Company Israel
The Need:
The use of cytotoxic drugs for cancer therapy is often limited by severe side effects resulting from drug toxicity. One way to reduce the toxicity is tumor targeting, which improves the therapeutic effect of anti-cancer drugs while minimizing side effects. This more efficient drug delivery system enables new applications for drugs whose patents have already expired.
The Product:
The product is a new anti-cancer drug .
(The by-product is a new, novel solution for delivery system of anti-cancer drugs).
The company is a biotech start-up company focusing on the development of molecular nano-capsules for targeting and delivering anti-cancer drugs to solid tumors by using a newly discovered exceptionally stable protein named SP1 (Stable Protein 1).
The Technology:
SP1, an ultra-stable, ring-shaped protein complex, is used to physically entrap cytotoxic drugs used for cancer therapy, for tumor targeting.
As the SP1/drug complex accumulates in the tumor due to the EPR effect (see below), the drug dissociates from the complex and attacks the tumorous cells. Since the SP1/drug complex will not be able to penetrate the walls of normal blood vessels, the concentration of the SP1/drug complex in healthy organs will be lower than the toxic levels tolerated in today's chemoceraputic treatments.
Passive tumor targeting is based on the "enhanced permeability and retention" (EPR) effect, which means increased permeability of tumor angiogenic blood vessels and the lack of effective lymphatic drainage from the tumor. The EPR effect results from the unique characteristics of tumor angiogenic blood vessels, which are not observed in normal blood vessels or organs.
SP1's advantage for this application is its stability under extreme conditions. SP1 binds cytotoxic molecules (such as Doxorubitsin, and Taxol). The crystallographic structure of SP1, observed in its high-resolution 3D X-rays, allows us to modulate its drug binding and release abilities and to engineer, on the periphery of SP1’s ring, tumor-binding peptides that will facilitate recognition by tumor cells - active tumor targeting.
Time table:
Timetable is three years: two years for the preclinical phases, and a year for Phase 1 and Phase 2a of the clinical trials.
Milestones:
Feasibly
Identification of anti-cancer cytotoxic drugs that bind to SP1.
Demonstration that the SP1/drug complex has a broader therapeutic effect than the free drug.
Physical, chemical & pharmacological characterization of the SP1/drug complex.
Lead optimization stage and Pre-clinical stage
Development of quality control procedures for SP1 production
Submission of a patent application for the product.
Beta-site experiments, under GLP conditions (Good Laboratory Practice), to confirm SP1/drug complex activity
GMP (Good Manufacturing Practice) production of the SP1/ drug complex
Acute toxicity & biocompatibility
Phase 1 and phase 2a clinical trials
The business advantage:
The anti-cancer drug-delivery market is expected to grow to $15.4 billion by the year 2007 and $23.5 billion by the year 2012. Many of the most highly profitable blockbuster drugs reach patent expiry by those dates, and the pharmaceutical industry will lose about $37 billion in market value to generic competition. The Company believes that large pharmaceutical companies will be interested in our technology because optimizing products through drug delivery might extend the patent expiration dates of existing drugs. Another avenue will be to develop a new cancer drug by combining SP1 with drugs that were too toxic to be used by current delivery technologies.
The Competition:
Other nano-scale drug delivery systems such as liposomes, polymeric nano-particles, block copolymer micelles and dendrimers have been tested. SP1's potential advantages include its uniform small size (11nm), and the fact that it is a protein, which is a biocompatible molecule. Preliminary studies indicate that SP1 limits antigenic response, and that it is easy to manipulate its physical properties by genetic engineering.
