24 September 2020 - - US-based clinical stage biopharmaceutical company Humanigen, Inc., (NASDAQ: HGEN) has forged a strategic collaboration with US-based life science company Thermo Fisher Scientific (NYSE: TMO) to expand the manufacturing capacity for lenzilumab, currently in a Phase 3 registration study in patients with COVID-19, to support a potential Emergency Use Authorization, the company said.

This multi-year manufacturing partnership adds to Humanigen's large scale commercial production efforts, including recently announced partnerships with Lonza and Catalent, in advance of a potential 2020 EUA and subsequent commercialization of lenzilumab, the company's proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody.

Thermo Fisher will begin the technical transfer of the lenzilumab bulk drug substance process and commercial scale production could begin before the end of this year.

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.

We believe that our GM-CSF neutralisation 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 minimize 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 neutralising 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.