InNexus Biotechnology Inc. (IXS)
Interview with:
Dr. Charles A. Morgan, President and Director
Business News, Financial News, Stocks, Money & Investment Ideas, CEO Interview
and Information on their
next generation of therapeutic, monoclonal antibodies using a SuperAntibody Technology Platform.

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InNexus Biotechnology’s SuperAntibodies is the only alternative for biotechs and pharmaceuticals not wanting to use toxic agents to increase the potency of their antibodies

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Healthcare
Biotechnology
(IXS-Toronto: Venture)

InNexus Biotechnology Inc.

400 Burrard Street, Suite 1400
Vancouver, BC, Canada V6C 3G2
Phone: 604-689-1749


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Dr. Charles A. Morgan
President and Director

Interview conducted by:
Lynn Fosse
Senior Editor

CEOCFOinterviews.com
January 2004

BIO:
Alton C. Morgan, Ph.D.
President and Director

An internationally recognized scientist and entrepreneur with over 100 publications and inventions protected in 56 patents or patent applications. A founder of four biotechnology companies, InNexus, Inc., Receptagen, Ltd., Phoenix  Biomedical, Inc., and NeoRx Corp.  A strong track record in managing technology from inception through development and FDA approval. Unique experience in new technology assessment and in obtaining venture and corporate support for biotechnology development. Proven experience in the development and implementation of business plans to accelerate corporate integration.


Company Profile:
InNexus Biotechnology Inc. (Toronto: Venture - IXS) is developing the next generation of therapeutic, monoclonal antibodies using its SuperAntibody Technology Platform. InNexus intends to apply this technology to improve the potency of existing antibody products while opening new markets and disease applications with other forms of SuperAntibodies. InNexus will develop the technology through partnerships with biotechnology and pharmaceutical companies while pursuing development of its own products for unmet medical needs.

SuperAntibody Technology seeks to improve upon the therapeutic potency of the second generation of "humanized" monoclonal antibody products by increasing the binding to target antigen, enhancing antibody effector functions, and installing new properties into antibodies such as the ability to trigger apoptosis, or "cell suicide". Put simply, SuperAntibody Technology allows antibodies to achieve a higher level of therapeutic usefulness.

CEOCFOinterviews:  Dr. Morgan, please give us some background on InNexus.

Dr. Morgan: “We started InNexus as a private company, but then did a reverse take-over of a public company, so we are still early in the process of being a public company. As a company over the last two years, we knew where we were going from the beginning – to acquire rights to a technology called SuperAntibodies and develop them. We had a very good understanding of the overall field of monoclonal antibodies and where it was going and how important this technology was in the further development of the monoclonal antibody industry. We felt SuperAntibodies is where the field would ultimately move. Certainly we have started down that path; but this is multi-year travelogue if you will, but at he same time we have gotten a lot of encouragement that this technology does make a difference in the therapeutic usefulness of antibodies as a whole, and ultimately will make a big impact on the market for monoclonal antibodies.”

CEOCFOinterviews: Will you give us an overview of what you do?

Dr. Morgan: “SuperAntibody technology addresses the inadequacies of monoclonal antibodies, a thirty-year-old discovery that was a Nobel Prize winning discovery. Over the 30 years, it has been proven that you can make drugs from monoclonal antibodies and that these drugs can probably be more useful than traditional drugs in treating different kinds of diseases. Currently, monoclonal antibodies do about three billion dollars a year in sales. It has gone from a great concept to a proven commercial approach in making drugs. What we do is improve the therapeutic activity of monoclonal antibodies. There are two big impacts of that; obviously the first means that we can treat diseases better with monoclonal antibodies and probably more importantly, it means that we can get them approved as drugs more readily. They have a much higher likelihood of being approved as a SuperAntibody rather than a regular monoclonal antibody.”

CEOCFOinterviews: Why?

Dr. Morgan: “It is an issue of potency. The best analogy I can give is if you have a very bad headache and go into your medicine cabinet and look for something to take for the headache, and are presented with  two options; you use children’s, junior strength Tylenol or the double strength adult Tylenol. You have the expectations with the higher strength Tylenol that you are going to have fast relief and more likelihood of getting relief. The same thing holds true with any type of drug; the higher the potency, the more likely it is going to do what you want it to do. The same thing is true with monoclonal antibodies, if we make a higher potency monoclonal antibodies, it will be more useful in treatment of the disease for which it was intended..”

CEOCFOinterviews: Will you tell us about the technology?

