First Patient Dosed in Early Feasibility Study Trial of its Cancer Therapy

July 07, 2025 09:19 AM EDT | By News File Corp
 First Patient Dosed in Early Feasibility Study Trial of its Cancer Therapy
Image source: Kalkine Media

Trial is expected to provide key insights on safety, tolerability and immune system response for its THT treatment of late-stage melanoma patients

Halifax, Nova Scotia--(Newsfile Corp. - July 7, 2025) -  Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona") an oncology-focused life sciences company developing innovative therapies based on its uniquely biocompatible gold nanorod technology, announces that a first dosing has been achieved in the previously announced early feasibility study of its Targeted Hyperthermia Therapy ("THT") cancer treatment.

Dr. Carman Giacomantonio, Sona's CMO, commented, "Our unique therapy aims to modify tumors making them more visible to the immune system with a view to enabling an elimination of the cancer. As with any new technology, we are required to demonstrate that we can safely and feasibly deliver the treatment in the clinical setting. We have smartly designed this inaugural study to also provide us with some key, first ever reported, insights into its effect in human cancer. Success in this study will enable us to proceed to our next planned study that will more critically evaluate the biological effects and clinical outcomes of this exciting technology."

David Regan, CEO, commented, "Getting to this first dosing of a patient with our Targeted Hyperthermia Therapy is a milestone achieved through the culmination of years of research, toil and many preclinical studies. We plan to follow this critical first clinical step quickly with a second, more expansive human trial following further engagement with regulators, as well as a peer-reviewed article in a leading scientific journal detailing our findings. We also expect the learnings from this study to help inform on THT's potential for complementing the treatment of other cancer types."

About the Study

The study is designed to assess THT's safety, tolerability, and preliminary efficacy as measured by tumor growth inhibition and the extent to which it causes immune system engagement with the cancer. The study includes two treatments of Sona's THT, one week apart, for patients with advanced melanoma who are, or have been on, standard of care immunotherapy protocols but have failed to respond or progressed during treatment. The study is anticipated to generate an initial read out of results this summer, with final results expected in the fall.

Technology will be evaluated for:

  • Ease of setting up and preparation for the treatment
  • Ease of administration of GNR's in a variety of different tumors
  • Reproducibility in the clinical setting, i.e. the ability to train others to use the technology
  • Resource requirements, i.e. what additional resources are required in the clinical setting
  • Time required to administer the treatment in the clinical setting

Participants will be evaluated for:

  • Tolerability to the treatment itself
  • Adverse events during and following treatment
  • Clinical response, i.e. did the tumor change in any way after treatment
  • Pathological immune response, i.e. histological evidence of immune activation in the tumor that is directly relatable to the treatment itself.

Sona Nanotech believes that its THT cancer treatment may provide benefits over current standard of care immunotherapy treatments alone which have shown limited response rates and can have undesirable side effects.

Contact:

David Regan, CEO
+1-902-442-0653
[email protected]

About Sona Nanotech Inc.

Sona Nanotech is developing Targeted Hyperthermia™, a photothermal cancer therapy, which uses therapeutic heat to treat solid cancer tumors. The heat is delivered to tumors by infrared light that is absorbed by Sona's gold nanorods in the tumor and re-emitted as heat. Therapeutic heat (42-48°C) stimulates the immune system, shrinks tumors, inactivates cancer stem cells, and increases tumor perfusion - thus enabling drugs to reach all tumor compartments more effectively. Targeted Hyperthermia promises to be safe, effective, minimally invasive, competitive in cost, and a valuable adjunct to drug therapy and other cancer treatments.

Sona has developed multiple proprietary methods for the manufacture of gold nanoparticles which it uses for the development of both cancer therapies. Sona Nanotech's gold nanorod particles are cetyltrimethylammonium ("CTAB") free, eliminating the toxicity risks associated with the use of other gold nanorod technologies in medical applications.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION: This press release includes certain "forward-looking statements" under applicable Canadian securities legislation, including statements regarding the anticipated applications and potential opportunities of Targeted Hyperthermia Therapy, and Sona's preclinical and clinical study plans. Forward-looking statements are necessarily based upon a number of assumptions or estimates that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements, including the risk that Sona may not be able to successfully obtain sufficient clinical and other data to submit regulatory submissions, raise sufficient additional capital, secure patents or develop the envisioned therapy, and the risk that THT may not prove to have the benefits currently anticipated. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Sona disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Not for distribution to United States newswire services or for dissemination in the United States

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/257929


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