Prima Biomed is a leader in
developing personalized immunocellular therapeutics that deal with cancer. It
has a flagship product known as the CVac vaccine that targets mucin-1
overexpressing cancer cells. It is a first or second-line treatment for
epithelial ovarian cancer in remission.
CVac
This is the company’s
“personalized immunocellular therapeutic” treatment for epithelial ovarian
cancer. The treatment stimulates the patient’s own immune system to target and
destroy tumors. The treatment is customized for each patient and works as
follows:
• The patient’s own immune
precursors are isolated from their blood
• The patient’s blood is
circulated through a special filter that takes out only the cells needed to
produce the immunocellular therapeutic
• These cells are matured in
the laboratory and treated with a tumor-specific cell surface protein called
mucin 1
• The unique form of mucin 1
is present in great amounts on epithelial ovarian tumors
• The CVac then moves
through the patient’s blood stream, and as CVac comes in contact with immune
cells (T cells), it activates them to recognize and subsequently destroy tumor
cells producing the tumor form of mucin 1 protein
CANVAS Clinical Trial
The CANcer VAccine Study
(“CANVAS”) is a phase 2 study of epithelial ovarian cancer patients. The study
objectives are to ascertain if CVac, as compared to a placebo, is able to
improve the time patients remain in remission before tumor progression. It also
hopes to extend the overall survival of patients.
The CANVAS study represents
a major investment by Prima in the future of the CVac program for ovarian
cancer. Prima has spent significant resources as it gets ready to begin this
trial. The highest quality training and cell collection procedures will be in
place to assure a smooth scale up in the manufacturing of CVac.
Ovarian Cancer Market Data
• Ovarian Cancer has an
overall incidence of 35,000 per year between the US and EU7
• Current standard of care
is debulking/platinum/Taxane/chemo
• Care has not changed in 20
years
In the United States, the
market is about 20,000 patients alone. There needs to be a more effective
therapy that can be tolerated and avoid the side effects of the present
acceptable treatments. For a treatment that can address these issues, the
potential market size is $1.0 billion annually.
Ovarian Cancer’s Treatment
Challenge
Prima’s ovarian cancer
market is quite a challenge. In a typical clinical journey, cancer patients
will see periods of remission and relapse of shortening duration until a
resistance to chemotherapy develops. Most women being treated for ovarian
cancer respond positively with “first-line” treatment. But the treatment is not
long-lasting. Seven out of 10 patients end up dying of a recurrence of the
cancer within five years of diagnosis. There is a lack of second-line therapy
for patients who relapse.
One important note for
investors is that the second-line treatment looked fine and is being
investigated further. When analyzing the potential market size, second-line
treatment is going to be the majority of research the company is looking for
anyway. Investors are waiting for more input into the first-line treatment
which will probably have its trial restarted sometime in the first quarter of
2014.
It is protected from
bio-similar competition, and intends to seek Orphan designation for enhanced
exclusivity in the US and EU.
For a small-cap company, it
has an extremely strong cash balance. As of the end of the last quarter, the
company had approximately $30 million in cash. Most of the research and
development in 2013 was centered on ongoing clinical trials for Cvac in ovarian
cancer and for its personalized immunocellular therapeutic platform.
Prima Biomed is a small-cap
stock with a platform that has strong revenue potential. It has good data and
efficacy in a huge ovarian cancer market. If the data comes out favorably in
2014, it would not be surprising if Prima’s share price finally took off. At
that point, investors are likely going to enjoy some long-term success.
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