Given the latest official data on prostate cancer prevalence
compiled by the CDC and the GLOBOCAN project, over 1.1 million cases of what is
the fourth most common cancer in both sexes combined and the second most common
cancer in men, were reported back in 2012 alone. Prostate cancer accounts for
roughly 15 percent of all cancers in men and is the fifth most lethal, with
around 307,000 deaths in 2012. A continually rising rate of incidents are being
reported in developed economies as prostate specific antigen (PSA) tests become
more and more ubiquitous, giving investors a clear portrait of the demand
landscape moving forward for therapeutics. Incident rates for prostate cancer
will only rise in parallel (or greater) alongside overall cancer rates, for
which the CDC estimates the figure will rise by 36.8 percent to 19.3 million
new cases by 2025.
PSA tests have helped to rapidly differentiate prostate
cancer from a common condition where the prostate enlarges on its own, which is
almost inevitable in men as they age, known as benign prostatic hyperplasia
(BPH). However, even with the emergence of five new drugs since 2010 from
players like Dendreon (OTC: DNDNQ) and Medivation (NASDAQ: MDVN) working in
partnership with Astellas (OTC: ALPMY), as well as heavy-hitters such as Sanofi
(NYSE: SNY), Johnson & Johnson (NYSE: JNJ) and Bayer (OTC: BAYRY) – the
space is still largely underserved, with extant indications only achieving
marginal efficacy. Even the more ingenious indications, which utilize aspects
of personalized medicine to program a specific patient’s immune system, have
seen only partial completeness in achieving the desired endpoints.
If patients can be diagnosed early enough, localized
prostate cancer is more easily treatable, but there is currently no curative
option available for patients once the disease has progressed to the point of
being classed as castration-resistant prostate cancer (CRPC). According to
forecasts by energy and healthcare research group GlobalData, the number of
late-stage pipeline agents that are commercially available will nearly double
by 2023, with the vast majority aimed at CRPC, triggering a three-fold increase
in the size of the therapy market across the nine major global economies. We
are looking at a 12.4 percent CAGR from 2013 through 2023 according to
GlobalData, when the therapeutics market will hit upwards of $8.3 billion,
driven by the advent of new premium-priced therapies and label extensions of
extant commercial indications. The robust pipeline for new therapies is
particularly interesting as many of the developing candidates possess wholly
unique mechanisms of action which set them apart from existing treatments, as
well as the targeting of different proteins and pathways.
One of the most exciting developers in this game today is a
clinical stage biopharma with truly innovative proprietary vaccine technology
at their disposal, OncBioMune Pharmaceuticals (OTCQB: OBMP), which recently
secured Notices of Allowance for patents on its leading prostate cancer vaccine
candidate ProscaVax™ in both China and Ukraine. Already well-established via a
phase 1/2 clinical trial in biopsy confirmed patients with elevated PSA,
ProscaVax, which is designed to stimulate the host immune system into attacking
the cancer without harming the patient, was administered in the phase 1/2 trail
using a one-two punch protocol developed from insights and techniques employed
in breast cancer vaccinations. Several weeks after an initial round containing
a pre-tuned concentration of prostate specific antigen and biological adjuvant,
serum PSA concentrations are again evaluated before a second course of shots
are administered in combination with low dose IL-2 (a cytokine signaling
molecule, interleukin 2) over a period of about six months.
The Chinese and Ukrainian Notices of Allowance add
substantially to OBMP’s already solid IP position and protect the vaccine in
those countries through 2031, reinforcing the earlier USPTO patent for
ProscaVax, as well as the related Notice of Allowance for an additional patent
application that was filed with the USPTO. Currently nearing completion of a
fully funded phase 1 trial this month (in part paid for by the US Navy Cancer
Vaccine Program) that is being conducted at UCSD Medical School under an IND from
the FDA, ProscaVax is already slated to begin its key phase 2 clinical study
early next year at Harvard Cancer Centers, and could rapidly become a leading
therapeutic vaccine with serious profitability for OncBioMune once FDA approval
has been granted.
Phase 1 trial data was recently offered in a poster
presentation at the CRI-CIMT-EATI-AACR: Inaugural International Cancer
Immunotherapy Conference in New York and the results offered in this poster
presentation roundly supports the work OBMP has been doing, showing increased
immunity to the PSA antigen after administration of the vaccine, as well as a
delimiting of the PSA progression rate in those who had previously received
standard therapies. With eight out of nine patients in the phase 1 trial showing
increased immune response to PSA at (validated via lymphocyte blastogenesis
assay) 31 weeks after the first vaccine and there being an unmistakably clear
lack of toxicity as a result of ProscaVax being administered, OBMP is now
well-equipped to receive FDA clearance for phase 2.
The company’s secondary candidate, OvcaVax, has similar
potential in the $55.5 million global breast cancer therapeutics market, which
is expected to hit upwards of $7.8 billion by 2023, growing at a CAGR of around
58.3 percent according to a recent report published by Transparency Market
Research. OncBioMune actually has a much larger and equally compelling
portfolio of targeted therapies under its belt as well, some of which are
biosimilars to current blockbuster drugs. OvcaVax could put OBMP in direct
competition with breast cancer therapeutic majors like Roche’s (OTC: RHHBY)
Genentech, as well as Eli Lilly (NYSE: LLY), Pfizer (NYSE: PFE), Novartis
(NYSE: NVS), and AstraZeneca (NYSE: AZN).
In fact, OncBioMune actually obtained the first U.S. patent
on a breast cancer vaccine back in 1994 and was also the first to employ GM-CSF
and IL-2 cytokines as adjuvants. The company is currently heavily focused on
tumor escape mechanisms in breast cancer via ongoing study of tumor stroma and
the microenvironment, setting the company up for potential breakthroughs in
specific adaptive immunotherapies, and OBMP already has some promising
preliminary results in this area to boast of. The company’s recent ticker
change and up-listing to OTCQB following the acquisition of Quint Media and
approval by FINRA, as well as the tapping of former president and CEO of
Entergy (NYSE: ETR) subsidiary Entergy New Orleans, Charles L. Rice, Jr. to its
Board of Directors, shows just how serious a contender the company has now
become. From both a clinical development and business model fundamentals
standpoint OBMP (currently trading at $2.50 per share) is now starting to turn
heads in the investment community as one of the most promising up-and-comer
clinical-stage biopharmas available.
OncBioMune has an extremely promising immuno-oncology
vaccine candidate in ProscaVax that is ready for phase 2 and which can directly
address the unmet demand for a powerful prostate cancer therapeutic. The
company has taken the proper steps to massively increase its market exposure
and the commercial potential for OBMP’s broader pipeline is just starting to be
understood by investors. OncBioMune has certainly become one to watch and
interested parties should keep their ears to the ground for news about the
upcoming phase 2 work on ProscaVax.
Take a closer look, visit http://oncbiomune.com/
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