On April 29, 2021 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, provided a business update and reported financial results for the first quarter ended March 31, 2021 (Press release, Corvus Pharmaceuticals, APR 29, 2021, View Source [SID1234578761]).
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"In the first quarter we initiated our registration Phase 3 clinical trial evaluating our B cell activating antibody, CPI-006, in hospitalized patients with COVID-19 and several sites are now enrolling patients," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "It is apparent that COVID-19 will be an ongoing global public health concern, with cases rising in some countries, the emergence of new variants, and waning immunity. To address this, we are working with U.S. and international trial sites and remain on track with our trial plan, with full enrollment expected by year end. Outside of COVID-19, we are advancing our partnership with Angel Pharmaceuticals and they anticipate filing an IND, in mid-2021, in China to begin our global Phase 2 trial of our ITK inhibitor, CPI-818, in patients with T cell lymphoma. And we continue to be one of the leaders in the area of adenosine blockade for cancer therapy and are moving forward with plans to conduct additional trials with ciforadenant and our anti-CD73 antibody, CPI-006 for cancer. In addition to blocking the production of adenosine, CPI-006 has demonstrated activation of B cells. Presentations by others at the recent American Association of Cancer Research Annual Meeting confirmed the role of CD73 in B cell activation supporting our original discoveries in this area."
2021 Key Areas of Focus
Corvus is focused on several potential transformational opportunities in its pipeline in 2021, headlined by the execution of its global Phase 3 study of CPI-006 in COVID-19. The Company is also efficiently advancing its other clinical programs, CPI-818 and ciforadenant, along with pre-clinical programs in its pipeline. The highlights from the Company’s clinical pipeline include:
CPI-006 Phase 3 Study for COVID-19
The Company is on track to complete enrollment in the fourth quarter 2021 in its Phase 3 registration clinical trial of CPI-006, an anti-CD73 B cell activating antibody, for the treatment of hospitalized patients with mild-to-moderate COVID-19. Study sites have been activated in the United States and Canada, and the Company expects additional sites in Europe, Latin America and South Africa will be activated in the near-term. The Company is prioritizing the activation of sites in geographies with a higher incidence of COVID-19 cases and will continue to adapt its site activation plan based on new case trends.
The CPI-006 Phase 3 study is a randomized, double-blind trial that is planned to enroll up to 1,000 patients, who will be randomized into one of three arms and receive either 1.0 mg/kg or 2.0 mg/kg of CPI-006, or placebo. The primary endpoint of the study is the proportion of patients that progress to requiring mechanical ventilation or death within 28 days of dosing. The study will include an interim safety and futility analysis.
CPI-006 for Cancer
The Company plans to expand a cohort in its ongoing Phase 1/1b study of CPI-006 for advanced cancer. The expansion of this cohort is based on the identification of tumor types with biologic features best addressed by the unique mechanism of action of CPI-006, including its immunostimulatory properties.
CPI-818 Phase 2 Study for T cell lymphoma in Partnership with Angel Pharmaceuticals
Angel Pharmaceuticals plans to file an investigational new drug application (IND) for CPI-818 by mid-year in China. If approved, Angel plans to initiate a Phase 2 clinical trial of CPI-818 for the treatment of refractory T cell lymphomas in late 2021, with the potential to expand into autoimmune and dermatological diseases over time.
Interim data from the Phase 1/1b clinical trial of CPI-818 for T cell lymphoma demonstrated tumor responses in very advanced, refractory, difficult to treat T cell malignancies. As of March 4, 2021, of seven patients with PTCL, there has been one complete response lasting over 15 months and one partial response lasting for over five months; both responses are ongoing. The interim data was presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in December 2020.
Ciforadenant Phase 2 Study for Front Line RCC
Corvus is a leader in the development of precisely targeted therapies targeting the adenosine pathway. Ciforadenant is small molecule antagonist of the adenosine A2A receptor. It is 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. In addition to its B cell activating properties, CPI-006 is a monoclonal antibody that is designed to react with the active site of CD73, blocking the conversion of AMP to adenosine. Ciforadenant and CPI-006 provide complementary approaches to a cancer immunotherapy approach via the adenosine pathway. The Company also discovered the Adenosine Gene Signature, which has demonstrated the potential to serve as a biomarker to identify patients most likely to respond to treatment with ciforadenant.
The Company plans to collaborate with the Kidney Cancer Consortium to initiate a Phase 2 trial of ciforadenant in first-line therapy for metastatic renal cell cancer (RCC) in combination with pembrolizumab and lenvatinib. The study is expected to enroll approximately 60 patients and is intended to increase complete responses and deep responses in the front-line setting. Preclinical studies indicate adenosine may be a cause of resistance to current therapies with anti PD(L)-1 and tyrosine kinase inhibitors. Tumor biopsies will be evaluated for expression of the adenosine gene signature.
Financial Results
As of March 31, 2021, Corvus had cash, cash equivalents and marketable securities totaling $68.0 million. This compared to cash, cash equivalents and marketable securities of $44.3 million as of December 31, 2020. The increase in cash of $23.7 million resulted from $32.0 million received on February 17, 2021 from the company’s follow-on equity offering with institutional investors, reduced by $8.3 million of cash used in the quarter ended March 31, 2021. Corvus expects full year 2021 net cash used in operating activities to be between $46 million and $48 million.
Research and development expenses for the three months ended March 31, 2021 totaled $8.2 million compared to $10.2 million for the same period in 2020. The decrease of $2.0 million was primarily due to lower clinical trial costs for ciforadenant and a decrease in personnel costs, partially offset by an increase in clinical trial costs for the Company’s CPI-006 Phase 3 Covid-19 trial.
The net loss for the three months ended March 31, 2021 was $11.6 million compared to a net loss of $12.9 million for the same period in 2020. Total stock compensation expense for the three months ended March 31, 2021 was $1.2 million compared to $1.8 million for the same period in 2020.