Privo Technologies Begins Dosing PRV131 in Arm 3 Of Clinical Study CLN-004, A First-In-Class Cisplatin Intratumoral Injectable Targeting Oral Cavity Cancer

Key Highlights:

• First-in-human milestone: The inaugural patient has been dosed with PRV131.
• Precise, localized delivery: Built on Privo's PRV Platform technology, PRV131 delivers high concentrations of cisplatin directly to tumors, while minimizing systemic exposure.

BOSTON, Mass., Dec. 10, 2025 /PRNewswire/ -- Privo Technologies, Inc., today announced that the first patient has been dosed in its first-in-human clinical trial evaluating PRV131, a nanoengineered intratumoral cisplatin injectable for the treatment of T1–T3 oral squamous cell carcinoma (OSCC).

The Phase 1/2 Dose Escalation and Dose Optimization Run-In Study (Arm 3 of CLN-004) is designed to refine dosing by evaluating safety, preliminary efficacy, tolerability, and pharmacokinetics of PRV131 across selected dose levels as a neoadjuvant therapy. With the intention of debulking tumors prior to surgery, the goal of PRV131 is to improve surgical outcomes, preserve oral tissue, and reduce the morbidity associated with traditional surgical approaches.

The trial has now opened at the first clinical site, where the inaugural patient received treatment with PRV131, marking a key milestone in the development of novel locoregional therapies for head and neck cancer.

About PRV131

Built on Privo's proprietary PRV Platform technology, PRV131 is a nanoengineered intratumoral injectable suspension designed to deliver high-concentration cisplatin directly into solid tumors while minimizing systemic exposure. This inaugural dosing represents an important expansion of the PRV program beyond topical and intraoperative patches (e.g., PRV111 and PRV211) toward intratumoral delivery of cisplatin for patients with oral cavity malignancies. PRV131 is engineered to address significant unmet needs in oral cavity cancer by:

• Shrinking or debulking tumors prior to surgery to improve functional and cosmetic outcomes
  
  
• Delivering high intratumoral drug concentration while limiting off-target toxicity
  
  
• Potentially preserving form and function of the oral cavity, which can be severely impacted by standard surgical interventions

Preclinical studies have demonstrated that PRV131 can shrink or eliminate several solid tumor types, including squamous cell carcinomas, while generating durable responses. In companion animal studies conducted in dogs with large, naturally occurring tumors, PRV131 reduced tumor volumes by over 80% with no observed systemic toxicity.

"We are incredibly pleased to begin dosing patients with PRV131 in this first-in-human study," said Dr. Manijeh Goldberg, PhD, Founder and CEO of Privo Technologies. "Patients with oral cavity cancer often face invasive surgeries that can dramatically affect their ability to speak, eat, and live comfortably. PRV131 is designed to shrink tumors directly at the site, helping preserve critical oral structures and maintain function, offering the potential for meaningful improvements in quality of life. This milestone represents an important step in our mission to transform local cancer treatment with precise, targeted, nanoengineered chemotherapy."

About Privo Technologies, Inc.

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.

Learn more at www.privotechnologies.com
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SOURCE Privo Technologies