Humanigen Inc. (NASDAQ:HGEN) has announced the signing of a strategic partnership deal with Thermo Fisher Scientific to expand the manufacturing capacity for lenzilumab. The company is currently evaluating lenzilumab in a third phase registration study in COVID-19 patients to support a possible Emergency Use Authorization.
Humanigen ramping production capabilities for lenzilumab
The partnership adds to the company’s efforts to expand the commercial production of lenzilumab. Recently Humanigen entered partnerships with Catalent and Lonza ahead of the possible 2020 EUA with subsequent lenzilumab commercialization. Lenzilumab is the company’s novel Humaneered® anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody. Following the collaboration agreement signing, Thermo Fisher is expected to commence technical lenzilumab drug substance process transfer and large scale production before the end of 2020.
Cameron Durrant, the CEO of Humanigne, said that production preparation, expertise, and precision are vital in the execution of the company’s aggressive strategy ahead for a possible EUA. The company hopes to deliver potential COVID-19 therapy thus winter, which can minimize ventilation risk or death and result in early discharge of hospitalized patients. Durrant added that Thermo Fisher will provide scalable capacity and manufacturing expertise to support Humanigne’s growth and production trajectory.
Thermo Fisher to help with expertise and supply chain capabilities
Thermo Fisher’s commercial operation for pharma services president, Leon Wyszkowski, stated that having effective therapeutics is vital in the overall approach to fight the impact of the COVID-19 pandemic. Wyszkowski added that they are dedicated to enabling leading therapeutic innovations for patients by providing comprehensive expertise and supply chain capabilities.
Humanigen is developing its lead drug, lenzilumab, through its propriety ultramodern GM-CSF neutralization and gene-knockout platforms. The company believes that the novel platform has the potential of reducing inflammatory cascade related to COVID-19 infection. The company’s immediate focus is prevention or minimizing cytokine release syndrome, which comes before ARDS and severe lung dysfunction in chronic SARS-CoV-2 infection cases. Humanigen is equally exploring GM-CSF neutralization technologies’ effectiveness in combination with CAR-T or natural killer T cells in immunotherapy treatments.