Humanigen and PCI Pharma Services have signed an agreement to offer import, release and marketing services for the investigational product lenzilumab in the UK.
A Humaneered monoclonal antibody, lenzilumab could attach to and neutralise granulocyte-macrophage colony-stimulating factor (GM-CSF).
GM-CSF is a cytokine and vital in the hyperinflammatory cascade or cytokine release syndrome or cytokine storm, linked to Covid-19 and other indications.
As per the deal, PCI will procure lenzilumab for resale and supply following the grant of a Conditional Marketing Authorization in the UK for usage in hospitalised Covid-19 patients.
On obtaining top-line data from the ACTIV-5/BET-B clinical trial of lenzilumab, Humanigen will conclude its response to the Medicines and Healthcare products Regulatory Agency (MHRA).
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Humanigen chief commercial officer Edward Jordan said: “We continue our commercial preparation in the UK and in parallel are working closely with the MHRA to address regulatory requirements for a potential Conditional Marketing Authorization.
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By GlobalData“With its global reach, PCI will provide a critical function in the supply chain, by directly purchasing lenzilumab for further distribution in the UK and facilitating this key process for Humanigen.”
The company believes that lenzilumab’s ability to neutralise GM-CSF can also potentially lower cytokine storm which is frequent in chimeric antigen receptor T-cell (CAR-T) therapy and acute Graft versus Host Disease (aGvHD).
In CAR-T, lenzilumab attained the pre-specified primary endpoint at the recommended dose in a Phase Ib trial along with Yescarta.
It also offered an overall response rate of 100% without any patient-experienced severe cytokine release syndrome or severe neurotoxicity reported.
Based on these data, Humanigen intends to begin the randomised, multicentre, Phase II SHIELD trial of lenzilumab to assess its safety and efficacy along with Yescarta and Tecartus CAR-T therapies in non-Hodgkin lymphoma.
In October last year, Humanigen and Clinigen Group signed a contract to implement a managed access programme for lenzilumab (LenzMAP).
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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