Humanigen, Inc. and Cenexi, announced a collaboration aimed at making Cenexi a preferred supplier of lenzilumab in France and the European Union. The initial step of the collaboration includes the execution of a Master Supply Agreement (“MSA”) providing for Cenexi to provide aseptic fill and finish services for lenzilumab for the next five years. Under the terms of the agreement, Humanigen will transfer the technology and knowledge to Cenexi to allow them to establish drug product processes utilizing their state-of-the-art high speed filling line at their Herouville-Saint-Clair facility in Normandy.

Humanigen and Cenexi will enter into discussions to potentially expand the agreement to other services Cenexi offers. These include labeling and packaging, importation of bulk drug substance and quality release of materials in France and throughout Europe. Humanigen plans to include the Cenexi Normandy site in certain of its future regulatory filings for lenzilumab for COVID-19 and other indications.

The companies will collaborate to secure potential funding and investment in capital equipment from AD Normandie, the regional authority and the Government of France, the national authority. In addition, Cenexi will assist Humanigen as it seeks an advanced purchase agreement for lenzilumab in France. In 2021, French authorities modified existing regulations to provide for early access to unauthorized medicinal products.

The early access authorization (autorisation d'acces precoce of “AAP”) allows for a manufacturer to supply product to a cohort of individuals for a specific use, for example, lenzilumab for COVID-19. Humanigen plans to file a request for AAP with the Haute Authorite de Sante in February 2022. Pending positive results from the NIH-sponsored ACTIV-5/BET-B study, Humanigen plans to amend the Emergency Use Authorization application in the United States.

For the European Union, Humanigen anticipates submission of a Conditional Marketing Authorization with a request for Accelerated Approval in the third quarter of 2022. Lenzilumab is an investigational product and is not approved or authorized in any country.