Latest News & Updates

Key Highlights

BOSTON, January 23, 2026 – Privo Technologies, Inc. today announced the successful completion of its Phase 1/2 clinical evaluation of PRV211, a first-in-class intraoperative chemotherapy patch for head and neck cancer patients. The study demonstrated excellent safety outcomes across all eight patients, positioning PRV211 as a promising approach to preventing cancer recurrence at the surgical site.

• Zero treatment-related serious adverse events (just one reported mild burning sensation while healing)
• No systemic toxicities or dose-limiting toxicities
• Normal wound healing with no surgical complications
• Negligible systemic absorption confirming targeted delivery
• Seamless integration into standard surgical procedures

Innovative Approach

PRV211 is applied directly to the tumor bed following surgical resection to address microscopic cancer cells that may remain in surgical margins. The nanoengineered patch delivers localized chemotherapy when tissue barriers are removed and access is optimal.

“This study represents an important step forward in our approach to cancer surgery,” said Dr. Manijeh Goldberg, PhD, Founder and CEO of Privo Technologies. “PRV211 is customized medicine that enables surgeons to deliver targeted treatment precisely where recurrence risk is highest.”

Addressing Clinical Need

Post-surgical recurrence remains a significant challenge in head and neck cancer. The study enrolled patients with invasive tumors (T1 – T4) requiring surgical excision, including advanced-stage cases requiring reconstructive surgery. PRV211’s targeted approach delivers chemotherapy directly to the surgical site with minimal systemic exposure.

Program Progress

PRV211 represents Arm 2 of Privo’s CLN-004 clinical program. Combined with Arm 1’s achievement of its primary efficacy endpoint and Arm 3’s dosing initiation, the program demonstrates continued progress in localized cancer therapy development.

Next Steps

Patients will be monitored for efficacy outcomes, including loco-regional recurrence at 12 months post-surgery. A future expansion study is planned to further evaluate PRV211’s potential to reduce cancer recurrence.

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.

PRV131 is a first-in-class cisplatin intratumoral injectable therapy being evaluated in CLN-004 (Arm 3). This Phase 1/2 clinical study is designed to identify a safe and effective dose for intratumoral treatment of oral cavity tumors.

The therapy is supplied as a kit containing a lyophilized powder and a proprietary diluent, which are reconstituted immediately prior to use. Once injected, PRV131 forms a localized drug depot within the tumor, enabling controlled release of cisplatin over time.

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.

PRV111 has demonstrated remarkable efficacy in ongoing Phase 2/3 trials for early-stage non-invasive oral cancer and high-grade dysplasias. This breakthrough represents a significant advancement in cancer treatment, offering patients a non-surgical alternative with targeted, localized therapy.

The treatment delivers chemotherapy directly to the tumor site, minimizing systemic exposure and side effects while maximizing therapeutic efficacy.

Privo Technologies, a leader in localized cancer therapies, announced the completion of enrollment in Arm 1 of the Phase 2 run-in portion of its ongoing Phase 2/3 clinical trial (CLN-004) evaluating PRV111.

PRV111 is a nano-engineered chemotherapy patch designed to treat early-stage oral cancer and high-grade dysplasias without the need for surgery. Trial results highlight the potential to spare patients from disfiguring surgical procedures.

Study Details

The CLN-004 trial is a Phase 2/3, open-label study designed to evaluate the safety, tolerability, and efficacy of PRV111. Strong efficacy signals observed in the Phase 2 run-in support advancement to the pivotal Phase 3 portion of the study.

Privo Technologies announced the activation of multiple premier clinical sites across the United States for its ongoing CLN-004 trial. This expansion enables increased patient enrollment and accelerates the development timeline for PRV111.

Partnership with Leading Institutions

The multi-center trial includes partnerships with top cancer treatment centers across the country, providing patients with greater access to this innovative therapy and ensuring robust clinical data collection.

This Phase 2/3, open-label, two-arm study is evaluating the safety and efficacy of PRV111 for the treatment of early-stage oral cancer and high-grade dysplasias.

Privo Technologies announced the launch of BeneVet Oncology, a new subsidiary dedicated to improving the health and well-being of companion animals through innovative drug delivery technologies.

Extending Innovation to Veterinary Medicine

BeneVet aims to revolutionize the way diseases in pets are treated by adapting Privo’s advanced platforms, originally developed for human medicine, to enhance therapeutic options for animals. With a strong focus on safety, efficacy, and ease of administration, BeneVet is poised to transform the landscape of companion animal healthcare.

"Our pets are family members, and they deserve the same level of innovation and care that we dedicate to human health," said Dr. Manijeh Goldberg, CEO of Privo Technologies.

Privo Technologies is proud to announce the receipt of $4.5 million in funding from the National Cancer Institute (NCI) to support its pivotal Phase 3 clinical trial for a groundbreaking nanotechnology-based treatment targeting carcinoma in situ of the oral cavity.

