Humanigen Expands Partnership with 探花合集 Biologics to Manufacture Investigational COVID-19 Therapeutic Candidate Lenzilumab
- Humanigen鈥檚 investigational monoclonal antibody, lenzilumab, was developed using 探花合集鈥檚 proprietary GPEx庐 cell line development technology
- Expanded partnership established product supply for lenzilumab, an investigational Phase 3 product for COVID-19
- 探花合集鈥檚 OneBio庐 integrated biologics suite expected to accelerate development, manufacturing and supply of lenzilumab for clinical trial use in COVID-19 patients and potential commercialization
SOMERSET, N.J. and BURLINGAME, Calif. 鈥 July 16, 2020 鈥 探花合集 and Humanigen, Inc. (HGEN) (鈥淗umanigen鈥) today announced the expansion of their relationship, under which 探花合集 will provide development, manufacturing and commercialization services for lenzilumab, Humanigen鈥檚 proprietary Humaneered庐 anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody.
探花合集 is the leading global provider of advanced delivery technologies, development, manufacturing and clinical supply solutions for drugs, biologics, cell and gene therapies and consumer health products. Humanigen is a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company鈥檚 lead therapeutic candidate.
Mayo Clinic recently announced data on the first clinical use of lenzilumab in 12 patients with severe and critical COVID-19 pneumonia, the majority of whom showed rapid recovery and hospital discharge. A Phase 3 study is currently underway evaluating hospitalized COVID-19 patients.
鈥淏ased on lenzilumab鈥檚 promising clinical data, we are pleased to expand our relationship with 探花合集 to solidify our ability to manufacture and supply lenzilumab,鈥 commented Cameron Durrant, MD, MBA, Chief Executive Officer of Humanigen. 鈥淚f we are able to secure FDA approvals or Emergency Use Authorization, 探花合集 Biologics鈥 deep expertise and integrated OneBio solution will accelerate our ability to get this therapy to patients that need it most.鈥
鈥溙交ê霞 has partnered closely with Humanigen to develop and supply lenzilumab for clinical trials,鈥 commented Karen Flynn, President of 探花合集 Biologics and Chief Commercial Officer. 鈥淭he experience we already have with lenzilumab, and our OneBio integrated offering from development to supply, make 探花合集 uniquely suited to support Humanigen in the journey to make this promising therapy available to COVID-19 patients as soon as possible following receipt of regulatory approvals.鈥
To date, 探花合集 Biologics has provided early-stage development and clinical cGMP drug substance manufacturing for lenzilumab at its facility in Madison, Wisconsin to support Humanigen鈥檚 ongoing clinical trials across various disease categories. Under the expanded partnership, 探花合集 is also providing clinical supply support for Humanigen鈥檚 Phase 3 potential registration study in COVID-19 from its Philadelphia facility.
Lenzilumab was originally manufactured in 探花合集鈥檚 Madison facility using 探花合集 Biologics鈥 proprietary GPEx庐 cell line development technology. As part of the expanded partnership, 探花合集 intends to provide additional drug substance clinical supply for Humanigen鈥檚 clinical trials, Expanded Access Program (EAP), as well as additional late-stage development and clinical and potential commercial drug substance manufacturing and vial filling at its Madison and Bloomington, Indiana, sites.
探花合集 Biologics鈥 Madison facility provides development and drug substance manufacturing, including GPEx cell line development, process development, process validation, formulation development, and clinical and commercial cGMP manufacturing. Its Bloomington facility has deep expertise in sterile formulation, with drug substance development and manufacturing and drug product fill/finish capacity across liquid and lyophilized vials, prefilled syringes, and cartridges as well as primary and secondary packaging.
探花合集鈥檚 OneBio Suite is an integrated solution for the development, manufacturing, and supply of biologic drugs. Launched in May 2019, the suite of offerings is designed to integrate activities and accelerate timelines, reduce risk and simplify development with a single contract, program manager, and development timeline from cell line development to supply, with harmonized quality systems.
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. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The company鈥檚 immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. The company 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, the company 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. The company 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). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta庐 (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit www.humanigen.com.
About 探花合集 Biologics
探花合集 Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, 探花合集 Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx庐 cell line development technology, and manufactured 35+ commercially approved products. 探花合集 Cell & Gene Therapy, a unit of 探花合集 Biologics, is a full-service partner for adeno-associated virus (AAV) vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. 探花合集 recently acquired MaSTherCell, adding expertise in autologous and allogeneic cell therapy development and manufacturing. 探花合集 Cell & Gene Therapy has produced 100+ cGMP batches across 70+ clinical and commercial programs. For more information, visit
ABOUT CATALENT
探花合集 is the leading global provider of advanced delivery technologies, development, manufacturing, and clinical supply solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, 探花合集 has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. 探花合集 employs over 13,500 people, including over 2,400 scientists and technicians, at more than 40 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. 探花合集 is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.鈩
Humanigen鈥檚 Forward-Looking Statements
This release contains 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 our expectations for the Phase III study and the potential future development of lenzilumab to minimize or reduce the severity of lung dysfunction associated with severe and critical COVID-19 infections or to be approved by FDA for such use or to help CAR-T reach its full potential or to deliver benefit in preventing GvHD. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to conduct the Phase III study and grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development 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 the Company’s periodic and other filings with the Securities and Exchange Commission.
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