I received news PR this morning about Galena Biopharma and wanted to share...
$6.00 BUY rating set by MLV Capital for Galena Biopharma (GALE)
Key Points
• Validated Target NeuVax targets the same antigen as Herceptin®
(trastuzumab), Genentech's (a wholly owned subsidiary of Roche OCT:RHHBY)
$5.6 billion blockbuster monoclonal antibody. However, NeuVax has the
potential to reach more patients, as it is being developed for patients with low
to intermediate HER2/neu oncogene over-expression (classified as HER2/neu
negative) with early stage breast cancer.
• Strong Phase II Data Support Ongoing Registrational Phase III Phase II data
has shown that the Phase III target population of node-positive, HER2/neu
negative patients have increased disease free survival rates at both 24 and 36
month timepoints. 100% of NeuVax treated patients in this population were
alive without disease after 36 months, a statistically significant improvement
over 77.8% in control patients (p=0.035). The FDA has accepted disease-free
survival at 36 months as a primary endpoint for this trial according to an SPA.
Full enrollment of 700 patients is expected by mid-2013.
• Unmet Clinical Need Despite effective initial surgery, chemotherapy and
radiation, patients with no evidence of disease still face the possibility of
disease recurrence. Nearly 25% of breast cancer patients with node-positive
disease will have recurrent breast cancer. NeuVax is given intradermally and
elicits an active immune response that can be visually monitored by clinicians
by virtue of patients displaying a delayed-type hypersensitivity response (DTH)
at the injection site. The ease of administration, we believe, will assist in
adoption of the drug, when and if the vaccine is approved and marketed.
• Potential Partnerships We believe that Galena will be able to maximize value
for investors by forming a partnership agreement after having top-line Phase
III data. If these data are similar to the Phase II data then NeuVax will present
a new therapeutic option for treating breast cancer, and the only one for
patients with early-stage HER2/neu negative disease. We think this makes
NeuVax a potential game changer in the field, and a potentially valuable asset,
and we would be accumulating at current levels of Galena's stock. |
