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.
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