Sona Nanotech Inc (CSE:SONA, OTCQB:SNANF) has reported promising first-in-human results for its targeted hyperthermia therapy (THT), showing tumor elimination in most treated patients with advanced melanoma who had stopped responding to standard immunotherapy. The findings mark a major milestone for the Halifax-based nanotechnology company as it transitions from preclinical research to clinical development.
Proactive spoke with David Regan, CEO of Sona Nanotech, to discuss the study results, how the therapy works, and what’s next for the company.
Proactive: You’ve just announced impressive first-in-human data for your targeted hyperthermia therapy, showing tumor elimination in most treated patients. Can you walk us through the results and what they mean for the company at this stage?
David Regan: We’re extremely excited about these results. This really marks the moment when we graduate from being a preclinical life sciences company to a clinical-stage life sciences company.
This was a small, 10-patient early feasibility study for a medical device — in our case, a two-device medical system. The therapy works by shrinking tumors and, in doing so, engaging the immune system. The results were quite profound: we enrolled ten patients with late-stage melanoma who were no longer responding to leading immunotherapies. Yet we saw responses in eight of the ten patients, six of which were complete responses.
In other words, biopsies taken from representative treated tumors came back within two weeks of treatment showing that those tumors no longer contained melanoma.
So, as you say, the therapy appears to have worked in patients who were resistant to standard immunotherapy. How does Sona’s targeted hyperthermia therapy differ from other cancer treatment approaches, and what potential does it have to address broader unmet medical needs?
That’s a great question, and one we get often. We started with melanoma because it’s accessible. Our therapy involves inserting nanoparticles into a tumor, then shining a near-infrared laser onto them. The laser passes harmlessly through about 2.5 cm of healthy tissue and excites the nanorods, converting non-thermal light energy into heat — and heat kills cancer.
What’s unique about our approach is that we limit the temperature to around 45 degrees Celsius, which is in the hyperthermia range. That temperature is high enough to selectively kill cancer cells, but not harm healthy cells, which can withstand up to 52 degrees. When cancer cells die at this gentler heat level, they undergo a natural apoptotic cell death that exposes new antigens — prompting the immune system to recognize and attack the cancer.
So we’re essentially helping the immune system fight the cancer on its own. Immunotherapies have been doing that for the past 15 years, but their efficacy is limited — around 21% across various cancer types, and about 33% for melanoma. We treated ten patients from the 67% of cases where immunotherapy doesn’t work — and still achieved significant responses.
Another key difference is safety. Immunotherapies can have substantial toxicity issues, while our therapy is gentle and causes no collateral damage. Yet, as these early results show, it can have a profound therapeutic impact.
You mentioned plans to advance into a Canadian clinical trial with Health Canada approval pending. What are the goals of this next study, and how will it build on the early feasibility study we’ve just seen?
We gained tremendous insights from the early feasibility study — both in terms of efficacy and the underlying biological mechanisms. We’ve released topline numbers, but we have a rich database of data we’re still analyzing to better understand what’s happening at the cellular level.
It’s a small, 10-patient study, so it’s not statistically significant, but we’ll be doing further detailed histological analysis of the tissues. Those findings will help shape the hypotheses and inform the protocol for our next study, which we hope to launch by next spring.
And what are the next key milestones investors should be watching for, David?
Key milestones ahead include more data from the histological analyses and further commentary on the direction of our next steps. The exciting thing about these results is that they open up many possibilities — not just in melanoma, but across a range of solid tumor types resistant to immunotherapy.
We’ll be taking some time to carefully plan our path forward and consult with the right experts. In the short term, we’ve submitted our application to Health Canada and expect to engage with them soon. There’s a lot coming up, and we look forward to keeping investors updated as we move ahead.
Quotes have been lightly edited for style and clarity