On August 8, 2022 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported financial results for the second quarter ended June 30, 2022 (Press release, Corvus Pharmaceuticals, AUG 8, 2022, View Source [SID1234617841]).
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"We continue to see encouraging clinical data from the Phase 1 clinical trial of CPI-818 in T cell lymphomas, both in its effects on tumor growth and its effects on normal T cells. Based on this data, along with new preclinical models that demonstrate its potential in autoimmune and allergic diseases, we have decided to focus our efforts on advancing the development of CPI-818," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "The intensification of efforts on this program brings other advantages – we expect that we can generate additional clinical data in the near-term, we believe CPI-818 is the most advanced program targeting ITK inhibition and our team has expertise developing and launching an analogous target in BTK inhibition with Ibrutinib."
"We will continue to advance ciforadenant, our adenosine 2a inhibitor, which also has the potential to deliver near-term clinical data from our planned Phase 2 clinical trial. We remain excited about mupadolimab, our B cell activating anti-CD73 antibody, which will now be paused in development but remains ready to enter a randomized Phase 2 clinical trial in front line lung cancer. Altogether, our portfolio prioritization extends our cash runway and gives us the potential to deliver near-term clinical data for CPI-818, which is uniquely positioned to address a broad range of indications in cancer, autoimmunity and allergy."
Business Update and Strategy
CPI-818 (selective ITK inhibitor)
Corvus and its partner in China, Angel Pharmaceuticals, are enrolling patients with relapsed T cell lymphomas (TCL) in Phase 1/1b trial evaluating single agent therapy with CPI-818. Angel Pharmaceuticals is responsible for all expenses related to conducting the clinical trial in China.
Monitoring of immune modulation of normal T cells as well as safety and anti-tumor activity are being assessed in the clinical trial, with additional data from the trial expected later this year.
As recently reported, the Company has identified 200 mg orally twice per day as the optimum dosing regimen for CPI-818. This dose regimen has been shown to affect T cell differentiation and induce the generation of Th1 helper cells while blocking the development of Th2 cells. Corvus and Angel are now enrolling additional patients with TCL in a 200 mg cohort of the clinical trial.
As of July 22, 2022 in the 200 mg cohort, 12 patients have been enrolled and 8 are evaluable for response. There has been 1 complete response (CR) lasting 25 months; 1 nodal CR lasting 16 months; 1 partial response (PR) ongoing at 2 months follow up. Five patients had stable disease (SD), 2 of the patients with SD have been on treatment for approximately 12 weeks and continue on study. Two additional patients are on treatment and have not yet had their disease monitoring assessments. An additional patient in the 600 mg cohort also had a PR.
As of July 22, 2022, analysis of blood in 4 of 4 patents treated in the 200 mg cohort showed increases in Th1 cells compared to baseline and increases in terminally differentiated T effector memory cells; these are T cells that are antigen primed and capable of destroying tumor cells. Tumor biopsy from 1 patient taken during response demonstrated an increase in these cells in the tumor.
Three of three patients in the 200 mg cohort with high baseline, pretreatment eosinophil counts demonstrated reductions in circulating eosinophils during treatment with CPI-818. Eosinophils are white blood cells that play a key role in allergic and autoimmune diseases and they are often elevated in patients with TCL.
As of July 22, 2022, no dose limiting toxicities (DLTs) have been observed at doses up to 600 mg orally twice per day.
Corvus is also developing CPI-818 for autoimmune and allergic diseases and is preparing to initiate clinical trials for certain autoimmune diseases.
CPI-818 has demonstrated activity in various animal models of autoimmunity including models of systemic lupus erythematosus, psoriasis, inflammatory bowel disease and graft versus host disease. Some of this research was presented at the annual meetings of the American Society of Hematology (ASH) (Free ASH Whitepaper) in 2020 and 2021.
In July, the Company appointed James Rosenbaum, M.D. as Senior Vice President, Research, with an initial focus on leading the Company’s development efforts for CPI-818 in autoimmune and allergic diseases. Dr. Rosenbaum previously served as Professor of Inflammatory Diseases and Chair, Division of Arthritis & Rheumatic Diseases, at Oregon Health & Science University and has authored over 600 publications.
Ciforadenant (adenosine 2a receptor antagonist)
The Company plans to collaborate with the Kidney Cancer Clinical Trials Consortium to initiate an open-label Phase 2 clinical trial evaluating ciforadenant as a first-line therapy for metastatic RCC in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1). The clinical trial, which is anticipated to be initiated in the third quarter 2022, will enroll up to 60 patients and is intended to evaluate the potential for ciforadenant to generate increased complete responses and deep responses in the front-line setting.
The Kidney Cancer Clinical Trials Consortium is comprised of a group of leading cancer centers in the United States led by investigators at MD Anderson. The trial design is based on Corvus’ preclinical research published in 2018 in Cancer Immunology Research that demonstrated impressive antitumor control and cures in several animal models using ciforadenant in combination with anti-CTLA4 and anti-PD1.
Mupadolimab (anti-CD73)
The Company has completed enrollment in its two Phase 1/1b clinical trial expansion cohorts of patients with (1) head and neck cancers that have failed previous treatment with anti-PD-1 therapy and chemotherapy and (2) relapsed refractory NSCLC who have failed previous treatment with anti-PD(L)-1 therapy and chemotherapy.
Based on the results to-date, the Company believes this program is ready to advance into a randomized Phase 2 clinical trial evaluating mupadolimab in combination with pembrolizumab and chemotherapy as a front-line therapy for the treatment of patients with NSCLC. However, the Company is delaying the initiation of this clinical trial in order to prioritize the development of CPI-818 and to conserve capital.
Angel Pharmaceuticals plans to continue the development of mupadolimab in China. The CDE (Center for Drug Evaluation) in China has accepted for filing the IND to initiate a Phase 1 trial with mupadolimab alone and together with pembrolizumab in patients with advanced NSCLC and head and neck cancer.
Financial Results
As of June 30, 2022, Corvus had cash, cash equivalents and marketable securities totaling $56.7 million. This compared to cash, cash equivalents and marketable securities of $69.5 million as of December 31, 2021. Corvus expects full year 2022 net cash used in operating activities to be between $27 million and $29 million, resulting in a projected cash balance of between $40.5 million and $42.5 million as of December 31, 2022. Based on its current plans, the Company expects its cash to fund operations into early 2024.
Research and development expenses for the three months ended June 30, 2022 totaled $4.9 million compared to $9.1 million for the same period in 2021. The decrease of $4.2 million was primarily due to reduced clinical trial costs associated with the mupadolimab Phase 3 trial in COVID-19 patients.
The net loss for the three months ended June 30, 2022 was $8.4 million compared to a net loss of $11.8 million for the same period in 2021. Total stock compensation expense for the three months ended June 30, 2022 was $0.7 million compared to $1.2 million for the same period in 2021 and the non-cash loss from the Company’s equity method investment in Angel Pharmaceuticals was $1.6 million for the three months ended June 30, 2022 compared to $0.5 million in the same period in 2021.
Conference Call Details
Corvus will host a conference call and webcast today, Monday, August 8, 2022, at 4:30 p.m. ET (1:30 p.m. PT), during which time management will provide a business update and discuss the second quarter 2022 financial results. The conference call can be accessed by dialing 1-844-825-9789 (toll-free domestic) or 1-412-317-5180 (international) and using the conference ID 10169996. The live webcast may be accessed via the investor relations section of the Corvus website. A replay of the webcast will be available on Corvus’ website for 90 days.