Corvus Pharmaceuticals has reported positive findings from an ongoing Phase I clinical trial of its immunotherapy candidate, CPI-006, in patients suffering from Covid-19.
The data covers 56-day follow-up results from the first two cohorts of a 0.3mg/kg and 1mg/kg dose, as well as preliminary results from the third cohort of a 3mg/kg dose.
According to the 56-day follow-up results, the 1mg/kg dose cohort demonstrated a dose-response, with higher and more prolonged titres of antibodies against SARS-CoV-2, compared to the 0.3mg/kg cohort.
The immunotherapy candidate also led to an increase in memory B-cell and memory T-cell levels. Investigators did not find any drug-related safety issues in the 15 patients treated as of 17 September 2020.
Last month, the company published promising initial results from the 0.3mg/kg and 1mg/kg dose cohorts online at medRxiv.org.
Corvus Pharmaceuticals president and CEO Richard Miller said: “We continue to see consistent, promising results with CPI-006 in hospitalised Covid-19 patients.
“The data supports continued evaluation of CPI-006 in this patient population, and potentially in outpatients with Covid-19 and in other infectious diseases.”
The open-label Phase I trial is designed to involve up to 30 hospitalised patients with mild to moderate Covid-19 symptoms. Apart from the 0.3mg/kg, 1mg/kg and 3mg/kg cohorts, the trial includes a 5mg/kg dose cohort.
During the study, participants will be given medicines, therapies and interventions according to standard Covid-19 treatment protocols.
The trial’s primary efficacy endpoint is the change in serum immunoglobulin anti-SARS-CoV-2 levels from baseline to day 28. It will also assess safety and other clinical endpoints, including time to resolution of symptoms and hospitalisation duration.
So far, the first three cohorts of the Phase I trial have completed patient enrolment and the final cohort is recruiting. The trial is expected to complete and report data during the fourth quarter of this year.
Based on these interim results, and if the remaining trial data supports it, Corvus intends to conduct a pivotal, randomised, double blind study in hospitalised Covid-19 patients before the end of the year.