Country for PR: United States
Contributor: PR Newswire New York
Wednesday, May 27 2020 - 22:07
Ajinomoto Bio-Pharma Services Signs Manufacturing Agreement with Humanigen for Lenzilumab, Currently in FDA-Approved Phase III Study for COVID-19
SAN DIEGO, May 27, 2020 /PRNewswire-AsiaNet/ --

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:

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, 

SOURCE Ajinomoto Bio-Pharma Services