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VOLUME 07: ISSUE 36
Immune
Response: New Name, New Company
For
all of you waiting for an update on Immune Response (OTCBB:
IMRP), today's your day. We think this latest round of news is ultimately
a very good move for investors, as it may end up being a catalyst for
the stock.
Before
we get to it though, we just wanted to give you a heads-up on a brand
new trading idea that could possibly be coming out as early as tomorrow.
We can't spill all the beans just yet, but we can say this
- we think you're gonna' be very excited....we know we were when
we first started examining the opportunity. Stay tuned.
In
the meantime, Immune Response just made a major announcement....though
you won't be calling them 'Immune Response' for much longer. Going forward,
the biotech company has decided to focus entirely on autoimmune diseases,
and intends to cease directing valuable resources towards HIV treatment
trials. To reflect the monumental shift in focus - and to better reflect
the medical philosophy behind their work - Immune Response will soon
be known as Orchestra Therapeutics Inc.
No,
that wasn't a typo - and we did something of a double-take as well. But,
it didn't take us long at all to agree with the decision...we feel it just
makes good sense in terms of maintaining maximum shareholder value now,
while at the same time setting up maximum shareholder value later.
Trust
us....you'll want to keep reading.
Where
It All Began
You
probably haven't heard of a FOXP3+ cell before. We didn't either, until
our contacts at Immune Response started explaining what they were a few
weeks ago. However, it may be a term worth remembering if they're even
half
as important as Immune Response's research indicates they are. In fact,
it may not be too far off base for us to say FOXP3+ cells were the reason
behind today's drastic news.
Not
to turn this into a science lesson, but a great number of illnesses and
diseases we're all familiar with actually fall into one broad category,
called autoimmune diseases. In layman's terms, an autoimmune condition
is simply a case where a person's own immune system 'thinks' it's attacking
a pathogen, when it's actually attacking part of a person's own body.
The
root cause in most autoimmune conditions - for lack of a better way we
can say it - is misdirected T-cells. Normally, T-cells make up a body's
self-regulated immune system, but if one or more of the T-cell groups don't
function properly, it can create obvious complications. Immune Response's
research to-date has shown that FOXP3+ Regulatory T-cells may play a critical
role in controlling those misdirected T-cells that are causing harm.
And?
The 'and' is not only the break-through work the company has done so far,
but in the widespread impact the work may have in the future. Back in early
March we highlighted how a Phase II trial milestone had been met as the
first multiple sclerosis patient had been injected with NeuroVax(tm) -
Immune Response's investigational therapy based on FOXP3+ research. What
we didn't mention was the sheer number of common autoimmune conditions
that could potentially be targeted by NeuroVax or a similar FOXP3+ platform.
Take
a look at just these few well-known conditions, each of which is an autoimmune
disease....
Multiple
sclerosis (MS)
Rheumatoid
arthritis (RA)
Crohn's
disease
Psoriasis
Lupus
Type-1
diabetes
And according
to Immune Response, there are as many as 60 autoimmune conditions. Even
if only a handful of them can be treated with FOXP3+ technology, we'd still
have to consider the opportunity an enormous one.
Bottom
Line
What's
our view? No song and dance here - we think this is ultimately a good move
for everyone, and shareholders in particular.
In
our opinion, biotech is one of the trickiest pieces of the market. These
stocks trade unlike anything else out there....and perhaps for good reason.
The time it takes to develop a drug and get it approved can be years, and
biotech research can be expensive, with companies spending millions and
millions in the drug development phase while not bringing in one red cent.
And, there's no guarantee a therapy will ever get approved by the FDA.
If it does, a company may have a few years to reap some gigantic rewards
before a patent expires. Yet, we've seen stocks of these developmental
companies sky-rocket just on news - well before a drug was actually
bearing any revenue.
It's
just something we bring up now to make this point.....the time to start
collecting any future rewards for Immune Response's work could actually
be sooner than you think, with 'now' perhaps being one of those
windows of opportunity.
And
what could draw out the buyers now as opposed to later? In
a word, potential. The potential upside of owning IMRP in
the future could mean waiting for the 'sure thing' actually means
you end up paying a highly-bloated price later.
Anyway,
see if the estimated numbers we found associated with some of the major
autoimmune conditions impress you as much as they impressed us.
Or more importantly, ask yourself if they'll impress other potential buyers
in the meantime:
Multiple
sclerosis - A $5 billion annual market, and it's growing fast
Diabetes
(type 1) - Though notably different than 'developed' type 2 diabetes,
analysts estimate an effective treatment for type 1 diabetes could mean
annual sales in excess of $1 billion per year
Lupus
- Biotech analysts are forecasting up to a potential $4 billion market
for other lupus therapies currently in development
Chron's
disease
- Potentially a $500 million annual market, at least
See what
we mean? While healthcare isn't always about dollars, eventually somebody
has to pay the bills...which may well be shareholders if appropriate
care isn't given to the venture.
