15 September 2020 - - US-based biopharmaceutical company Humanigen and Switzerland--based chemicals and biotechnology company Lonza have forged a strategic collaboration to expand the manufacturing capacity for lenzilumab, currently in Phase 3 clinical trials for COVID-19, in advance of potential Emergency Use Authorization in 2020 and subsequent commercialization, the companies said.

The collaboration enables Humanigen to leverage Lonza's monoclonal antibody manufacturing and regulatory expertise.

Lenzilumab represents Humanigen's proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody with the potential to prevent and treat cytokine storm, which is believed to trigger the acute respiratory distress syndrome in severe cases of COVID-19.

This collaboration provides Humanigen with additional capacity for cGMP production of lenzilumab with operations intended to start in 2021. Production of lenzilumab will begin at Lonza's 2,000L manufacturing facilities at Hayward, USA.

Technology transfer is expected to begin in 3Q20.

Lonza is a global partner to the pharmaceutical, biotech and specialty ingredients markets. It offers a range of microbial control solutions, which help to create and maintain a healthy environment.

Founded in 1897 in the Swiss Alps, Lonza currently operates in 120 sites and offices in more than 35 countries.

The company generated sales of CHF 5.9bn in 2019 with a CORE EBITDA of CHF 1.6bn.

Humanigen 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.

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.