Significance of the Award

The continued support from the National Cancer Institute not only affirms the potential of our technology but also accelerates our ability to move forward in the regulatory process..

Privo Technologies received IRB approval for its CLN-004 study from WCG IRB. CLN-004 is a Phase 1/2, open-label, safety and efficacy study assessing the tolerability, anti-tumor effects, systemic exposure, and device technical effects of PRV211.

About PRV211

PRV211 is a sterilized derivative of the nano engineered PRV platform intended for intraoperative chemotherapy treatment for all solid tumor surgeries, immediately following surgical excision.

The goal is to treat the tumor bed locally, eliminating any remaining micro metastases or close margins that are unable to be fully resected while avoiding system circulation.

Privo Technologies was awarded a $2M Direct-to-Phase II SBIR Contract from the National Cancer Institute (NCI), part of the National Institutes of Health. The contract will be used to further the development of PRV311, Privo’s third lead asset, for the treatment of cervical cancer in low resource settings.

Expanding the PRV Platform

This funding enables Privo to extend its innovative PRV platform technology to address cervical cancer, expanding the company's pipeline and potential patient impact. The Direct-to-Phase II designation recognizes the strong preliminary data and accelerates the development timeline.

Privo is excited to share the Forbes article titled "Going Beyond Target Or Mechanism Of Disease: Disruptive Innovation In Drug Delivery Systems," written by Dr. Alex Zhavoronkov, one of Privo's manuscript authors.

Recognition of Disruptive Innovation

The article highlights Privo's nanoengineered PRV Platform as a disruptive innovation in drug delivery systems. It emphasizes how the platform goes beyond traditional approaches by focusing on optimizing drug delivery rather than solely targeting disease mechanisms. Click the below to access the full Forbes article.

Disruptive Innovation In Drug Delivery System (forbes.com)

Click the below to access the Nature Commuinications Publication on the PRV Platform.

A nanoengineered topical transmucosal cisplatin delivery system induces anti-tumor response in animal models and patients with oral cancer | Nature Communications

Privo Technologies announced that Nature Communications, a prestigious peer-reviewed scientific journal, published the results of the company's nanoengineered drug delivery platform for locoregional treatment.

Peer-Reviewed Validation

Publication in Nature Communications represents significant validation of Privo's scientific approach and technology. The peer-review process ensures that the research meets the highest standards of scientific rigor.

The publication details the design, development, and preclinical results of the PRV platform, demonstrating its ability to safely deliver highly potent drugs locoregionally while minimizing systemic toxicity.

Key Highlights

• Third orphan designation granted: The U.S. Food and Drug Administration granted Orphan Drug Designation to Privo's PRV platform delivery of cisplatin for the treatment of carcinoma in situ (CIS) of the anterior 2/3 of the oral cavity.
• Expands orphan drug portfolio: This represents Privo's third ODD for a rare disease, following previous approvals for oral cavity cancers and anal cancers, demonstrating the broad potential of the PRV platform.
• Significant regulatory milestone: “Achieving this important regulatory milestone means we are one step closer to bringing new treatment options to patients diagnosed with oral CIS. The standard of care currently is surgery, resulting in severe disfigurement and poor quality of life. Our novel transmucosal delivery system with embedded cisplatin loaded nanoparticles, PRV111, allows for patients to be treated with topical chemotherapy providing an alternative to surgery that effectively treats cancer while maintaining the form and function of the oral cavity,” said Dr. Goldberg.

FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug status provides benefits to drug developers that includes assistance in the drug development process, tax credits for clinical costs, exemption from FDA PDUFA fees, and seven years of post-approval exclusivity.

Key Highlights

• $2.5 million NCI grant: Privo received funding as part of the National Cancer Institute's Notice of Special Interest announcement to support the first-in-human clinical study of PRV211.
• Revolutionary intraoperative treatment: PRV211 is applied to the tumor bed immediately following surgical resection to eliminate micrometastases and treat nearby lymph nodes, preventing cancer recurrence.
• Addresses surgical challenge: The treatment helps surgeons balance the challenging act of removing enough tissue without damaging functionality, while ensuring no tumor cells are left behind.
• Broad applicability: The clinical trial will initially enroll patients with advanced head and neck cancer and then expand to patients with other solid tumors.

Event Overview

• Premier investor conference: Privo Technologies will present at the 24th Annual BIO CEO & Investor Conference, one of the biotech industry's most prestigious investor events held February 14-17, 2022.
• Virtual company presentation: The company will deliver a virtual presentation showcasing its PRV platform technology, clinical progress, and commercialization strategy to a global audience of investors and industry leaders.
• One-on-one investor meetings: Privo's leadership team will participate in individual investor meetings, providing opportunities to discuss partnership opportunities and investment potential in detail.
• On-demand availability: The company's presentation will be available on demand on the BIO CEO & Investor Conference website through March 20, 2022, extending reach to interested parties unable to attend live.

