France Humanigen, Inc. a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ and Cenexi, a French CDMO specializing in the formulation, analytical development, and manufacture of complex molecule drugs, 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.
“The goal of the collaboration with Cenexi is to further our efforts to establish a supply of lenzilumab made in Europe. Cenexi is an ideal partner for sterile filling and with their strong base of resources and aggressive growth plan, we may expand our collaboration beyond the typical customer/vendor relationship. We may work with Cenexi to become our preferred partner for multiple services and to establish a stable and secure supply chain for lenzilumab in France and Europe longer-term.”
Cameron Durrant, chief executive officer of Humanigen
In 2021, French authorities modified existing regulations to provide for early access to unauthorized medicinal products. The early access authorization 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.
“Cenexi desires a leadership position in France to assist in establishing a strong supply chain for COVID-19 and for future pandemics. Since 2004, Cenexi has been at the forefront of bringing critical medicines to patients and we continue to build on our strong reputation for value, high quality, flexibility and timeliness,” commented Christophe Durand, chief executive officer of Cenexi. “Our partnership with Humanigen will use our core competencies of sterile filling and to potentially expand into to an end-to-end solution for lenzilumab in France and other countries in Europe.”
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.
Humanigen, Inc. is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’. Lenzilumab is a first-in class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in the cytokine storm. Humanigen is developing lenzilumab as a treatment for cytokine storm associated with COVID-19 and CD19-targeted CAR-T cell therapies and is also exploring the effectiveness of lenzilumab in other inflammatory conditions such as acute Graft versus Host Disease in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma, and rheumatoid arthritis. In addition, Humanigen is progressing a Phase 1 program focused on another proprietary monoclonal antibody, ifabotuzumab, in solid tumors.
Cenexi, a major French CDMO operating in Europe with 1,500 employees and some €200 million in turnover (2021), is experiencing steady growth with four production sites and a center of expertise dedicated to new product introduction.