Stabilitech is developing a novel recombinant form of human BuChE.

Why is BuChE important?

Butyrylcholinesterase (BuChE) is a naturally occurring protein found in minute quantities in human blood (2 mg/liter), which acts as a natural bio-scavenger to absorb and degrade poisons (e.g. nerve agents) before they cause neurological damage. Multiple efficacy studies, using a broad spectrum of live nerve agents, demonstrate that rBuChE is a potent bio-scavenger of nerve agents and can act as both a prophylactic as well as a post-exposure therapeutic.

Opportunity

Both the U.S. Department of Defense (DoD) and the civilian Health and Human services (HHS) have requirements for a broad spectrum pre- and post- exposure prophylaxis for nerve agent exposure. The current DoD policy requires full force protection, so the stockpile would need to be sufficient to protect all of the branches of the military, as well as civilian first-responders.

Challenges

Approaches to utilizing cross species sources or recombinant technologies (including bacterially expressed and expression in goat’s milk) to generate sufficient quantities for use in an emergency have met with a multitude of problems including immunological issues and lower functional efficacy.

Stabilitech’s approach

Stabilitech is developing a novel recombinant form of human BuChE, which is being developed as a pre- and post-exposure therapy following exposure to susceptible agents. Stabilitech is in the unique position of being able to deliver reproducible doses of infectious non-replicating viral vectors to the luminal surface of the intestinal mucosa. Once the epithelial lining cells are infected they can produce proteins, which can accumulate in the blood. The proteins can be expressed for several days, but if necessary further doses of vector can be administered to extend the period over which the cells express the protein of interest.

Benefits

  • Transient vectored-production of enzyme via GI cells within the GI tract
  • Systemic availability of enzyme