TIMOTHY COOKE - MOJAVE THERAPEUTICS INC
CEO Interview - published 10/14/2002

DOCUMENT # RAM619

TIMOTHY COOKE has served as Chief Executive Officer of Mojave
Therapeutics, Inc., since August 2000. Previous to joining Mojave, he
spent nine years at Merck & Co., Inc., where he held various domestic
and international sales and marketing positions in the company's newly-
formed Vaccine Division. Dr. Cooke was a founding member of Aventis
Pasteur MSD, a joint venture between Merck and Aventis Pasteur formed in
1994 to market vaccines in Western Europe. Prior to joining Merck, Dr.
Cooke held marketing and sales positions at Membrex, a development-stage
company focused on biopharmaceutical purification. Dr. Cooke has a PhD
in Bio-Organic Chemistry and an MBA from Columbia University.

Sector:  biotechnology

TWST: Would you give us a brief history of Mojave Therapeutics as well
as an overview of what your company does?

Dr. Cooke: Mojave was founded in 1997. We were spun out of the Memorial
Sloan-Kettering Cancer Center in New York, and the technology was based
on work by

Dr. James Rothman, who is the Vice Chairman of the Sloan-Kettering
Institute. We're based just north of New York City, in Hawthorne, New
York. We currently have 32 employees and we've raised approximately $25
million to date with our key investors being Apax Partners and Johnson &
Johnson Development Corporation. What we do is strive to make the
treatment of chronic viral diseases and cancer as simple and safe as a
flu shot with well-characterized off-the-shelf products. The way we want
to do that is to utilize a known human biochemical pathway for T-cell
activation. And that is based on heat shock protein technology and so we
use heat shock proteins to activate T-cells to fight cancer and chronic
viral diseases.

TWST: Can you explain to us, if it can be explained simply, the actual
concept behind this technology?

Dr. Cooke: The concept is fairly simple in that it is known that a class
of proteins called heat shock proteins delivers antigens to immune
system cells, and these immune system cells, which are called antigen
presenting cells, then take these antigens and present them at the cell
surface to specifically activate killer T-cells. The killer T-cells are
like sentinels of the immune system that can recognize antigens, which
are molecules on the surface of the cells, and kill those diseased cells
selectively while leaving normal cells intact. The technology that was
developed by

Dr. Rothman modifies the antigens so that they can bind more effectively
and predictably to heat shock proteins. The company produces
formulations that are comprised of recombinant human heat shock protein,
made from E. coli, and antigens, which are synthetic peptides. So it's a
totally synthetic, biopharmaceutical formulation that we give, which is
well characterized and off-the-shelf, so it's not a patient-specific
kind of approach.

TWST: Is there any other company that is developing a drug with a
concept similar to yours?

Dr. Cooke: There are two other companies that are using heat shock
protein technology in order to activate T-cells. Antigenics is a company
that uses an autologous approach where they remove heat shock proteins
and any associated antigens from a patient's tumor, purify them, and
then inject them back into the same patient. And then there is
Stressgen, which uses a fusion protein comprised of mycobacterial, not
human, heat shock protein, fused with a protein antigen.

TWST: Could you lay out your business strategy for how you intend to
bring your products to the commercial stage?

Dr. Cooke: We have a two-pronged approach. The first is to bring
products through internal clinical development with in-licensed
antigens. We have our first product in which we have Phase I/II trials
completed for melanoma patients. But at the same time that we carry
products through clinical development and increase value, we also will
demonstrate the tremendous value in the technology platform so that we
can then form joint product development partnerships with other
companies that have antigens that they've discovered but have no way to
deliver. While there is a lot of antigen discovery work being performed,
there are actually no predictable ways to deliver these antigens to get
a T-cell response.

TWST: What about strategic alliances? Could you outline them in more
detail?

Dr. Cooke: We intend to have two kinds of strategic alliances. One would
be a combination of technology platforms because we are very much in the
antigen delivery business, focusing on the delivery of antigens to the
immune system. Many other companies are focused on discovery of antigens
that would be clinically relevant to treating certain diseases. The
first kind of partnerships that we're looking at would be taking a
partner's antigens and combining them with our antigen delivery system
in order to treat certain diseases. So one kind of partnership would be
marrying antigens with our antigen delivery platform. The other kind of
partnership we envision would be as we take our product through clinical
development, we anticipate looking for partnerships, likely post-Phase
II, that would be for late stage commercialization and clinical
development and commercialization.

TWST: Since you are not in the hunt for an actual cure for cancer,
instead your emphasis is on the delivery of the cure of cancer, what has
been the FDA stance on a situation such as yours?

