Sona Nanotech set to launch first human trial of its gold nanoparticle cancer therapy

Sona Nanotech Inc. (CSE: SONA | OTCQB: SNANF), a nanotechnology life sciences developer specializing in biocompatible gold nanorod therapies and diagnostics, has received ethics committee approval to begin its first human clinical trial for Targeted Hyperthermia Therapy (THT). The trial will test the safety and early efficacy of Sona Nanotech’s proprietary cancer treatment in patients with advanced melanoma who have stopped responding to conventional immunotherapy. The announcement, made on June 27, 2025, paves the way for immediate patient enrollment in Chile.

The Halifax-based oncology-focused biotech firm is collaborating with Bradford Hill Investigacion Clinica in Santiago, Chile, for the execution of this early feasibility study. The trial is expected to include up to ten patients, each receiving two treatments of THT one week apart. The results from this study are expected to be available by September, depending on enrollment rates and treatment timelines.

Sona Nanotech’s Chief Executive Officer David Regan confirmed that dosing will begin shortly and noted that Chief Medical Officer Dr. Carman Giacomantonio will provide on-site training and observe initial treatments. The company’s experimental platform is drawing attention from institutional investors and oncology researchers due to its potential to minimize side effects while enhancing tumor response compared to traditional therapies.

How does Sona Nanotech’s Targeted Hyperthermia Therapy work, and why is it seen as a breakthrough for melanoma patients?

Sona Nanotech is advancing a photothermal therapy platform that uses precisely engineered gold nanorods to convert infrared light into localized heat within cancerous tissues. This controlled heat — within the range of 42°C to 48°C — can damage tumor cells, disrupt cancer stem cells, improve immune system recognition, and increase blood flow, thereby enhancing drug delivery into the tumor microenvironment.

Unlike chemotherapy or systemic immunotherapy, the Canadian biotech firm’s approach relies on localizing heat within the tumor through externally applied infrared light. This eliminates the need for cytotoxic compounds and limits off-target effects. In the current trial, Sona Nanotech’s gold nanorods are injected directly into tumors, where they accumulate and respond to near-infrared light applied from outside the body.

The firm’s gold nanorods are CTAB-free — an important distinction, as cetyltrimethylammonium bromide (CTAB) is a surfactant commonly used in nanoparticle production that has been linked to toxicity in medical applications. By eliminating CTAB, Sona Nanotech aims to provide a safer formulation suitable for human use and regulatory progression.

What is the clinical trial design and who are the targeted patient groups for this THT study?

The early feasibility study is a non-randomized clinical trial designed to evaluate both safety and initial biological signals of efficacy in up to ten patients with advanced melanoma. Participants will be individuals who have previously received — and failed to respond to — standard of care immunotherapy. These patients are considered high-need, given the limited available treatment options and low response rates typically observed after checkpoint inhibitor failure.

The patients will receive two THT treatments spaced one week apart. Investigators will measure tumor shrinkage, biomarker-based immune engagement, and tolerability. Dr. Carlos Rojas, principal investigator and executive director at Bradford Hill, expressed confidence in the trial’s ability to uncover important clinical signals. He pointed to the clinic’s prior experience conducting melanoma studies for leading global pharmaceutical firms as a strong foundation for managing this study effectively.

Dr. Carman Giacomantonio, Sona Nanotech’s CMO, emphasized that indicators of success will include signs of tumor cell death and evidence of immune activation. These parameters are critical not only for proving therapeutic potential but also for shaping the company’s regulatory path and partnership strategy moving forward.

What preclinical safety data underpins Sona Nanotech’s progression to first-in-human trials?

On May 27, 2025, Sona Nanotech announced the successful completion of a pivotal FDA-required preclinical toxicity study, performed by CBSET, Inc. under Good Laboratory Practice (GLP) conditions. The study involved three cohorts of rats injected intravenously with the firm’s proprietary gold nanorods at doses up to 100 times higher than the expected clinical dosage. The results showed no signs of acute or systemic toxicity and a favorable tissue distribution profile consistent with nanoparticle pharmacokinetics.

Dr. Donald Hodges, head of integrated toxicology at CBSET, noted that the results supported not only the safety of the nanorod platform but also its broader applicability in nanomedicine. Dr. Giacomantonio added that the outcome provides a strong rationale for initiating human trials, especially in comparison to conventional cancer immunotherapies that carry substantial risk of toxicity and immune-related side effects.

The study marks a critical milestone in the company’s translational development, and Sona Nanotech expects it to aid in future applications for regulatory clearances such as the U.S. FDA’s Investigational Device Exemption (IDE).

What is the institutional and investor sentiment toward Sona Nanotech’s oncology platform?

Although still in early clinical stages, Sona Nanotech’s platform has drawn attention from institutional investors focused on emerging cancer therapies. With increasing demand for minimally invasive, targeted oncology solutions that can be safely combined with other modalities, analysts view Sona Nanotech’s platform as a potentially valuable adjunct to checkpoint inhibitors, chemotherapy, or targeted small molecules.

The oncology-focused biotech firm is also seen as addressing key unmet needs in melanoma — a tumor type that can be highly resistant to existing treatments in advanced stages. Institutional sentiment appears cautiously optimistic, especially as the company demonstrates methodical progression from preclinical safety to early human testing within a relatively short window.

While Sona Nanotech has not disclosed new fundraising plans or upcoming capital requirements tied to the trial, the firm’s progress on both regulatory and clinical fronts could serve as a springboard for strategic investor outreach or industry collaboration in the second half of 2025.

What are the near-term catalysts and long-term outlook for Sona Nanotech’s THT platform?

Over the next quarter, key milestones include successful dosing of initial trial participants, readouts of interim results, and any regulatory updates related to further trial expansion or combination studies. The firm expects topline data from the melanoma feasibility study to be available by September 2025, assuming enrollment proceeds on schedule.

In the longer term, Sona Nanotech aims to position its THT platform for broader solid tumor indications, potentially beginning with tumors where immune evasion and stem cell resistance are well-documented challenges. The modular nature of the gold nanorod system also lends itself to future integration with drug delivery, imaging, or biomarker detection — opening avenues for combination device-drug strategies or companion diagnostics.

Sona Nanotech may also benefit from a growing regulatory and investor appetite for precision oncology platforms that are mechanistically novel and demonstrate reduced toxicity compared to standard drug regimens.