July 7, 2020 09:36 AM ET (BZ Newswire) -- News
Shares of Corvus Pharmaceuticals Inc (NASDAQ:CRVS) are "" rel="nofollow ugc" target="_blank">https://www.benzinga.com/pre-market-outlook/20/07/16530313/18-healthcare-stocks-moving-in-tuesdays-pre-market-session"; rel="nofollow ugc">advancing strongly Tuesday following an announcement concerning its foray into COVID-19 treatment.
What Happened: The Burlingame, California-based company said the FDA has reviewed and accepted its investigational new drug application for initiating a COVID-19 study. Accordingly, the company said it has initiated a Phase 1 study to investigate a novel immunotherapy approach for patients with COVID-19.
The company said it's studying an agonistic humanized monoclonal antibody, designated as CPI-006, which has demonstrated a potential new approach to immunotherapy of infectious diseases and cancer.
CPI-006, according to the company, has demonstrated binding to various immune cells and the inducement of a humoral adaptive immune response – B cell activation and lymphocyte trafficking leading to the production of antigen-specific immunoglobulin antibodies.
It has also led to increased levels of memory B cells, which are the cells responsible for long-term immunity, it added.
The company said these may provide immediate and long-term clinical benefits, including shortened recovery time and improved long-term protective immunity, for patients infected by SARS-CoV-2, the virus that causes COVID-19.
What's Next: Corvus expects to enroll up to 30 COVID-19 patients with mild to moderate symptoms in the Phase 1 study, with the patients receiving a single dose of CPI-006, with levels of 0.3, 1, 3 and 5 mg/kg, escalating in four cohorts as the study progresses.
The primary efficacy endpoint is the change in serum immunoglobulin anti-SARS-CoV-2 levels compared to baseline at day 28. The study also will examine the safety and other clinical endpoints, including time to resolution of symptoms and duration of hospitalization.
The company expects to report data from the study later this year.
If the study meets its objectives, Corvus said it intends to work with the FDA to initiate a broader, randomized study at a fixed dose of CPI-006 that could potentially be adapted into a pivotal study to support a regulatory submission for FDA approval.
Shares were rallying 85.04% to $5.07