Certainly
it wasn't an easy decision to make, but we agree the fiscally responsible
- and fruitful - thing for Immune Response to do was focus on the
best opportunity, and pare the projects that weren't aligned with the company's
new vision. We expect the result to be a streamlined operation - and one
that makes very good progress with FOXP3+ therapy research. The benefit
to shareholders is tremendous, in our view.
We're
sure we'll have more details soon; look for them in the blog or in an upcoming
newsletter. In the meantime, the press release below discusses a few more
things we didn't even mention.
THE IMMUNE RESPONSE
CORPORATION ANNOUNCES REBRANDING TO REFLECT EXPANDED FOCUS ON TREATMENT
OF AUTOIMMUNE DISEASES
-- HIV Clinical Trials
Terminated in Order to Redirect Resources --
CARLSBAD,
California, April 4, 2007 - The Immune Response Corporation (OTCBB:
IMRP) announced today that effective April 16 the company will be known
as Orchestra Therapeutics, Inc. This new corporate identity reflects the
Company's expanded focus on the treatment of autoimmune diseases. The Company
will announce a new ticker symbol prior to April 16.
"This
is a transformative moment in the Company's history," said Dr. Joseph O'Neill,
President and CEO of The Immune Response Corporation. "We believe we have
a substantial opportunity to benefit patients living with autoimmune diseases
by concentrating our resources and further leveraging the scientific technology
pioneered with our investigational MS therapy NeuroVax(tm)."
Autoimmune
processes are implicated in more than 60 conditions, including multiple
sclerosis (MS), rheumatoid arthritis (RA), Crohn's disease, psoriasis,
lupus and type-1 diabetes. Orchestra Therapeutics' unique approach to controlling
autoimmune diseases uses small peptide vaccines that appear to stimulate
FOXP3+ Regulatory T-cells; a component of the immune system that is now
recognized as being key in autoimmune pathogenesis.
In MS,
for example, a specific subset of a patient's own white blood cells, pathogenic
T-cells, attack myelin, a fatty tissue in the central nervous system, which
surrounds and protects nerve fibers. This pathologic process creates multiple
areas of inflammation that ultimately lead to scarring (sclerosis) and
that interfere with normal transmission of nerve impulses. This nerve damage,
in turn, leads to a variety of chronic and often debilitating neurological
symptoms, ranging from serious movement and balance problems to vision
impairment.
NeuroVax(tm),
an investigational T-Cell Receptor peptide vaccine for the treatment of
relapsing-remitting forms of MS, appears to work by enhancing levels of
FOXP3+ Regulatory T-cells within the immune system, which may help control
levels of pathogenic T-cells in MS patients. Data from the Company's most
recent Phase II clinical trial in MS showed that reduced levels of FOXP3
can be restored to normal levels after repeated vaccinations with NeuroVax(tm).
The Company recently announced the injection of the first patient in a
large multi-center Phase II study to assess the safety and efficacy of
NeuroVax(tm).
Recognizing
that a growing base of scientific research has demonstrated the potential
significance of the role of FOXP3+ Regulatory T-cells in the prevention
and treatment of a variety of autoimmune diseases, the Company has made
a strategic decision to emphasize this program and will redirect its resources
toward the execution and expansion of product development in this area.
The Company
is in discussions with several academic institutions to conduct pre-clinical
work on therapeutic vaccines to treat psoriasis and RA. Based on findings
to be derived from these product development programs, the Company plans
to initiate Phase I trials in one of these new autoimmune areas in 2008.
The transition
to the new name coincides with the Company's decision to terminate the
HIV clinical trials to fully focus the weight of the Company's resources
on the autoimmune program. The 52-week data from the first large cohort
of HIV clinical-trial participants have already been gathered, and analysis
of the data will be completed and disclosed in the second quarter of 2007.
Based on this data, the Company will consider strategic alternatives for
the HIV program.
Additionally
the Company has decided to scale back operations at its manufacturing facility
in King of Prussia, Pennsylvania, effective immediately. This decision
will reduce costs by approximately $3 million per year, while allowing
the Company to maintain the facility pending strategic decisions about
the HIV program.
The Company
raised $902,000, gross, from the exercise of warrants in the last week
of March 2007. These were from the second tranche of warrants issued in
the Company's spring 2006 Private Placement. Under special amended terms,
each exercising warrant holder received 2.5 common shares for each $2 of
exercise price paid. A total of 5,530,125 second tranche warrants expired
on March 30, thereby significantly reducing the Company's overhang.
Orchestra
Therapeutics, which will soon be the new name of The Immune Response Corporation
(OTCBB: IMRP), is an immuno-pharmaceutical company focused on the discovery
and development of novel treatments for autoimmune diseases. The Company's
lead immune-based therapeutic product candidate is NeuroVax(tm) for the
treatment of MS. In addition to MS, the Company has proprietary technology
and prior clinical experience for clinical evaluation of TCR peptide-based
immune-based therapies for RA and psoriasis. The targeted strategy behind
the Company's autoimmune therapies is reflected in the name Orchestra.
Rather than disrupting the function of the entire immune system, these
therapeutic vaccines are designed to elicit a very specific response -
akin to correcting one instrument in an orchestra that is out of tune -
to help control disease.
This news
release contains forward-looking statements. Forward-looking statements
are often signaled by forms of words such as should, could, will, might,
plan, projection, forecast, expect, guidance, potential and developing.
Actual results could vary materially from those expected due to a variety
of risk factors, including whether the Company will continue as a going
concern and successfully raise proceeds from financing activities sufficient
to fund operations and clinical trials of NeuroVax(tm), REMUNE(r) or IR103,
the uncertainty of successful completion of any such clinical trials, the
fact that the Company has not succeeded in commercializing any drug, the
risk that NeuroVax(tm), REMUNE(r) or IR103 might not prove to be effective
as either a therapeutic vaccine, whether future trials will be conducted
and whether the results of such trials will coincide with the results of
NeuroVax(tm), REMUNE(r) or IR103 in preclinical trials and/or earlier clinical
trials and the unresolved status of the Company's HIV program. A more extensive
set of risks is set forth in The Immune Response Corporation's SEC filings
including, but not limited to, its Annual Report on Form 10-K for the year
ended December 31, 2005, and its subsequent Quarterly Reports filed on
Form 10-Q. The Company's Annual Report on Form 10-K for the year ended
December 31, 2006 will be filed soon and the set of risks set forth there
should also be studied. The Company undertakes no obligation to update
the results of these forward-looking statements to reflect events or circumstances
after today or to reflect the occurrence of unanticipated events.
REMUNE(r)
is a registered trademark of The Immune Response Corporation. NeuroVax(tm)
is a trademark of The Immune Response Corporation.
MEDIA
CONTACT:
Rachel
Kessler
Chamberlain Communications
Group Inc.
(212) 389-9155
rkessler@chamberlainpr.com
INVESTOR
CONTACTS:
Robert
Giordano
ROI Associates
(212) 495-0201
rgiordano@roiny.com
Gene Marbach
Makovsky & Company
(212) 508-9645
gmarbach@makovsky.com
COMPANY
CONTACT:
Michael
K. Green, COO
The Immune Response
Corporation
(760) 431-7080
info@imnr.com
We
Value Your Feedback
Got comments, questions or suggestions?
Send 'em on over: Email
the Editor
If you wish to send a written request
or inquiry, please send it to our physical address:
TGR Group, LLC
4653 Carmel Mtn Rd Suite 308 #402
San Diego, CA 92130
Is
It Time For Biotech?
Though
not necessarily our usual 'small cap' fare, we still think we have to point
out something most of the market seems to be missing....a mini-bull market
may be starting - or perhaps we should say restarting - in the biotech
arena.
The
AMEX Biotech Index (BTK)
is up 9.5% from lows hit in early March, which easily tops the S&P
500's 4.5% gain during the same period. On a six-month basis, biotech's
9.5% rally tops the SPX's 6.4% gain. Over the last two years, the biotech
index is up by 52.9%, versus the S&P 500's 22.6% run.
The
point is, we see a distinct advantage in biotech stocks right now....an
advantage we don't think is likely to go away anytime soon.
So
what's the deal? Is it cyclical? Well, yes and no. It's cyclical in the
sense that biotech can come and go over time, but biotech rarely moves
in tandem with the market's overall bull/bear cycles. However, knowing
biotech how we know biotech, it is indeed cyclical....just on a different
schedule than almost all other stocks. From that perspective, it looks
like a secular bull market for biotech.
To
read more about our view on biotech, complete with a handful of specific
biotech stock ideas, just click
here.
Titan
Global Is Really Becoming 'Global'
You
may have missed this late Friday, but we sure didn't....Titan Global Holdings
(OTCBB: TTGL) announced
a joint venture that will put them into the Asian market.
Not
content with just dominating the United States/Latin American telecom market,
Titan will be managing Prism System's (an Asian telecom service provider)
facility in Hong Kong. Titan will give Prism a per-minute fee; Titan keeps
the rest.
Presumably,
the venture - as far as Titan is concerned - will mirror the Oblio (Latin
American telecom) venture, which is largely the sale of pre-paid calling
cards. Instead of Central/South America, the new venture's service will
focus on U.S.-to-Pacific Rim connections.
Considering
Titan has done 'off-the-charts' well with the Hispanic market and service,
we have no reason to believe success with a different target audience would
be any less impressive. So, this is a big deal for the company, and ultimately
a big deal for shareholders.
Better
still, if the concept proves to be viable, we can see more partnerships
like this being forged in the short-term as well as the long-term. That
was, after all, the plan all along.
For
more details on the Prism/Asian market deal, click
here.
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