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9
DECEMBER 2015
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The Canadian Business Journal
(comprised of AFP and paclitaxel) can success-
fully target cancers without the “off-target”
healthy cell hit and at a lower dose than conven-
tional chemotherapy.
Cancer and Autoimmune
Treatments in the
Pipeline
Alpha Cancer has had multiple projects on the
go since it acquired AFP rights from the U.S.
company, Merrimack Pharmaceuticals. It is cur-
rently collaborating with PolyTherics Limited, a
U.K. company that provides technologies and
services to develop biopharmaceuticals. The
collaboration is producing a range of AFP conju-
gates with cytotoxic payloads attached to AFP in
order to target cancer cells with chemotherapy.
The company is also working on prepar-
ing a preclinical package for ovarian cancer that
includes manufacturing and toxicology work.
It expects to start treating patients in 2017 and
apply for approval approximately three years
thereafter. Because ovarian cancer is an orphan
disease (i.e., relatively small number of patients
are annually diagnosed in U.S. with ovarian can-
cer), the company can access an FDA program
that allows businesses to market drugs after
Phase II trial. The FDA program stipulates, how-
ever, that the company must complete Phase III
trial to confirm Phase II results, or the drug will
be taken off the market.
Additionally, Alpha Cancer is continuing the
development path for AFP that was originally
pursued by Merrimack. Sherman says the protein
shows considerable promise for treating auto-
immune diseases, such as myasthenia gravis. In
fact, studies in Israel and the U.S. showed that
AFP blocks the antibodies that attack the nerve
and muscle junction (called Acetylcholine recep-
tors), improving the symptoms of the disease.
Sherman explains that because Merrimack com-
pleted several Phase I trials and a large Phase II
trial, the protein can advance quickly to market
by entering Phase II trial in myasthenia gravis.
Sherman adds that AFP could also be useful in
treating other autoimmune diseases, such as
multiple sclerosis and lupus.
Business of Treating
Cancer
Alpha Cancer holds exclusive worldwide rights
to AFP with patents that extend to 2024. It
expects to secure up to 12 years of market and
data exclusivity following marketing approval
in the U.S. and Europe. The company has ben-
efitted from over $100 million that Merrimack
already spent on development, including a large
drug master file with the U.S. Food and Drug
Administration and human safety data from over
400 patients treated in Phase I and II clinical tri-
als. As a result, the company has a significantly
mitigated risk profile in every area of develop-
ment and a speedy path to market.
As a virtual company, Alpha Cancer out-
sources all of its projects to research institutes
and contract research organizations such as
1,2,3,4,5,6,7,8 10,11,12
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