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.”

关于味之素生物制药服务公司

味之素生物制药服务公司是一家业务完全整合的合同开发与生产组织，在比利时、美国、日本和印度均设有生产基地，为小分子和大分子活性药物成分（API）及中间体提供全面的开发、cGMP生产以及无菌灌装和包装服务。 味之素生物制药服务公司为从临床前和试点项目到商业化规模的生产提供广泛的创新平台和技术能力，包括Corynex®蛋白质表达技术、寡核苷酸合成、抗体药物偶联物（ADC）、高活性原料药（HPAPI）、生物催化、连续流生产等。 味之素生物制药服务致力于提供高品质的服务，以满足客户的需求。了解更多信息：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