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Interview
conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published –
February 24, 2012
CEOCFO:
Dr. Gundel, what attracted you to Amorfix, and what strengths do you bring
to the table that the company needed when you became CEO?
Dr. Gundel:
There were several things that really attracted me to Amorfix including the
technology, the therapeutic space the company works in and the small company
culture and environment. The technology is truly innovative and represents
an entirely new approach to the identification of therapeutic targets that
enables the development of drugs that are specific to diseased cells and do
not affect normal cells. This approach is extremely important in treating a
disease like cancer because it represents a way to kill the cancer but leave
the normal functioning cells intact and untouched. The technology, called
ProMIS discovery, is a computer based algorithm that predicts areas where
proteins will either misfold when they are originally produced inside the
cell, or once they are produced and expressed outside of the cell, will
partially unfold. Our technology identifies those areas and we use this
information to generate monoclonal antibodies that will bind exclusively to
the novel areas that are exposed due to the partial unfolding. This enables
us to develop therapeutics that are specific to diseased cells and will not
bind to normal cells because it is only the diseased cells that expresses
the misfolded or partially unfolded form of the protein. That is the concept
that attracted me to the company. It is a way to develop therapeutics that
will be much more effective at treating disease and have a much better
safety profile. In addition, Amorfix also has technology for developing
diagnostics for diseases that are known to be associated with aggregated
misfolded proteins. Misfolded proteins represent a very small portion of the
total amount of protein found in an excess of normally folded proteins;
sometimes more that a million to one excess. This makes detecting them and
measuring them very difficult. Our technology masks the normally folded
proteins and so enables us to detect and measure those very small amounts of
misfolded proteins found in a variety of samples including blood and
cerebrospinal fluid and is the basis of our diagnostic programs. The Epitope
protection technology allows us to find the needle in the haystack.
I have been working in the
pharmaceutical industry for more than 30 years. I have worked for both big
pharma companies as well as small company start-ups and have just about seen
it all. Drug development is a complicated process for a variety of reasons
and there is really nothing short of having years of experience to
understand it and excel at it. This is what I bring to the table at Amorfix.
CEOCFO: What is a misfolded protein?
Dr.
Gundel:
There is a whole set of machinery inside the cell that puts amino acids
together in the right sequence to form proteins. It is important that
everything is assembled correctly such that the protein assumes the proper
three-dimensional structure and part of the cell machinery acts as quality
control to ensure that each protein has the proper configuration. The
function of the protein is dependent on this three-dimensional structure and
when the protein is not assembled correctly it becomes “misfolded” and does
not have the proper structure and, subsequently, the proper function.
Normally these misfolded proteins are identified by the cell and reprocessed
into their normal configuration or destroyed. In diseases such as ALS,
Alzheimer’s Disease and cancer, the normal quality control system in cells
becomes overwhelmed and unable to keep up with the amount of misfolded
proteins produced. As a result, the misfolded protein escapes the normal
control system. When a protein is misfolded or becomes partially unfolded,
it either loses its function entirely or gains a different function and that
is the basis behind a variety of different diseases that fall under the
umbrella of misfolded protein diseases.
CEOCFO:
What is Amorfix doing with the knowledge that you have developed?
Dr. Gundel:
On the diagnostics front, we have two big programs that we are working on.
One is for Alzheimer’s disease and the other is for ALS. The protein that we
are focused on for Alzheimer’s disease is called Abeta amyloid. It turns out
that in Alzheimer’s disease the Abeta protein is misfolded and forms clumps
of protein that eventually accumulate in the brain leading to the
characteristic plaque formation and dementia symptoms. Currently, the only
way Alzheimer’s disease is definitively diagnosed is by autopsy where these
distinctive plaques can be seen. Our diagnostic can detect and measure these
clumps of Abeta protein in cerebrospinal fluid and thus represents a way to
identify patients with early-stage Alzheimer’s disease. This is the only
diagnostic that measures the aggregated form of Abeta which is a hallmark of
Alzheimer’s disease. We believe the immediate utility of this diagnostic is
to aid in the improvement of clinical trials for testing new therapeutics
for the treatment of Alzheimer’s disease. Currently, the mis-diagnosis rate
for Alzheimer’s disease can be as high as 30% which is problematic and
basically means that up to 3 of 10 subjects enrolled in a study might not
actually have the disease but rather some other form of dementia. Our
diagnostic can significantly improve those statistics as well as identify
patients with early-stage disease. These are patients much more likely to
benefit from therapeutic intervention and, therefore, the most desirable to
enroll in a clinical trial. The rule is that, in most cases, the earlier one
can diagnose and begin treatment of a disease, the better the chances are of
a successful outcome.
Our ALS diagnostic program
involves another misfolded protein called super oxide dismutase-1 (SOD1).
This protein, in its native form acts as an anti-oxidant and protects
neurons. In its misfolded form SOD1 has the exact opposite activity. It
becomes a pro-oxidant and actually kills neurons. Our diagnostic will
measure misfolded SOD1 in the blood of ALS patients and offers an entirely
new way to diagnose the disease. The situation with ALS is desperate and a
new way to diagnose the disease is needed. Today ALS is diagnosed based on
symptoms and, basically, by a process of elimination of other potential
neurological diseases. This process takes time, which for ALS patients is a
very costly thing. The normal survival time is only 3 to 5 years after
diagnosis. Our diagnostic will be a very simple blood test which can be
administered early-on in the disease process. It has the potential to
revolutionize the way ALS is diagnosed and treated.
CEOCFO: Where are you in the process?
