Profile: Nano Bio Pharma Ltd. (NBP)
Industry: Pharmaceuticals
Markets: Cytotoxic (anti-cancer) drugs

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:
Our product is a new anti-cancer drug .
(The by-product is a new, novel solution for delivery system of anti-cancer drugs).

The Business:
Nano Bio Pharma 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). Our goal is to develop the product to the point where it can be marketed to pharmaceutical companies.

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.

Company Structure:
NBP is newly formed subsidiary of Fulcrum SP Ltd., specifically to complete development and implement the new anti-cancer drug (and the new delivery system of anti-cancer drugs).

Fulcrum SP itself is a biotech company in operation since 2001. To date, approximately $1.6M have been applied by Fulcrum to the development, refinement and marketing of SP1 systems and applications. Fulcrum currently funds NBP’s work.

NBP is seeking equity capital from private investors and VC firms to fund the anti-cancer program.

Intellectual Property:
The SP1 based technology is protected by a patent pending applied for by the Hebrew University. The Hebrew University and Fulcrum SP Ltd. have granted NBP an exclusive worldwide license to commercialize SPs to their full potential for anti-cancer applications. The patent application includes claims for composition of matter, methods of production and applications for the entire family of SP chaperones.

IFinancing Required:
NBP seeks a total of $4.3 Million in two rounds, ($2.5M for the first round, i.e., all needed pre-clinical trial work; and $1.8 for Phase 1 and Phase 2a of the clinical trials, marketing and follow-on development). This will develop the product to the point where it can be successfully marketed to pharmaceutical companies worldwide.

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.

The Advisory board:
Prof. Shimon Slavin is a renowned international leader in stem cell transplantation (SCT), cancer immunotherapy and transplantation biology. Chairman of Israel’s National Bone Marrow Transplantation Center. In addition, he has been the director of the Baxter-Hadassah Research Center, director of The Danny Cunniff Leukemia Research Laboratory and since 2001 has served as Medical Director of Cancer Immunotherapy at Cancer Treatment Centers of America (CTCA). His contributions include a new series of proprietary procedures and therapeutic tools for ultimate treatment of an otherwise incurable broad spectrum of malignant and non-malignant diseases.

Prof. Oded Shoseyov, Scientific founder of Fulcrum SP and NBP. Professor in the Faculty of Agriculture at the Hebrew University; scientific founder of CBD-Technologies Ltd. and scientific consultant to several biotechnology companies. Prof. Shoseyov holds 16 biotechnology-related patents.

Prof. Arie Altman, Scientific founder of Fulcrum SP and NBP. Chair of the Institute of Plant Sciences and Genetics at the Faculty of Agriculture, the Hebrew University, visiting professor in other major research institutions; member of the Israeli National Committee for Biotechnology and Chairman of the National Sub-Committee for Plant Genomics.

Dr. Amnon Wolf, CTO, Graduate of the Weizmann Institute (1990) and post doctorate fellow at UC Berkeley; wide experience in the biotechnology industry includes management of projects in the areas of drug discovery and high throughput screening of chemical libraries (Peptor, Ltd), co-founder of Fulcrum SP and NBP.

Vision and exits:
The development of these anti-cancer drug solutions will enable the company to become a significant player in the multi billion dollar anti-cancer drug market. The first target is one anti-cancer drug, and our drug delivery system will enable us to develop many other anti-cancer drugs using the SP1 technology.
A significant exit opportunity is expected after the successful completion of phase 1 and 2a of the clinical trials.