Catalent Partners With Humanigen to Support FDA-Approved Phase 3 Lenzilumab Study for COVID-19

Catalent recently welcomed the news by Humanigen, Inc., that it has dosed the first COVID-19 patient in its previously announced Phase 3 study for lenzilumab, the company’s proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody. From its Philadelphia facility, Catalent has provided clinical supply support to Humanigen and its partners to accelerate the instigation of this clinical trial.

“We are honored to have supported Humanigen on this important project and have ensured that all possible resources were allocated to allow these trials to begin as soon as possible,” said Ricci Whitlow, President Clinical Supply Services at Catalent. “Our team in Philadelphia, and across the company as a whole, feel great pride in doing whatever we can in these times of global uncertainty to help in the treatment of those suffering greatly.”

“I would like to thank the staff at Catalent for their continued work, responsiveness, and partnership, which has helped ensure we were able to commence the trial as quickly as we have to evaluate the potential benefits to patients hospitalized with COVID-19 pneumonia and at high risk of progression,” commented Dr. Cameron Durrant, Chairman and Chief Executive Officer of Humanigen.

Catalent’s 200,000 square-foot Philadelphia facility provides comprehensive clinical supply services, including clinical supply management, comparator sourcing, package engineering primary packaging, secondary packaging and labeling, demand led supply services, cold chain distribution, clinical storage, and returns and destruction.

Catalent is a global leader in clinical supply services, with comprehensive and flexible solutions for small molecules, biologics, and cell and gene therapies and integrated solutions to accelerate speed to clinic. Catalent offers a full range of services, including clinical supply management, comprehensive packaging solutions, comparator sourcing, cold chain storage, and global distribution and specialized supply chain services, including its FlexDirect direct-to-patient services and FastChain demand-led supply solution. With nine GMP clinical packaging facilities and over 50 strategically located depots on six continents combined with more than 25 years’ experience across thousands of studies in more than 80 countries, Catalent has the comprehensive services, global scale, and expertise necessary to reliably supply clinical trials of all sizes and complexity anywhere in the world.

 Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,500 people, including approximately 2,400 scientists and technicians, at more than 40 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.

Humanigen, Inc. is developing its portfolio of clinical and preclinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. Humanigen believes that its GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection as well as the serious and potentially life-threatening CAR-T therapy-related side effects while preserving and potentially improving the efficacy of the CAR-T therapy itself, thereby breaking the efficacy/toxicity linkage. The company’s immediate focus is to prevent or minimize the cytokine storm that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection and also in combining FDA-approved and development stage CAR-T therapies with lenzilumab, the company’s proprietary Humaneered anti-human-GM-CSF immunotherapy, which is its lead product candidate. A clinical collaboration with Kite, a Gilead Company, to evaluate the sequential use of lenzilumab with Yescarta, axicabtagene ciloleucel, in a multicenter clinical trial in adults with relapsed or refractory large B-cell lymphoma is currently enrolling. 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). For more information, visit www.humanigen.com.