Home Therapeutic relationship Humanigen and Cenexi announce a collaboration to manufacture Lenzilumab in France

Humanigen and Cenexi announce a collaboration to manufacture Lenzilumab in France


BURLINGAME, CA & FONTENAY-SOUS-BOIS, FRANCE–(BUSINESS WIRE)–Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called “cytokine storm,” and Cenexi, a CDMO French company specializing in the formulation, analytical development and manufacturing of complex molecule drugs, announced a collaboration aimed at making Cenexi a preferred supplier of lenzilumab in France and in the European Union. The first stage of the collaboration includes the signing of a Master Supply Agreement (“MSA”) providing that Cenexi will provide aseptic fill and finish services for lenzilumab for the next five years.

Under the terms of the agreement, Humanigen will transfer technology and knowledge to Cenexi to enable them to establish pharmaceutical product processes using their state-of-the-art high-speed filling line at their Hérouville-Saint-Clair plant in Normandy. Humanigen and Cenexi will enter into discussions to possibly extend the agreement to other services offered by Cenexi. These include labeling and packaging, import of drug substance in bulk and quality release of materials in France and throughout Europe. Humanigen plans to include the Cenexi Normandie site in some of its future regulatory filings for lenzilumab for COVID-19 and other indications. The companies will work together to secure potential funding and investment in capital equipment from AD Normandy, the regional authority and the French government, the national authority. In addition, Cenexi will assist Humanigen in seeking an advance purchase agreement for lenzilumab in France.

“The goal of working with Cenexi is to continue our efforts to establish a supply of lenzilumab manufactured in Europe,” commented Cameron Durrant, Managing Director of Hunigen. “Cenexi is an ideal partner for sterile filling and with its strong resource base and aggressive growth plan, we can expand our collaboration beyond the typical customer/supplier relationship. We could 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 in the longer term.

In 2021, the French authorities modified the existing regulations to allow early access to unauthorized medicines. Early Access Authorization (“EAA” Early Access Authorization) allows a manufacturer to provide a product to a cohort of individuals for a specific use, for example, lenzilumab for COVID-19. Humanigen plans to file an AAP application with the Haute Autorité de Santé in February 2022.

“Cenexi wants a leadership position in France to help establish 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 speed,” commented Christophe Durand, Chief Executive Officer. of Cenexi. “Our partnership with Humanigen will utilize our core competencies in sterile filling and allow us to potentially scale 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 modify the US emergency use authorization application. For the European Union, Humanigen expects to file a Conditional Marketing Authorization with an application for Accelerated Approval in the third quarter of 2022.

Lenzilumab is an investigational product and is not approved or licensed in any country.

About Humanigen

Humanigen, Inc. (Nasdaq: HGEN) (“Humanigen”) is a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called a “cytokine storm”. Lenzilumab is a first-in-class antibody that binds and neutralizes granulocyte-macrophage colony-stimulating factor (GM-CSF). Results from preclinical models indicate that GM-CSF is an upstream regulator of many inflammatory cytokines and chemokines involved in cytokine storm. Humanigen is developing lenzilumab as a treatment for the cytokine storm associated with CAR-T cell therapies targeted at COVID-19 and CD19 and is also exploring the efficacy of lenzilumab in other inflammatory conditions such as acute graft versus graft disease. host in patients undergoing allogeneic hematopoietic stem cell transplantation, eosinophilic asthma, and rheumatoid arthritis. In addition, Humanigen is pursuing a Phase 1 program focused on another proprietary monoclonal antibody, ifabotuzumab, in solid tumors.

For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter and Facebook.

About Cenexi

Cenexi, a major French CDMO operating in Europe with 1,500 employees and some 200 million euros in turnover (2021), is experiencing steady growth with four production sites (Fontenay-sous-Bois, Osny and Hérouville-Saint -Clair in France and Braine -l’Alleud in Belgium) and a center of expertise dedicated to the introduction of new products.

Created in 2004, the Cenexi Group is positioned on the very dynamic international market for drugs with major therapeutic indications, relying on its spirit of innovation and its great expertise in the manufacture and development of products.

The Group’s new management team has revitalized the company, in particular by strengthening its sterile expertise which already represents 70% of its activity.

Cenexi has facilities to produce many pharmaceutical forms and has strong expertise in cytotoxic, hormonal and narcotic drugs.

Hunigen Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management’s current knowledge, assumptions, judgments and expectations regarding future performance or events. Although management believes that the expectations reflected in these statements are reasonable, it does not guarantee that these expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as “will”, “expect”, “intend”, “plan”, “potential”, “possible”, “goals”, “accelerate”, “continue” and similar expressions identify forward-looking statements, including, without limitation, statements regarding our goals to establish manufacturing capabilities for lenzilumab in Europe; statements regarding the potential benefits of our agreement with Cenexi; statements regarding our anticipated future regulatory filings following the completion of the ACTIV-5/BET-B trial; and other statements regarding our plans for lenzilumab and ifabotuzumab.

Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, risks inherent in our lack of profitability and our need for additional capital to continue our operations as a business. in activity ; our reliance on partners to further develop our product candidates; the uncertainties inherent in developing, obtaining required regulatory clearances and approvals, and launching any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the “Risk Factors” sections of our most recent annual and quarterly reports and other filings with the SEC.

All forward-looking statements are expressly qualified in their entirety by this cautionary statement. You should not rely on forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unforeseen events, or to update the reasons why actual results could differ materially. of those anticipated in the forward-looking statements, in each case, except as required by law.