCRC in an open-label Phase 1b/2 clinical trial evaluating ciforadenant as a first line therapy for metastatic RCC in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The clinical trial is expected to enroll up to 60 patients and is intended to evaluate the potential for ciforadenant to generate increased complete responses and deep responses in the first line setting.
- The KCRC is comprised of a group of leading cancer centers in
the United Statesled by investigators at The University of Texas MD Anderson Cancer Center. The trial design is based on Corvus’ preclinical research published in 2018 in Cancer Immunology Researchthat demonstrated impressive antitumor control and complete tumor elimination in several animal models using ciforadenant in combination with anti-CTLA-4 and anti-PD-1.
September 2022, the Center for Drug Evaluationof the China National Medical Products Administrationapproved an IND application to initiate a Phase 1/1b clinical trial with mupadolimab alone and together with pembrolizumab in patients with relapsed refractory non-small cell lung cancer and head and neck squamous cell cancers. Corvus anticipates that the study will be initiated by Angel Pharmaceuticalsin the near-term.
R&D Conference Call and Webcast on
The Company will host a conference call on
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, Thursday, November 3, 2022, at 4:30 p.m. ET (
About Corvus Pharmaceuticals
CPI-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. ITK controls the differentiation of T cells into various T cell subsets that function in destruction of pathogens, cancer cells and in inflammation. 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 Th2 cells. Th1 T cells are required for immunity to tumors, viral infections and other infectious diseases. Th2 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 the drug 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.
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 in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine triphosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity.
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 CPI-818, ciforadenant and mupadolimab; 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 and Angel’s Phase 1/1b clinical trials of CPI-818, the Company’s planned clinical development of CPI-818 for autoimmune diseases, the Company and KCRC’s Phase 1b/2 clinical trial of ciforadenant, as well as Angel Pharmaceutical’s planned Phase 1/1b clinical trial of mupadolimab; the timing of the availability and announcement of clinical data and certain other product development milestones, including the timing of results in the Phase 1/1b clinical trial for CPI-818 and initial results in the Phase 1b/2 clinical trial for ciforadenant; the expected trial design and number of patients enrolled in the Company’s upcoming planned clinical trials; and the estimated amount of net cash used in operating activities for 2022, the Company’s estimated cash balance as of
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
|Three Months Ended
||Nine Months Ended
|Research and development||$||10,365||$||6,991||$||20,388||$||24,327|
|General and administrative||2,108||2,056||6,511||7,493|
|Total operating expenses||12,473||9,047||26,899||31,820|
|Loss from operations||(12,473||)||(9,047||)||(26,899||)||(31,820||)|
|Interest income and other expense, net||225||(11||)||336||(7||)|
|Sublease income - related party||147||94||439||94|
|Loss from equity method investment||(2,730||)||(1,709||)||(5,367||)||(2,272||)|
|Net loss per share, basic and diluted||$||(0.32||)||$||(0.24||)||$||(0.68||)||$||(0.84||)|
|Shares used to compute net loss per share, basic and diluted||46,553,511||43,947,004||46,553,511||40,270,954|
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash, cash equivalents and marketable securities||$||49,617||$||69,451|
|Operating lease right-of-use asset||2,467||3,190|
|Liabilities and stockholders' equity|
|Accounts payable and accrued liabilities and other liabilities||$||12,797||$||8,646|
|Operating lease liability||2,870||3,647|
|Total liabilities and stockholders' equity||$||80,348||$||109,455|
Chief Financial Officer
Source: Corvus Pharmaceuticals, Inc.