Privo’s initial treatments can address multiple unmet needs described below. However, based on recommendations by key opinion leaders and as a proof of concept, the company has conducted several studies in oral squamous cell carcinoma or oral cancer.

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 and claims the life of 1 American every hour. According to the Oral Cancer Foundation, approximately 50,000 Americans were diagnosed with oral and oropharyngeal cancer in 2020, resulting in 9,700 deaths and is increasing among all population segments due to the rising prevalence of oral human papillomavirus (HPV). According to the National Cancer Institute’s SEER database, patients with localized or regional OC comprise 81% of newly-diagnosed cases. Standard of care surgical/radiation treatments for OC can severely damage a patient’s ability to speak, chew, and swallow. Scars, serious discomfort, decreased quality of life, and social isolation result in one of the highest suicide rates of all cancers. Despite recent advances in imaging, surgery, radiation, and systemic therapies, overall survival (OS) has improved only 5% in the last decade.

In general, Privo’s initial products can address several unmet needs within the oncology space.

PRV111 Topical System:

1. Preventing progression of carcinoma in situ/ High risk Dysplasia: PRV111 has the potential to prevent accessible high-risk lesions from becoming invasive cancers. It can also eliminate or reduce the need for disfiguring surgery that can destroy form and functionality of the organ. Examples include High grade oral and cervical dysplasias.
2. Treating invasive Locoregional accessible tumors: Cancers such as mucosal and cutaneous tumors can be treated topically with PRV111 topical chemoimmunotherapy. PRV111 topical system can be used in neoadjuvant settings to reduce the chance of recurrence and disfiguring surgeries.

PRV211 Intraoperative Chemoimmunotherapy:

1. Eliminating the residual cancer cells in the tumor bed after resection: This treatment can be used for nearly all solid tumor surgeries in order to reduce that chance of micrometastasis and relapse.
2. Reducing the need for adjuvant therapy: Currently adjuvant treatment is used after recovery from surgery such as radiation and chemotherapy. These treatments can have severe side effects.

Currently, PRV111 system is topically applied to mucosal cancers to treat the primary tumor and locoregional lymph nodes. This can be applied before or after surgery and in conjunction with standard of care therapy to augment its efficacy with minimal downside – the treatment remains in the tumor’s local and regional areas and does not cause systemic toxicity. PRV111 offers the benefit of rapidly killing cancer cells, shrinking tumors and eliciting a powerful innate immune response while avoiding systemic exposure (Figure 1, clearly shows human tumor responses to the PRV111 topical system).

PRV111 has shown a “Two Punch” effect at the tumor site, simultaneously killing tumor cells and activating immune cells such as those positive for CD3, CD4 and CD8, which have been associated in previous studies with improved rates of overall survival. This can create long-term treatment durability, effectively making a “cold” tumor “hot”.

PRV111 has the potential to eliminate or reduce the extent of surgery for patients with mucosal cancers to spare organ form and function and improve quality of life. For example, surgery for oral cancer can leave patients with lasting facial disfigurement that impacts their ability to speak and chew. Patients with anal or colorectal cancer frequently are left with a colostomy bag from the radical surgery. The ultimate goal is to reduce the chance of recurrence and disfiguring surgery using chemoimmunotherapy.