Humanigen has partnered with Thermo Fisher for the manufacture of its potential COVID-19 therapy lenzilumab as it enters Phase III trials.

Lenzilumab is being explored as a treatment for ‘cytokine storm’, an overreaction of the immune system, which has occurred in those suffering from the disease.

Humanigen agreed the deal with Thermo Fisher in anticipation of a potential approval for Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) later this year.

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The two partners have agreed a multi-year deal that will see Thermo Fisher provide large-scale commercial production.

According to Humanigen, the technology transfer of the bulk drug substance process for lenzilumab and commercial scale production could begin before the end of the year, as part of the company’s plan to deliver the COVID-19 therapeutic this winter.

The drug at the center of the deal is an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody (mAb). The company is currently recruiting participants for the Phase III trial that will be used to support a potential EUA.

Alongside exploring the mAb against COVID-19, Humanigen is working with Kite for the use of lenzilumab in combination with Yescarta (axicabtagene ciloleucel) for the treatment of diffuse large B-cell lymphoma.

Third manufacturing deal

Humanigen’s latest agreement adds a third manufacturing partner to produce lenzilumab, as the company works on an ‘aggressive strategy’ to build out capacity ahead of the potential EUA utilisation of the treatment.

A spokesperson for the company confirmed to Bioprocess Insider that, with the entire industry mobilizing against COVID-19, it is currently a competitive environment to secure services for manufacturing.

“We’ve seen heightened demand for access to medical supply chain manufacturing resources and even reports of medical glass shortages spanning several months.”

Earlier this month, Humanigen signed a collaboration agreement with Lonza to expand the manufacture of the mAb, with commercial manufacture expected to begin in 2021 out of the latter company’s Hayward, US, site.

Prior to this, the company had also sealed an end-to-end services deal with Catalent, building on a working relationship extending back to 2007. Catalent will provide services, such as cell line development and clinical drug substance manufacturing, out of its Madison, Wisconsin, and Bloomington, Indiana, locations.

As a result of these agreements, the spokesperson noted that the company is ‘well-positioned’ to achieve its production capacity aims for lenzilumab.

COVID-19 demand

For Thermo Fisher, the partnership with Humanigen represents one of a number of deals struck amid the global pandemic.

Leon Wyszkowski, president, commercial operations and pharma services at Thermo Fisher, told Bioprocess Insider that the company is currently working on over 200 projects developing COVID-19 therapies and vaccines.

In regard to how the company is coping with such demand, he said, “Over the last few months, we have worked closely with our supplier partners, validated alternative sources of supply, monitored our supply chains and expedited transportation modes wherever possible to ensure critical inventories for both COVID and vital non-COVID medicines.”

During its second quarter financials, Thermo Fisher noted that COVID-19-related business alone had contributed $1.3 billion in revenues, with this expected to continue over the coming years.