Corvus Pharmaceuticals Provides Business Update and Reports First Quarter 2021 Financial Results
“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
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 Statesand Canada, and the Company expects additional sites in Europe, Latin Americaand South Africawill 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 Pharmaceuticalsplans 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) 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 Consortiumto 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.
Research and development expenses for the three months ended
The net loss for the three months ended
About Corvus Pharmaceuticals
CPI-006 is an investigational, potent humanized monoclonal antibody that is designed to react with a specific site on CD73. In preclinical studies, it has demonstrated immunomodulatory activity resulting in activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking. While there are other anti-CD73 antibodies and small molecules in development for treatment of cancer, such agents react with a different region of CD73. CPI-006 is designed to react with a region of the molecule that acts to stimulate B cells and block production of immunosuppressive adenosine.
CPI-818 is an investigational small molecule drug given orally that has selectively inhibited ITK (interleukin-2-inducible T-cell kinase) in preclinical studies. It was designed to possess dual properties: to block malignant T-cell growth and to modulate immune responses. ITK, an enzyme, is expressed predominantly in T-cells and plays a role in T-cell and natural killer (NK) cell lymphomas and leukemias, as well as in normal immune function. Interference with ITK signaling can modulate immune responses to various antigens. The Company believes the inhibition of specific molecular targets in T-cells may be of therapeutic benefit for patients with T-cell lymphomas and in patients with autoimmune diseases. The Company is conducting a Phase 1/1b trial in patients with refractory
Ciforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor 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. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity.
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of CPI-006, CPI-818 and ciforadenant, the Company’s ability and Angel Pharmaceutical’s ability to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company’s Phase 3 clinical trial of CPI-006 for COVID-19, the timing of the availability and announcement of clinical data and certain other product development milestones, and the sufficiency of the Company’s cash resources and operating expenses for the full year 2021. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Quarterly Report on Form 10-Q for the quarter ended
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
|Three Months Ended
|Research and development||$||8,230||$||10,163|
|General and administrative||3,253||3,106|
|Total operating expenses||11,483||13,269|
|Loss from operations||(11,483||)||(13,269||)|
|Interest income and other expense, net||3||334|
|Loss from equity method investment||(100||)||-|
|Net income (loss)||$||(11,580||)||$||(12,935||)|
|Net income (loss) per share, basic and diluted||$||(0.34||)||$||(0.44||)|
|Shares used to compute net loss per share, basic and diluted||34,515,116||29,411,233|
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash, cash equivalents and marketable securities||$||67,969||$||44,259|
|Operating lease right-of-use asset||1,455||1,648|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued liabilities and other liabilities||$||12,801||$||11,071|
|Operating lease liability||2,050||2,310|
|Total liabilities and stockholders’ equity||$||109,236||$||85,529|
Chief Financial Officer
Source: Corvus Pharmaceuticals, Inc.