First Clinical Use of Lenzilumab™ to Neutralize GM-CSF in Patients with Severe and Critical COVID-19 Pneumonia

COMPANY OVERVIEW

Humanigen, Inc. is a clinical stage biopharmaceutical company, developing our clinical stage COVID-19 immunology and immuno-oncology portfolio of monoclonal antibodies. We are focusing our efforts on the development of our lead product candidate, lenzilumab™, our proprietary Humaneered® (“Humaneered” or “Humaneered®”) anti-human granulocyte-macrophage colony-stimulating factor (“GM-CSF”) immunotherapy.

Our proprietary and patented Humaneered technology platform is a method for converting existing antibodies (typically murine) into engineered, high-affinity human antibodies designed for therapeutic use, particularly for chronic conditions. We have developed or in-licensed targets or research (mouse) antibodies, typically from academic institutions, and then applied our Humaneered technology to them. Lenzilumab and our other two product candidates, ifabotuzumab and HGEN005, are Humaneered antibodies. Our Humaneered antibodies are closer to human antibodies than chimeric or conventionally humanized antibodies and have a high affinity for their target but low immunogenicity. We believe our Humaneered antibodies offer additional advantages, such as lower likelihood to induce an inappropriate immune response when used chronically, high potency, and a slow off-rate.

Lenzilumab is a monoclonal antibody that has been proven in animal models to neutralize GM-CSF, a cytokine that we believe is of critical importance in the inflammatory cascade, sometimes referred to as cytokine release syndrome (“CRS”) or cytokine storm, associated with COVID-19, chimeric antigen receptor T-cell (“CAR-T”) therapy and acute Graft versus Host Disease (“GvHD”) related side-effects. Lenzilumab binds to and neutralizes soluble, circulating GM-CSF.

While we believe our leadership position in GM-CSF pathway science and cytokine storm presents us with a diverse set of development opportunities, we currently are focused on developing lenzilumab for three primary indications:

  • As a therapy targeting severe outcomes in hospitalized patients with confirmed COVID-19 pneumonia;

  • As a sequenced therapy ahead of CAR-T administration in CD19 targeted CAR-T therapies; and

  • As an early treatment or potential prophylaxis for acute GvHD in high and intermediate risk patients.

 

Our development pipeline also includes the development of lenzilumab as a potential therapy for patients with refractory chronic myelomonocytic leukemia, and work with another Humaneered monoclonal antibody, ifabotuzumab, as a potential therapy for solid tumors, hematologic malignancies and serious pulmonary conditions. 

LEADERSHIP

Cameron Durrant, MD, MBA

Chairman & CEO

  • Serial biotech experience as Exec Chair, CEO, CFO

  • Pharmacia, J+J, GSK, Merck

  • Led previous deals with Gilead (HIV) while at J+J and also competed with Gilead (HCV)

  • Launched 5 blockbusters during career

Timothy Morris, CPA

Chief Operating and Financial Officer

  • Over 36 years of professional finance and accounting experience

  • Over 22 years as Chief Financial Officer with public biotechnology companies (IOVA, ACRX, VVUS, QCOR)

  • Raised over $2 billion in equity and convertible securities for seven companies, completed four offerings for IOVA with over $1 billion in proceeds

  • Oversaw increase in market cap of Iovance Biotherapeutics from $550 million to $4.2 billion (7x increase)

  • Extensive deal experience with over 75 transactions and combined value in excess of $4 billion

Bob Atwill, MBA

Head of Asia-Pacific Region

  • Over 30 years of executive pharma, biotech, cell therapy and healthcare experience

  • Corporate Officer in listed NYSE, NASDAQ, LSE, ASX and in other organisations for over 23-years

  • Expertise in COVID-19, GvHD, virology, I/O and cell & gene therapy

  • GSK, Sanofi-Synthélabo, Mesoblast and Benitec Biopharma

  • APAC based cross-border M&A and capital service principal with Eaton Square

Edward P. Jordan, MBA
Chief Commercial Officer 

  • Over 20 years experience building and leading commercial organizations

  • Broad commercial experience spanning many therapeutic areas

  • Biotech builder with biologic experience

  • Extensive launch experience and builder of new therapeutic markets

  • DBV Technologies, AMAG, TEVA, Schering-Plough

Dale Chappell, MD, MBA

Chief Scientific Officer

  • Founder, Black Horse Capital Advisors

  • Decades of biotechnology investment experience

  • HHMI Fellow, National Cancer Institute, Rosenberg Lab

  • Multiple publications in T-cell therapy, GM-CSF and immunology pathways

David Tousley, MBA, CPA

Chief Accounting and Administrative Officer,

Corp Secretary and Treasurer

  • Significant Pharma and Biotech experience, President, COO, CFO

  • Sanofi Pasteur, AVAX Technologies, DARA BioSciences, Peat, Marwick, Mitchell & Co.

  • IPOs, PIPEs, follow-ons, Debt; 

  • Public, Private & international experience

  • Mergers, acquisitions, divestitures, partnerships and JVs in U.S. and internationally

  • AICPA, NJSCPA

Omar Ahmed, PharmD

SVP. Clinical, Medical and Scientific Affairs

  • ​20-year pharmaceutical executive at Roche, Novartis, J&J

  • Led multiple blockbuster launches setting a new SOC globally

  • Led development of Janssen’s immunology portfolio strategy

  • Deep expertise in I/O and biologics development

  • Led collaborations with GSK, Merck, Astellas, Vertex, Idenix, and others ​

 

BOARD OF DIRECTORS

Rainer Boehm, M.D., MBA

Robert Savage, MBA

Cameron Durrant, M.D., MBA

Ronald Barliant, JD

Cheryl Buxton

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