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Collaboration further strengthens manufacturing capabilities and capacity in advance of potential Emergency Use Authorization in 2020
Humanigen, Inc., (Nasdaq: HGEN) ("Humanigen"), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate lenzilumab, today announced a strategic collaboration with Thermo Fisher Scientific, a world leader in serving science, to expand the manufacturing capacity for lenzilumab, currently in a Phase 3 registration study in patients with COVID-19, to support a potential Emergency Use Authorization (EUA).
This multi-year manufacturing partnership adds to Humanigen’s large scale commercial production efforts, including recently announced partnerships with Lonza and Catalent, in advance of a potential 2020 EUA and subsequent commercialization of lenzilumab, the company’s proprietary Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody. Thermo Fisher will begin the technical transfer of the lenzilumab bulk drug substance process and commercial scale production could begin before the end of this year.
"Manufacturing preparation, precision and expertise are critical as we execute on an aggressive strategy, pending a potential EUA from the FDA, to deliver a COVID-19 therapeutic this winter that has the potential to reduce the risk of ventilation or death and send patients home from the hospital earlier," said Cameron Durrant, MD, MBA, Chief Executive Officer of Humanigen. "Thermo Fisher provides biologics manufacturing expertise and scalable capacity to further support our production and growth trajectory."
"Effective therapeutics are an important part of the overall approach to curb the arc of the current pandemic and we are committed to enabling leading therapeutic innovations forward for patients through comprehensive supply chain capabilities and expertise," said Leon Wyszkowski, president, commercial operations for Thermo Fisher’s pharma services business.
More details on Humanigen’s programs in COVID-19 can be found on the company’s website at www.humanigen.com under the COVID-19 tab, and details of the US Phase 3 potential registration study can be found at clinicaltrials.gov using ClinicalTrials.gov Identifier NCT04351152.
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. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The company’s immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit www.humanigen.com.
This release contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding our expectations for the Phase 3 study and the potential future development of lenzilumab to minimize or reduce the severity of lung dysfunction associated with severe and critical COVID-19 infections or to receive an Emergency Use Authorization from, be approved by, FDA for such use or to help CAR-T reach its full potential or to deliver benefit in preventing GvHD. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to conduct the Phase 3 study and grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.
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