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InNexus Finds Fast Track To Capitalize On Multi-Billion Dollar
'Monoclonal Antibody' Market

By Marc Davis, Managing Editor
January 2003

The prospect of finding a cure for cancer and other pervasive life-threatening diseases may still be some years away. But recent medical breakthroughs in 'monoclonal antibody' genetic engineering are now making it possible for patients' immune systems to fight back, thereby improving their well-being and even extending life spans in many cases. Among the companies at the forefront of this new revolution in non-toxic, immune-system-boosting therapies is InNexus, Inc. This Seattle-based biotechnology company (which is being renamed InNexus Biotechnology Inc.) is soon to trade on Canada's TSX Venture Exchange under the symbol CUS, subject to a near-completed reverse take-over of an affiliated company.

SmallCapMedia has chosen InNexus for special consideration due to a product-licensing business model that could make it cash-flow-positive in record time. However, let us start by considering the dramatic possibilities for the marketplace in which InNexus is expecting to make a name for itself.

First of all, what are genetically modified or engineered antibodies? One type is based on Super Antibody Technology (SAT), a patented procedure for modifying monoclonal antibodies to improve their therapeutic potency, resulting in a 'super' antibody. Simply stated, Super Antibody Technology allows existing monoclonal antibodies to achieve a higher level of therapeutic usefulness in fighting cancer cells or other disease-causing foreign invaders.

What makes monoclonal antibody therapy different from conventional treatments like chemotherapy is that it is relatively non-toxic and targets only sick or foreign cells, not other related organisms or healthy cells. This 'specificity' (as it is referred to by scientists) is what also makes monoclonal antibody technology so commercially valuable. As a result of only attacking target cells, use of these antibodies results in greatly diminished side effects. And not only can such antibodies be used to treat disease; they can also be used to vaccinate against a wide variety of illnesses with an improvement in specificity versus traditional vaccine approaches. Additionally, they can also help to diagnose a wide variety of illnesses and can detect the presence of drugs, viral and bacterial products and other unusual or abnormal substances in the blood.

Furthermore, an antibody response, once activated by the occurrence of a disease, may continue to attack and confer resistance against that disease. For instance, that is how we build up a resistance to repeat attacks by common childhood illnesses such as chickenpox and measles. This key characteristic of antibodies thus makes it possible to develop vaccines.

What does all of this mean to the business world? Well, since the discovery of monoclonal antibodies by doctors Kohler and Milstein some 25 years ago (which earned them the Nobel Prize), great strides have been made. But this biotechnology did not really come of age until about five years ago, when the Food and Drug Administration approved Rituxan, the most potent antibody for cancer treatment to date. And the viability of such monoclonal antibody therapies has been further accelerated with the most recent major breakthroughs in the Human Genome Project. Indeed, the mapping of the human genome has identified a plethora of gene-based cancer targets that can be treated with monoclonal antibodies. Hence, these developments have ignited considerable excitement on Wall Street. And they have culminated in some of the largest private placements in the history of the Street for developmental stage monoclonal antibody companies.

Most analysts even consider monoclonal antibodies to be the new driving force behind the biotechnology industry. For instance, Wall Street now estimates that this represents the largest segment of this multi-billion dollar business sector with 260 companies, private and public, working on over 700 therapeutic super antibody products. Evidence of this 'New Age' is the high valuations of biotechnology companies at various stages of clinical development. Early winners in this exciting new marketplace include the previously mentioned drug, Rituxan as well as Herceptin, marketed by Genentech. Rituxin was approved in 1997, and has seen sales catapult to $818 million in 2001, an 84 per cent jump over the previous year. Sales are expected to easily exceed $1 billion in 2002.

Already, companies nearing or with pending market approvals are boasting market capitalizations comparable to large pharmaceutical companies. The primary reason for these high valuations is that monoclonal antibodies are currently leading all other segments of the biotechnology industry for product introduction. About 14 products are already approved and an additional 18 are pending approval. Fortunately, these developments are improving the quality of life for countless people with cancer, rheumatoid arthritis and a whole range of infectious diseases. Furthermore, sales for monoclonal antibody products such as Rituxan have risen dramatically across the board, setting big dollar records for market introduction and penetration. InNexus expects to be one of these success stories within the next few of years.

Unlike many other companies in the antibody enhancement field, InNexus aims to eventually market its own specific Super Antibody products. To this end, InNexus is pursuing the fast track to financial success by emphasizing early corporate partnering with recognized pharmaceutical and biotechnology companies. Thus, these major companies stand to benefit immeasurably by way of improving the effectiveness of their existing monoclonal antibody-based products. Industry sources estimate that there are currently 260 biotechnology companies worldwide involved in the development of at least 700 antibody-based products. Any or all of them represent potential partners, which could be expected to bolster InNexus' bottom line by each paying to license the company's technology.

In fact, monoclonal antibodies as a market segment have a virtually unlimited potential for generating new products. The appeal of InNexus' technology platform to pharmaceutical and biotechnology companies can be manifold, including the ability to:

• Convert existing antibodies into ones with product potential. This probably represents the largest potential use of InNexus' technology platform with thousands of such antibody candidates.
  

• Increase potency, and thus profitability, as well as extending the patent life of FDA-approved products. There are currently dozens of approved and pending super antibody products with combined markets of billions of dollars; such products have consumed one-half to two-thirds of their patent life before reaching the product approval stage.
  

• Achieve an 'end around' existing patents on antibody diagnostic and therapeutics. Each antibody developed with the super antibody technology platform likely represents a new, patentable invention; this allows InNexus and its partners to pursue products and markets in which there are already established competitors.
  

• Create new uses and large new markets for antibody products which did not previously exist. This includes the use of cell-penetrating super antibodies and related antibody-based vaccines.
  

Now we hope you understand why SmallCapMedia believes that InNexus' share price has a strong upside once it completes an upcoming merger with Vancouver-based Cusil Venture Corp. The deal will lead to a new name for the combined companies -- InNexus Biotechnology Inc. And their combined strength will allow them to expedite the development of an initial SuperAntibody product based on the IF7 antibody. InNexus' inaugural product targets viral infections that are related to the onset of HIV or Hepatitis C. Currently, the SuperAntibody form of IF7 is in pre-clinical study. This initial product marketplace is worth up to a billion dollars or more.

And what do patients (the beneficiaries) of monoclonal antibody drugs think of this new scientific breakthrough? Recently the Seattle Times spoke with Georgia Hough, a breast cancer survivor who has been taking an FDA-approved monoclonal antibody drug.

"If I have a choice of filling my whole body full of toxins or having something focus very specifically on certain cancer cells, I'll go for that every time. I think most people would," she said.

InNexus firmly believes that there are millions of affected North Americans who feel the same way. And so does SmallCapMedia, which is why we will be following the fortunes of InNexus' stock very closely in the coming year.