NIH Innovation Zone: Meet Privo Technologies

Cancer is less the death sentence that it used to be. That does not mean that cancer treatment can’t be profoundly life-altering or that all treatments fit all patients. For example, in the case of oral cancers, treatment sometimes results in the removal of lymph nodes around the cancer site, which result in the fundamental alteration of how a patient looks. In the case of cervical cancers, treatments sometimes result in infertility. And for some patients, traditional chemotherapy options for treatment are out of reach due to factors like age and overall health. 

How do we treat situations like these? Privo Technologies is working to find a solution.

As part of Bio. News’ coverage of the National Institute of Health’s (NIH) Innovation Zone at the 2023 BIO International Convention in Boston, we talked to Privo Technologies about their groundbreaking work in cancer treatment that aims to not only make the treatment of cancer less traumatic but also more accessible to a wider patient population.

We spoke with Privo CEO Manijeh Goldberg, Ph.D., MBA, on the show floor and learned more about the company.

Q: How is the standard of care model for cancer patients changing? What change/improvement does Privo Technologies want to bring and why?

The first line of treatment for most stages of oral cancer is surgical resection of the tumor. If nodal involvement is suspected, the patient will also undergo neck dissection for removing lymphatic nodes. Following surgery, these patients will receive radiation alone or combined with chemotherapy. Depending on the stage of the tumor, the current standard of care treatment can lead to a high rate of recurrence due to unclear tumor margins, inadequate resection, and chemoresistance. Oral cavity cancer patients’ standard of care journey is a long and painful one impacting their ability to speak and swallow following surgery. Patients must undergo reconstructive surgery leading to a decreased quality of life and social isolation which contributes to oral cancer having one of the highest rates of depression and suicide of all cancers. Additionally, oral cancer is also one of the most expensive cancers to address due to the combination of surgery, radiation, chemotherapy, and a lengthy rehabilitation period.  

Privo Technologies has developed a nanoengineered drug delivery technology that can be administered in several dosage forms such as a topical patch, intraoperative patch/hydrogel, and intratumoral injectable. Our novel platform allows Privo scientists to reformulate existing chemotherapy drugs to have the ability to deliver and retain high concentrations localized in the tumor. This can significantly improve the efficacy of current therapies and decrease their systemic toxicities.  

In the case of oral cavity cancer, Privo has clinically tested the topical patch PRV111, embedded with cisplatin-loaded nanoparticles, in patients diagnosed with T1-T2 oral cancer. Results indicate: 

• an 87% response rate with 5.5 days median time to response; 
• over 70% tumor reduction in a single week of treatment; 
• no dose-limiting toxicities; 
• no severe adverse events or systemic toxicities; 
• high concentrations of the drug in both tumor and lymph nodes; 
• negligible concentration in systemic circulation; and 
• long tissue residence time of the drug more than 30 days following treatment.  

Privo’s goal is to eliminate the need for surgery for oral cavity carcinoma in situ and severe dysplasia. However, for advanced cancer stages, Privo’s topical patch can control tumor growth and reduce tumor size prior to surgery. In human studies, Privo’s treatment has shown to increase the immune response in cold tumors. This provides opportunities for combination therapy with immunotherapy to improve the treatment eligibility and response rate. In addition to PRV111’s treatment effect on the tumor and immune system, Privo’s clinical studies have illustrated success in PRV111’s ability to treat the nearby lymph nodes to control tumor metastasis.  

These results of clinical and preclinical studies suggest safer and efficacious treatment for oral cancer patients with PRV111. More broadly, the improved safety and efficacy apply to patients with solid tumors treated with PRV211 during surgery and PRV131 and with intratumoral injectable, as well as PRV131 for deeper and harder-to-reach tumors that could require injections with bronchoscopes and endoscopes.  

Q: How do you explain PRV111, PRV211, and PRV131 to patients? And what cancer types are these treatments most suitable for?

Patients often associate chemotherapy with the commonly known side effects of hair loss, vomiting, fatigue, and infection over a period of six to eight weeks. Privo’s treatment is designed so patients do not have to experience those commonly known side effects.  

The best way to describe our treatments to patients is to provide them with a visual they are familiar with. Privo’s PRV111 and PRV211 treatments can be easily compared to a topical Band-Aid that includes an antibiotic within the Band-Aid mesh. However, instead of an antibiotic, Privo’s products contain a chemotherapeutic. In the case of PRV111 for treating oral cavity cancer patients, the patch is applied directly onto the tumor and the properties of the patch are mucoadhesive so it will stick right onto the tumor, similar to a band-aid. You leave the patch in place for 10 minutes for the cisplatin-loaded nanoparticles to penetrate below the epithelial surface. The patch is then removed and discarded.  

