Ajinomoto Bio-Pharma Services Signs Manufacturing Agreement with Humanigen for Lenzilumab, Currently in FDA-Approved Phase III Study for COVID-19
May 27, 2020 – San Diego, CA – 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.
“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® 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.”
À propos d'Ajinomoto Bio-Pharma Services
Ajinomoto Bio-Pharma Services est une organisation de développement et de fabrication sous contrat (CDMO) entièrement intégrée, disposant de sites en Belgique, aux États-Unis, au Japon et en Inde. Elle propose des services complets de développement, de fabrication conforme aux normes cGMP et de conditionnement aseptique pour les principes actifs pharmaceutiques (API) de petite et grande taille ainsi que pour les intermédiaires. Ajinomoto Bio-Pharma Services propose un large éventail de plateformes et de capacités innovantes, allant des programmes précliniques et pilotes jusqu’aux quantités commerciales, notamment la technologie d’expression protéique Corynex®, la synthèse d’oligonucléotides, les conjugués anticorps-médicaments (ADC), les principes actifs pharmaceutiques à haute puissance (HPAPI), la biocatalyse, la fabrication en flux continu, et bien plus encore. Ajinomoto Bio-Pharma Services s’engage à fournir un niveau élevé de qualité et de service afin de répondre aux besoins de ses clients. Pour en savoir plus : 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® 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®, 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
