Biopharmaceutical company Corvus Pharmaceuticals, Inc. (CRVS) announced Thursday 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.
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.
The company also said it has completed enrollment in the third cohort and plans to meet with FDA to discuss plans for a pivotal study.
Additional data from this study is expected to be available in late 2020, including results from the 3.0 and 5.0 mg cohorts and longer follow-up data from the 0.3 and 1.0 mg cohorts.
In addition, if the study meets its objectives, Corvus intends to work with the FDA to initiate a broader, randomized study that could potentially be adapted into a pivotal study to support a regulatory submission for FDA approval.
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