Celldex Stumble Makes Space for OncBioMune at Head of Cancer Vaccines
By Sara Bowman, Senior Writer, Online Media Group, Inc.
BATON ROUGE, May 12, 2016 /PRNewswire/ - Developing cancer vaccines, a type of immunotherapy, has been notoriously difficult in the past, but not impossible. Most notably, there are FDA approvals for three vaccines, although two, Gardasil and Cervarix, are preemptive in nature, fighting human papillomavirus (HPV) that often leads to cancer. Gardasil, a product of Merck subsidiary Merck Sharp & Dohme Corp., is a vaccine that protects against four different types of HPV, namely in girls and young women (and males with anal cancer) in helping to prevent cervical, vaginal, vulvar and anal cancers. GlaxoSmithKline's Cervarix is indicated for girls and young women for the prevention of certain diseases cause by oncogenic HPV (types 16 and 18), including cervical cancer, adenocarcinoma and different grades of abnormal cell growth that can lead to cervical cancer (cervical intraepithelial neoplasia).
Dendreon garnered FDA approval of Provenge (sipuleucel-T) in 2010 for metastatic castrate resistant (hormone refractory) prostate cancer patients who demonstrate minimal or no symptoms. Although expectations were high, Provenge was a commercial failure due to its high cost, formulation difficulties, small patient population and narrow window of extending median survival by only 4.1 months. In February 2015, Valeant Pharmaceuticals acquired all of assets of Dendreon during the company's Chapter 11 bankruptcy protection.
Better understanding of immunotherapies and ongoing clinical trials are providing valuable data for scientists to learn more about and advance new cancer vaccines. As listed on ClinicalTrials.gov, there are more than 1,750 clinical trials related to cancer vaccines, including trials currently recruiting for melanoma, breast cancer, blood cancers, brain cancer, pancreatic cancer and more.
OncBioMune Pharmaceuticals 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."
Cosme Odabachian and his partners indeed have a history of success. He was part of the management team at 3M Pharma, divesting his interest in the company as part of the transition related to 3M Pharma's operations in the U.S., Canada, and Latin America region being acquired in 2007 for $875 million by Graceway Pharmaceuticals. He assumed the role of Country Manager for the new startup Graceway Mexico, heading the business in Central and Latin America and expanding products into the Caribbean and from Guatemala to Brazil.
Subsequently, Graceway sold the operations for the U.S. and Canada to Medicis (who was later acquired by Valeant) and the operations in Mexico, Central and Latin America to More Pharma, who was later acquired by the Mexican drug maker and distributor Laboratorios Sanfer SA.
Again, Cosme Odabachian divested his interest in Graceway Mexico, from there moving to a position to head up the start of another company. He served as Country Manager for Chiesi Pharma, the Italy-based pharma giant, ultimately being integral to the opening of Chiesi Mexico in July 2012 as Chiesi's 25th subsidiary, with Chiesi Mexico taking over the licensed partner and registration of past decisions.
Next, he then moved on to start Avivia Pharma in January 2013. The company gained fame for developing the first gel for erectile dysfunction, marketed as Osidea GL. When Avivia was sold to Ultra Laboratorios, Cosme Odabachian went on to start Vitel Laboratorios in early 2015. As it seems, one of Cosme Odabachian's first interests with his new company is the development and hope to commercialize ProscaVax for prostate cancer. Given his track record, it would seem plausible that if the clinical trials are positive that Cosme Odabachian will be tapping his network for opportunities on all levels.
The first trial in Mexico is expected to be a 100-patient 2a/2b study of ProscaVax for the treatment of PSA recurrent prostate cancer in hormone-naïve and hormone-independent patients. While the trial is anticipated to last three years, should the data be positive, the company plans to pursue an expedited pathway called a Preliminary Marketing Authorization to commercialize ProscaVax in Mexico before the trial is completed. This could happen in as little as two years, according to OncBioMune and confirmed by Cosme Odabachian. Thus, there is the potential for the young company to be generating revenue to fund future drug development.
Cancer vaccine therapies are gaining traction and they're moving closer to hitting their stride. When they do, it could transform the way cancer patients of all disease stages are treated. As with any growing industry, it takes some setbacks, such as what just happened with Celldex and Rintega – and before that Merck with Stimuvax and GlaxoSmithKline with MAGE-A3 – to make meaningful progression. Celldex also demonstrated the high value that Wall Street puts on promising vaccines in development, in losing about $400 million in market capitalization upon news of the unsuccessful trial. These other new vaccines maneuvering towards and through the FDA process exemplify the next breed of promising therapies and hope that the list of FDA cancer vaccine approvals will soon be expanded.
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