Humanigen and Chime Biologics Enter Into Manufacturing Agreement for COVID-19 Therapeutic Candidate Lenzilumab
Humanigen (Nasdaq:HGEN) has partnered with Chime Biologics to produce its lead drug candidate, lenzilumab, for commercial sale outside the U.S. The agreement follows the positive results from the LIVE-AIR Phase 3 clinical trial. Chime will utilize its advanced KuBio facility in China, with an initial capacity of 56,000L for annual production. The planned commercial product availability is set for 2022, pending necessary regulatory approvals in regions like Europe, India, and Brazil. This collaboration aims to fulfill the anticipated demand for lenzilumab.
- Partnership with Chime Biologics for lenzilumab production enhances market capability.
- Production planned for 2022, indicating readiness for commercialization.
- Chime Biologics' facility has significant production capacity (initially 56,000L annually).
- Dependence on regulatory approvals in various regions poses uncertainties.
- No immediate sales or financial metrics provided, indicating potential risks.
Humanigen, Inc. (Nasdaq:HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab™, and Chime Biologics (“Chime”), a world-class contract development and manufacturing organization (CDMO), today announced that they have entered into a manufacturing services agreement to produce lenzilumab bulk drug substance and drug product for Humanigen for commercial sale following receipt of the requisite regulatory authorizations or approvals in regions outside of the United States including Europe, the United Kingdom, India and Brazil.
“With the recent announcement of the results from the LIVE-AIR Phase 3 clinical trial of lenzilumab, we are pleased to enter into a partnership with Chime to help with our anticipated commercial production of lenzilumab,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. “Following a competitive process focused on quality, technical abilities, supply chain and economic criteria we selected Chime as our first foreign CDMO to supply lenzilumab to ex-US markets.”
Under the terms of this agreement, Chime will use the state-of-the-art modular single use KuBio (Cytiva) biologics facility in China. The cell culture capacity at the facility is 24,000L with planned expansion to 140,000L and Chime would be willing to commit at least 56,000L for Humanigen manufacture annually. Technical transfer work has already begun, and commercial product is planned to be available in 2022.
“We are pleased to have been selected by Humanigen as a manufacturing partner for ex-US supply of lenzilumab. Since 2013, Chime Biologics has developed and produced more than 30 products and supplied to over 20 countries from its latest generation single use facility. We are proud of our record for quality, compliance, bioprocessing expertise, and cost effectiveness, and very much look forward to supporting Humanigen in this important program,” said Dr. John Zeng, CEO of Chime Biologics.
About Chime Biologics
Chime Biologics is a world-class CDMO with operations in China that provides customer-centric and cost-effective outsourcing services for biopharmaceutical development and manufacturing. Its GE KuBio facility is located at Wuhan’s BioLake biotech industry development zone. Chime Biologics is ISO 14001:2015 and ISO 45001:2018 certified, and is committed to uphold the highest degree of integrity. Since 2016 Chime Biologics has been providing customers with clinical materials for pre-clinical and clinical stages globally and supporting their production scales from 50L, 200L, 500L to 2,000L across IND-enabling studies to late-stage CMC. Since then, Chime Biologics has been providing clinical supply to over 20 countries worldwide. https://chimebiologics.com/
About Humanigen, Inc.
Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. Humanigen’s immediate focus is on the development of lenzilumab as a therapy for hospitalized, hypoxic COVID-19 patients. Humanigen recently announced plans to initiate a randomized, multicenter, potentially registrational, Phase 2 study to evaluate the efficacy and safety of lenzilumab combined with all commercially available CD19 CAR-T therapies in diffuse large B-cell lymphoma.
Humanigen is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, Humanigen is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. Humanigen is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). For more information, visit www.humanigen.com and follow Humanigen on LinkedIn, Twitter and Facebook.
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, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such 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 the volume and timeline for Chime’s production of commercial lenzilumab product, as well as statements regarding Humanigen’s beliefs relating to the technologies in Humanigen’s current pipeline.
Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in the company’s lack of profitability and potential need for additional capital to grow its business; its dependence on partners to further the development of its product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in Humanigen's periodic and other filings with the Securities and Exchange Commission.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. The company undertakes no obligation to revise or update any forward-looking statements made in this presentation to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210517005490/en/
FAQ
What is the significance of Humanigen's partnership with Chime Biologics for HGEN?
What are the production capabilities of Chime Biologics for HGEN's lenzilumab?
When is lenzilumab expected to be available for sale from HGEN?
What regions are targeted for lenzilumab production and sales by HGEN?
What recent clinical trial results does HGEN highlight in the partnership announcement?