Event Overview

• Premier industry kickoff event: Privo Technologies will attend Biotech Showcase held January 17-19, 2022, during J.P. Morgan Healthcare Week, the biotech industry's most significant annual gathering.
• Investor and partner engagement: Members of Privo's management team will be available for 1-on-1 meetings with interested parties.

Event Overview

• Elite partnering event: Privo Technologies will attend Bio Partnering at JPM held January 10-14, 2022, one of the most exclusive and productive partnering events in the biotech industry.
• Strategic partnership focus: The event is specifically designed to facilitate business development discussions between biotech innovators and pharmaceutical companies seeking licensing or collaboration opportunities.

Key Highlights

• 87.5% overall tumor response rate: PRV111 demonstrated significant efficacy in treating early-stage Head and Neck Squamous Cell Carcinoma with an average time to response of just 5.5 days.
• 35-100% tumor volume reduction: Patients experienced observable tumor volume reduction with a mean of 69%, demonstrating the treatment's powerful anti-tumor effects.
• Zero systemic toxicity: No severe adverse events or dose-limiting toxicities were observed. PRV111 achieved >350x higher cisplatin levels in tumors while maintaining >700x lower levels in blood compared to IV treatment.
• 100% no recurrence at 6 months: All subjects who completed six-month follow-up showed no loco-regional recurrence, with increased tumor-infiltrating lymphocytes post-treatment.

Key Highlights

• $3 million commercialization grant: The National Institute of Dental and Craniofacial Research (NIDCR) awarded Privo a significant commercialization grant to accelerate PRV111's path to market.
• Focus on market readiness: Funding supports activities critical to preparing PRV111 for commercial launch, including manufacturing scale-up, regulatory preparation, and commercial strategy development.
• Validation of technology: This award represents NIDCR's confidence in the PRV platform's potential to transform oral cancer treatment and address significant unmet medical needs.

Event Overview

• Virtual attendance: Privo Technologies participated in the BIO International Convention held online from June 14-18, 2021, adapting to the virtual format while maintaining networking and partnership opportunities.
• Technology showcase: The company presented its innovative PRV platform and clinical progress to a global audience of biotechnology leaders, investors, and potential partners.
• Strategic partnerships: The conference provided opportunities to explore collaborations with pharmaceutical companies, research institutions, and industry stakeholders interested in novel cancer therapies.

Despite the conference being held online this year due to COVID-19, Bio International 2021 was informative and enjoyable. The company connected with potential investors and industry partners in discussing their PRV111 and PRV211 technology. In addition, the company discussed technology collaborations with pipeline products.

Key Highlights

• Prestigious ASCO presentation: Privo presented a posteron on the safety and efficacy of PRV111 in patients with early-stage Head and Neck Squamous Cell Carcinoma (HNSCC) at the 2021 ASCO Annual Meeting held June 4-8, 2021.

The poster, titled "A phase II study of PRV111 nanoengineered cisplatin patch as a neoadjuvant therapy for early-stage oral squamous cell carcinoma (OSCC)," detailed the Phase 1/2 CLN-001 trial results demonstrating PRV111's ability to dramatically reduce tumor volume while maintaining an excellent safety profile with no systemic toxicity.

Key Highlights

• $900,000 investment award: Privo and CEO Dr. Manijeh Goldberg were selected as the winner of the 2020 AIM-HI Accelerator Fund's Inaugural Women's Venture Competition, receiving investments totaling $900,000.
• Selected from 47 female-led startups: Privo was chosen from among 47 female-led oncology start-ups as the winner, highlighting the innovation and promise of both the technology and leadership.
• Supporting women in oncology innovation: The AIM-HI Women's Venture Competition addresses the funding gap for female scientists and entrepreneurs developing breakthrough cancer treatments.

Key Highlights

• 30+ years pharmaceutical experience: Dr. Mackay brings over three decades of experience in pharmaceutical development with a proven track record of bringing multiple drugs to market and improving patient outcomes.
• CEO of Aristea Therapeutics: As founder, president, and CEO of Aristea Therapeutics, an immunology company focused on orphan diseases, Dr. Mackay brings entrepreneurial leadership and rare disease expertise.
• Led $1.2B Ardea acquisition: Prior to founding Aristea, Dr. Mackay successfully led the $1.2 billion acquisition and transition of Ardea Biosciences into AstraZeneca, demonstrating his strategic and operational excellence.

