Pharmaceutical Business review

Corvus begins phase 1 Covid-19 clinical trial with novel immunotherapy

Corvus has commenced the phase 1 Covid-19 clinical trial with novel immunotherapy. (Credit: fernando zhiminaicela from Pixabay)

The company is evaluating an agonistic (immunostimulatory) humanised monoclonal antibody, dubbed CPI-006, which is said to show a potential new approach to immunotherapy of infectious diseases and cancer.

The CPI-006 is a potent humanised monoclonal antibody, which reacts with a specific site on CD73. It is said to show immunomodulatory activity that led to the activation of lymphocytes, induction of antibody production from B cells and effects on lymphocyte trafficking.

Corvus will recruit up to 30 Covid-19 patients with mild to moderate symptoms in the open-label phase 1 study.

Patients will secure a single dose of CPI-006 with levels of 0.3, 1.0, 3.0 and 5.0 mg/kg. The doses will be increased in four cohorts as the study advances.

Patients will secure medications, therapies, and interventions per standard treatment protocols for Covid-19 for the duration of the study.

The first cohort of five patients recruited in the trial has been treated at Temple University Hospital in Philadelphia, Pennsylvania.

According to the company, the change in serum immunoglobulin (IgM and IgG) anti-SARS-CoV-2 levels compared to baseline at day 28 is the primary efficacy endpoint of the study.

The trial will also evaluate the safety and other clinical endpoints, including the time to resolution of symptoms and duration of hospitalisation. Corvus intends to reveal data from the trial by the end of this year.

Corvus stated that the trial’s objective is to demonstrate that CPI-006 has the capacity to induce the patient to generate an enhanced antibody response to SARS-CoV-2.

Corvus president and CEO Richard Miller said: “Our B cell-activating monoclonal antibody may be a potential immunotherapy for COVID-19 based on its ability to stimulate the production of anti-SARS-CoV-2 antibodies.

“Our preclinical and clinical research has elucidated important biological mechanisms underlying this approach and we are eager to apply it to addressing the devastating COVID-19 pandemic.”

Recently, Eli Lilly commenced a phase 3 clinical trial with baricitinib, marketed as Olumiant, for hospitalised Covid-19 patients.