Corvus Pharmaceuticals Discontinues Phase 3 Study of Mupadolimab (Anti-CD73) for COVID-19 Due to Vaccine Effectiveness in Reducing Hospitalizations
Mupadolimab Phase 1/1b oncology clinical trial continues, with a focus on leveraging B cell activation and enhancement of anti-viral antibodies in an expansion cohort for patients with HPV+ (human papilloma virus) head and neck cancer
Reduces projected 2021 net cash used in operating activities by an estimated
Company to host conference call and webcast today at 4:30 p.m. ET / 1:30 p.m. PT
“Since the initiation of our Phase 3 study, it has been confirmed that COVID-19 vaccines are highly effective, particularly in terms of preventing serious disease and hospitalizations; the patient population we intend to treat with mupadolimab,” said
“Mupadolimab is one of the most studied anti-CD73 antibodies in clinical development and demonstrates robust B cell activation, which we have reported in both our oncology and COVID-19 programs. Emerging data suggests that enhanced immunity to viral antigens in virally associated cancers could be an important approach to therapy of these cancers, and we already have early evidence of mupadolimab’s activity in HPV+ head and neck cancer from our Phase 1 study. We are now enrolling an expansion cohort for this indication and our goal is to present initial results from this cohort at a medical meeting later this year.”
Mupadolimab (formerly CPI-006) is a humanized anti-CD73 antibody that binds to various immune cells including most B cells. Binding to CD73 inhibits production of immunosuppressive adenosine in the tumor microenvironment, similar to other recently described anti-CD73 antibodies. In addition, mupadolimab appears to have other distinctive properties including effects on B cell function. Upon binding to CD73 on B cells, mupadolimab has demonstrated agonistic properties that result in activation of B cells, trafficking to lymph nodes, differentiation into plasmablasts and secretion of antibodies.
To date, over 90 cancer patients have been treated with mupadolimab in a Phase 1/1b study evaluating it as a monotherapy and in combination with ciforadenant and combination with pembrolizumab in patients with a variety of cancers who have failed standard therapies. Another cohort of the study is evaluating the triplet of mupadolimab, ciforadenant and pembrolizumab. In addition, Corvus has published results from the initial cohorts of its Phase 1 COVID-19 study and pre-clinical data characterizing the novel immunotherapy approach with mupadolimab online at medRxiv.org. Across the treatment of cancer and COVID-19, one of the common factors in patients where mupadolimab has shown activity is the presence of viral antigens. The induction of antibody secretion is antigen specific and is dependent on exposure to antigens such as the SARS-CoV-2 virus, or in the case of patients with HPV+ head and neck cancer, exposure to the human papilloma virus (HPV).
During the second quarter, Corvus began enrolling patients in an expansion cohort of up to 15 patients with advanced, HPV+ head and neck cancer that have failed treatment with anti-PD-1 antibodies and chemotherapy. In this cohort, mupadolimab will be given in combination with pembrolizumab. HPV+ head and neck cancers are increasing in incidence in the
The preliminary financial results announced today are based on the Company’s current expectations and may be adjusted as a result of, among other things, completion of customary quarter-end close review procedures and further financial review.
Conference Call and Webcast
Corvus will host a conference call and webcast today,
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
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 to develop and advance product candidates into and successfully complete preclinical studies and clinical trials, including the Company’s Phase 1/1b clinical trial of mupadolimab, 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
Chief Financial Officer
Source: Corvus Pharmaceuticals, Inc.