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HALIFAX, NS, May 5, 2026 /CNW/ - Sona Nanotech Inc., (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona"), is pleased to announce its clinical strategy to further the development of its Targeted Hyperthermia Therapy ("THT") cancer treatment. Based on both the success of Sona's first-in-human clinical study with THT, which demonstrated its ability to shrink and prime tumors immunogenically when used alone, and the published results from preclinical testing of Sona's THT showing the higher and more durable response rates that were observed when THT is combined with standard immunotherapies, the Company now intends to trial advanced applications of THT in two innovative clinical studies in melanoma patients combining THT with immunotherapy drugs.
With a view to assessing how THT's effectiveness and durability can be enhanced for late-stage melanoma sufferers, Sona will undertake its next clinical study of THT, (the "IGNITE-THT Study" - Immunotherapy + THT to Generate Novel Immune Tumor Eradication). In this study, Sona's THT would be administered in conjunction with a regimen of intratumoral and systemic dosing of the same immunotherapy drugs on which a cohort of patients had previously failed. The IGNITE-THT Study is expected to demonstrate the same safety and tolerability as experienced in the Company's previous clinical study, but with enhanced efficacy and long-term durability from the combination therapy anticipated after tumors are immunogenically activated by Sona's THT treatment (as experienced in the Company's recently published pre-clinical study).
A second study, (the "PRIME-THT Study" - Precision Regional Immunotherapy for Melanoma Enhanced by THT) will assess the same concept but in newly diagnosed early-stage melanoma sufferers, which represents a much larger number of affected people worldwide (estimated by management to be up to 275,000 globally each year). Patients in this study would be given THT in combination with intratumoral immunotherapy with a view to stopping tumors from spreading (metastasising) by THT activating strong immune responses prior to standard-of-care surgical tumor resection. In addition to evaluating the safety and tolerability of Sona's THT treatment in an 'up-front' (neo-adjuvant) setting, the PRIME-THT Study will also measure the immediate treatment effect and the long-term durability of responses related to this novel, early-stage, neo-adjuvant combination therapy.
These new studies are designed to answer the same questions from different ends of the patient journey: can THT convert immunogenically 'cold' tumors into tumors that respond to immunotherapies? The IGNITE-THT Study will ask it for patients who have already failed on treatment and remain on immunotherapy's treatment plateau. The PRIME-THT Study asks it earlier, enabling and bringing the benefits of immunotherapy forward into the pre-resection window, where stopping metastases is still possible.
Dr. Carman Giacomantonio, Sona's Chief Medical Officer, commented, "Having shown Sona's THT's ability to safely prime and shrink tumors in humans, we will now assess THT's ability to enable the efficacy of immunotherapy drugs, turning previously refractory tumors into responders. Our pre-clinical combination studies in multiple cancer model types have demonstrated success increasing immunotherapy response rates and response durability so we have good reason for optimism. Additionally, our intratumoral approach to administering the immunotherapy is expected to significantly reduce patient's typical immunotherapy-related side-effects."
David Regan, Sona's CEO, commented, "These studies test the central question THT was built to answer: can we improve response rates to immunotherapy while lowering the well-recognized immunotherapy-related toxicities patients frequently experience? With stage IV melanoma patients having less than a 50% chance of surviving past five years due to low immunotherapy response rates, a plateau the field has not been able to break, and up to 20% of resected stage II melanoma patients developing metastases, we have an opportunity to improve the quality of life for hundreds of thousands of patients affected by this growing problem. Our goal with these studies is to demonstrate the potential for Sona's THT to improve on the current standards-of-care in multiple indications in our first solid cancer target."
Early result read-outs from the IGNITE-THT and PRIME-THT studies are expected within six and eight months of their initiation, respectively.
What This Means for Sona's Shareholders:
- An expansion to a second cancer indication. Demonstrating THT in both early and late-stage melanoma indications shows a greater breadth of potential treatment market size.
- Two near-term valuation catalysts. A clear strategy to demonstrate long-term potential to the investment community with relatively near-term deliverables.
What This Means for Those Living With Melanoma:
- Potential for greater chances of cure. Priming tumors with THT to engage the immune system prior to the administration of today's best immunotherapy drugs could result in higher response rates to those drugs.
- Potential for reduced risk of metastases. Pre-treating early-stage melanoma tumors could reduce the chances that the cancer spreads to lymph nodes prior to standard-of-care resection.
The Company also continues to lay the groundwork for a larger scale, clinical trial in Canada for late-stage melanoma patients, working with Health Canada to secure the required investigational testing authorization ("ITA"). Feedback received from Health Canada is guiding the Company's ITA application for a combination strategy clinical trial which it expects to begin early in 2027 and run for up to 18 months with multiple read-out milestones.
The Company will hold an investor webinar on Thursday, May 7th, 2026, at 1pm ET. Registration link: https://bit.ly/4mZSoN2.
About Sona Nanotech Inc.
Sona Nanotech is developing Targeted Hyperthermia™, a photothermal cancer therapy, that 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, an approach aligned with the melanoma research community's active focus on converting immunogenically 'cold' tumors, which resist immunotherapy, into 'hot' tumors that the immune system can recognize and attack, 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 and diagnostic testing platforms. 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; impact and effectiveness of Sona's THT cancer treatment; the timing and receipt of expected positive histological results supporting first-in-man treatment results obtained to date, including the anticipated design, conduct, and outcomes of the IGNITE-THT and PRIME-THT clinical studies; potential future applications of Sona's THT cancer treatment, including the estimated addressable patient population for early-stage melanoma; the timing and completion of Sona's proposed Canadian pilot study and Sona's preclinical and clinical study plans and the potential market impacts of such studies. 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 secure the remaining required regulatory approvals for its clinical trials, including the ITA; enroll study participants in a timely manner, successfully obtain sufficient clinical and other data to submit regulatory submissions, raise sufficient additional capital, secure patents or develop the envisioned therapy, the risk that THT may not prove to have the benefits currently reported and anticipated, and general economic, market, competitive and business conditions . 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. The forward-looking statements contained in this press release are made as of the date hereof, and 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.
SOURCE Sona Nanotech Inc.
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