Puma Biotechnology,
which continues executing a very shrewd strategy of in-licensing
promising/innovative candidates for further commercial development that have
already tested out their technology through ongoing or completed initial
clinical trials, has most recently garnered considerable attention for their
initial foray, PB272 (oral Neratinib), both as a single agent and in
combination with other drugs or chemotherapeutic agents for treating a variety
of cancers.
The company held a
conference call last month (Dec 17) to go over the ongoing Phase 2 and 3
clinical trial progress achieved in PB272, which is an extremely potent
irreversible tyrosine kinase inhibitor focusing on the HER2 (human epidermal
growth factor receptor 2) mutation, whose over-expression is typical among
breast and other aggressive cancers, and which is strongly associated with both
an increased recurrence rate of disease and poor prognosis. HER2 (or ERBB2, the
gene in which the receptor tyrosine-protein kinase erbB-2 is encoded) has become
an accepted biomarker standard for roughly 30% of breast cancer patients but
the typical indication, approved drug Trastuzumab (Herceptin), is useful only
in cases of HER2-positive individuals exhibiting over-expression and poses
serious cardiotoxicity risks, not to mention the high cost of the drug. It is
noteworthy here to point out that Journal of Clinical Oncology-published data
from back in March of 2010, shows Phase 2 clinical trial work comparing
Neratinib (as a single agent) and Trastuzumab in HER2+ metastatic breast cancer
patients, clearly indicating that Neratinib was well tolerated, even by
patients who had previously undergone Trastuzumab treatment.
Significant progress
in HER2 mutated non-small cell lung cancer with PB272, as well as HER2-negative
breast cancer patients with the HER2 mutation, adds significant weight to the
report earlier last month (Dec 4) of top line results from the Phase 2
neoadjuvant treatment work done in breast cancer (I-SPY 2 TRIAL). I-SPY 2
essentially looked at Stage 2 (HER2-positive breast cancer) and higher women,
to see how effective Neratinib could be in combination with standard
chemotherapy in a neoadjuvant context and having graduated this unique trial,
which is a collaborative effort from 20 major cancer research centers across
the U.S. (as well as the FDA and major industry and foundation supporters),
with statistically superior performance (Paclitaxel plus Neratinib versus
Paclitaxel plus Trastuzuma), PBYI has been really starting to turn heads in the
oncology space for their technology.
The recent
conference call also gave PBYI a chance to look at their clinical trial
progress in solid tumors that have an HER2 activating mutation (basket trial)
and the broad-spectrum applicability evident in this open-label work further
reinforces just how compelling their HER2 mutation-focused technology really
is. The PBYI technology approach is more like Galena Biopharma’s (GALE) NeuVax
technology, which uses the HER2-derived E75 peptide and immune adjuvant
granulocyte macrophage colony stimulating factor to induce a targeted “killer”
T cell assault on over-expressing cells, going right after root phenomena. In
the case of PBYI, they are going straight after signal transduction through the
epidermal growth factor receptors (EGFRs, for HER1 and HER4 as well). Efficacy
in combination and as a standalone agent is abundantly clear from the clinical
trial work and investors should take note of the potential for broad-spectrum
Neratinib applicability in the oncology space as a driving factor for future
performance of the stock.
2014 is shaping up
to be a momentous year for PBYI, with Phase 2 or 3 trials across the board for
their evolving pipeline. Investors should keep a close eye on the company for
announcement of further results on Neratinib, with the Temsirolimus plus
Neratinib trial in metastatic HER2-amplified (triple negative) breast cancer
and the Neratinib plus Capecitabine vs Lapatinib plus Capecitabine trial in
HER2+ metastatic breast cancer, likely occupying center stage.
To learn more about
Puma Biotechnology, visit www.PumaBiotechnology.com
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