Privo Technologies announced the appointment of Dr. James Mackay to its Board of Directors, strengthening the company's leadership with deep pharmaceutical industry expertise. Dr. Mackay joins with an impressive background in drug development, commercialization, and corporate strategy that will prove invaluable as Privo advances PRV111 through late-stage clinical trials.

Event Overview

• Strategic partnering event: Privo Technologies participated in the BioNetwork Partnering Summit, a premier event connecting innovative biotechnology companies with pharmaceutical partners, investors, and industry leaders.
• Technology showcase: The company presented its PRV platform technology and early clinical data to potential collaborators interested in novel oncology therapies and drug delivery systems.
• Partnership discussions: The summit provided opportunities for one-on-one meetings with pharmaceutical companies exploring partnerships in mucosal cancer treatments and localized drug delivery technologies.

Privo Technologies attended the BioNetwork Partnering Summit to showcase its innovative PRV platform and explore strategic partnerships for the development and commercialization of its oral cancer therapies. The event brought together biotechnology innovators and pharmaceutical industry leaders to facilitate collaborations that accelerate the development of breakthrough therapies.

The company used this platform to highlight the clinical progress of PRV111, the unique advantages of its nanotechnology-based drug delivery system, and the broad potential applications across multiple mucosal cancer indications. These discussions helped establish relationships that would support Privo's growth and expansion into new therapeutic areas.

Key Highlights

• $2 million FDA funding: Privo Technologies was awarded approximately $2 million in funding from the FDA through its Office of Orphan Product Development (OOPD) to expedite clinical trial activities.
• Orphan product development support: The FDA OOPD program provides funding to support clinical development of therapies for rare diseases that affect fewer than 200,000 people in the United States.
• Accelerated trial timeline: The grant enables Privo to accelerate enrollment and data collection in its Phase 1/2 clinical trial for PRV111 in oral cavity cancers, bringing this innovative therapy to patients faster.

Privo Technologies received a significant $2 million grant from the FDA's Office of Orphan Product Development (OOPD) to expedite its ongoing clinical trial for PRV111. This funding demonstrates the FDA's recognition of the urgent medical need for new treatment options in orphan indications and Privo's innovative approach to addressing these needs.

The Orphan Product Grant supports critical clinical trial activities including patient enrollment, data management, safety monitoring, and efficacy analysis. This non-dilutive funding allows Privo to maintain its rapid development timeline while ensuring the highest standards of clinical research quality and patient safety.

Event Overview

• Invited by NIDCR: Privo Technologies attended the BIO International Convention as an invited guest of the National Institute of Dental and Craniofacial Research (NIDCR), highlighting the institute's confidence in Privo's technology.
• World's largest biotech event: The BIO International Convention is the premier global event for biotechnology, bringing together over 18,000 attendees from more than 70 countries including industry leaders, investors, and researchers.
• Platform for collaboration: The event provided Privo with opportunities to present its PRV platform to a global audience and engage in discussions with potential partners, collaborators, and investors.

Privo Technologies participated in the BIO International Convention as a recognized innovator in oral cancer treatment. The company's invitation by NIDCR underscored the scientific merit and clinical promise of the PRV platform, as well as the strong partnership between Privo and federal research institutions.

During the convention, Privo engaged with pharmaceutical companies, contract research organizations, and investment groups interested in novel oncology therapies. These interactions helped raise awareness of Privo's innovative approach to cancer treatment and established connections that would support the company's clinical and commercial development plans.

Key Highlights

• Selected by NCI: Privo has been selected for the prestigious Phase IIB Bridge Award from the National Cancer Institute (NCI). The NCI SBIR Bridge Award supports Privo’s clinical trial for its nanotechnology-based treatment of oral cancer. This award was given to only 4 companies in the United States (2018).

Manijeh Goldberg, Privo’s Chief Executive Officer, is honored by this recognition that NCI conferred on just four companies in 2018. “As a CEO, I am grateful to NCI, as well as the National Institute of Dental and Craniofacial Research, for their continued support. They remain instrumental in Privo’s ability to proceed confidently with the clinical trial phase of its PRV111 treatment.”

Key Highlights

• Clinical Trial Begins: Privo Technologies was granted the green light from the FDA and several hospitals this summer to begin patient recruitment for a prospective clinical trial (NCT03502148) targeting early-stage oral cavity squamous cell carcinoma (OCSCC).

Privo’s PRV 111 (topical patch) is placed directly onto a mucosal tissue. This topical patch is intended for the locoregional treatment of oral cavity squamous cell carcinoma without systemic toxicity.

Privo has developed a nano-engineered product called PRV111 consisting of a topical patch designed to deliver and retain high concentrations of various existing systemic agents within the primary tumor and associated nodal basins. Dr. Manijeh Goldberg, Privo’s founder, and CEO is very encouraged by the result of Privo’s preclinical studies and expects PRV111 to provide a safer and more effective treatment option to patients suffering from oral cancer.