Corvus Pharmaceuticals Reports Third Quarter 2018 Financial Results and Provides Business Update
“We continue to make significant progress in the clinic both with CPI-444 and with CPI-006,” said
CPI-444: A2A Receptor Antagonist of Adenosine
- Continued enrollment of up to 50 patients with renal cell cancer (RCC) in an amended Phase 1/1b clinical trial evaluating CPI-444, the Company’s lead product candidate, administered alone and in combination with Genentech’s Tecentriq® (atezolizumab), an anti-PD-L1 antibody. Patients in the study have failed no more than two prior treatment regimens, which must have included an anti-PD-(L)1 and a tyrosine kinase inhibitor, compared to having failed up to five (median three) prior treatment regimens in prior CPI-444 studies.
- Continued enrollment of up to 60 patients with non-small cell lung cancer (NSCLC) in a Phase 1b/2 trial being conducted by Genentech as part of their MORPHEUS platform. The study is evaluating CPI-444 and Tecentriq in patients who have failed no more than two prior regimens.
- CPI-444 preclinical study results were published in and featured on the cover of the October issue of the journal
Cancer Immunology Research, which is an official journal of the American Association for Cancer Research(AACR). The results demonstrated that CPI-444 induces dose dependent anti-tumor responses as a monotherapy and in combination with anti-PD-1, anti-PD-L1 and anti-CTLA-4 therapies.
- Presented new data on the “adenosine gene signature,” a biomarker associated with patient response to therapy with CPI-444, in a poster presentation at the
European Society for Medical Oncology( ESMO) 2018 Congress.
CPI-006: 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 CPI-444, and in combination with an anti-PD-1. The trial is designed to select the dose and evaluate the safety, pharmacokinetics, immune biomarkers and efficacy in patients with NSCLC, RCC, and other cancers who have failed standard therapies.
CPI-818: A small molecule ITK inhibitor
- Plan to submit an Investigational New Drug (IND) filing for CPI-818, the Company’s interleukin-2-inducible kinase (ITK) inhibitor, in early 2019.
- Preclinical data on CPI-818 to be presented by
Douglas H. Thamm, VMD, DACVIM (Oncology) at the EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium, November 13 through 16, 2018in Dublin, Ireland.
Research and development expenses for the three months ended
General and administrative expenses for the three months ended
The net loss for the three months ended
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.
About CD73 and Adenosine
CD73 is a cell surface enzyme whose function is to convert adenosine monophosphate (AMP) to adenosine by removing phosphate from AMP. CD73 is expressed on cells of the immune system, including T-cells and B-cells. CD73 is also present on many tumors, including lung, renal, melanoma, colon, prostate, breast and others. In the tumor microenvironment, CD73 produces adenosine, which binds to the adenosine A2A receptor on immune cells and inhibits various immune responses including those directed against the tumor. Tumors utilize this immunosuppressive mechanism to escape attack by the immune system.
CPI-006 is a potent humanized monoclonal antibody that reacts with the active site of CD73, blocking the conversion of AMP to 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 an oral small molecule that selectively inhibits ITK. ITK is involved in T cell receptor signaling and plays a role in T cell lymphomas and leukemias, and normal immune function. Interference with ITK signaling can modulate immune responses to various antigens.
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of CPI-444 and CPI-006, 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 CPI-444, the Company’s Phase 1/1b clinical trial of CPI-006 and the Company’s IND-enabling studies of CPI-818, the basis for and the timing of any future clinical trials of CPI-818 and the utility of biomarker data collected and the suitability of dosing regimen selected for clinical trials. 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
|CORVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
|Three Months Ended
|Nine Months Ended
|Research and development||$||8,374||$||10,733||$||30,192||$||36,617|
|General and administrative||2,775||2,211||7,859||7,718|
|Total operating expenses||11,149||12,944||38,051||44,335|
|Loss from operations||(11,149||)||(12,944||)||(38,051||)||(44,335||)|
|Net loss per share, basic and diluted||$||(0.36||)||$||(0.62||)||$||(1.35||)||$||(2.14||)|
|Shares used to compute net loss per share, basic and diluted||29,087,129||20,501,382||26,906,463||20,426,263|
|CORVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|September 30,||December 31,|
|Cash, cash equivalents and marketable securities||$||122,639||$||90,055|
|Liabilities and stockholders' equity|
|Accounts payable and accrued liabilities and other liabilities||$||8,375||$||9,940|
|Total liabilities and stockholders' equity||$||127,222||$||94,775|
Chief Financial Officer
Source: Corvus Pharmaceuticals, Inc.