Lenzilumab COVID-19 Case-Control Study Published in Mayo Clinic Proceedings Journal

COMPANY OVERVIEW

We are a clinical stage biopharmaceutical company, developing our 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”) anti-human granulocyte-macrophage colony-stimulating factor (“GM-CSF”) monoclonal antibody. 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 hyperinflammatory 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”) associated with bone marrow transplants. Lenzilumab binds to and neutralizes GM-CSF.

Lenzilumab is currently in a phase III registrational trial for severe and critical COVID-19 pneumonia, which could lead to our potential filing of an Emergency Use Authorization (“EUA”) application in Q4 2020, which, if approved, could allow us to begin limited commercialization pursuant to such EUA. Lenzilumab also is currently being studied in a multicenter phase Ib/II potential registrational trial in combination with Yescarta® (axicabtagene ciloleucel) to reduce CRS and neurotoxicity in patients with relapsed or refractory diffuse large B-cell lymphoma (“DLBCL”). The trial is being conducted in partnership with Kite Pharmaceuticals, Inc., a Gilead company (“Kite”), which markets Yescarta. We are also in the planning stages to conduct a Phase II/III trial for lenzilumab to treat patients who have undergone allogeneic hematopoietic stem cell therapy (“HSCT”) who are at high risk for acute GvHD. The trial is expected to be conducted by the IMPACT Partnership, a collection of stem cell transplant centers located in the United Kingdom.

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 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.

Humanigen Corporate Presentation

November 2020

Humanigen Fact Sheets

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, MA

©2020 Humanigen, Inc.  All rights reserved