Corvus Pharmaceuticals Provides Business Update and Reports Second Quarter 2019 Financial Results
“Corvus continues to be a leader in the field of drug development targeting the adenosine pathway, with complementary lead programs – ciforadenant and CPI-006 – that have shown promising activity in a range of solid tumors. We also have a third program in the clinic, CPI-818, which is an ITK inhibitor for the treatment of patients with advanced T-cell lymphomas. Together, I believe these three programs position Corvus as a leader in the development of second-generation immuno-oncology agents,” said
Ciforadenant (CPI-444): A2A Receptor Antagonist of Adenosine
- Continued enrollment of patients with renal cell cancer (RCC) in an amended Phase 1b/2 clinical trial evaluating ciforadenant in combination with Genentech’s Tecentriq® (atezolizumab), an anti-PD-L1 antibody. The RCC patients in the trial have failed treatments with anti-PD-(L)1 antibodies and tyrosine kinase inhibitors. This trial is also evaluating the use of a novel gene expression biomarker known as the Adenosine Signature, that may have the potential to predict patients most likely to respond to therapy.
- Amending our ongoing Phase 1b/2 study to include an arm evaluating ciforadenant in combination with Tecentriq in patients with prostate cancer. This arm will also evaluate the use of the Adenosine Signature.
- Continued follow-up in a Phase 1b/2 trial of ciforadenant and Tecentriq being conducted by Genentech as part of their MORPHEUS platform. The study is evaluating this combination in patients who have failed no more than two prior regimens.
CPI-006: Immunomodulatory Anti-CD73 Antibody
- Continued enrollment of up to 350 patients with advanced cancer in a Phase 1/1b clinical trial evaluating CPI-006 as a single agent and in combination with either ciforadenant or pembrolizumab. The trial is currently enrolling patients in the dose escalation phase for CPI-006 administered as a monotherapy and in combination with ciforadenant.
- Initial clinical data covering 20 patients with advanced, refractory cancer from the Phase 1/1b trial was delivered in an oral presentation at the 2019
American Society of Clinical Oncology( ASCO) Annual Meeting in June 2019. The initial data showed a trend toward longer disease control with higher doses of CPI-006, and enhanced disease control with CPI-006 in combination with ciforadenant compared with monotherapy. Additional highlights from the presentation:
- Clinical and laboratory results demonstrated potential for a new immuno-oncology approach with CPI-006 via activation of immune cells and the inhibition of adenosine production.
- Dose-dependent disease control when administered as a monotherapy and in combination with ciforadenant.
- CPI-006 was well tolerated at all dose levels, with no dose-limiting toxicities. Grade 1 infusion reactions were detected (N=3 patients) and mitigated with premedication with acetaminophen and antihistamine. Grade 3 or 4 toxicities included a grade 3 anemia (N=1).
CPI-818: A small molecule ITK inhibitor
- Continued enrolling patients with T-cell lymphomas, including peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and others, in a Phase 1/1b study with CPI-818, an ITK inhibitor.
Anticipated Events in 2H 2019
- Updated clinical and immunologic data from the Phase 1/1b clinical trial of CPI-006 monotherapy and combination with ciforadenant is expected to be presented at the
Society for Immunotherapy of Cancer( SITC) annual meeting in November 2019.
- Presentation on identification and role of biomarkers in adenosine pathway therapies is expected to be presented at
- Preclinical and early clinical data regarding CPI-818 is expected to be presented in late 2019 or early 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,
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies. Corvus’ lead product candidates are ciforadenant (CPI-444), a small molecule inhibitor of the A2A receptor, and CPI-006, a humanized monoclonal antibody directed against CD73 that exhibits immunomodulatory activity and blockade of adenosine production. These candidates are being studied in ongoing Phase 1 and 2 clinical trials in patients with a wide range of advanced solid tumors. Ciforadenant is being evaluated in a successive expansion cohort trial examining its activity both as a single agent and in combination with Genentech’s atezolizumab, an anti-PD-L1 antibody. CPI-006 is being evaluated in a multicenter Phase 1/1b clinical trial as a single agent, in combination with ciforadenant, and with pembrolizumab. The Company’s third clinical program, CPI-818, an oral, small molecule drug that has been shown to selectively inhibit ITK, is in a multicenter Phase 1/1b clinical trial in patients with several types of T-cell lymphomas. For more information, visit www.corvuspharma.com.
Tecentriq® is a registered trademark of Genentech.
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. In vitro and preclinical studies have shown that dual blockade of CD73 and the A2A receptor may be synergistic.
CPI-006 is a potent humanized monoclonal antibody that reacts with the active site of CD73, blocking the conversion of AMP to adenosine. This antibody also possesses immunomodulatory activity resulting in activation of lymphocytes and effects on lymphocyte trafficking, which are independent of adenosine. In vitro studies of CPI-006 have shown it is capable of substantially inhibiting the production of adenosine by blocking the CD73 enzyme.
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. BTK is now an established target for treating various B-cell lymphomas, and two BTK inhibitors, ibrutinib and aclarabrutinib, have been approved by the
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of ciforadenant, CPI-006 and CPI-818, the potential similarities of BTK inhibition and ITK inhibition, the Company’s ability 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 ciforadenant, the Company’s Phase 1/1b clinical trial of CPI-006, and the Company’s Phase 1/1b clinical trial of CPI-818, the utility of biomarker data collected and the suitability of dosing regimen selected for clinical trials, the potential timing and availability of data from the Company’s ongoing clinical trials, and expected cash needs and operating expenses for the second half of 2019 . 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
|CORVUS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
|Three Months Ended
|Six Months Ended
|Research and development||$||10,640||$||9,715||$||20,059||$||21,818|
|General and administrative||2,956||2,543||5,842||5,084|
|Total operating expenses||13,596||12,258||25,901||26,902|
|Loss from operations||(13,596||)||(12,258||)||(25,901||)||(26,902||)|
|Interest income and other expense, net||618||627||1,280||970|
|Net loss per share, basic and diluted||$||(0.44||)||$||(0.40||)||$||(0.84||)||$||(1.01||)|
|Shares used to compute net loss per share, basic and diluted||29,309,150||28,979,514||29,301,505||25,785,543|
|CORVUS PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
|June 30,||December 31,|
|Cash, cash equivalents and marketable securities||$||96,840||$||114,597|
|Operating lease right-of-use asset||2,634||—|
|Liabilities and stockholders' equity|
|Accounts payable and accrued liabilities and other liabilities||$||9,882||$||7,896|
|Operating lease liability||3,580||—|
|Total liabilities and stockholders' equity||$||103,116||$||118,232|
Source: Corvus Pharmaceuticals, Inc.