PRV111 can pioneer a new treatment paradigm for oral cavity cancer. The goal is for early detection and early intervention with PRV111 treatment. It is a safe and effective way to administer chemotherapy.  

PRV Platform products (PRV111-topical patch, PRV211 intraoperative gel, PRV131 intratumoral injectable) can be used on many different solid tumor cancer types that best fit the best course of treatment. PRV111 can be used to treat skin cancer, cervical/vaginal cancers, and nasal cancers. PRV211 can be applied in surgical cases where tumor resection is to be administered for a solid tumor. There may be cases where a tumor size exceeds that of surgical resection criteria. PRV211 can be applied to these large tumors to shrink them down to a size that makes the patient eligible for surgical intervention. The  PRV211 patch can be placed in the resected tumor bed to eliminate micrometastases and treat nearby lymph nodes. PRV131 intratumoral injectable can be used in cases where a patch cannot be administered, such as in brain tumors and lung tumors.  

Q: How are these treatment methods different and what are some of the major goals of these methods when it comes to oral cancer?

Privo Technologies’ PRV Platform opens up a variety of treatment options for patients. Below we have included five potential use cases.  

1. PRV platform-based treatments can be used for patients that cannot tolerate chemotherapy due to its toxicity when delivered intravenously. 
   • Systemic toxicity of cisplatin can be severe, causing an inability to tolerate the side effects. A large number of patients are unable to use systemic chemo due to health issues such as compromised kidney function.
     • Currently, 1/3 of patients are unable to receive platinum-based chemotherapies which are the most common anticancer drugs.
     • PRV111 and PRV211 are well-suited to be used in this patient population since these localized products have shown no systemic toxicity.
2. PRV111 and PRV211 provide treatment options for transplant patients.
   • These patients are not eligible for immunotherapy, as they are on immunosuppressive drugs. Organ transplant recipients have a two-to-four-fold greater overall risk of malignancy than the general population. Some of the most common malignancies after transplant include skin cancers and post-transplant oral cancers.  
3. Use in OBGYN cancers such as cervical and vaginal cancers  
   • Topical treatment with PRV111 can reduce the chance of issues in childbearing women with cervical cancer. Currently, surgery is the first line of treatment for patients with cervical cancer, which can affect their ability to bear children. PRV111 has the potential to eliminate the need for surgery in some of the early stages of cancer and reduce the disfigurement and damage for more advanced cases.
4. Use of PRV111 and PRV211 for elderly 
   • Baby boomers are the second-largest population group in the U.S. in 2022, comprising 69.6 million people ages 58 to 76. A large portion of the baby boomer population will not be prime candidates for systemic chemotherapy due to the severe systemic toxicities associated with these treatments. These baby boomers and the elderly patient population, in general, would be excellent candidates for topical/localized chemotherapy treatment via the use of PRV platforms. In Privo’s CLN-001 study, 30% of its patients were over the age of 70. The data generated from that study supports use in elderly populations. (It should be noted that one patient from the study was over 90 years old. In 2021, the patient’s physician informally followed up with Privo and informed the team that they had no recurrence since receiving the PRV treatment three years earlier.)
5. Use of PRV111 and PRV211 for patients with compromised kidney(s)
   • A variety of kidney diseases and electrolyte disorders can result from drugs that are used to treat malignant diseases, including conventional cytotoxic agents such as platinum-based chemotherapy. Kidney disease affects more than 1 in 7 adults in the U.S. Systemic chemotherapy is known to affect renal function and cause nephrotoxicity. This patient population stands to significantly benefit from localized chemotherapy such as PRV111 and PRV211 treatment, which have been shown to cause no systemic toxicity.

Q: What’s next for Privo Technologies?

Privo is currently seeking a partner to embark on a Phase 3 registration, enabling clinical trials for PRV111. This Phase 3 study will be targeting patients with very early-stage cancer categorized, such as carcinoma in situ where we aim to treat patients using the topical PRV111 patch and eliminate the need for disfiguring and life-changing surgery. This clinical trial design is in line with our mission for early detection and early intervention providing patients with non-surgical and less disfiguring alternatives.  

For PRV211, Privo has designed a Phase 1/2 clinical study, supported by the National Cancer Institute, that aims to treat patients with oral cancer tumors that are amenable to surgery. The PRV211 intraoperative treatment will be applied to the resected tumor bed to kill any remaining cancer cells left and prevent the chance of recurrence.  

PRV131, Privo intratumoral injectable, is actively being evaluated in pre-clinical studies in collaboration with Johns Hopkins University to find alternative treatment options in areas that represent significant unmet medical needs such as glioblastoma. Privo Technologies is seeking a strategic partner to take PRV131 to clinical trials initially targeting glioblastoma, meningioma, and lung cancer.