On August 2, 2021 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported a business update and reported financial results for the second quarter ended June 30, 2021 (Press release, Corvus Pharmaceuticals, AUG 2, 2021, View Source [SID1234585530]).
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"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 Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We believe mupadolimab is well positioned to improve patient outcomes based on its dual mechanism of inhibiting immunosuppressive adenosine and enhancing antibody responses to viruses, which have been shown to cause certain cancers. This is based on the known B cell stimulating properties of mupadolimab and data we have generated in cancer and viral diseases such as COVID-19. We also continue to advance our other oncology programs, including with our Chinese partner, Angel Pharmaceuticals, who recently filed an IND in China to initiate Phase 1/2 clinical development of CPI-818 for the treatment of T cell lymphomas."
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 States and 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.
In 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 Pharmaceuticals
Angel Pharmaceuticals has 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 Consortium to 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.
Financial Results
As of June 30, 2021, Corvus had cash, cash equivalents and marketable securities totaling $66.5 million. This compared to cash, cash equivalents and marketable securities of $44.3 million as of December 31, 2020. The increase in cash of $22.2 million resulted from the receipt of approximately $43.8 million in net proceeds from the sale of common stock through an underwritten offering and the Company’s at the market equity offering program, and was reduced by $21.4 million of cash used in operating activities in the six months ended June 30, 2021. With the discontinuation of the mupadolimab Phase 3 clinical trial in COVID-19, Corvus now expects full year 2021 net cash used in operating activities to be between $35 million and $37 million, a decrease of an estimated $11 million compared to the previously expected range of $46 million and $48 million and resulting in a projected balance of cash, cash equivalents and marketable securities of between $51.1 million to $53.1 million at December 31, 2021.
Research and development expenses for the three months ended June 30, 2021 totaled $9.1 million compared to $7.9 million for the same period in 2020. The increase of $1.2 million was primarily due to an increase in clinical trial costs for the Company’s mupadolimab Phase 3 COVID-19 clinical trial, which was partially offset by lower clinical trial costs for CPI-818 and ciforadenant.
The net loss for the three months ended June 30, 2021 was $11.8 million compared to a net loss of $10.6 million for the same period in 2020. Total stock compensation expense for the three months ended June 30, 2021 was $1.2 million compared to $1.4 million for the same period in 2020.