On November 1, 2021 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported financial results for the third quarter ended September 30, 2021 (Press release, Corvus Pharmaceuticals, NOV 1, 2021, View Source [SID1234594008]).
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"Corvus is a leader in the development of precisely targeted therapies targeting the adenosine pathway. This includes mupadolimab, our anti-CD73 antibody, and ciforadenant, our small molecule antagonist of the adenosine A2A receptor," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We continue to advance mupadolimab with a focus on non-small cell lung cancer (NSCLC) and HPV positive (human papilloma virus) head and neck cancers (HNSCC). Two expansion cohorts in our Phase 1b/2 trial are enrolling patients with these tumors and we are evaluating treatment with a combination of mupadolimab and pembrolizumab. We believe mupadolimab is well positioned to potentially improve patient outcomes based on its mechanism of inhibiting immunosuppressive adenosine in the tumor microenvironment and by enhancing immune responses to the tumor. Its novel immune enhancing properties are based on its known B cell stimulating activities, which have been observed in our cancer and COVID-19 clinical trials. We also continue to expand our other oncology programs, including with our Chinese partner, Angel Pharmaceuticals, who recently received an IND approval notice in China to initiate Phase 1/1b 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 for NSCLC and Head and Neck Cancer
The Company has completed enrollment of patients with NSCLC and Head and Neck Cancer in its Phase 1/1b clinical trial of mupadolimab monotherapy; combination with ciforadenant, Corvus’ small molecule inhibitor of the A2A receptor; combination with pembrolizumab; or triplet combination with ciforadenant and pembrolizumab. We anticipate that the results will be presented at the annual meeting of the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2021.
Mupadolimab for HPV+ Oropharyngeal Cancer of the Head and Neck
The Company is enrolling a Phase 1b/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 initial results are anticipated in 2022.
Mupadolimab for NSCLC
In September 2021, the Company began enrolling patients in a Phase 1b/2 clinical trial in patients with relapsed refractory NSCLC who have failed previous treatment with anti-PD(L)-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 trial is response rate and results are anticipated to be reported in 2022.
Mupadolimab for Viral Associated Cancers and Viral Diseases
The Company is evaluating 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.
The Company is evaluating partnership opportunities to continue the development of mupadolimab as a therapeutic for the treatment of COVID-19. We believe this approach is supported by results from the Company’s discontinued Phase 3 randomized, double blind placebo-controlled clinical trial of mupadolimab for hospitalized patients with COVID-19, which were published in September. The primary endpoint of the clinical trial was the proportion of patients progressing to respiratory failure or death during the 28 days after dosing with either mupadolimab 2mg/kg, 1mg/kg or placebo. Forty patients were enrolled in the clinical trial prior to its voluntary discontinuation. In the 2mg/kg cohort, 93.3% of patients were alive and free from respiratory failure, compared to 85.7% in the 1mg/kg cohort and 81.1% in the placebo cohort. In addition, positive trends favoring mupadolimab treatment compared to placebo were seen for all the key secondary endpoints, including time to clinical improvement, time to sustained clinical improvement and time to hospital discharge. Due to the number of participants enrolled in the trial before it was discontinued, the foregoing results were not sufficiently powered for statistical significance.
CPI-818 Phase 1/1b Clinical Trial for T cell Lymphoma in Partnership with Angel Pharmaceuticals
The Company’s ongoing Phase 1/1b trial with CPI-818 has been expanded to enroll patients with certain types of T cell leukemias in addition to T cell lymphomas.
The Company’s partner in China, Angel Pharmaceuticals, plans to initiate a Phase 1/1b clinical trial of CPI-818 for the treatment of refractory T cell lymphomas, with the potential to expand into autoimmune diseases over time. In October, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) approved Angel’s IND for CPI-818 and the trial is expected to open by early 2022. Angel Pharmaceuticals will be responsible for all expenses related to executing the trial in China.
Ciforadenant Phase 2 Clinical Trial for Front Line RCC
In addition to developing mupadolimab for blocking adenosine production, the Company is developing Ciforadenant, a 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 another approved therapeutic agent for RCC. 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. Tumor biopsies will be evaluated for expression of the Adenosine Gene Signature.
Financial Results
As of September 30, 2021, Corvus had cash, cash equivalents and marketable securities totaling $76.3 million as compared to cash, cash equivalents and marketable securities of $44.3 million as of December 31, 2020. The increase in cash of $32.0 million resulted from the receipt of approximately $32 million in net proceeds from the sale of the Company’s common stock through an underwritten offering, approximately $29 million in net proceeds from the Company’s at the market equity offering program, and approximately $1 million in proceeds from the exercise of common stock options and was reduced by approximately $30 million of cash used in operating activities in the nine months ended September 30, 2021. Consistent with last quarter, Corvus expects full year 2021 net cash used in operating activities to be approximately $36 million, resulting in a projected balance of cash, cash equivalents and marketable securities of approximately $70 million at December 31, 2021.
Research and development expenses for the three months ended September 30, 2021 totaled $7.0 million compared to $6.6 million for the same period in 2020. The increase of $0.4 million was primarily due to an increase in clinical trial costs.
The net loss for the three months ended September 30, 2021 was $10.7 million compared to a net loss of $9.8 million for the same period in 2020. Total stock compensation expense for the three months ended September 30, 2021 was $1.1 million compared to $1.3 million for the same period in 2020.