Celldex Stumble Makes Space for OncBioMune at Head of Cancer Vaccines

A recent article by Online Media Group highlighted OncBioMune Pharmaceuticals (OTCMKTS:OBMP) and the developing of a novel immuno-oncology products using its proprietary vaccine technology.
As quoted in the article:

OncBioMune Pharmaceuticals (OTCQB: OBMP) was founded by Dr. Jonathan Head and Dr. Robert Elliott, the two men behind the first patented autologous breast cancer vaccine.  Leveraging technology that has been shown in hundreds of patients to be safe, OncBioMune, which only became public late in 2015, is primarily focused on prostate cancer at this point. According to the company, the decision to transition to prostate cancer was made based upon compelling research and belief that their prostate cancer vaccine, called ProscaVax, could address the 200,000 patients diagnosed with prostate cancer annually without the significant morbidities and side effects associated with current therapies, something no one else could lay claim to.
ProscaVax is a protein therapeutic cancer vaccine, which combines prostate-specific antigen PSA with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF) to stimulate the patient’s immune system to selectively destroy cancerous tumors without damaging healthy cells.   A true platform technology, the company says that vaccines can be developed for any solid tumor by switching to antigens  specific to the type of cancer.
GM-CSF is believed to be a key in cancer vaccines because of their relationship to tumor specific T-cells, a type of white blood cell that is integral in cell-mediated immunity.  T-cells are the buzzword in immunotherapy and a topic of focus for companies like Kite Pharmaceuticals, Advaxis, Celldex  and more.  Celldex was considered a leader in the cancer vaccine space, but recently suffered a setback when a Phase 3 trial of Rintega plus GM-CSF added to temozlomide for glioblastoma was discontinued early for failing to increase median survival compared to placebo.  It’s not over for Celldex who has other trials ongoing in its pipeline and continues to offer access to Rintega as it decides the next step with its vaccine.
GM-CSF has been shown in extensive early research across the industry to have potent anti-tumor potential.  This pertains to vaccines with GM-CSF inducing a massive accumulation of dendritic cells at the point of injection.  These dendritic cells then engulf, process and present tumor antigens to activate tumor-specific T-cells, effectively slowing tumor cell growth and cell proliferation.
ProscaVax, which, in addition to GM-CSF, also uses interlukin-2 (a naturally occurring cytokine that stimulates cells to destroy cancer cells), is at the tail end of a Phase 1 study in late-stage prostate cancer patients.  Data to date from the trial, which was funded in part through a $5.2 million grant from the Department of Defense, shows the vaccine to reduce the rise in PSA levels (a key measure of biochemical progression in prostate cancer) in 60% ( 6 out of 10) of patients receiving six vaccinations and an increased immune response in 89% (8 out of 9) patients at 31 weeks post vaccine.  As with earlier research, toxicity has been very minimal without a single drug-related adverse event reported in the trial.
OncBioMune is gearing up for two Phase 2 studies of ProscaVax.  The first is expected to be hosted at Harvard’s Medical School affiliates, including Beth Israel Deaconess Medical Center and Dana-Farber Cancer Institute, with Dr. Glenn Bubley to be the Principal Investigator.  This study will exclusively focus on patients at prostate cancer presentation, a time when patients are in the “active surveillance” category.
Being in the active surveillance group generally means that the prostate cancer has been caught early and the patient and the doctor have agreed to postpone therapies that can cause side effects, including impotence (inability to get and maintain and erection) and incontinence (inability to control urine flow).  Instead, patients undergo regular PSA testing, DREs (digital rectal exams) and yearly prostate biopsies until the disease progresses.
Instead of forcing patients to just sit and wait to get worse, OncBioMune’s ProscaVax is aiming to slow or arrest the inevitable progression and for the first time ever provide patients a safe and effective option at disease presentation.
In a second Phase 2 trial, OncBioMune is joining forces with Mexico’s Vitel Laboratorios via a recently announced Joint Venture that will result in the creation of OncBioMune Mexico S.A. de C.V.  (“S.A. de C.V.” is akin to “Corp.” in the U.S.).  Broadly, the plan is to leverage Vitel’s regulatory experience and distribution network to develop and commercialize OncBioMune’s pipeline throughout Mexico and all of Latin America.
Manuel Cosme Odabachian, CEO of Vitel, explained in a phone interview that it was a chance meeting with Dr. Head on an airplane that introduced him to the OncBioMune.  He immediately was intrigued with the vaccine technology and negotiations ensued for months between the two companies to work jointly on clinical research in Mexico.  “I’ve been successful in the past with healthcare technologies and believe that OncBioMune’s platform has tremendous potential,” said Cosme Odabachian.  “The demand is certainly there in Mexico and Latin America and we have the distribution networks to quickly introduce ProscaVax to the market should the Phase 2 trial result in a safe, clinical benefit to prostate cancer patients.”

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