COVID-19, the USA and the drug of Cuba: Itolizumab adopted in the United States, Mexico, and Brazil

By Cristiano Antonino On Nov 8, 2020

COVID-19, Itolizumab, a monoclonal antibody developed by the Center for Molecular Immunology (CIM), in collaboration with the Indian company Biocon, has received authorization to begin phase III clinical trials in coronavirus patients in the USA, Mexico, and Brazil.

Hospitals in Cuba have adopted the drug since April, with excellent results, a monoclonal antibody of human origin as part of the health care protocol for coronavirus patients.

Itolizumab is a molecule developed in IMC for the treatment of lymphomas and leukemias and is capable of blocking the proliferation and activation of T-cells, acting as an immune-modulator.

COVID-19, from Cuba and India a good treatment against coronavirus

Biocon has announced that the Drugs Controller General of India (DCGI), the regulatory agency that oversees drug approvals, has granted restricted emergency use of itolizumab for the treatment of cytokine release syndrome (CRS) in COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS) in India.

Based on the encouraging topline results of the study reported by Biocon and subsequent DCGI approval to treat COVID-19 patients, Equillium is planning to conduct a global randomized controlled clinical trial of itolizumab in COVID-19 patients for which it will file a U.S. investigational new drug application (IND).

The study conducted on Itolizumab between Cuba and India on COVID-19 patients

Biocon conducted a randomized, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalized COVID-19 patients with moderate to severe ARDS.

Twenty patients were randomized to receive itolizumab plus best supportive care, while 10 patients received best supportive care alone.

The primary endpoint was mortality at one month. As reported by Biocon:

In the itolizumab arm there were no deaths and all patients have recovered; in the control arm three patients died and the remainder have recovered
The mortality benefit observed in the itolizumab arm was statistically significant
Consistent with the observed clinical improvement, patients who received itolizumab also experienced significant reductions in inflammatory cytokines such as IL-6 and TNFα

Itolizumab, Equillium reactions and future studies in the USA

“The results of this clinical trial reported by Biocon are encouraging and support the hypothesis that itolizumab’s novel immune-modulating mechanism may have promise in addressing the severe immuno-inflammatory complications experienced by COVID-19 patients,” said Bruce Steel, co-founder and CEO of Equillium.

“We are working with Biocon to review its full dataset with the goal to move swiftly in determining appropriate next steps to accelerate further development of itolizumab to treat moderate to severely ill COVID-19 patients in the U.S. and abroad in the face of this global crisis.”

“As the entire world grapples with the ongoing COVID-19 pandemic it is critical to identify new treatments that improve outcomes for the sickest patients, and these reported early clinical data suggest that itolizumab holds promise,” said Siddhartha Mukherjee, M.D., Ph.D., a clinical advisor to Equillium and Biocon, Pulitzer Prize Award-winning author, and an Associate Professor of Medicine at Columbia University’s Herbert Irving Comprehensive Cancer Center.

Ivor S. Douglas, M.D., FRCP (UK) Professor of Medicine, Chief of Pulmonary and Critical Care and Medical Director, Medical Intensive Care Denver Health Medical Center, added, “Patients with COVID-19 experience acute respiratory failure caused by the immune system flooding the bloodstream with inflammatory proteins, which can kill tissue, damage organs and pathologically activate clotting cascades in the lungs, heart, and kidneys.

The novel mechanism of itolizumab, which works by inhibiting CD6 to reduce the activation and trafficking of pathogenic T cells that release pro-inflammatory cytokines, may be well suited to address SARS-CoV-2 induced inflammation that drives respiratory failure in patients with COVID-19.

The preliminary data as reported by Biocon is encouraging and highlights the urgent importance of further evaluating the potential therapeutic efficacy of itolizumab in treating patients diagnosed with COVID-19.”

From Cuba and India to North America and the southern continent: the fight to COVID-19 must unite, not divide

Itolizumab is a first-in-class immune-modulating antibody therapeutic with a novel mechanism of action that inhibits the activity and trafficking of pathogenic T cells that release pro-inflammatory cytokines in a range of autoimmune and inflammatory diseases.

Equillium acquired rights to develop and commercialize itolizumab in the U.S., Canada, Australia and New Zealand through an exclusive collaboration and license agreement with Biocon.

Equillium is currently evaluating itolizumab under two open U.S. INDs for the treatment of acute graft-versus-host disease and lupus nephritis, as well as conducting a clinical study in uncontrolled asthma in Australia and New Zealand.

Biocon previously developed and received approval of Itolizumab for the treatment of plaque psoriasis in India, demonstrating the product was safe and well tolerated. Biocon manufactures itolizumab at commercial scale at its cGMP bio-manufacturing facility that is regulated by the U.S. Food & Drug Administration.

In March of this year, as a result of the emerging COVID-19 pandemic, Equillium announced that it was pausing enrollment in the EQUIP trial for uncontrolled asthma and the EQUALISE trial for lupus nephritis.

Today Equillium announces that patient enrollment in both of these studies has resumed.