On May 9, 2019 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported financial results for the first quarter ended March 31, 2019 (Press release, Corvus Pharmaceuticals, MAY 9, 2019, View Source [SID1234536064]).

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"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 Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Looking forward, we have several important milestones for each of our programs in 2019."

"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 ASCO (Free ASCO Whitepaper) annual meeting in June. In addition, we expect incremental data updates on these programs at major medical meetings over the course of the year."

"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.

Recent Achievements
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) (Free ASCO Whitepaper) 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) (Free AACR Whitepaper) Annual Meeting in March highlighting the selectivity and immunologic activity of CPI-818 and its anti-tumor activity in spontaneous canine T-cell lymphoma.
Financial Results

At March 31, 2019, Corvus had cash, cash equivalents and marketable securities totaling $105.8 million, as compared to cash, cash equivalents and marketable securities of $114.6 million at December 31, 2018.

Research and development expenses for the three months ended March 31, 2019 totaled $9.4 million compared to $12.1 million for the same period in 2018. The decrease of $2.7 million was primarily due to a decrease in ciforadenant program costs.

The net loss for the three months ended March 31, 2019 was $11.6 million, compared to a net loss of $14.3 million for the same period in 2018. Total stock compensation expense for the three months ended March 31, 2019 was $2.0 million compared to $1.8 million of total stock compensation expense for the same period in 2018.

Conference Call Details
Corvus will host a conference call and webcast today, Thursday, May 9, 2019, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the first quarter 2019 financial results. The conference call can be accessed by dialing 1-800-479-1004 (toll-free domestic) or 1-720-543-0206 (international) and using the conference ID 5606517. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.