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

PR87738

SAN DIEGO and BURLINGAME, Calif., Jan. 27, 2021 /PRNewswire=KYODO JBN/--

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.  

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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