PRV111, in Development as the First Non-Surgical Therapy for Early-Stage Non-Invasive Oral Cancer and High-Grade Dysplasias, Meets Its Primary Efficacy Endpoint in Ongoing Phase 2/3 Trial

Key Highlights:

• 92% complete response (CR) rate: Eleven of twelve evaluable patients achieved a centrally confirmed pathologic CR following a single cycle of PRV111; the remaining patient was down-staged from high-grade to low-grade dysplasia.
• All patients avoided surgery: PRV111 cleared or downgraded lesions without the need for surgical excision. Treated mucosa healed completely, with normal appearance and no scarring.
• Durable responses: Patients continue to be monitored. As of now, no recurrences have been observed, with a median follow-up of about 6 months and responses about 12 months in the longest-treated patient.
• Well-tolerated: Systemic cisplatin exposure remained negligible; 85% of treatment-related adverse events were mild, and none were serious.

PEABODY, Mass., Nov. 17, 2025 /PRNewswire/ -- Privo Technologies today announced results from the CLN-004 Phase 2/3 (Cohort 1) trial evaluating PRV111, a nanoengineered, cisplatin-releasing patch for the treatment of non-invasive oral cancer and high-grade dysplasia (HGD). These conditions are common, recur frequently, and typically require repeated surgical excision, which can impair speech, swallowing, and appearance.

In this trial, PRV111 delivered a 92% pathologic CR rate, eliminated the need for surgery in all patients, and demonstrated durable local control. Manijeh Goldberg, PhD, MBA, Founder and CEO of Privo Technologies, commented:
"The complete response rate achieved with PRV111 is among the highest reported for localized therapies in this setting. Patients typically face repeated surgical resections, which can lead to fibrosis, scar formation, and anatomic distortion that can permanently affect speech and other functionality. This non-surgical patch not only cleared the tumors but preserved native tissue function. These results reinforce PRV111's potential to redefine the standard of care for oral precancer and early carcinoma in situs. We are one step closer to providing patients with an office-based, non-surgical alternative to repeated operative procedures."

The CLN-004 study builds upon Privo's earlier clinical experience with PRV111 (CLN-001), which showed promising local tumor responses with no systemic toxicity in a first-in-human setting. The results of that earlier trial were published in Nature Communications and highlighted by Forbes for their innovative approach to localized cancer drug delivery.

Detailed Results:
Twelve patients with biopsy-confirmed non-invasive oral cancers or high-grade dysplasia received a single cycle of PRV111. Eleven patients achieved centrally confirmed pathologic CRs; the twelfth patient was down staged to low-grade dysplasia, eliminating the need for surgery. All treated lesions resolved, and mucosal surfaces regenerated without scarring or distortion. At a median follow-up of ~6 months, no recurrences were observed; several patients have maintained responses beyond six months, and the longest ongoing response now ~12 months. There were no systemic toxicities, dose-limiting toxicities, or treatment-related serious adverse events. Treatment-related events were primarily mild, transient oral symptoms.

Transforming the Treatment Paradigm:
Current management of non-invasive oral cancer and HGD relies on surgical excision, which is associated with high recurrence and morbidity. PRV111 is designed to deliver high concentrations of cisplatin directly into dysplastic tissue through a brief, office-based procedure, avoiding systemic side effects associated with traditional chemotherapy. This topical approach represents the first non-surgical alternative in development focused on treating this class of disease.

Next Steps:
Privo Technologies is initiating a registrational study of PRV111 in non-invasive oral cancers and high-grade dysplasias. The company will also explore PRV111 in other early malignant and premalignant lesions where non-surgical alternatives could provide significant benefits.

About PRV111:
PRV111 is a nanoengineered, polymeric topical patch designed to deliver high-dose cisplatin directly into oral lesions and adjacent mucosa while minimizing systemic exposure. The patch adheres to the lesion, achieves rapid drug permeation into dysplastic tissue and regional lymphatics, and is removed after treatment.

About Privo Technologies:
Privo Technologies is a late-stage clinical biopharmaceutical company pioneering localized, minimally invasive therapies for solid tumors using its proprietary nanoengineered delivery platform. Privo is committed to developing innovative, patient-centric therapies that improve outcomes and preserve quality of life for patients with solid tumors.

To learn more, visit www.privotechnologies.com
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SOURCE Privo Technologies