Country for PR: United States
Contributor: PR Newswire New York
Wednesday, January 27 2021 - 23:00
AsiaNet
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
SAN DIEGO and BURLINGAME, Calif., Jan. 27, 2021 /PRNewswire-AsiaNet/--

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(TM), 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.  

Logo - https://mma.prnewswire.com/media/751177/Aji_BioPharma_Logo.jpg 

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(R) 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(R) (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 ( 
https://c212.net/c/link/?t=0&l=en&o=3045063-1&h=2779707163&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fhumanigen-inc%2F&a=LinkedIn 
), Twitter ( 
https://c212.net/c/link/?t=0&l=en&o=3045063-1&h=3865509595&u=https%3A%2F%2Ftwitter.com%2Fhumanigen&a=Twitter 
) and Facebook ( 
https://c212.net/c/link/?t=0&l=en&o=3045063-1&h=4294134784&u=https%3A%2F%2Fwww.facebook.com%2FHumanigen%2F&a=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.

SOURCE:  Ajinomoto Bio-Pharma Services; Humanigen, Inc.

CONTACT: Ajinomoto Contact: info@us.ajibio-pharma.com
Translations

Japanese