Advanced Monoclonal Antibody Clinical Trial Targeting COVID-19 Comes to California’s Imperial Valley

Oct 4, 2020 | California, COVID-19, Imperial College of London, Monoclonal Antibody, News

Advanced Monoclonal Antibody Clinical Trial Targeting COVID-19 Comes to California’s Imperial Valley

Imperial County’s El Centro Regional Medical Center (ECRMC) will be participating in yet another clinical trial battling COVID-19. The health system in the very southern most part of California reported in June it would collaborate with University of California, San Diego School of Medicine on a trial for COVID-19 treatment using ACE inhibitors. Now they have added a study sponsored by Corvus Pharmaceuticals, Inc., investigating the use of a novel immunotherapy for hospitalized patients with COVID-19. The novel humanized monoclonal antibody called CPI-006 is designed as an immunotherapy for mild to moderately ill COVID-19 patients requiring hospitalization. ECRMC is an acute-care medical center serving the needs of the Imperial Valley since 1956.

COVID-19 & The Imperial Valley

With just under 200,000, few around the nation know California’s unique Imperial County. Adjacent to the Mexican border and about 115 miles east of San Diego, the region traditionally depends on agriculture and includes a massive inland body of water called the Salton Sea. The region is heavily Hispanic as Latinos represent over 80 percent of the population.

According to the Imperial County Public Health Department, the county currently has 12,047 positive COVID-19 cases and 326 deaths.

Although the region’s population has a rich history based in the land use of this region, economic challenges persist as the region seeks transitions to sectors other than agriculture. The demographics of the county are such that it would be more difficult to enroll participants in clinical trials without community outreach such as the type associated with the ECRMC.

ECRMC Principal Investigator Point of View

Christian A. Tomaszewski, MD, leads the study for ECRMC and reports, “We’ve seen a great deal of challenges with COVID-19 treatment,” and continued, “But the potential for new treatments is there and ECRMC is pleased to be able to help study these treatments.”

The physician, also an investigator with University of California, San Diego, commented, “The purpose of this trial is to study a novel humanized monoclonal antibody, designated CPI-006, as an immunotherapy for mid to moderately ill COVID-19 patients that require hospitalization. CPI-006 activates B cells leading to the production of antigen-specific immunoglobulin (IgM and IgC), as well as increased levels of memory B cells, which are responsible for long-term immunity.

The Study

The first Phase 1 (safety) single-dose, dose-escalation clinical trial (NCT04464395) is an open label trial evaluating the safety of CPI-0006, a humanized monoclonal antibody targeting CD73 cell-surface ectonucleotidases, as immunotherapy for stable hospitalized mild or moderately symptomatic COVID-19 patients. The study started July 1 and is scheduled to conclude August 2021. Primary trial sites listed include Icahn School of Medicine (NYC) and Temple University (Philadelphia).

Recent updates on study results from the Phase 1 study indicate that all evaluable patients treated in the first two cohorts (0.2 and 1.0 mg dose of CPI-006) of the stud produced significant titers of antibody to SARS-CoV-2 within seven days of receiving the treatment, with levels of neutralizing antibodies, continually increasing out to 28 days.

Additionally, all of the patients were discharged from the hospital with clinical improvement while non experienced any drug-related safety issues. The study has completed enrollment in the third cohort (3.0 mg dose of CPI-006) of five patients, with overall study expected to enroll up to 30 patients.

This new study will enroll up to 25 inpatient participants; they must be at least 18 years of age, and diagnosed with mild to moderate COVID-19 and hospitalization. If successful, this study will lead to faster viral clearance, shorter recovery time, less complications and longer lasting immunity.

The Sponsor

Covus Pharmaceuticals founded in 2014 by Joseph J. Buggy and Richard A. Miller, focuses on the development of novel, first-in-class agents that target the immune system to treat patients with cancer. The company filed for a $90 million IPO in 2016.

Priced currently at $4.07, the company has a market capitalization of $114 million. Like most small biotech they operate in the red and must continuously raise capital.

CPI-006

CPI-006 is an immunomodulatory antibody that binds to human cells, leading to activation of B cells and antibody production that they believe can destroy the SARS-CoV-2 virus. For more information about the early-stage investigational product performance in Phase 1 research, see the link to the preprint server medRxiv

The Trial Site

El Centro Regional Medical Center is an acute-care medical center serving the health care needs of the Imperial Valley since 1956. Thanks to a $44 million expansion the center has grown from a 34-bed licensed hospital to a 161 bed, state-of-the-art facility including trauma center and rooftop heliport. Led by Dr. Adolphe Edward, the regional health provider maintains a close affiliation with University of California, San Diego

Lead Research/Investigator

Christian A. Tomaszewski, MD 

Call to Action: If you have a loved one hospitalized in Imperial County with COVID-19, consider this study.

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