is this right, page-16

This report in Bioshares latest issue looks very good.
Bioshares Number 308 – 24 April 2009 Page 2
Shares in Prima Biomed have had an extraordinary run over the past few weeks, increasing
by 347% from 1.5 cents on April 8, 2009 to 6.7 cents on Friday. The company is now
capitalised $23.6 million. If 169 million, $0.02 December 2011 options, which are now well
in the money, are factored in, then on a fully diluted basis, Prima Biomed is capitalised at
$35 million. Prima is developing CVac, an immunotherapy (vaccine ) to treat ovarian
cancer. What has been behind this stellar run for a company that until recently was
verging on oblivion?
There are two components to the move in Prima Biomed share price. Firstly, the company
announced on March 11 that it had secured a $12 million equity draw down facility from
Fortrend to support registration trials of CVac. The net effect of this arrangement is that
it has enabled Prima to approach other potential investors on a more confident basis,
demonstrating that a key risk with the company (funding) is essentially underwritten.
Secondly, and perhaps much more significant for Prima, has been the massive increase in
Dendreon's share price, which increased by 132% on April 14, 2009. Like Prima, Dendreon
has been developing a cancer immune-therapy, named Provenge, but targeted at prostate
cancer. Dendreon said that its treatment increased overall survival times in a just completed
512 patient Phase III study, although by how much was not revealed at the time
(but will be at a forthcoming oncology conference).
The company was confident enough to say that Provenge "significantly prolongs survival".
It would appear that the result is the validation sought for many years by immunotherapy
developers that cancer vaccines not only stabilize disease but increase survival.
Previously we have used Dendreon as a proxy for Prima's potential (see Bioshares 210),
however in May 2007 the FDA sought more information from Dendreon regarding the
clinical evaluation and manufacturing of Provenge. At that time, Prima's financial situation
was very weak (with only $1.2 million in cash) and the negative Dendreon news was
a setback for Prima. Until board changes commenced in October 2007, with the appointment
of Martin Rogers and Ata Gokyildirim in December 2007, Prima Biomed was a company
in a parlous condition.
Phase IIb/III Clinical Trial Plan for CVac
Prima Biomed has made significant progress towards filing an Investigational New Drug
application for CVac with the FDA. The company has been guided by Professor Ian
Frazer from the University of Queensland, who is noted for his co-invention with Jian
Zhou of the vaccine HPV vaccine Gardasil (Merck/CSL). Frazer has provided, along with
several other interested parties, in-kind support for the next stages of clinical development
of CVac. Other members of the Prima scientific team include Dr Bruce Loveland, who
was involved with the Phase I and Phase II trials of CVac and Dr Cassian Yee and Dr Heidi
Gray from the Fred Hutchinson Cancer Research Center in Seattle.

Interestingly Prima Biomed now looks set to follow positively in
the path of Dendreon and benefit from the questions posed to
Dendreon by the FDA regarding manufacturing of autologous
immunotherapies, with a clearer pathway mapped out. Prima will
also be using the same manufacturer that Dendreon has used.
Based on discussions with the FDA, instead of running a 120
patient trial as was considered at one stage, the company may
only need to conduct a randomised 60 patient trial, with 35 in a
treatment arm and 25 in a standard of care arm ( e.g. second line
therapy that includes a platinum based drug and taxol). The trial is
likely to require 15 sites in the US and 15 sites in Australia and
New Zealand. While the primary endpoints have yet to be made
known, they will not include stabilization of CA125 biomarker levels
as occurred in the Phase II trial.
The trial is likely to commence as a Phase IIb and roll into a Phase
III trial. The company anticipates receiving the IND acceptance
by June with enrollments to commence in the September quarter.
For Australia, Prima plans to submit the Phase IIb data to the
Therapeutic Goods Administration (TGA) and seek approval for
CVac as a Category 3 product, which are applications that do not
need to include clinical, preclinical, or bioequivalence data. If successful,
this would then enable the Australian New Zealand Gynaecological
Oncology Group (ANZGOG) to administer CVac offlicence
although Prima would be providing CVac on a not-forprofit
basis.
Summary
Prima Biomed looks to have found, after several tumultuous years,
a stronger footing and a clearer focus, with the commercialisation
of CVac its principle goal. The company also holds three other
assets which it aims to divest. The CVac product warrants continued
clinical investigation and the current treatment regimes for
ovarian cancer are unsatisfactory.
Prima Biomed is a stock to watch. However, we recommend that
investors wait until the FDA 'approves' the company's IND application
and full clinical trial protocol details are made available by
the company. When that event occurs, a more timely and detailed
assessment of the clinical and funding risks in front of the company
can be made.