Ajinomoto Bio-Pharma Services Signs Manufacturing Agreement With Humanigen for Lenzilumab, Currently in FDA-Approved Phase 3 Study for COVID-19
Ajinomoto Bio-Pharma Services, a leading provider of biopharmaceutical contract development and manufacturing services, recently announced it has entered into a manufacturing agreement with Humanigen, Inc., for the fill finish supply of lenzilumab, currently being studied in a Phase 3 clinical trial in adult, hospitalized patients with COVID-19.
“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, PhD, 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 anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, is being administered as part of a US 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.”
Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, US, 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 preclinical 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. For more information, visit www.AjiBio-Pharma.com.
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 anti-human-GM-CSF immunotherapy, for which a US multi-center, randomized, placebo-controlled, double-blinded Phase 3 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, 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.
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