On Sept. 10, 2020, Corvus Pharmaceuticals announced updated data from its ongoing Phase 1 study investigating the potential for CPI-006 to provide a novel immunotherapy approach for patients with COVID-19. The results demonstrated that all evaluable patients treated in the first two cohorts (0.3 and 1.0 mg dose of CPI-006) of the study produced significant titers of antibody to SARS-CoV-2 within seven days of receiving the treatment, with levels of antibody, including neutralizing antibodies, continually increasing out to 28 days. In addition, all of these patients were discharged from the hospital with clinical improvement and none experienced any drug-related safety issues. The study has completed enrollment in the third cohort (3.0 mg dose of CPI-006) of five patients, with the overall study expected to enroll up to 30 patients.

The open-label, Phase 1 study is expected to enroll up to 30 hospitalized COVID-19 patients with mild to moderate symptoms. Patients will receive a single dose of CPI-006, with levels of 0.3, 1.0, 3.0 and 5.0 mg/kg, escalating in four cohorts as the study progresses. Patients will receive medications, therapies, and interventions per standard treatment protocols for COVID-19 for the duration of the study. The primary efficacy endpoint is the change in serum immunoglobulin (IgM and IgG) anti-SARS-CoV-2 levels compared to baseline at day 28. The study also will examine safety and other clinical endpoints, including time to resolution of symptoms and duration of hospitalization.

The Company  has submitted a manuscript describing the initial results from the first two cohorts (five patients receiving 0.3 mg dose and five patients receiving 1.0 mg dose) of the study for publication online at medRxiv.org. In the study, the median age of the patients was 64 years (range 28-76 years) and all the patients had comorbidities that increased their COVID-19 risk: diabetes, hypertension, obesity, and/or cancer. The median duration of symptoms prior to treatment with CPI-006 was 8 days (range 1-21 days).