Dr. Cooke: We don't think of ourselves, first of all, as a drug delivery
kind of company. In the immune therapy area, we call it active
immunotherapy, meaning that we're activating a person's own immune
system to then fight disease, and in order to activate a person's immune
system to fight disease, you need to have an antigen that will serve as
a marker to the immune system that differentiates a diseased cell from a
healthy cell. So you need to have the antigen, but the antigen alone
doesn't get any kind of immune response in patients, so you need to
combine that with some kind of approach that will activate the immune
system to that antigen. There are a lot of different technologies that
are being used to do that. So we're really not so much in drug delivery,
but enabling the immune system to be able to recognize certain antigens.
In the field of therapeutic vaccines, the FDA hasn't licensed any yet.
Clearly, there's a long history in the preventative vaccine world of
licensed preventative vaccines, but the FDA's view in the cancer area
has largely been looking at survival in patients, or time-to-disease
progression. There are certain surrogate endpoints that they've been
looking at. Similar products would be Canvaxin by Cancervax, for
example, which is in later stage development, and GVAX from Cell
Genesys. So there are definitely other products the FDA is reviewing,
but there are no surrogate endpoints in the cancer field. It's a bit
different in the chronic viral disease space because you have certain
viral load endpoints that may be acceptable to the FDA to give you a
surrogate marker for efficacy.

TWST: How long, in your estimate, will it take for you to bring your
product into the commercial market?

Dr. Cooke: It depends very much on the disease target. If you're looking
at some of the chronic viral diseases, one can look at a five- or six-
year time horizon from initiation of the first Phase I/II studies until
completion of the Phase III study, and then filing at that point. In the
cancer area, depending on which type of cancer indication you choose, it
can vary out to, probably, eight or nine years. But again, it really
depends on whether you are doing an approach of later stage patients who
are sicker, and therefore, their survival time is easier to measure.
With the less severely ill cancer patients, the time to survival is
obviously a lot longer, and those trials take significantly longer.

TWST: You mentioned that you are venture financed. Do you have the
finances at this juncture to carry your company through to the point
where you will start generating revenue, or are you going to be needing
additional financing down the road?

Dr. Cooke: We'll definitely need additional financing. But right now, we
have completed a Phase I/II trial in melanoma patients, which was
carried out at Memorial Sloan-Kettering Cancer Center, and we received
very encouraging results from that trial in that the formulation was
safe and well tolerated, and there were specific T-cell responses to the
antigens in that trial. But we still have several more years of
development in order to bring a product to market and be revenue
generating. So we are very much looking at future rounds of financing.

TWST: Have you had good responses from venture financiers? Have they
been receptive to your company's technology and results?

Dr. Cooke: Yes, we've received a very good response in the venture
community and we have quality investors in the company already, Apax
Partners and Johnson & Johnson Development Corporation. And I think they
see the leverage in the technology platform that we have, being able to
go after a broad range of different disease targets with an estimated
market potential of $50 billion with fairly minor modifications within
our technology platform.

TWST: Do you have the management team in place to accomplish your goals?

Dr. Cooke: Yes, we do. Over the last two years, I've built a great
management team here at Mojave. I come from nine years at Merck, where I
was in sales and marketing positions in their vaccine division. We've
recently hired Brian Barber as Chief Scientific Officer, who was a Vice
President at Aventis Pasteur, focused on cancer and viral vaccine
development. And then we have Jane Boswick from Celera Genomics and
Covance, heading up our business development efforts. Chris Fenimore,
Vice President of Finance, is from CW Ventures, Needham Company and
KPMG. So I think we've got a great team in place to provide the
leadership to bring the company forward.

TWST: As CEO, where are you spending most of your time?

Dr. Cooke: It's certainly a mix of internal versus external, trying to
keep our company focused on our R&D goals and implementing our strategy,
while at the same time, keeping in touch with current and potential
future investors and partners.

TWST: If you were to sit down with a potential investor, what would be
the two or three reasons you would give to convince them to invest?

Dr. Cooke: I would say that we've got a great platform technology in
place with a strong intellectual property portfolio. We have our first
positive results in human clinical trials. We've got great scientific
founders, advisors, high-quality investors, and an experienced
management team. And I think it's a great investment opportunity.

TWST: Give us your vision for Mojave Therapeutics.

Dr. Cooke: Mojave can be a transforming company in the field of
therapeutic vaccines. I think we've got a platform technology that is
potentially as impactful as monoclonal antibodies, where, with fairly
slight variation in the molecule, you can go after a broad range of
different disease targets with safe, well-defined biopharmaceuticals.

TWST: Thank you. (WT)

TIMOTHY COOKE
 CEO
 Mojave Therapeutics, Inc.
 22 Saw Mill River Road
 Hawthorne, NY 10532
 (914) 347-0290
 (914) 347-0292 - FAX
 www.mojave-therapeutics.com
 e-mail: mojave@mojave-therapeutics.com

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