Corvus Pharmaceuticals has launched a Phase I clinical trial of its new immunotherapy product, CPI-006, for the treatment of patients with Covid-19.
The US Food and Drug Administration (FDA) reviewed and accepted the investigational new drug (IND) application for the trial.
Corvus said that the first cohort of five participants received treatment at Temple University Hospital in Philadelphia, US. A total of up to 30 patients will be enrolled at various sites across the US.
CPI-006 is an agonistic humanised monoclonal antibody that showed potential as a new approach to immunotherapy in infectious diseases and cancer indications.
The drug candidate was able to bind to different immune cells and trigger a humoral adaptive immune response in-vitro, as well as in-vivo studies in cancer patients.
In addition, CPI-006 increased the levels of memory B cells, which are associated with long-term immunity.
According to the company, the similar generation of antibodies and memory cells against pathogens such as SARS-CoV-2 may provide immediate and long-term clinical benefits for patients.
Corvus Pharmaceuticals president and CEO Richard Miller said: “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.
“We believe that Covid-19 patients treated with CPI-006 may benefit from an improved time to recovery and building longer term immunity.”
The open-label, Phase I Covid-19 trial will involve four cohorts of patients with mild to moderate symptoms. The primary efficacy endpoint is the change in serum immunoglobulin anti-SARS-CoV-2 levels from baseline to day 28.
The trial will also monitor safety and other clinical endpoints, including time to resolution of symptoms and time of hospitalisation.
Results from the study are expected to be available later this year. If positive data is obtained, the company intends to conduct a broader, randomised study with a fixed CPI-006 dose.