On March 5, 2020 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies and the utilization of novel biomarkers to enhance patient selection, provided a business update and reported financial results for the fourth quarter and year ended December 31, 2019 (Press release, Corvus Pharmaceuticals, MAR 5, 2020, View Source [SID1234555220]).
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"In 2019, we continued to efficiently advance our pipeline and exited the year with three candidates in clinical trials," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We have presented updated data for each of these programs at major medical meetings and our academic collaborators are beginning to publish data from our studies in peer-reviewed journals, including a key publication for ciforadenant, our most advanced product, in Cancer Discovery in January. This article presented results demonstrating responses in patients with advanced refractory renal cell cancer and also reported on the identification of the Adenosine Gene Signature, a novel predictive biomarker."
"We presented data from our ongoing Phase 1/1b clinical trial with ciforadenant in prostate cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancer Symposium (ASCO GU) meeting in February 2020 and on CPI-818 at the T-Cell Lymphoma Forum in January 2020. We look forward to reporting more mature data from these trials during the year."
Recent Achievements
CPI-444: A2A Receptor Antagonist of Adenosine
Publication of peer-reviewed study in Cancer Discovery covering results in 68 patients with advanced refractory renal cell cancer (RCC) treated with ciforadenant monotherapy and in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody. The publication describes the discovery of the Adenosine Gene Signature, which was shown in the study to identify patients most likely to respond to treatment with ciforadenant. In the study, for patients with available tumor biopsies, Adenosine Gene Signature positive patients had a 17% overall response rate by RECIST criteria vs 0% in Adenosine Gene Signature negative patients.
Enrolled additional patients (25 to date) with advanced refractory RCC in an amended Phase 1b/2 clinical trial evaluating ciforadenant in combination with Tecentriq intended to further evaluate the findings of the 68 patient study published in Cancer Discovery. To date, the results appear consistent with earlier results that Adenosine Gene Signature positive patients are more likely to respond to ciforadenant.
Presentation of safety and preliminary efficacy data in 35 patients with advanced refractory metastatic castrate resistant prostate cancer (mCRPC) treated with ciforadenant monotherapy and in combination with Tecentriq at the ASCO (Free ASCO Whitepaper) GU Cancer Symposium in February 2020. The preliminary data indicated that ciforadenant is active in mCRPC, and that the Adenosine Gene Signature correlated with CD73 expression in tumor biopsies.
CPI-006: Anti-CD73 Antibody
Oral presentation summarizing the safety and immunologic effects of CPI-006 in a phase 1/1b clinical trial at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2019. The presentation reported the in vivo effects of CPI-006 on B-cell activation, function and migration, supporting a new immuno-oncology approach with CPI-006 via activation of immune cells and the inhibition of adenosine production.
The trial will enroll up to 350 patients with advanced cancer evaluating CPI-006 as a single agent and in combination with ciforadenant or pembrolizumab.
Selected recommended dose of 18 mg/kg, or a fixed dose of 1200 mg, and initiated the disease expansion phase in the monotherapy and in combination with ciforadenant arms of the study. CPI-006 was well tolerated at all levels, with no dose limiting toxicities (doses ranged from 1 to 18 mg/kg).
Initiated enrollment in the combination cohort of CPI-006 and pembrolizumab.
Preliminary anti-tumor activity has been seen in mCRPC and renal cell cancer using monotherapy and in combination with ciforadenant.
CPI-818: A small molecule ITK inhibitor
Presentation of safety, pharmacokinetics and immunologic effects of CPI-818 in patients with refractory T-cell lymphomas in a poster at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2019 and in an oral session at the T-Cell Lymphoma Forum in January. These studies demonstrated that CPI-818 blocked proliferation of lymphoma cells in vitro.
The presentation at the T-Cell Forum reported on Phase 1 data in 16 patients. No dose limiting toxicities were observed at doses up to 600 mg oral, twice per day. Two patients with cutaneous T-cell lymphoma (CTCL) have shown improvement and 11 patients remained on the study as of the data cut-off date of January 2020.
Receptor occupancy studies indicate that complete occupancy may occur with doses of 600 mg twice per day.
Financial Results
As of December 31, 2019, Corvus had cash, cash equivalents and marketable securities totaling $78.0 million. This amount compared to cash, cash equivalents and marketable securities of $114.6 million at December 31, 2018. Corvus expects full year 2020 net cash used in operating activities to be between $39 million and $42 million.
Research and development expenses for the three months and full year ended December 31, 2019 totaled $8.9 million and $38.0 million, respectively, compared to $8.4 million and $38.6 million for the same periods in 2018. In the fourth quarter of 2019, the increase of $0.5 million was primarily due to an increase in outside CPI-006 and CPI-818 costs, partially offset by a decrease in outside ciforadenant costs. For the full year 2019, the decrease of $0.6 million was primarily due to a decrease in outside ciforadenant costs, partially offset by an increase in outside CPI-006 and CPI-818 costs and an increase in personnel costs.
The net loss for the three months and year ended December 31, 2019 was $11.0 million and $46.7 million, respectively, compared to $10.5 million and $46.9 million for the same periods in 2018. Total stock compensation expense for the three months and year ended December 31, 2019 was $1.7 million and $7.3 million, respectively, compared to $1.8 million and $7.1 million for the same periods in 2018.
Conference Call Details
Corvus will host a conference call and webcast today, Thursday, March 5, 2020, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the fourth quarter 2019 financial results. The conference call can be accessed by dialing 1-800-263-0877 (toll-free domestic) or 1-720-543-0197 (international) and using the conference ID 3380789. 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 following the call.