Corvus Pharmaceuticals Provides Business Update and Reports Second Quarter 2020 Financial Results
Provides Update on CPI-006 Phase 1 COVID-19 Study
Conference Call Today at
“In the second quarter, we advanced each of our three clinical oncology programs, highlighted by the presentation of new data at ASCO on the identification of a refined biomarker that enriches for responding patients with renal cell cancer treated with our lead candidate, ciforadenant,” said
“We also added a fourth program utilizing our novel immunomodulatory antibody CPI-006 for treatment of patients with mild-to-moderate COVID-19. Our unique approach is based on the ability of CPI-006 to activate B cells, leading to the production of anti-SARS-CoV-2 IgM and IgG antibodies and memory B cells, which has the potential to shorten recovery time and improve long-term protective immunity. The study is advancing on track with the first cohort of five patients fully enrolled and four of five patients now enrolled in the second cohort. We expect to report anti-SARS-CoV-2 antibody and memory B cell results from our study later this year.”
Ciforadenant (CPI-444): A2A Receptor Antagonist of Adenosine
- Presented updated data from the Phase 1b/2 clinical trial of ciforadenant in patients with refractory renal cell carcinoma (RCC) at the ASCO20 Virtual Scientific Program. The data covered 51 patients and showed an objective response rate (ORR) of 17% by RECIST criteria in Adenosine Gene Signature positive patients (n=31) and 0% ORR in the Adenosine Gene Signature negative group (n=20). The ORR improved to 27% with a refined version of the test, which is based on the measurement of CD68 positive myeloid cells, the downstream target of adenosine.
CPI-006: Anti-CD73 Antibody with Immunomodulatory Activity
- Initiated an open-label, Phase 1 study of CPI-006 in COVID-19 patients with mild to moderate symptoms. Patients will receive a single dose of CPI-006, with levels of 0.3, 1.0, 3.0 and 5.0 mg/kg, escalating in four cohorts as the study progresses. Patients will receive medications, therapies, and interventions per standard treatment protocols for COVID-19 for the duration of the study. The primary efficacy endpoint is the change in serum immunoglobulin (IgM and IgG) anti-SARS-CoV-2 levels compared to baseline at day 28. The study will also examine safety and effects on anti-viral memory B cells and other clinical endpoints, including time to resolution of symptoms and duration of hospitalization.
- COVID-19 Study Update: Since the announcement of the study and enrollment of the first cohort of five patients in early July, four of five patients in the second cohort have been enrolled in the study. As of the cutoff date of
July 30, 2020, no dose limiting toxicities had been noted and early anti-SARS-CoV-2 antibody response data was encouraging with relatively high titers of IgG and IgM to both spike and receptor binding domain (RBD) viral proteins observed. In the first two patients receiving the lowest dose of CPI-006 and tested at an early Day 7 time point, IgG titers to spike protein were > 1:25,000 and > 1:50,000. One of these patients has also completed Day 14 testing, which showed the titers to viral spike protein and RBD had increased to > 1:100,000. Significant levels of IgM antibodies were also detected. The Company remains on track to report 28-day follow up results from the Phase 1 study later this year.
- Completed enrollment in three dose escalation arms of the CPI-006 Phase 1/1b cancer clinical trial: monotherapy, combination with ciforadenant and combination with pembrolizumab and we continue to enroll the triplet combination dose escalation arm with ciforadenant and pembrolizumab. Updated clinical data from the Phase 1/1b oncology clinical trial is targeted to be presented later this year.
CPI-818: A small molecule ITK inhibitor
- Completed enrollment in the dose escalation portion (N=16) of the CPI-818 Phase 1/1b clinical trial, which included patients with several types of advanced, refractory T-cell lymphomas. Based on results from this portion of the study, including a confirmed complete response in one patient with peripheral T-cell lymphoma (PTCL) who previously failed chemotherapy and high dose chemotherapy with autologous bone marrow transplantation, the Company selected the CPI-818 optimum dose and began the next portion of the study with a focus on patients with PTCL and cutaneous T-cell lymphoma (CTCL).
Anticipated Future Events
- Data from the Phase 1 trial of CPI-006 used to treat COVID-19 patients later this year.
- The Company plans to meet with the FDA to discuss the study design and plans for a ciforadenant pivotal study in advanced refractory RCC using the Adenosine Gene Signature as a biomarker.
- Updated clinical data from the CPI-006 Phase 1/1b oncology clinical trial is planned to be presented later this year.
- Updated clinical data from the CPI-818 Phase 1/1b clinical trial is planned to be presented at the
American Society of Hematology(ASH) annual meeting in December 2020.
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,
About Corvus Pharmaceuticals
Ciforadenant (CPI-444) is a 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 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. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine.
Adenosine Gene Signature and CD68+ Myeloid Cells
The adenosine gene signature is a biomarker that reflects adenosine induced immunosuppression in the tumor. These genes express chemokines that recruit myeloid cells including immunosuppressive tumor associated CD68+ myeloid cells, which are thought to mediate resistance to anti-PD-(L)1 treatment. To date, in our clinical trial of renal cell cancer, this biomarker has been associated with a higher rate of response to ciforadenant. CD68+ cells can be enumerated using standard immunohistochemical techniques that are routinely available in pathology laboratories.
CPI-006 is a potent humanized monoclonal antibody that reacts with a specific site on CD73. 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 in development for treatment of cancer, such antibodies have been reported to react with a different region of CD73 and are designed to block production of adenosine, which is not involved in the immunomodulatory processes seen with CPI-006.
CPI-818 is a small molecule drug given orally that has been shown to selectively inhibit ITK (interleukin-2-inducible T-cell kinase). It was developed to possess dual properties: to block malignant T-cell growth and 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. Interference with ITK signaling can modulate immune responses to various antigens. The inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas – similar to the role of Bruton’s tyrosine kinase (BTK) in B-cells.
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of ciforadenant, CPI-006, and CPI-818, the Company’s ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company’s Phase 1b/2 clinical trial of ciforadenant, the Company’s Phase 1/1b clinical trial of CPI-006, the Company’s Phase 1/1b clinical trial of CPI-818, in each case, for certain cancers, as well as the Company’s Phase 1 trial of CPI-006 for COVID-19, the timing of the availability and announcement of clinical data, the suitability of dosing regimen selected for clinical trials, and the impact of COVID-19 and related “shelter in place” orders and other public health guidance measures on our clinical programs and business operations, and the expected cash needs and operating expenses for the second half of 2020. 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 quarter ended
Chief Financial Officer
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
|Three Months Ended
||Six Months Ended
|Research and development||$||7,857||$||10,640||$||18,020||$||20,059|
|General and administrative||2,910||2,956||6,016||5,842|
|Total operating expenses||10,767||13,596||24,036||25,901|
|Loss from operations||(10,767||)||(13,596||)||(24,036||)||(25,901||)|
|Interest income and other expense, net||156||618||490||1,280|
|Net loss per share, basic and diluted||$||(0.36||)||$||(0.44||)||$||(0.80||)||$||(0.84||)|
|Shares used to compute net loss per share, basic and diluted||29,428,249||29,309,150||29,419,741||29,301,505|
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash, cash equivalents and marketable securities||$||59,258||$||77,982|
|Operating lease right-of-use asset||1,996||2,327|
|Liabilities and stockholders' equity|
|Accounts payable and accrued liabilities and other liabilities||$||10,577||$||9,347|
|Operating lease liability||2,760||3,188|
|Total liabilities and stockholders' equity||$||64,177||$||83,646|
Source: Corvus Pharmaceuticals, Inc.