SBIR-STTR Award

Oral cancer (OC) is an underserved disease, which is often overlooked by the medical community. Yet it is the 6th mostcommon and deadliest cancer in the world. According to the Oral Cancer Foundation, over 90% of all oral cancers are oralsquamous cell carcinoma (OSCC) - a common subset of head and neck cancers. OC claims the life of one American everyhour of each day. Additionally, it is on the rise due to the increasing prevalence of oral human papilloma virus (HPV).Overall, OC has a 60% survival rate after 5-year remission target, with recurrence being an important prognostic factor.Data shows a high correlation between OC risks and low socioeconomic, as well as risk factors related to lifestyle. Even inthe clinical settings of industrialized nations, such as the United States (US), many patients receive suboptimal care forOSCC due to limited resources. Although targeted agents (i.e., tyrosine kinase inhibitors) and immunotherapy (i.e.,checkpoint inhibitors) have shown promise in multiple solid tumor types, their applicability in the setting of advanced OSCCremains questionable. Unpredictable side effects, complications, and (especially) high cost limit their US use in low resourcesettings and in low/mid-income countries (LMICs). Survival in patients with advanced OSCC is driven primarily bylocoregional treatment failure/recurrence (i.e., primary site or cervical nodal basins). Escalation of conventional treatmentregimens, such as surgery, radiation, and systemic chemotherapy is not feasible due to dose-limiting toxicities. As a resultof these converging factors, there is a need for novel treatments that can augment existing modalities, while improvinglocoregional control without toxicities. To address this need, Privo has developed the PRV211 intraoperative product(PRV211), a nano-engineered hydrogel that, immediately after tumor resection or debulking, can be applied directly ontothe tumor bed. PRV211, retains high concentration of immuno/chemotherapy nanoparticles, locally in tumor bed andregional lymph nodes to treat the locoregional disease and reduce tumor recurrence.

Public Health Relevance Statement:
R44 PA-21-260 application entitled "Clinical Study for Improving Survival Rates for Oral Cancer Patients in Low Resource Settings" Project Narrative Privo's Nanotechnology-Engineered Hydrogel, PRV211 is applied as an intraoperative therapy for oral cancer patients. Following tumor resection, PRV211 is applied directly within the tumor bed to kill remaining cancerous cells and prevent micrometastasis or recurrence. PRV211's safety and efficacy has been proven through multiple sets of animal studies. The team is strongly motivated to pursue effective prevention of tumor recurrence, with negligible side effects, and planning for a clinical study to evaluate the impact of PRV211 on the recurrence rate and overall survival in OSCC patients. This treatment has the potential for improving the progression free survival rates with a great impact on patients' lives.

Project Terms:

Oral cancer (OC) is an underserved disease, which is often overlooked by the medical community. Yet it is the 6th most common and deadliest cancer in the world. According to the Oral Cancer Foundation, over 90% of all oral cancers are oral squamous cell carcinoma (OSCC) - a common subset of head and neck cancers. OC claims the life of one American every hour of each day. Additionally, it is on the rise due to the increasing prevalence of oral human papilloma virus (HPV). Overall, OC has a 60% survival rate after 5-year remission target, with recurrence being an important prognostic factor. Data shows a high correlation between OC risks and low socioeconomic, as well as risk factors related to lifestyle. Even in the clinical settings of industrialized nations, such as the United States (US), many patients receive suboptimal care for OSCC due to limited resources. Although targeted agents (i.e., tyrosine kinase inhibitors) and immunotherapy (i.e., checkpoint inhibitors) have shown promise in multiple solid tumor types, their applicability in the setting of advanced OSCC remains questionable. Unpredictable side effects, complications, and (especially) high cost limit their US use in low resource settings and in low/mid-income countries (LMICs). Survival in patients with advanced OSCC is driven primarily by locoregional treatment failure/recurrence (i.e., primary site or cervical nodal basins). Escalation of conventional treatment regimens, such as surgery, radiation, and systemic chemotherapy is not feasible due to dose-limiting toxicities. As a result of these converging factors, there is a need for novel treatments that can augment existing modalities, while improving locoregional control without toxicities. To address this need, Privo has developed the PRV211 intraoperative product(PRV211), a nano-engineered hydrogel that, immediately after tumor resection or debulking, can be applied directly onto the tumor bed. PRV211, retains high concentration of immuno/chemotherapy nanoparticles, locally in tumor bed and regional lymph nodes to treat the locoregional disease and reduce tumor recurrence.

Public Health Relevance Statement:
Project Narrative Privo's Nanotechnology-Engineered Hydrogel, PRV211 is applied as an intraoperative therapy for oral cancer patients. Following tumor resection, PRV211 is applied directly within the tumor bed to kill remaining cancerous cells and prevent micrometastasis or recurrence. PRV211's safety and efficacy has been proven through multiple sets of animal studies. The team is strongly motivated to pursue effective prevention of tumor recurrence, with negligible side effects, and planning for a clinical study to evaluate the impact of PRV211 on the recurrence rate and overall survival in OSCC patients. This treatment has the potential for improving the progression free survival rates with a great impact on patients' lives.

Project Terms: