1. Published by Redington, Inc. for investment professionals. All rights reserved.
KEY CONSIDERATIONS
immune modulating response is induced,
which provides clinical benefit to the
underlying disease.
CNDO-201 consists of microscopic eggs
of the porcine whipworm. It is administered
Trichuris suis
orally as a tasteless and odorless liquid,
typically every two weeks in doses of 2,500
TSO. TSO is an appropriate helminth
for therapy because it is able to colonize
in humans briefly without invading or
infecting the host, since humans are not its
natural host.
Initial data from Coronado’s product
candidate has shown it to be safe and
effective in treating Crohn’s disease and
ulcerative colitis.
In a study conducted at the University of
Iowa, researchers found that more than 70
percent of Crohn’s disease patients treated
with CNDO-201 entered remission within
24 weeks.
In another trial of ulcerative colitis
patients, 43.3 percent of the patients on
study drug in the intent to treat group
achieved a positive response vs. 16.7
percent on placebo. CNDO-201-treated
baseline in stool frequency, blood in stool,
mucosal appearance, and overall well
being of the patient.
A Phase I single dose/dose escalation
study for patients with Crohn’s disease is
expected to be completed by the end of 1Q
2012, followed by a multi-center placebo-
controlled Phase II study scheduled to start
1H 2012.
CNDO-201 FOR AUTOIMMUNE Earlier this year, preliminary results of
DISEASES a five-patient study at the University of
Coronado’s CNDO-201 is a biological Wisconsin found CNDO-201 showed
helminth therapeutic product which positive trends in the treatment of multiple
originates from the work of Joel V. sclerosis. The mean number of new
Weinstock, MD, Chief of the Division gadolinium-enhancing MRI lesions fell
of Gastroenterology/Hepatology at Tufts from 6.6 at baseline to 2.0 at the end of
Medical Center in Boston, a member of treatment. Two months after treatment was
discontinued, the mean number of new
consultant to the company. Dr. Weinstock lesions rose to 5.8. Additional patients are
discovered that when the microscopic eggs currently being studied for up to 10 months
of certain TSO are administered to patients with results expected in the second half of
2012.
expectations with respect to FDA approval of new products, technology and product development milestones, the ability of the company to leverage its product development and negotiate favorable collaborative
results may occur as a result of varying milestone payments and the timing of costs and expenses related to the company’s research and development programs. This is not a solicitation of any offer to buy or sell.
Redington, Inc. acts as the company’s investor relations counsel and it, its employees or members of their families may from time to time own an equity interest in companies mentioned herein.
2. ABOUT THE HYGIENE HYPOTHESIS SUMMARY POINTS
A r a n d o m w alk through the treatment of autoimmune-related
barnyard could be better for your diseases.
health than a low-carb diet. First postulated in the late 1980s
Sound surprising? with respect to common allergies such
As it turns out, the barnyard is a as hay fever allergies, the Hygiene
perfect place to meet up with natural Hypothesis has been extensively
pathogens like bacteria and helminths investigated by immunologists and
that could ultimately prevent the epidemiologists and now serves as
development of serious diseases. an important theoretical framework
Many of those pathogens, it is now for the study of both allergies and
believed, can act very much like diseases of the immune system.
modern-day vaccines, strengthening Epidemiological data reported in
the human immune system so it’s the New England Journal of Medicine
able to prevent the onset of certain (2002) and Inflammatory Bowel
diseases. Disease (2009) show that incidence
of autoimmune-related diseases is
this notion started to build in the highest in the developed world with
1 9 3 0 s a s e p i d em io lo gis ts a n d positive correlations noted among
immunologists sought to learn why persons of higher socioeconomic
the incidence of certain diseases was status and high levels of domestic
much higher in industrial societies hygiene.
than in the undeveloped world.
Scores of studies published in peer diseases is in inverse relation to the
reviewed journals started piecing the prevalence of certain helminths.
puzzle together. The Hygiene Hypothesis suggests
O n e b y o n e , t h e y b e g a n t h a t e l i m i n a t i o n o f i n t e s t i n a l
documenting how the hygienic helminths (tiny parasitic worms) in the
ways of an industrialized society, industrialized world has eliminated
like modern sewage treatment, a natural regulatory mechanism that
cement sidewalks, and regulated prevents excessive immune system
food industries, had created an T-cell activation, which causes tissue
unforeseen consequence; namely, destruction in inflammatory bowel
the gradual but certain elimination of diseases and other immune-mediated
conditions such as multiple sclerosis,
the human immune system protect rheumatoid arthritis, psoriasis and
against diseases like Crohn’s disease, Type 1 diabetes.
ulcerative colitis, and multiple The helminth-based therapy being
sclerosis. developed by Coronado is designed
T h e s t u d i e s b e c a m e t h e to use parasitic worms as a FDA-
i n t e l l e c t u a l f o u n d a t i o n o f t h e approved pharmaceutical product to
now widely accepted Hygiene naturally re-regulate immune system
H y p o t h e s i s , w h i c h u n d e r p i n s response in patients with autoimmune
Coronado’s therapeutic strategy for diseases.
The company is developing plans for a $1.0 billion, and for multiple sclerosis it's potentially severe side effects.
Phase II study for patients with multiple $5.4 billion. In a seven-patient investigator initiated
sclerosis. CNDO-109 FOR CANCER Phase I clinical trial in the UK, patients
In addition to inflammatory bowel CNDO-109 is a biologic product with AML had remission durations
diseases and multiple sclerosis, more than a candidate that activates the immune and overall survival much greater than
dozen company and investigator-sponsored system’s NK cells to target and kill cancer expected. Based on preclinical studies,
trials for the treatment of other autoimmune cells. It is derived from a patient’s own NK Coronado believes CNDO-109 may be
diseases are currently underway or being cells, or a donor’s NK cells. The NK cells active against a variety of cancers.
planned. are activated ex-vivo by CTV-1, which Coronado plans to submit an IND in
Coronado holds an exclusive license for primes them without the use of cytokines or early 2012. It intends to initiate a Phase I/II
use of the CNDO-201 for all indications in long-term culture/expansion. clinical trial in the US for treatment of AML
North and South America and Japan. Coron a d o ’ s C N D O - 1 0 9 o f f e r s a n patients with relapsed disease. It is also
Annual drug sales for treating Crohn’s alternative to activating NK cells through planning selected pilot Phase I clinical trials
in the US and Japan are estimated at $2.4 the use of Interleukin-2 (IL-2), a method in other tumor types, including multiple
billion; for ulcerative colitis it’s just over that's effective but whose use is limited by myeloma.
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