Ajinomoto Bio-Pharma Services & Humanigen Expand Manufacturing Agreement to Support Fill Finish for Investigational COVID-19 Therapeutic

Ajinomoto Bio-Pharma Services and Humanigen, Inc. recently announced the companies will be expanding their manufacturing agreement for the fill finish supply of lenzilumab, which is one of the few Phase 3 treatment options in development for patients hospitalized with COVID-19.

Aji Bio-Pharma will assume a key role in simplifying the supply chain efforts for Humanigen by providing drug product aseptic fill finish services at its San Diego facility to support continued clinical trial efforts through potential commercialization. Humanigen is actively enrolling patients in a Phase 3 study in the US and Brazil and preparing for a potential COVID-19 Emergency Use Authorization (EUA) for lenzilumab.

“We are very pleased to be working with Aji Bio-Pharma for the fill finish production of lenzilumab,” said Cameron Durrant, MD, MBA, Chief Executive Officer of Humanigen. “This partnership allows us to utilize Aji Bio-Pharma’s high quality drug product aseptic fill finish services to provide a timely supply of lenzilumab as we near the end of our clinical phase 3 study and prepare for EUA application submission.”

“We are excited to continue to support Humanigen’s efforts to provide this potential therapeutic in the fight against COVID-19,” said Kristin DeFife, PhD, Sr. VP of Operations & Site Head at Ajinomoto Bio-Pharma Services. “Through this collaboration, we are able to leverage our drug product experience, infrastructure and strong regulatory track record to assist in the efforts that may ultimately help patients struggling with this devastating disease.”

Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, US, Japan, and India, providing comprehensive development, cGMP manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities for pre-clinical and pilot programs to commercial quantities, including Corynex protein expression technology, oligonucleotide synthesis, antibody drug conjugations (ADC), high potency APIs (HPAPI), biocatalysis, continuous flow manufacturing, and more. Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our client’s needs. For more information, visit www.AjiBio-Pharma.com.

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 believes that its GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. Humanigen’s 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. 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). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit www.humanigen.com.