Ajinomoto Bio-Pharma Services and Humanigen Expand Manufacturing Agreement to Support Fill Finish for Investigational COVID-19 Therapeutic, Lenzilumab, Nearing Completion of Phase 3 Study
Humanigen, Inc. (NASDAQ: HGEN) and Ajinomoto Bio-Pharma Services have expanded their manufacturing agreement for the investigational COVID-19 therapeutic lenzilumab. This expansion facilitates the aseptic fill-finish supply of lenzilumab, which is in Phase 3 trials for hospitalized COVID-19 patients. Humanigen is preparing for a potential Emergency Use Authorization (EUA) and is actively enrolling patients in the U.S. and Brazil. The partnership aims to streamline the supply chain for lenzilumab, enhancing its availability as the clinical phase concludes.
- Expansion of manufacturing agreement for lenzilumab with Ajinomoto Bio-Pharma.
- Lenzilumab is nearing completion of Phase 3 clinical trials.
- Preparation for Emergency Use Authorization (EUA) submission.
- None.
SAN DIEGO and BURLINGAME, Calif., Jan. 27, 2021 /PRNewswire/ -- Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of biopharmaceutical contract development and manufacturing services, and 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™, today 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 U.S. 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, Ph.D., 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."
About Ajinomoto Bio-Pharma Services
Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, 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. Learn more: www.AjiBio-Pharma.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 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 and follow Humanigen on LinkedIn, Twitter and Facebook.
Humanigen Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although Humanigen 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 use of lenzilumab to treat patients hospitalized with COVID-19, Humanigen's expectations regarding the timeline to file for and obtain EUA, statements regarding Humanigen's ability to attain necessary manufacturing support from contract development and manufacturing organizations, the potential for an expanded manufacturing services relationship with Aji-BioPharma, and statements regarding Humanigen's beliefs relating to any of the other technologies in Humanigen's current pipeline. These forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in Humanigen's lack of profitability and need for additional capital to grow Humanigen's business; Humanigen's dependence on partners to further the development of Humanigen's product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory approvals or authorization for emergency or broader patient use for the product candidate 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 Humanigen's periodic and other filings with the Securities and Exchange Commission.
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SOURCE Ajinomoto Bio-Pharma Services; Humanigen, Inc.
FAQ
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