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Temple Treats First Patients in the U.S. in Clinical Trial of Novel Immunotherapy for Patients with COVID-19

News July 07, 2020

Temple University Hospital has treated the first five patients in the United States as part of a Phase 1 clinical trial investigating a novel immunotherapy approach for patients with COVID-19. CPI-006, developed by Corvus Pharmaceuticals, Inc., has demonstrated a potential new approach to immunotherapy of infectious diseases and cancer. 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, is the principal investigator at Temple.

“COVID-19 has had such a profound impact on the lives of patients around the globe,” said Dr. Criner. “It’s crucial that new treatments are identified that can improve outcomes for these patients. We’re pleased to be participating in a variety of clinical trials investigating potential treatments for patients with COVID-19.”

CPI-006 is an agonistic, or immunostimulatory, humanized, monoclonal antibody. In both in vitro and in vivo in cancer patients, CPI-006 has demonstrated binding to various immune cells and the inducement of an immune response (B cell activation and lymphocyte trafficking) that leads to the production of antigen-specific immunoglobulin (igM and IgG) antibodies. Administration of CPI-006 has also led to increased levels of memory B cells, which are the cells responsible for long-term immunity. It’s hypothesized that the similar production of antibodies and memory cells to pathogens such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, may provide immediate and long-term benefits for patients including shortened recovery time and improved long-term protective immunity.

The open-label, Phase 1 study is expected to enroll up to 30 COVID-19 patients with mild to moderate symptoms at several sites in the U.S. 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. Patients will receive medications, therapies, and interventions per standard treatment protocols for COVID-19 for the duration of the study. The primary efficacy endpoint is the change in serum immunoglobulin (IgM and IgG) anti-SARS-CoV-2 levels compared to baseline at day 28. The study also will examine safety and other clinical endpoints, including time to resolution of symptoms and duration of hospitalization.

The objective of the study is to show that CPI-006 has the potential to induce the patient to produce an enhanced antibody response to SARS-CoV-2. If the study meets its objectives, Corvus 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.

Editor’s Note: Neither Dr. Criner nor any member of his immediate family has financial interest in Corvus Pharmaceuticals, Inc.