10 August 2020 - - The Brazilian regulatory agency, Anvisa has granted US-based clinical stage biopharmaceutical company Humanigen, Inc permission to commence a Phase III study of lenzilumab in patients with COVID-19 in Brazil, the company said.

Lenzilumab is the company's proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody.

This study, now set to begin recruiting patients in Brazil, follows the same protocol approved by the US Food and Drug Administration in April a multicenter, randomised, placebo-controlled, double-blinded clinical trial focused on hospitalized severe and critical adult COVID-19 patients at high risk of disease progression.

Humanigen said it is working with Clinical Trial and Consulting, recently named the top global contract research organization, to conduct this trial in Brazil.

Currently, Brazil has the second highest reported rates of COVID-19 infection in the world, second only to the US.

Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralisation and gene-knockout platforms.

It believes that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection.

The company's immediate focus is to prevent or minimise the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection.

The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity.

In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders.

The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease in patients undergoing allogeneic hematopoietic stem cell transplantation.

Additionally, Humanigen and Kite, a Gilead company, are evaluating lenzilumab in combination with Yescarta (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration.

CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization recently named #1 CRO in the world for quality, delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization.

CTI's focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations.

CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations.

With clinical trial experience across six continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs.

CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, and Asia-Pacific.