Humanigen has signed a contract with Clinigen Group to implement a managed access programme for investigational product lenzilumab (LenzMAP).
The first-in-class antibody Lenzilumabbinds to and neutralises granulocyte-macrophage colony-stimulating factor (GM-CSF).
It is being developed by Humanigen ed to treat an immune hyper-response known as ‘cytokine storm’ and is associated with Covid-19 and CD19-targeted CAR-T cell therapies.
At present, the product is not authorised or approved in any country.
However, through LenzMAP, hospitalised Covid-19 patients can get access to lenzilumab by their doctors on a case-by-case basis once the programme is set up.
The programme will be available in 16 European countries, namely Denmark, Croatia, Cyprus, Netherlands, Greece, Austria, Bulgaria, Ireland, Lithuania, Luxembourg, Estonia, France, Portugal, Spain, Sweden and Switzerland.
Humanigen chief operating officer and chief financial officer Timothy Morris said: “We are working with Clinigen to provide access to lenzilumab on a patient-by-patient basis in specific European countries.
“While we continue to pursue a marketing authorization application (MAA) for lenzilumab and await the associated review by the European Medicines Agency (EMA), as well as a decision regarding conditional marketing authorisation, the Managed Access Program will enable Humanigen to respond positively to requests for access from healthcare professionals to treat hospitalised patients where allowed by the local regulatory authorities.”
Under the deal, Clinigen will be responsible for handling the key elements of the managed access programme including logistics, access management and regulatory oversight.
Furthermore, the company is exploring the effectiveness of lenzilumab in other inflammatory conditions that include eosinophilic asthma and rheumatoid arthritis.
Clinigen Services Division executive vice-president Pete Belden said: “We are pleased to partner with Humanigen to offer this important treatment option to help address a significant unmet need for hospitalised patients with Covid-19 across Europe.
“This agreement underlines Clinigen’s strength in partnering with biotechnology companies to provide services that enable quicker and broader access to critical medicines.”