HALIFAX, NS — May 5, 2026 — Leads & Copy —
Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) has announced its clinical strategy to advance the development of its Targeted Hyperthermia Therapy (THT) cancer treatment. The company will initiate two clinical studies in melanoma patients, combining THT with immunotherapy drugs.
Based on 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 preclinical testing results showing higher and more durable response rates when THT is combined with standard immunotherapies, the company intends to trial advanced applications of THT.
Sona’s next clinical study of THT, called the IGNITE-THT Study (Immunotherapy + THT to Generate Novel Immune Tumor Eradication), will assess how THT’s effectiveness and durability can be enhanced for late-stage melanoma sufferers. The study will administer Sona’s THT 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 the company’s previous clinical study, but with enhanced efficacy and long-term durability from the combination therapy. This is anticipated after tumors are immunogenically activated by Sona’s THT treatment, as experienced in the company’s recently published pre-clinical study.
The second study, called the PRIME-THT Study (Precision Regional Immunotherapy for Melanoma Enhanced by THT), will assess the same concept in newly diagnosed early-stage melanoma sufferers, estimated by management to be up to 275,000 globally each year. Patients in this study will be given THT in combination with intratumoral immunotherapy to stop 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.
Both studies are designed to determine if THT can convert immunogenically ‘cold’ tumors into tumors that respond to immunotherapies. The IGNITE-THT Study will focus on patients who have already failed on treatment and remain on immunotherapy’s treatment plateau. The PRIME-THT Study will focus 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, said that after showing Sona’s THT’s ability to safely prime and shrink tumors in humans, they will now assess THT’s ability to enable the efficacy of immunotherapy drugs, turning previously refractory tumors into responders. He also noted that the company’s pre-clinical combination studies in multiple cancer model types have demonstrated success increasing immunotherapy response rates and response durability.
David Regan, Sona’s CEO, said the studies test the central question THT was built to answer: can the company improve response rates to immunotherapy while lowering the well-recognized immunotherapy-related toxicities patients frequently experience? He also said that with stage IV melanoma patients having less than a 50% chance of surviving past five years due to low immunotherapy response rates, and up to 20% of resected stage II melanoma patients developing metastases, Sona has an opportunity to improve the quality of life for hundreds of thousands of patients affected by this growing problem.
Early result read-outs from the IGNITE-THT and PRIME-THT studies are expected within six and eight months of their initiation, respectively.
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.
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.
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.
The company will hold an investor webinar on Thursday, May 7th, 2026, at 1pm ET. Registration link: https://bit.ly/4mZSoN2.
Source: Sona Nanotech Inc.