Dr. Morgan: “It is based upon natures own experiment; as is true of many discoveries that scientists have made over the years; we have found out that nature made a discovery long before we did and we have tried to learn from it. The first SuperAntibody was discovered by researchers looking for antibodies that were going to be more therapeutically active. They started studying this single antibody and they were able to discover the molecular basis as to why it was so much more potent than other antibodies. We are now able to engineer that property into any monoclonal antibody.”

CEOCFOinterviews: Tell us about the business side of things?

Dr. Morgan: “Our business is an out-licensing business. It is not a small undertaking because the types of companies we work with are on the leading edge of the monoclonal antibody field and their partners are at the leading edge of pharmaceutical drug development. We license out our technology and have an ongoing role in not only making these SuperAntibodies and developing them through clinical trials and marketing. We may even form joint development agreements with Companies for products we feel we can add more to than just technology enhancement. A Company may come to us with an antibody that they know can detect and bind to a disease and for which they would like a more therapeutically active version. We create a SuperAntibody version, have it evaluated in both our labs and theirs and then proceed into the development of the product and through clinical trials. We don’t actually do the clinical development ourselves; we rely on our partners to do that. We are more involved at the early stages of the product’s development.”

CEOCFOinterviews: Do you have a part in whatever develops business-wise?

Dr. Morgan: “Yes, we can have many different roles from joint partnerships where we share development costs and revenues from products to simple, antibody specific licenses. In this latter case our revenue comes in the form of licensing and milestone payments, and royalties on sales.”

CEOCFOinterviews: When they give you the monoclonal antibody, and you are going to give them the SuperAntibody, what are they physically giving you and what how long does it take?

Dr. Morgan: “We announced in the summer, a relationship with Corixa Corporation (Nasdaq: CRXA), which is one of the top tier biotech companies working on monoclonal antibodies. Our relationship with them is illustrative of what goes on. They have provided us a monoclonal antibody that they want to see developed for treatment of certain diseases. They already knew that this particular antibody had some therapeutic activity on it own and what they wanted to do with our technology was to increase it. They provided us with purified antibody and we created the SuperAntibody form in the laboratory. We do a variety of different tests to show the improvement in therapeutic activity, including tests to demonstate that it binds better to its target and is more therapeutically active in culture systems. We then provide them with a larger amount of the SuperAntibody form and they do further and more extensive testing. This leads to the point where we can start preparing formal documents for pre clinical testing and then to ultimately filing for an IND (Investigational New Drug Application) and going into clinical trials. We perform the early, critical developmental work they do further more extensive testing and further development.” This frees up our laboratories for further collaborations."

CEOCFOinterviews: Are you alone in this field?

Dr. Morgan: “We are alone with regard to producing SuperAntibodies. There are other technologies that may allow you to increase potency of antibodies but they rely upon putting toxic agents onto the antibody. You can tether to an antibody, a drug, protein toxin or isotope. The conjugated antibody may then be able to kill or treat the cells for which it is targeted. There are a number of platform technologies out there that do that and seek to take an antibody that binds and selects the target well, and then turn it into a therapeutically effective antibody. They all rely upon using toxic substances; our technology instead installs a simple, non-toxic peptide into an antibody and allows the antibodies to link arm-in-arm across the surface of a cell. That appears to be sufficient to trigger the death of a targeted cell.”

CEOCFOinterviews: Will you tell us a little bit about the process of getting partners to notice you?

Dr. Morgan: “The key element to everything you do is having what you do presented to the scientific and medical, research community. Unfortunately, publications and scientific literature are about two years behind where you actually are in the laboratory but you have to build a track-record of publishing and going to scientific meetings and making presentations. It is a way of advertising what you do. This opens the doors to collaborations. Ultimately, it always comes down to the same thing even after you form a relationship and you then have to prove that you can do what you said you could do, which is to deliver a super antibody which is more potent than the original one. Once you have done that a few times with a few different companies, then most people will be willing to take a chance on your technology.”

CEOCFOinterviews: How big a factor is your long history in this field?

Dr. Morgan: “It always helps to have people with very good scientific and business reputations that are behind the technology and the company. That obviously helps to provide an entrée and to initilize relationships but ultimately, it comes down to the technology proving itself. That takes time.”

CEOCFOinterviews: How do you fund your activity?

