Benzinga | Feb 4, 2021 09:57AM EST

Corvus Initiates CPI-006 Pivotal Trial In COVID-19 Patients; Results Expected by 2021 End

* Corvus Pharmaceuticals Inc (NASDAQ: CRVS) has initiated a Phase 3 trial to evaluate the efficacy and safety of CPI-006 compared to placebo in hospitalized patients with mild-to-moderate COVID-19.

* The 1000-subject study's primary endpoint is the proportion of patients progressing to respiratory failure or death during the 28 days after dosing. Additional secondary endpoints include time to recovery, time to resolution of COVID-19 symptoms, antiviral antibody responses.

* An independent data monitoring committee will conduct an interim futility and efficacy analysis when approximately 60% of subjects complete the 28-day post-treatment visit. Results from the study are expected to be available in the fourth quarter of 2021.

* In a Phase 1 study in 28 hospitalized, high-risk COVID-19 patients showed no patients progressed to requiring mechanical ventilation and the median time to discharge from the hospital was 3.5 days.

* CPI-006 is a humanized monoclonal antibody designed to bind to and activate B cells that can potentially provide an immunotherapy approach for the treatment of infectious diseases, including COVID-19.

* Corvus also announced that its collaborating partner in China, Angel Pharmaceuticals, plans to initiate a global Phase 2 trial with CPI-818, an ITK inhibitor, in refractory peripheral T cell lymphoma by the end of this year.

* The Company also announced its plans to collaborate with an academic consortium to evaluate ciforadenant, its A2A receptor antagonist, for the first-line treatment of metastatic renal cell carcinoma in combination with pembrolizumab and a tyrosine kinase inhibitor.

* Price Action: CRVS shares are trading lower by 0.95% at $4.15 on the last check Thursday, after going up pre-market.