Ajinomoto Bio-Pharma Services Signs Manufacturing Agreement with Humanigen for Lenzilumab, Currently in FDA-Approved Phase III Study for COVID-19

Ajinomoto Bio-Pharma Services

PR84158

 

SAN DIEGO, May 27, 2020 /PRNewswire=KYODO JBN/ --

 

Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of

biopharmaceutical contract development and manufacturing services, is pleased

to announce it has entered into a manufacturing agreement with Humanigen, Inc.,

for the fill finish supply of lenzilumab, currently being studied in a Phase

III clinical trial in adult, hospitalized patients with COVID-19.

 

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"We are extremely pleased to partner with Humanigen in the fight against

COVID-19 and to use our unique position as a US-based manufacturer to help

simplify and secure a key part of their supply chain," said Kristin DeFife,

Ph.D., Sr. VP of Operations & Site Head at Ajinomoto Bio-Pharma Services.

"Through this collaboration we uphold our mission to improve the health of

humankind, and our employees take great pride in knowing that our efforts may

ultimately help patients survive this devastating disease."

 

Under the terms of the agreement, Aji Bio-Pharma will provide drug product

aseptic fill finish services for Humanigen at its San Diego facility.

Lenzilumab, Humanigen's proprietary Humaneered(R) anti-human granulocyte

macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, is being

administered as part of a U.S. multi-center, randomized, placebo-controlled,

double-blinded Phase III study for COVID-19 patients. Lenzilumab neutralizes

GM-CSF, a key cytokine in the initiation of a cytokine storm.

 

"We are excited to be working with Aji Bio-Pharma for the fill finish

production of lenzilumab," said Dr. Cameron Durrant, Chairman and CEO of

Humanigen. "This partnership allows us to utilize Aji Bio-Pharma's drug product

expertise and infrastructure to provide a timely supply of lenzilumab."

 

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. 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 with

lenzilumab, the company's proprietary Humaneered(R) anti-human-GM-CSF

immunotherapy, for which a U.S. multi-center, randomized, placebo-controlled,

double-blinded Phase III study for COVID-19 patients is underway. The company

also is working to combine FDA-approved and development stage CAR-T therapies

with lenzilumab. A clinical collaboration with Kite, a Gilead Company, to

evaluate the sequential use of lenzilumab with Yescarta(R), axicabtagene

ciloleucel, in a multicenter clinical trial in adults with relapsed or

refractory large B-cell lymphoma is currently enrolling. For more information,

visit www.humanigen.com

 

SOURCE Ajinomoto Bio-Pharma Services

 

CONTACT: info@us.ajibio-pharma.com

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