On March 7, 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 fourth quarter and year ended December 31, 2018, and provided a business update (Press release, Corvus Pharmaceuticals, MAR 7, 2019, View Source [SID1234534121]).

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"We continue to make significant progress in the clinic both with CPI-444 and with CPI-006, both as monotherapies and in combination with other agents and each other, positioning Corvus as a leader in the development of medicines that modulate the adenosine pathway," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "In addition, we recently discovered an adenosine gene signature that we believe sheds important insight on the mechanisms of action for CPI-444 and CPI-006, and provides a biomarker that could be vital in future clinical trials. The FDA also recently cleared our IND for CPI-818, an ITK inhibitor that represents a novel approach for the treatment of T-cell lymphomas and that will mark our third product candidate in the clinic."

Recent Achievements

CPI-444: A2A Receptor Antagonist of Adenosine

Continued enrollment of up to 50 patients with renal cell cancer (RCC) in an amended Phase 1b/2 clinical trial evaluating CPI-444 administered alone and in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody.
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) (Free AACR Whitepaper). 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 updated results from the original Phase 1/1b trial of CPI-444 at the SITC (Free SITC Whitepaper) 33rd Annual Meeting covering 33 patients receiving CPI-444 as a monotherapy and 35 patients receiving CPI-444 in combination with Tecentriq. The results showed disease control for more than 6 months was achieved in 17 percent and 35 percent of patients receiving monotherapy and combination therapy, respectively. In addition, for patients receiving combination therapy, 11 percent experienced a confirmed partial response (PR; as determined by RECIST criteria). For patients receiving monotherapy, one patient experienced a confirmed PR and one experienced an unconfirmed PR. Several patients in both groups experienced tumor regression not meeting the PR criteria.
Presented new data on the "adenosine gene signature" (AdenoSig), a biomarker associated with patient response to therapy with CPI-444, in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress. Presented updated AdenoSig data at the Immuno-Oncology 360° Conference that showed a relationship between this biomarker and angiogenesis gene expression data (or angiogenesis signature). These data suggest that patients with a high AdenoSig are potentially more likely to respond to treatment with CPI-444 and less likely to respond to VEGFR inhibitors.
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 CPI-444 or an anti-PD-1. Enrollment is now in the dose escalation phase for CPI-006 administered as a single agent and in combination with CPI-444.
Presented updated biomarker data at the Immuno-Oncology 360° Conference that showed CPI-006 given as a monotherapy activated B cells, led to a redistribution of these cells and led to changes in other immune cells (e.g., changes in T helper to T suppressor ratios). These data are consistent with immune stimulation induced by CPI-006. It was also reported that CPI-006 reacted with an epitope on CD73 that led to blockade of adenosine production and expression of lymphocyte activation antigens that are independent of adenosine.
CPI-818: A small molecule ITK inhibitor

Preclinical data on CPI-818 was presented at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium, in November 2018. Such preclinical data demonstrated that orally-administered CPI-818 produced tumor regression in companion dogs with spontaneous, naturally occurring T-cell lymphomas, without significant toxicity.
The Company plans to evaluate CPI-818, an interleukin-2-inducible kinase (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, with patient enrollment planned in March 2019.
Corporate Updates

Appointed Linda S. Grais, M.D., J.D., to the Company’s Board of Directors, replacing Peter Moldt, Ph.D., who served as a director since January 2015 and resigned his position.
Appointed Mehrdad Mobasher, M.D., M.P.H., as Vice President and Chief Medical Officer to oversee the Company’s pipeline of precisely-targeted investigational oncology therapies.
Financial Results

As of December 31, 2018, Corvus had cash, cash equivalents and marketable securities totaling $114.6 million. This compared to cash, cash equivalents and marketable securities of $90.1 million at December 31, 2017. The Company expects net cash utilization of $43 million to $47 million in 2019.

Research and development expenses for the three months and full year ended December 31, 2018 totaled $8.4 million and $38.6 million, respectively, compared to $9.7 million and $46.3 million for the same periods in 2017. In the fourth quarter of 2018, the decrease of $1.3 million was primarily due to a $2.8 million decrease in CPI-444 costs, partially offset by an increase of $1.2 million in CPI-818 costs. For the full year 2018, the decrease of $7.7 million was primarily due to a $12.8 million decrease in CPI-444 costs, partially offset by an increase of $2.9 million in CPI-818 costs and a $1.8 million increase in personnel and outside research costs.

The net loss for the three months and year ended December 31, 2018 was $10.5 million and $46.9 million, respectively, compared to $11.9 million and $55.7 million for the same periods in 2017. Total stock compensation expense for the three months and year ended December 31, 2018 was $1.8 million and $7.1 million, compared to $1.7 million and $6.2 million for the same periods in 2017.