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News Headlines Materials & Formulation |
Technology for long-acting proteins here to
stay
By Katrina
Megget
20/06/2007 - Modigene has made inroads into its
development of long-acting proteins through the use of its
Carboxyl Terminal Peptide (CTP)
technology.
The
Virginia-based biopharmaceutical company announced positive
results for its long-lasting pre-clinical formulations of human
growth hormone, interferon beta and erythropoietin, which
aim to be, at most, once per week injections.
This
would be a stark therapeutic contrast to the three-plus a week
injections required with the currently marketed
drugs.
Over the past few years there has been a real
drive by biopharm companies to extend the life span of
therapeutic proteins, with two main techniques evolving. One
is to increase the size of the therapeutic protein; the other
is to alter the physical structure.
However,
there are downfalls with these techniques and as a result only
three long-lasting therapeutic proteins are on the market:
Pegasys (PEGinterferon alfa-2A) from Schering-Plough and Roche
for the treatment of hepatitis C; Aranesp (Darbepoetin alfa)
from Amgen for the treatment of anemia; and Neulasta
(PEGfilgrastim) from Amgen a colony stimulating
factor.
Collectively, these treatments have a revenue
of more than $8bn a year.
Modigene's technology
however, takes a mother nature approach to finding a
long-lasting solution.
Discovered by researchers at
Washington University in St. Louis, Missouri, CTP
technology involves using CTP, a small peptide naturally
occurring in the body as a portion of the protein human
Chorionic Gonadotropin (hCG), a female hormone that helps
maintain pregnancy.
By attaching CTP to other proteins
it can extend the life span of the protein. Meanwhile, as both
females and males, during the nine-month pregnancy period, are
exposed to the protein, there is less likelihood of having an
immune response to it.
Currently, Dutch biotech
company Organon has attached CTP to a follicle-stimulating
hormone (FSH), which is a hormone prescribed to females
undergoing fertility treatments, and is in Phase III clinical
trials with the product. So far, results suggest only one
injection is required with FSH-CTP compared to the seven daily
injections required with regular FSH.
"We are very
excited about Modigene's
pre-clinical work to date," Modigene's largest
shareholder and board member and Teva Pharmaceutical
Industries vice chairman Dr Phillip Frost said in a
statement.
"With four CTP-modified proteins
demonstrating to date exceptional results, including Schering-Plough/Organon's
FSH-CTP now in Phase III clinical trial, and Modigene's human
growth hormone, interferon beta and EPO [erythropoietin] in
pre-clinical models, the CTP platform is gaining credibility
as having the potential to become the platform of choice for
developing long-acting
therapeutic proteins."
The advantages with the technology show CTP can be
attached to a variety of proteins without increasing toxicity
or loss of biological activity.
According to
Modigene's website, CTP-modified proteins can be manufactured
using established recombinant DNA techniques in widely used
mammalian protein expression systems.
"The
accomplishment of this milestone was important for
Modigene," the company's president Shai Novik said in a
statement.
"We are moving forward with our
preparations for GMP production of our lead protein candidates
and initiation of clinical trials thereafter. We have also
commenced development of a long-acting version of GLP-1, a
therapeutic peptide that is prescribed for diabetes type II
patients, and is currently injected twice daily, and will
continue to apply the technology to several other key
blockbuster therapeutic proteins," he said.
The
three proteins Modigene are developing reflect a big-bucks
segment in the pharmaceutical industry. The human growth
hormone market is worth about $2.2bn; interferon, prescribed
for the treatment of multiple sclerosis, is worth $3.8bn; and
Amgen's Aranesp reported sales of $4.1bn last year, out of
estimated EPO market of $11.7bn.
Just yesterday,
Merck-Serono announced it would be
collaborating with US firm Ambrx on the development and
commercialization of new product ARX201, a long-acting growth
hormone product, using Ambrx's protein engineering platform
ReCODE. The technology enhances hGH performance by allowing
precise positioning of the site of a polyethylene glycol (PEG)
polymer through biosynthetically incorporating a chemically
unique amino acid.
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