Dr. Morgan: “To fund our early development we have raised money in the equity markets. Our financing needs are a bit different from a typical biotech company. A typical biotech company will raise tens of millions of dollars to fund development of their technology platform, with the intention of proving at least one product works with that technology in clinical trials. This is usually a process, which takes years because proving the technology platform progresses at the rate of clinical development which is slow. We have elected to do early licensing and as a result our partners are doing the development work that we would have ordinarily paid for through equity funds. We still do a lot of research ourselves, but it is mostly targeted to pushing the boundaries of the technologies forward into new applications whether than product development. We also look forward to the day that we can be profitable as a licensing company, getting revenues from this technology. Do demonstrate how unusual we are, the first quarterly financial that we filed after becoming a public company showed that we were profitable.”

CEOCFOinterviews: Is it hard to get your business concept across to people looking at biotech companies because it is different from the usual approach?

Dr. Morgan: “It is different! To be frank, if every biotech company could do what we are doing, they would choose to do so. The problem is that when you start off with a new technology platform, you have to go through this ‘proving yourself’ process and it is a rare that you can license something to a company at an earlier stage than, say Phase II clinical trials. The only reason we can do so it that we have such a compelling technology that companies are willing to take a chance at an earlier stage. We are taking advantage of that. The fact that we can do this sort of licensing, allows us to take a low-risk approach when it comes to financing a company.”

CEOCFOinterviews: What are challenges do you face?

Dr. Morgan: “This is a challenge from a business approach standpoint. It is not from the standpoint that people don’t understand the concept, but it is difficult to enact. That is always a challenge but the more we are able to license and achieve revenues from these licensing deals, the more we prove to people that we can do it. We have done it once, twice, and we will be able to do it more time also.”

CEOCFOinterviews: What’s on the horizon for InNexus?

Dr. Morgan: “We just put out a press release in December; not everyone knew this because it was getting close to Christmas, but it was very important because it hits upon what you said. Despite 3-4 billion in sales and a growth rate of more than 15% annum, some think of the monoclonal antibody field as somewhat limited; I don’t think it is limited in fact I have done a survey that in early clinical development; there are 230 trials of monoclonal antibodies being developed by various companies, so there is a lot of new drug development going on with monoclonal antibodies and those companies will certainly be interested in our technology.

What we announced in December was even more important; especially for the long-term and that is that we could use a monoclonal antibody in place of small molecule drugs. The particular announcement was coincident with a scientific publication that showed we could deliver a monoclonal into a cell not just bind it to the outside of the cell.

What we showed in this scientific publication was that we could stop the process of cell death triggered by chemotherapy. Chemotherapy not only kills cancer cells but it kills normal cells too. We showed that we could protect normal cells with the monoclonal antibody. We conjugated a peptide to an antibody that allows it to traverse the membrane, move into the cell, and target an intracellular molecule. What we were targeting in this particular case was one of the key enzymes involved in the process of cell death triggered by this chemotherapy drug. It was a demonstration that was important for the area of chemotherapy but more importantly, it showed that we can develop a new class of monoclonal antibodies that could target intracellular molecules.

Up until now, intracellular molecules could only be targeted with small molecule drugs that were traditionally developed by large pharmaceutical. These are the pills, which we are used to taking. These pills are small molecule drugs that have been developed to go into the cells, and target intracellular molecules and regulate their activity. Many small molecule drugs fail in clinical trials because of toxicity. We can now target those same intracellular molecules with an antibody, which is much more specific and has no inherent toxicity. We think that is ultimately going to be more important for the company because it greatly expands the application of monoclonal antibodies.”

CEOCFOinterviews: What do you spend your time doing as CEO?

Dr. Morgan: “I have founded three public companies of various sizes and market cap, and taken them public. One thing I like about being in a small company is you can do many things. I am currently involved in aspects of the research even though I don’t run the research; I am actively involved in it. I am actively involved in the filing and patent side of things, which is very key to our technology. Obviously, I am involved with contacting and interactions with various companies looking to license our technology and then subsequently sitting down with them and negotiating structure and deals and so on. I get to be involved in all of those processes right now.”

CEOCFOinterviews: In closing, for potential investors, why is now a good time to invest, and what is your timetable for the future?

Dr. Morgan: “The timetable for investment is now which is based on announcements we will be able to make over the next year. Obviously we believe that the announcements that we are going to make in the coming year, will certainly be perceived as adding value to the company and they are all related to our licensing business. It is different when you are announcing progress in preclinical development and clinical development of a product. Those are certainly very good milestones for the company. What we announcements is announce will be relationships, which not only bring cash to us but essentially fund the development of our products through our partners. I think people will appreciate the value that is coming from that and we have a number of those types of announcements coming this year.”

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