Dr. Gundel:
For our Alzheimer’s disease diagnostic, we just completed an analysis of
over two hundred clinical samples. The data show very good specificity and
sensitivity with our assay, meaning that the number of false positives and
false negatives are low. We are now looking for a pharma partner or other
suitable partner to take this assay and assist in the commercialization for
clinical trials and to continue the development of the assay to be used as a
diagnostic. As I said earlier, this assay could be used for enrollment
criteria for patients going into Alzheimer’s disease studies as a way of
improving clinical studies. Alzheimer’s disease is one of the most active
areas of clinical investigation with almost 900 clinical studies in progress
right now. We feel our diagnostics could greatly improve the quality and
outcome of some of these studies, meaning that they would be more accurate
and better reflective of what is actually happening in Alzheimer’s disease.
So, that is our first plan to market this diagnostic. Longer term, we want
to find a development partner to help complete all the clinical studies
required to have this approved by the FDA for use as a general diagnostic.
CEOCFO: How do you get the attention of
the right people that might partner with you?
Dr. Gundel:
One of the challenges is increasing the visibility of the company. We press
release all important business-related events and important scientific
discoveries. We also attend scientific conferences. For instance, in
Alzheimer’s disease there is the ICAD Conference that occurs once a year.
That is one of the big international meeting that all of the Alzheimer’s
researchers attend and all the Pharma companies working in the area of
Alzheimer’s disease are represented. We use that meeting to present our
progress on our Alzheimer’s disease program and network with various
companies for possible collaborations and business deals. We also
communicate our message through various media channels, publications and
industry organized partnering events. It certainly is one of the challenges
for us as a small biotech company in Canada, to get the word out on our
programs. I am hoping that this publication will help a great deal.
CEOCFO: What else are you working on at
Amorfix?
Dr.
Gundel:
We have made considerable progress developing our product portfolio of new
cancer treatments. We use the ProMIS discovery technology to generate
therapeutics that selectively kill tumors while leaving normal cells intact.
One of the big issues with cancer treatments today is the adverse side
effects from treatment. Our technology enables us to generate therapeutics
that will have good anti-tumor activity without the dose-limiting side
effects seen with most other cancer treatments. We are advancing our lead
program to a proof of concept study in animal models of cancer as quickly as
possible and expect to be initiating these studies in the second quarter
this year.
CEOCFO: Have you considered licensing
your technology?
Dr. Gundel:
Yes, that is a major part of our business strategy. We licensed our ALS
therapeutics technology in 2010. We are seeking to establish strategic
alliances with other pharmaceutical companies for co-development of some of
our programs. We will bring our programs to a certain stage of development
and then partner them out or out-license to a big company that can take them
through to commercialization. We are also looking to partner with companies
that could use our technology to develop diagnostics and therapeutics
outside of our focus disease areas; so called platform technology deals. In
those cases, we can either collaborate with them or out-license the
technology to them altogether.
CEOCFO:
How does Amorfix manage working on several fronts, with several products?
Dr. Gundel:
One of the most important things is to remain focused. We have a lot of
projects going but we are very focused. Our organization is lean and mean.
One hears this all the time, but we really are. We have a process in place
where we eliminate anything that does not look like it has a chance of
making it all the way as early in the development process as possible. That
way we do not waste time and money on programs that have a low probability
of success. We are constantly evaluating our programs and making adjustments
as we go along. It is definitely a challenge to make the hard decisions on
our programs but it is critical to our success. I think the real challenge
is obviously funding, especially in today’s environment. It is really tough
out there right now. My analogy of being the head of a small company is as
follows: you are driving a car and you have a quarter of a tank of gas and
300 miles to go. What can you do to make sure that you get there? The first
thing you can do is make sure the car you are driving gets great gas
mileage; so you try to maximize the amount of mileage that you can get with
what you have. I mentioned that our company is lean, mean and very focused,
so we absolutely have done that. The other thing you need to do is to make
sure that the road map that you have and the directions that you are
following are accurate and are going to get you where you need to be at the
end of the day. You need to make sure that the path that you are taking is
the right one. Problematic for sure because there is no GPS for drug
development. We have an organization that is very focused. Our burn rate is
at a minimum and we move our programs forward in the direction that we think
we need to be moving in. It is a little nerve racking at times, but
certainly challenging and rewarding when you get it right.
CEOCFO: What is the financial picture
like for Amorfix Life Sciences today?
Dr. Gundel:
We have just completed a private placement, so the financial picture is
actually pretty good. We determined how much funding we needed to drive our
programs past some of the critical milestones, what I call “strategic
inflection points.” One is the proof of concept in animal models for our
cancer therapeutic program. Once we have that proof of concept data, we
believe the floodgates will open and a lot of big pharma companies will
become aware of our technology and will want to partner and work with us.
Our Alzheimer’s disease diagnostic is ready for prime time and we are
actively involved in partnering discussions with a number of companies. We
will be raising enough cash to get us to where we need to be to complete
business deals.
CEOCFO: Why should Amorfix Life Sciences
stand out for potential investors?
Dr. Gundel:
There are a number of things that distinguish Amorfix from our competitors.
Our proprietary technology enables us to do things that other companies
cannot. We are developing important diagnostics and therapeutics in disease
areas that have large unmet medical need and large commercial market
opportunities. I believe we are a very undervalued company right now. Most
of our projects have short term milestones and strategic inflection points
which means added value for our shareholders in a short period of time. -In
short, I see the company as a great investment opportunity at the present
time.
CEOCFO: Final thoughts, what should
people remember most about Amorfix?
Dr. Gundel:
Amorfix is a company with unique and valuable technology that provides a
competitive advantage over other companies that are working in the same
space. We have strong science and an emerging pipeline of novel diagnostic
and therapeutics that have the potential to become blockbuster commercial
products. We have an exceptional management team and experienced Board of
Directors. You have to have the right team in place to make it all happen. I
believe we have that at Amorfix.
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