Alopexx Pharmaceuticals invited present overview of PNAG technology at the World Health Organization consultation on scientific and regulatory pathways for the development, approval and use of monoclonal antibodies against infectious diseases

November, 2014

Alopexx Pharmaceuticals invited present overview of PNAG technology at the World Health Organization consultation on scientific and regulatory pathways for the development, approval and use of monoclonal antibodies against infectious diseases

WHO consultation on scientific and regulatory pathways for the development, approval and use of monoclonal antibodies against infectious diseases, with a particular focus on Global Health Security, Ebola, pandemic influenza and emerging diseases.

PAHO, Washington DC, 18-21 November 2014

Purpose of the meeting:

WHO convened this meeting in order to discuss the opportunities and challenges of the development of mAbs for the control of infectious diseases and to bring the scientific and public health community together to gain a better understanding of the state of development of the field. The meeting aimed to:

  1. Present an overview of the current pipeline and challenges of product development.
  2. Discuss clinical pathways for approval of mAbs where efficacy trials are difficult or not feasible, such as for diseases with rare incidence.
  3. Review possible regulatory approval pathways for mAbs against infectious agents, which would take into consideration the ethical and feasibility issues related to their clinical evaluation.
  4. Define critical components of target product profiles (TPPs) for mAbs targeting infectious agents.
  5. Propose a process for switching from polyclonal serum derived immunoglobulins as standard of care to single mAbs or mAb cocktails.
  6. Propose potential funding and procurement mechanisms to make protective mAbs available to people in need in resource-poor settings, including through stockpiling.
  7. Discuss specific challenges related to the characteristics of each disease and development pathway

Alopexx was one of 2 companies asked to present an overview of its monoclonal antibody for the treatment and prevention if bacterial infection.  A copy of the presentation can be found here.