Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that it has discontinued its Phase 3 study of mupadolimab for COVID-19 due to positive trends exhibited by COVID-19 vaccines in lowering serious infection and hospitalizations. The discontinuation is not related to any safety or efficacy issues observed in study patients. The Company will continue to advance the development of mupadolimab in oncology, where it is currently being studied in a Phase 1/1b clinical trial.
"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 Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We are prioritizing resources on mupadolimab in oncology and intensifying our efforts in our cancer programs."
"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 U.S. and HPV is believed to be the causative factor in about 75% of head and neck cancers. HPV is also associated with cervical, anal, vulvar, penis and other cancers. More broadly, many other cancers are believed to be associated with or caused by viruses including hepatoma, lymphomas, brain tumors, skin cancer and others.
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