Corvus Pharmaceuticals Initiates Phase 3 Clinical Trial of CPI-006 for Patients with COVID-19
Novel immunotherapy approach designed to stimulate immune response by activating B cells to enhance polyclonal antibody production and potentially reduce hospitalization and progression to respiratory failure
Randomized, double-blind, placebo-controlled study expected to enroll ~1,000 patients across global sites with results expected in Q4 2021
Company to host conference call and webcast today at 8:30 a.m. ET / 5:30 a.m. PT
BURLINGAME, Calif., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ: CRVS), a clinical-stage biopharmaceutical company, today announced that it has initiated a Phase 3 clinical trial of CPI-006 for the treatment of hospitalized patients with COVID-19. The study is expected to enroll approximately 1,000 patients at sites in North America, Europe, South Africa and Latin America.
“The COVID-19 pandemic has been devastating to patients and the healthcare system, and it is critical that we develop new therapies that can improve patient outcomes,” said Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University and Director of the Temple Lung Center and one of the lead investigators of the trial. “CPI-006 has already shown promising results in COVID-19 patients and its proposed mechanism of stimulating the immune system to specifically target the SARS-CoV-2 virus may have several potential advantages over existing therapies, including the potential to address recently emerging variants of the virus. We look forward to offering this therapy to our patients as part of the Phase 3 study.”
CPI-006 is a humanized monoclonal antibody that is designed to bind to and activate B cells that Corvus believes has the potential to provide a unique immunotherapy approach for the treatment of infectious diseases, including COVID-19. In a Phase 1 study involving 28 hospitalized, high-risk patients with moderate COVID-19 treated with CPI-006, no patients progressed to requiring mechanical ventilation and the median time to discharge from the hospital was 3.5 days. This compares favorably to published reports showing that, on average, approximately 20% of similarly affected patients will progress to requiring invasive mechanical ventilation. Patients in the study generated high titers of polyclonal antibodies against a diverse range of targets on the SARS-CoV-2 virus that were sustained over several months. They also had increased levels of circulating memory B cells, which could lead to long-term immunity.
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 tretment, 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.”
Corvus also announced that in collaboration with its Chinese partner, Angel Pharmaceuticals, it plans to initiate a global Phase 2 trial with CPI-818, an ITK inhibitor, in refractory peripheral T cell lymphoma by the end of 2021. 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.
Conference Call, Webcast and Slide Presentation Details
About Corvus Pharmaceuticals
About Angel Pharmaceuticals
One of the main strategic rationales for Corvus’ collaboration with Angel is to gain clinical study synergies and accelerate development timelines, whereby data from patients enrolled in China studies could potentially be used as part of U.S. regulatory submissions as part of a global pivotal study protocol. Based on the tumor responses observed in the CPI-818 Phase 1/1b clinical trial, the companies are planning to collaborate on the next clinical study for CPI-818 for the treatment of T cell lymphomas.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4418f37c-2b88-4eb5-95b4-e24383051a5e.