Cancer vaccines have been very hard to come by. So when a New York-based biotech company, Antigenics, saw the results of its recent trial
testing a vaccine for kidney cancer (Oncophage), enthusiasm was high. Even though the vaccine did not meet the
primary end point of the trial, it did seem to work in a subset of the
patients. But, the FDA, in its disputable
wisdom, did not accept the finding and required the company to design and
conduct a new Phase III trial. The
company’s response? Get approval for the
vaccine in Russia.
Could this be a new strategy for small
biotechs? Read the article below for more details.
By Alla Katsnelson, April 9, 2008 on TheScientists.com
NewsBlog
A New York-based biotech company announced today (April 8)
that it has received approval for the first therapeutic cancer
vaccine -- in Russia. It is the first approval by a regulatory body of a cancer immunotherapy.
The therapy's approval in Russia won't in itself boost its chances for approval
in the US or the EU, or improve the prospects of other cancer vaccines that are
in the biotech pipeline, Ren Benjamin, senior biotech analyst at the New York
investment firm Rodman and Renshaw told The Scientist. But Russia is "novel ground" for small
biotech, he said: Seeking first approval in a country outside of the US and EU is a bold move, and both biotech
companies and investors will be closely watching to see how lucrative a market Russia
turns out to be.
The antibody-based therapy, Oncophage, received a registration certificate from
the Russian Ministry of Public Health to treat a subset of kidney cancer
patients who are at intermediate risk for disease recurrence, the company,
Antigenics, said in a press
release The treatment, made from patients' tumor cells, increased
recurrence-free survival by 1.7 years according to the results of a phase III
clinical trial, the release said.
Cancer immunotherapy has long been a field riddled with scientific challenges,
and as we reported in 2006, Antigenics' vaccine
was no exception. The company's phase III study in patients with nonmetastatic
kidney cancer did not meet its primary endpoint, the company reported last
year. Further analysis revealed that the treatment did seem to work for a
subgroup of patients who had a lesser risk of recurrence. But such post-hoc
analysis isn't enough for the FDA, which has already said that Antigenics needs
to conduct a new trial looking explicitly at this patient group.
"I think that other (cancer vaccine) companies in the past -- main one
being Dendreon -- have gotten phase III trial results that have shown promise
in a subset of patients," said Benjamin. "However, no one has been
entrepreneurial enough to seek registration in a country like Russia."
According to recent
reports, he noted, the pharma market there is growing astronomically.
"This will really be a landmark analysis -- not only to see whether small
biotechs can do it alone in these other countries, but also, are these other
countries worth pursuing," he said.
Meanwhile, Christopher Wood, a cancer researcher at MD Anderson Cancer Center
who led the Oncophage trial, told
CNBC that the company had assured him they plan to use proceeds from
Russian sales to fund a study for FDA approval. Wood also noted that the data
has been submitted for publication. (Wood wasn't available to comment by the
time I posted this blog.)
Antigenics is also looking into approval in the European Union based on its
current data.
+++++++++++++++
Further comments on the FDA’s response to Antigenics’
vaccine trial can be found on BiotechBlitz (April 10, 2008).
_____________________________________________________________________________
© 2008 Steven S. Clark, PhD. All Rights
Reserved.
Disclaimer: The authors used their best
efforts in collecting and preparing the information published herein. However,
neither Steven S. Clark, nor other authors, assume, and hereby disclaim, any and
all liability for any loss or damage caused by errors or omissions, whether
such errors or omissions resulted from negligence, accident, or other causes.
Articles contained herein, are meant to be
distributed freely to interested parties. However, any excerpts from any
article must credit BioScience Biz.
Is there an advantage to Angel vs VC backing during an IPO?
For companies that go public, how do those that were backed primarily by angel investors fare against those primarily backed by venture capitalists? That was one of the questions addressed in a working paper recently published by two professors from the University of New Hampshire. They examined data related to the pre-initial public offering (IPO) shareholders of companies that subsequently went public. The conclusions from the study provide interesting information that should be considered for companies looking to go public as part of their long term capitalization plan.
Read more from the article by Matt Storms that was recently published by the Wisconsin Technology Network News.
Posted by Steven S. Clark, PhD on August 05, 2009 at 07:43 AM | Permalink | Comments (0) | TrackBack (0)
Technorati Tags: Angel investors, capitalization, IPO, Matt Storms, VC, Venture Capitalist
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