Bio-Path Shares are Attractive now
By Grant Zeng, CFA
Pipeline Expanded by New Indications of Liposomal
Recently, Bio-Path Holdings ( OTC
Markets:BPTH) announced that it is initiating development of
its lead cancer drug BP-100-1.01 (Liposomal Grb-2) to treat triple
negative breast cancer (TNBC) and inflammatory
breast cancer (IBC), two cancers characterized by
formation of aggressive tumors and relatively high mortality
Liposomal Grb-2 (L-Grb-2) is the Company's lead
drug candidate currently in a Phase I clinical
trial. L-Grb-2 is a liposomal delivered antisense
cancer drug that targets an multibillion dollar annual
market for Chronic Myelogenous Leukemia (CML), Acute
Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), and
Myelodysplastic Syndrome (MDS).
Grb-2 (growth factor-bound protein-2) is an adaptor protein
which is essential to cancer cell signaling because it is utilized
by oncogenic tyrosine kinases to induce cancer progression.
Suppressing the function or expression of Grb-2 should interrupt
its vital signaling function and have a therapeutic application in
cancer. L-Grb-2 is a neutral-charge, liposome-incorporated
antisense drug substance designed to inhibit Grb-2
- Discussions with senior breast cancer researchers at the MD
Anderson Cancer Center indicated strong scientific case that
blocking Grb-2 protein using L-Grb-2 has the potential to be an
effective treatment for TNBC and IBC
- Bio-Path's plan is to develop Liposomal Grb-2 as a targeted
therapy against TNBC and IBC
- Treatment goals are two-pronged:
- the first is to develop Liposomal Grb-2 as a tumor reduction
agent in combination with other approved drugs in
- the second is to develop Liposomal Grb-2 as a drug to treat and
control or eliminate cancer metastasis in TNBC and IBC
- Both of these treatment goals address high need situations for
- Development plan: 2013 comprised of pre-clinical development
followed immediately by Phase I clinical trial;
- The preclinical programs are expected to start in 2013 and last
one year, after which time the Phase I clinical trial could begin
after FDA approval to proceed;
- Safety of L-Grb-2 established in leukemia trial can speed
dosing in the TNBC/IBC trial
We think the development of Liposomal Grb-2 for the treatment of
TNBC and IBC is a major milestone for Bio-Path that has the
opportunity to produce substantial value for the Company.
Successful development of these applications will be of great
benefit to TNBC and IBC patients. Further, the treatment goal for
tumor inhibition and reduction in a pre-operative setting provides
a potential pathway for rapid approval by the FDA of Liposomal
Grb-2, while the longer term effects of controlling or eliminating
metastasis will build long term use of our drug.
The new development of L-Grb-2 also expands Bio-Path's
Market for TNBC and IBC is Rather
Triple negative breast cancer (TNBC) tumors do not express
estrogen receptors, progesterone receptors, and low HER2. These
negative results mean that the growth of the cancer is not
supported by the hormones estrogen and progesterone, or by the
presence of too many HER2 receptors. Therefore, TNBC does not
respond to hormonal therapy or therapies that target HER2
receptors. In addition, TNBC tumors are very aggressive.
Approximately 15 to 20 percent of breast cancers are
Inflammatory breast cancer (IBC) is a rare and very aggressive
disease in which cancer cells block lymph vessels in the skin of
the breast. This type of breast cancer is called "inflammatory"
because the breast often looks swollen and red, or "inflamed." IBC
accounts for two to five percent of all breast cancers. IBC tumors
are very aggressive and are frequently hormone receptor negative,
which means hormone therapies may not be effective. Five year
survival rate for IBC is 40 percent versus 87 percent for all
breast cancers combined, making IBC a priority area for development
of new treatments.
The combined market for TNBC and IBC is very large in our view
due to the huge market for breast cancer in our view. Together with
the CML, AML and MDS, L-Grb-2 is targeting a multibillion dollar
In addition to CML, L-Grb-2 also targets AML and MDS as well as
the TNBC and IBC, each has a significant market.
Valuation is Attractive
We are moving to Buy rating on Bio-Path Holdings Inc. from
Neutral. Our new twelve-month price target is $1.00 per share.
Our call is based on recent progress the Company has made and
current valuation of the Company's shares.
We believe Bio-Path's neutral lipid drug delivery
platform technology has great potential to systemically
deliver antisense drug candidates in human bodies. Its pipeline has
been expanded by new indications and can be easily expanded into
other therapeutic areas if the delivery platform technology proves
successful for current cancer indications.
We are encouraged by the progress BPTH has made with its lead
drug candidate Liposomal Grb-2. We are impressed by the interim
results, which have demonstrated the safety and potential efficacy
of the candidate. We are especially impressed by the suggestion of
possible anti-leukemia activity at the very low dosage, which was
an unexpected and very positive result. We are also pleased to see
the Company is expanding its pipeline by developing new indications
of its lead compound L-Grb-2.
In terms of valuation, we think Bio-Path shares are undervalued
at this point. By comparing to its peers in the biotech industry
and considering the potential of its drug delivery technology and
progresses the Company has made in the past few months, we think
Bio-Path's stock should be trading around $1.00 per share, which
value the Company at about $62 million in market cap.
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