Corvus Pharmaceuticals Provides Business Update and Reports First Quarter 2019 Financial Results
Announces Initiation of Enrollment in Phase 1/1b Trial of ITK inhibitor CPI-818
Conference CallToday at
“With the initiation of patient enrollment in our Phase1/1b trial of CPI-818, Corvus now has three agents with novel mechanisms of action in clinical trials for a wide range of cancers,” said
“For the adenosine pathway, we continue to be in a leadership position with ciforadenant (CPI-444), our small molecule inhibitor of the A2A receptor, and CPI-006, our anti-CD73 antibody. We are enrolling patients in two ciforadenant Phase 1b/2 trials and we have discovered a potentially predictive genetic biomarker, the Adenosine Signature, that may provide clinicians with the ability to select patients most likely to benefit from therapy. This positions us to potentially initiate a molecularly defined, late stage study of ciforadenant in patients with renal cell cancer around the end of the year. For CPI-006, the initial clinical data from both the monotherapy and combination arms of our Phase 1/1b clinical trial will be presented in an oral presentation at the
“Turning to CPI-818, we are very excited to be investigating it in patients with T-cell lymphomas, a patient group that often has limited treatment options and poor clinical outcomes,” continued Dr. Miller. “We believe that CPI-818 represents a novel approach for these patients and the Phase 1/1b study is designed to evaluate both anti-tumor activity and its effect on normal T-cells, which could provide valuable information for future trials of CPI-818 in other types of cancer and autoimmune diseases. We currently anticipate that initial data from the study will be presented in late 2019, providing another potential catalyst for the Company.”
CPI-818, an oral, covalent, selective interleukin-2-inducible kinase (ITK) inhibitor, is based on a similar targeting strategy to that of Bruton’s tyrosine kinase (BTK) inhibitors. Key members of the scientific team at Corvus led the development of the first BTK inhibitor, ibrutinib, which is approved for the treatment of several types of B-cell lymphomas. ITK, the T-cell homologue of BTK, has many biochemical and functional similarities with BTK. T-cell lymphomas are often incurable, especially after relapse. As ITK is frequently overexpressed in T-cell lymphoma, we believe the selective inhibition of ITK may represent a new treatment strategy for this type of cancer, possibly analogous to the effects of BTK inhibition with ibrutinib in B-cell lymphomas. Unlike other ITK inhibitors, the selectivity of CPI-818 has been shown in preclinical studies to shift immune responses to a T-cytotoxic type 1 (Th1) phenotype. We believe CPI-818 has the potential to display a dual mechanism of action: direct cytotoxicity to T-cell lymphoma and enhancement of the immune system by increasing the Th1 immune response.
Ciforadenant (CPI-444): A2A Receptor Antagonist of Adenosine
- Continued enrolling 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.
- Continued enrollment of up to 65 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 ciforadenant and Tecentriq in patients who have failed no more than two prior regimens.
- Presented updated data on the Adenosine Gene Signature (AdenoSig) highlighting its potential to enable patient selection for treatment with ciforadenant based on a molecularly defined gene signature, that may predict which patients may be more responsive to the adenosine blockade.
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 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 from the Phase 1/1b study will be delivered in an oral presentation at the 2019
American Society of Clinical Oncology( ASCO) Annual Meeting in June 2019. This will build upon data presented in February that demonstrated early signs of immunologic activity across multiple pathways that may be important in cancer therapy.
CPI-818: A small molecule ITK inhibitor
- Initiated enrollment of CPI-818, an ITK inhibitor, in a Phase 1/1b study in patients with several types of T-cell lymphomas, including peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and others.
- Presented preclinical and biochemical studies with CPI-818 at the
American Association for Cancer Research(AACR) Annual Meeting in March highlighting the selectivity and immunologic activity of CPI-818 and its anti-tumor activity in spontaneous canine T-cell lymphoma.
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,
Tecentriq® is a registered trademark of Genentech.
Ciforadenant 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. 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 Phase 1/1b Trial Design
The Phase 1/1b clinical trial employs an adaptive, expansion cohort design to select the dose and evaluate the safety, pharmacokinetics, immune-related biomarkers and efficacy of CPI-818 in patients with several types of T-cell lymphomas, including peripheral T-cell lymphoma (PTCL), angioimmunoblastic T-cell lymphoma (AITL), cutaneous T-cell lymphoma (CTCL) and others. The initial phase of the trial is evaluating single escalating doses in successive cohorts of patients in order to determine the optimum dose. A second phase will evaluate safety and tumor response to CPI-818 in disease-specific patient cohorts that may be expanded based on early signs of efficacy. The study is expected to enroll patients at trial sites in
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, and the potential timing and availability of data from the Company’s ongoing 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
Chief Financial Officer
|CORVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
|Three Months Ended
|Research and development||$||9,419||$||12,103|
|General and administrative||2,886||2,541|
|Total operating expenses||12,305||14,644|
|Loss from operations||(12,305||)||(14,644||)|
|Interest income and other expense, net||662||343|
|Net loss per share, basic and diluted||$||(0.40||)||$||(0.63||)|
|Shares used to compute net loss per share, basic and diluted||29,292,135||22,580,620|
|CORVUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
|March 31,||December 31,|
|Cash, cash equivalents and marketable securities||$||105,807||$||114,597|
|Operating lease right-of-use asset||2,781||—|
|Liabilities and stockholders' equity|
|Accounts payable and accrued liabilities and other liabilities||$||7,843||$||7,896|
|Operating lease liability||3,769||—|
|Total liabilities and stockholders' equity||$||112,309||$||118,232|
Source: Corvus Pharmaceuticals, Inc.