Corvus Pharmaceuticals Provides Business Update and Reports Second Quarter 2021 Financial Results
“We continue to advance mupadolimab, our anti-CD73 antibody, with a focus on HPV positive (human papilloma virus) head and neck cancer and other viral associated cancers,” said
2021 Key Areas of Focus
The Company is efficiently advancing its clinical programs – mupadolimab, CPI-818 and ciforadenant – along with pre-clinical programs in its pipeline. The highlights from the Company’s clinical pipeline include:
Mupadolimab Expansion Clinical Trial for HPV+ Oropharyngeal Cancer
- The Company began enrollment of a Phase1b/2 clinical trial in patients with HPV+ oropharyngeal cancers that have failed previous treatment with anti-PD-1 therapy and chemotherapy. Up to 15 patients will be enrolled in this clinical trial and will receive mupadolimab in combination with pembrolizumab. The endpoint of the clinical trial is response rate and results are anticipated by year end 2021. HPV is a transmissible DNA virus that causes approximately 75% of head and neck cancers. The incidence of this disease has been increasing in
the United Statesand elsewhere.
Mupadolimab Focus on Viral Associated Cancers
- The Company plans to evaluate mupadolimab in other viral associated tumors such as cancer of the cervix and head and neck cancers caused by Epstein Barr virus (EBV), which is a member of the herpes virus family and one of the most common human viruses.
July 2021, the Company discontinued its Phase 3 clinical trial of mupadolimab in COVID-19 due to positive trends exhibited by COVID-19 vaccines in lowering serious infection and hospitalizations. The discontinuation was not related to any safety or efficacy issues observed in trial patients. As a result, the Company’s projected 2021 net cash used in operating activities decreased by an estimated $11 million.
CPI-818 Phase 2 Clinical Trial for T cell Lymphoma in Partnership with
Angel Pharmaceuticalshas filed an investigational new drug application (IND) for CPI-818 with the Center for Drug Evaluation(CDE) 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 diseases over time.
Ciforadenant Phase 2 Clinical Trial 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. 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 clinical trial of ciforadenant in first-line therapy for metastatic renal cell cancer (RCC) in combination with pembrolizumab and a tyrosine kinase inhibitor. The clinical trial is expected to enroll up to 60 patients and is intended to increase complete responses and deep responses in the front-line setting. Preclinical studies and data from earlier clinical trials with ciforadenant 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
Mupadolimab (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. Mupadolimab is designed to react with a region of the molecule that acts to stimulate B cells and block production of immunosuppressive adenosine. Mupadolimab is being studied in combination with pembrolizumab in a Phase 1/1b study in patients with advanced HPV+ (human papilloma virus) head and neck cancers. It is postulated that the activation of B cells will enhance immunity to viral antigens within the tumors of these patients, leading to improved clinical outcomes.
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 T-cell lymphomas.
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 mupadolimab, 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 1b/2 clinical trial of mupadolimab , Angel’s plans to initiate a Phase 2 clinical trial of CPI-818, the timing of the availability and announcement of clinical data and certain other product development milestones, the estimated amount of net cash used in operating activities for 2021 and the projected balance of cash, cash equivalents and marketable securities at
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
|Three Months Ended
||Six Months Ended
|Research and development||$||9,106||$||7,857||$||17,336||$||18,020|
|General and administrative||2,184||2,910||5,437||6,016|
|Total operating expenses||11,290||10,767||22,773||24,036|
|Loss from operations||(11,290||)||(10,767||)||(22,773||)||(24,036||)|
|Interest income and other expense, net||1||156||4||490|
|Loss from equity method investment||(463||)||-||(563||)||-|
|Net income (loss)||$||(11,752||)||$||(10,611||)||$||(23,332||)||$||(23,546||)|
|Net income (loss) per share, basic and diluted||$||(0.28||)||$||(0.36||)||$||(0.61||)||$||(0.80||)|
|Shares used to compute net loss per share, basic and diluted||42,247,094||29,428,249||38,402,464||29,419,741|
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash, cash equivalents and marketable securities||$||66,460||$||44,259|
|Operating lease right-of-use asset||1,264||1,648|
|Liabilities and stockholders' equity|
|Accounts payable and accrued liabilities and other liabilities||$||11,207||$||11,071|
|Operating lease liability||1,784||2,310|
|Total liabilities and stockholders' equity||$||109,394||$||85,529|
Chief Financial Officer
Source: Corvus Pharmaceuticals, Inc.