According to the Oral Cancer Foundation, over 51,000 Americans are diagnosed with oral and pharyngeal cancer this year, causing over 10,000 deaths, roughly one person every hour. Over 640,000 new oral cancer cases were diagnosed worldwide, and only half will live more than 5 years after initial diagnosis. By 2020, the annual worldwide incidence is predicted to increase to over 840,000, a 30% rise, and the annual mortality to increase to nearly 480,000, approximately a 37% increase. Oral cancer has one of the highest suicide rates of all cancers due to permanent physical disabilities resulting from disfiguring surgeries. These include permanent speech impairment, an inability to swallow, and/or the loss of the jawbone due to the surgical removal of the tongue and other oral tissue. The long-term costs associated with the treatment and these disabilities can range from $100,000-$250,000, resulting in oral cancer persisting as one of the most expensive of all cancers to treat. Despite these realities, oral cancer remains underserved and remains on the rise in incidence both within the US and worldwide. Survival in patients with advanced OSCC is driven primarily by locoregional treatment failure/recurrence. To address this need, Privo has developed its lead product, PRV111. It is a nano-engineered patch that can be placed directly onto the tumor. By retaining its cisplatin-chemotherapy nanoparticles local, PRV111has shown to destroy cancer cells in the tumor and regional lymph nodes without any systemic side effects. PRV111’s locoregional treatment can address the treatment needs of over 75% of OC patients at the time of their initial diagnosis. The goal of PRV111 is to reduce tumor recurrence while decreasing the amount of facial disfigurement. PRV111 treatment is currently in a Phase 2 clinical trial with promising results. Based on PRV111’s interim data, the FDA has funded the clinical study $2M to support the current clinical study to completion. In this proposal Privo is requesting funds to complete its commercialization of its GMP manufacturing, to expand its patent portfolio and to conduct market research and develop pricing and reimbursement strategies. If funded, Privo has also secured commitments for $3M non-SBIR funds from investors to be used toward PRV111’s commercialization needs if this proposal is awarded. Privo believes that PRV111 treatment aligns closely with the aims of NIDCR in providing a safer, more effective, and less costly treatment for oral cancer patients.

Oral cancer (OC) is the 6th most common cancer globally and 76% of cases are locoregional disease which has a recurrence rate of around 50% despite aggressive multi-modality treatment involving surgery, radiotherapy and chemotherapy or EGFR inhibition. OC has become a progressively serious global problem and unlike most cancers, its incidence is rapidly on the rise. The five-year survival rate is only 60% and escalation of conventional treatments is not feasible due to severe treatment related toxicities. Even with the current advancements in immunotherapy, only a small fraction of OC patients is eligible for this treatment while serious side effects are still high and the response rates are low. Currently, surgery is the first line of treatment for OC and intravenous (IV) cisplatin is the most administered chemotherapeutic agent. However, both are hindered by disfiguring side effects or severe dose-limiting toxicity. Despite recent advances in imaging, surgery, radiation, and systemic therapies, overall survival has improved only 5% in the last decade. Therefore, there is a great need for treatments that can offer less toxic, more effective and affordable options for all patients with various socioeconomic backgrounds. Privo is requesting this NIH funding to support the company’s commercialization activities for its lead product PRV111, a topically applied chemotherapy patch for treating locoregional OC.