Corvus Pharmaceuticals Initiates Phase 3 Clinical Trial of CPI-006 for Patients with COVID-19 - Seite 2

Serum from 2 of 2 patients treated with CPI-006 early in the pandemic (July 2020), and before variants were discovered, were tested in neutralization assays against both the UK variant and wild type receptor binding domain of SARS-CoV-2 (N501Y mutation). Day 28 post CPI-006 treatment serum showed increases in neutralization titers of 4.5 fold and 1.7 fold to the UK variant for the two patients respectively, compared to the wild type virus. These data will require further confirmation with many more additional patients, but suggest that CPI-006 elicited a broad anti-viral response that may address the problem of immune escape.

The Phase 3 double-blind study, which was designed with guidance from the Food and Drug Administration (FDA), will evaluate the efficacy and safety of CPI-006 compared to placebo in hospitalized patients with mild-to-moderate COVID-19. Patients will be randomized in a 1:1:1 ratio to receive a single intravenous CPI-006 dose of either 2.0 mg/kg or 1.0 mg/kg or placebo; all patients will receive standard of care treatments for COVID-19. The primary endpoint is the proportion of patients progressing to respiratory failure or death during the 28 days after dosing. Respiratory failure is defined as requiring non-invasive or invasive mechanical ventilation. Additional secondary endpoints include time to recovery, time to resolution of COVID-19 symptoms, anti-viral antibody responses, etc. An interim futility and efficacy analysis will be conducted by an independent data monitoring committee 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 2021.

“The devastating nature of the pandemic and emerging understanding of this disease compels us to rapidly develop CPI-006 for the treatment of COVID-19,” said Richard A. Miller, M.D., president and chief executive officer of Corvus. “We believe CPI-006’s novel mechanism of action, supported by Phase 1 results obtained to date, indicate that this agent may be well suited to combat this virus, which is now demonstrating a propensity to mutate, become more transmissible and potentially escape from current vaccination and therapeutic approaches such as the administration of passive anti-viral monoclonal antibodies. The advancement of this study is the top priority for the Company given the growth in new COVID-19 cases and could provide the foundation for its potential use in other infectious diseases. If successful and ultimately approved for treatment, we believe CPI-006 could be an important therapy if it is able to shorten recovery times and keep COVID-19 patients out of the intensive care unit and off of mechanical ventilators, while also providing durable, longer-term immunity and potential protection against re-infection.”