David J. Kovacs to Organize Public Policy Initiatives Involving Coronavirus
BURLINGAME, CA / ACCESSWIRE / March 24, 2020 / Humanigen, Inc., (HGEN) ('Humanigen'), a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company's proprietary Humaneered® anti-human- granulocyte-macrophage colony stimulating factor (GM-CSF) monoclonal antibody, announced that the company has appointed David J. Kovacs, initially in a consulting role, to the newly created role of head of public policy relating to COVID-19 issues.
Commenting on the appointment, Dr. Cameron Durrant stated, 'Given the recent news regarding our plans for a Phase III study of coronavirus treatment, we will be required to work across disciplines when interacting with regulatory and administrative agencies at the municipal, state, and federal levels, not only domestically but also abroad. David brings a unique perspective to the development of public policies relating to such issues and will assist in formulating and executing our plans in this area.'
Mr. Kovacs has extensive experience shaping policy and financial strategy in both mature and emerging markets and currently serves as a strategic advisor for multiple public and private companies. Previously, Mr. Kovacs served in senior roles in private equity and the investment banking industry at such organizations as Blackstone Group, Citigroup, and the Hinduja Group.
'Humanigen has pioneered the field of GM-CSF neutralization with lenzilumab,' Kovacs commented, 'and with the completion of two Phase I and Phase II studies, including in patients with severe respiratory disease, lenzilumab has demonstrated an excellent and proven safety and tolerability profile, offering an alternative potential therapeutic solution in COVID-19 for already fragile, high-risk patients. With the potential to prevent acute respiratory distress syndrome (ARDS) and death in these patients, I am very excited about the prospect of helping Humanigen advance lenzilumab's delivery to market,' Kovacs concluded.
About COVID-19-Induced ARDS
COVID-19 is an infectious disease caused by SARS-CoV-2. COVID-19 has become a global pandemic, with over 380,000 confirmed cases and over 16,000 deaths reported to date. Patients with severe cases of COVID-19 experience severe viral pneumonia that can progress to acute respiratory distress syndrome (ARDS) and death.
ARDS is an acute, life-threatening inflammatory lung injury characterized by hypoxia - a lack of oxygen to the tissue - and stiff lungs due to increased pulmonary vascular permeability. ARDS necessitates hospitalization and mechanical ventilation. A rapid increase in patients with ARDS presents a major challenge for the global public health system given limited hospital beds and ventilators. When implementing standard of care, including mechanical ventilation, ARDS has an overall mortality rate of greater than 40%.
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 as well as the serious and potentially life-threatening CAR-T therapy-related side effects while preserving and potentially improving the efficacy of the CAR-T therapy itself, thereby breaking the efficacy/toxicity linkage. 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 and also in combining FDA-approved and development stage CAR-T therapies with lenzilumab, the company's proprietary Humaneered® anti-human-GM-CSF immunotherapy, which is its lead product candidate. A clinical collaboration with Kite, a Gilead Company, was recently announced 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. 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). The company has established several partnerships with leading institutions to advance its innovative cell and gene therapy pipeline. 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 a Phase III study and the future development of lenzilumab to minimize or reduce the severity of lung dysfunction associated with severe coronavirus infections 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 Black Horse Capital and its affiliates owning more than 50% of our outstanding common stock, including their ability to control the company; our lack of profitability and need for additional capital to conduct the Phase III study and operate our business as a going concern; 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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SOURCE: Humanigen, Inc.
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