On July 30, 2020 Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, reported a business update and announced financial results for the second quarter ended June 30, 2020 (Press release, Corvus Pharmaceuticals, JUL 30, 2020, View Source [SID1234562572]).

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"In the second quarter, we advanced each of our three clinical oncology programs, highlighted by the presentation of new data at ASCO (Free ASCO Whitepaper) on the identification of a refined biomarker that enriches for responding patients with renal cell cancer treated with our lead candidate, ciforadenant," said Richard A. Miller, M.D., president and chief executive officer of Corvus. "Based on this data, we are planning to meet with the U.S. Food & Drug Administration (FDA) to discuss the initiation of a pivotal study of ciforadenant in renal cell cancer. For CPI-006 and CPI-818, we have largely completed enrollment in the current portions of their Phase 1/1b studies and expect to report updated results at medical meetings later this year."

"We also added a fourth program utilizing our novel immunomodulatory antibody CPI-006 for treatment of patients with mild-to-moderate COVID-19. Our unique approach is based on the ability of CPI-006 to activate B cells, leading to the production of anti-SARS-CoV-2 IgM and IgG antibodies and memory B cells, which has the potential to shorten recovery time and improve long-term protective immunity. The study is advancing on track with the first cohort of five patients fully enrolled and four of five patients now enrolled in the second cohort. We expect to report anti-SARS-CoV-2 antibody and memory B cell results from our study later this year."

Recent Achievements

Ciforadenant (CPI-444): A2A Receptor Antagonist of Adenosine

Presented updated data from the Phase 1b/2 clinical trial of ciforadenant in patients with refractory renal cell carcinoma (RCC) at the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program. The data covered 51 patients and showed an objective response rate (ORR) of 17% by RECIST criteria in Adenosine Gene Signature positive patients (n=31) and 0% ORR in the Adenosine Gene Signature negative group (n=20). The ORR improved to 27% with a refined version of the test, which is based on the measurement of CD68 positive myeloid cells, the downstream target of adenosine.
CPI-006: Anti-CD73 Antibody with Immunomodulatory Activity

Initiated an open-label, Phase 1 study of CPI-006 in COVID-19 patients with mild to moderate symptoms. Patients will receive a single dose of CPI-006, with levels of 0.3, 1.0, 3.0 and 5.0 mg/kg, escalating in four cohorts as the study progresses. Patients will receive medications, therapies, and interventions per standard treatment protocols for COVID-19 for the duration of the study. The primary efficacy endpoint is the change in serum immunoglobulin (IgM and IgG) anti-SARS-CoV-2 levels compared to baseline at day 28. The study will also examine safety and effects on anti-viral memory B cells and other clinical endpoints, including time to resolution of symptoms and duration of hospitalization.

COVID-19 Study Update: Since the announcement of the study and enrollment of the first cohort of five patients in early July, four of five patients in the second cohort have been enrolled in the study. As of the cutoff date of July 30, 2020, no dose limiting toxicities had been noted and early anti-SARS-CoV-2 antibody response data was encouraging with relatively high titers of IgG and IgM to both spike and receptor binding domain (RBD) viral proteins observed. In the first two patients receiving the lowest dose of CPI-006 and tested at an early Day 7 time point, IgG titers to spike protein were > 1:25,000 and > 1:50,000. One of these patients has also completed Day 14 testing, which showed the titers to viral spike protein and RBD had increased to > 1:100,000. Significant levels of IgM antibodies were also detected. The Company remains on track to report 28-day follow up results from the Phase 1 study later this year.

Completed enrollment in three dose escalation arms of the CPI-006 Phase 1/1b cancer clinical trial: monotherapy, combination with ciforadenant and combination with pembrolizumab and we continue to enroll the triplet combination dose escalation arm with ciforadenant and pembrolizumab. Updated clinical data from the Phase 1/1b oncology clinical trial is targeted to be presented later this year.
CPI-818: A small molecule ITK inhibitor

Completed enrollment in the dose escalation portion (N=16) of the CPI-818 Phase 1/1b clinical trial, which included patients with several types of advanced, refractory T-cell lymphomas. Based on results from this portion of the study, including a confirmed complete response in one patient with peripheral T-cell lymphoma (PTCL) who previously failed chemotherapy and high dose chemotherapy with autologous bone marrow transplantation, the Company selected the CPI-818 optimum dose and began the next portion of the study with a focus on patients with PTCL and cutaneous T-cell lymphoma (CTCL).
Anticipated Future Events

Data from the Phase 1 trial of CPI-006 used to treat COVID-19 patients later this year.

The Company plans to meet with the FDA to discuss the study design and plans for a ciforadenant pivotal study in advanced refractory RCC using the Adenosine Gene Signature as a biomarker.

Updated clinical data from the CPI-006 Phase 1/1b oncology clinical trial is planned to be presented later this year.

Updated clinical data from the CPI-818 Phase 1/1b clinical trial is planned to be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2020.
Financial Results
At June 30, 2020, Corvus had cash, cash equivalents and marketable securities totaling $59.3 million, as compared to cash, cash equivalents and marketable securities of $78.0 million at December 31, 2019. Corvus expects net cash used in operating activities for the second half of 2020 to be between $12 million and $14 million resulting in a cash balance of between $47 million and $45 million at December 31, 2020.

Research and development expenses for the three months ended June 30, 2020 totaled $7.9 million compared to $10.6 million for the same period in 2019. The decrease of $2.7 million was primarily due to a $0.5 million decrease in ciforadenant clinical trial expenses, a $1.7 million decrease in CPI-006 drug manufacturing costs, a $0.5 million decrease in CPI-818 drug manufacturing costs and a $0.8 million decrease in outside service costs, partially offset by a $1.1 million increase in CPI-006 clinical trial expenses.

The net loss for the three months ended June 30, 2020 was $10.6 million, compared to a net loss of $13.0 million for the same period in 2019. Total stock compensation expense for the three months ended June 30, 2020 was $1.4 million compared to $1.9 million of total stock compensation expense for the same period in 2019.

Conference Call Details
Corvus will host a conference call and webcast today, Thursday, July 30, 2020, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second quarter 2020 financial results. The conference call can be accessed by dialing 1-855-327-6837 (toll-free domestic) or 1-631-891-4304 (international) and using the conference ID 10010533. 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.