Grant will support the largest interventional

canine clinical trial ever conducted

The Open Philanthropy Project awarded a multi-year grant of 
$6,421,402 to Stephen Albert Johnston at Arizona State
University to support the largest interventional canine clinical
trial ever conducted. The trial will assess the effectiveness of
a unique vaccine in preventing any type of cancer in dogs.

The trial will enroll at least 800 owners’ pets to test the efficacy
of a novel vaccine to prevent cancer.

“Our goal has always been, that if this is possible, we should
at least try it,” said Johnston, who directs the Biodesign
Center for Innovations in Medicine and is a professor in the
School of Life Sciences. “Open Philanthropy was the only
organization that responded to support our high-risk project,
the biggest cancer intervention trial in dogs ever. I really
admire them for that.”

Searching for a vaccine

It is widely thought that all cancers are unique and therefore
a general, preventative vaccine would not be possible. However,
Johnston’s team has discovered a potentially high-impact way
of identifying tumor antigens that are common among cancers;
these make up the key components of their vaccine.

The new vaccine, called a multi-valent frameshift peptide (FSP)
vaccine, was developed by Johnston and his team over the last
ten years. The vaccine already has been tested for efficacy in
mice and is shown to be safe in dogs.

Johnston and his team eventually want to take the next leap
and test the vaccine in humans. However, they feel that first
testing the vaccine in dogs has many advantages. 

Cancer is the leading cause of death in pet dogs and their
cancers are very similar to their human counterparts. Some
breeds have a very high cancer rate, as much as 40 percent.
The canine immune system responds to tumors and vaccines
similarly to that of humans, but the course of tumor development
in dogs is much shorter.

Johnston thinks they can evaluate the effectiveness of the
vaccine in five years or less, versus the 15 to 20 years it would
take in a human trial. The vaccine they are testing in dogs will
have a comparable composition to the one they would test in
people.

“We have been working over 10 years to develop a vaccine
that could potentially prevent any cancer,” said Luhui Shen,
senior science director of the vaccine project.

“Our next goal is to test the vaccine in owner-enrolled, healthy
dogs. We are fairly confident that if the vaccine works in dogs,
it could work in people.”

How the trial will work

The trial will be conducted under the direction of Douglas Thamm,
director of clinical research at the Flint Animal Cancer Center at
Colorado State University. Healthy, middle-aged pet dogs will be
enrolled, continuing to live their normal lives at home and receiving
biannual exams with a complete clinical pathology workup.

Dogs will be randomly chosen to receive either the vaccine or a
mock version. Dogs receiving the mock vaccine are expected to
develop cancer at normal rates. The experiment will determine
whether the test vaccine can prevent cancers.

Any owner whose dog develops cancer during the trial, on either
the test or control arm, will be given a credit toward medical
expenses.

If successful, this trial would provide strong support for the
concept of employing FSP vaccines to prevent cancer in its
earliest stages, possibly leading to a canine cancer vaccine, \
and could eventually justify human clinical trials for both
treatment and prevention.

“We consider this a high-risk project with an unusual opportunity
for high impact as it could possibly reduce the incidence of cancer
and cancer metastasis,” the Open Philanthropy Project grant
announcement said. “We believe cancer preventative vaccines
have a higher expected value than curative cancer therapies,
since an effective vaccine would likely be a less expensive way
to provide decades of healthy life compared to current cancer
therapies, which often only extend life for a few months or years.
We also believe cancer vaccines would be tractable in developing 
countries, which have a high cancer burden.  FSP vaccines are 
particularly attractive compared to other proposed cancer  
vaccines because they may work against many cancer cell types.”

A daring gift

Cancer is increasingly placing a toll on developing countries,
according to a World Health Organization (WHO) report published
in 2010. The latest WHO statistics cite that cancer causes around
7.9 million deaths worldwide each year. Of these deaths, around
70 percent, or 5.5 million deaths, are now occurring in the
developing world.

A disease once associated with affluence now places its heaviest
burden on the poor and disadvantaged who can not afford the
advanced treatments available in developed countries, some of
which cost $200,000 or more.

“If the vaccine works it should be inexpensive enough that
everyone in the world could get it,” according to Johnston.

Johnston foresees this commitment on the Open Philanthropy
Project’s part to be an inspiration to other philanthropic efforts
to be more daring and risk-taking.

“It wasn’t easy to identify an organization interested in funding
such a trial,” Johnston said. “Open Philanthropy came to us,
rigorously reviewed our proposal and offered to fund the trial. 
We are extremely grateful that they would support this high-risk
effort.  This vaccine may not work, but if it does it will be thanks
to the commitment of Open Philanthropy to funding potentially 
transformative efforts.”

Johnston is the director of the Biodesign Center for Innovations in
Medicine and CEO of Calviri, Inc, a cancer vaccine company. He is
known for his success as an innovator, inventor and disruptor of
conventional science.

Johnston and his interdisciplinary team have developed a system
for continuous, comprehensive, inexpensive health monitoring
known as immunosignature diagnostics. More recently, his team
successfully answered a call from the U.S. Department of Defense
via the Defense Advanced Research Program Agency, or DARPA, to
develop a technique for producing 1,000 doses of an antimicrobial
in a week — a discovery that will potentially safeguard populations
that are threatened by infections and outbreaks of Ebola and Zika.