Candel Therapeutics Inc (NASDAQ:CADL) earlier this week shared updated clinical data from a Phase 2a study evaluating its immunotherapy candidate CAN-2409 in patients with advanced non-small cell lung cancer.
The company said the study enrolled patients who had exhausted standard treatment options, including chemotherapy and checkpoint inhibitors. It highlighted that 90% of participants had stage four metastatic disease and poor prognostic indicators, such as low PD-L1 expression and smoking history.
Dr Paul Peter Tak, CEO of Candel Therapeutics, told Proactive the results were “striking in light of what’s available in standard of care and in the pipeline of the industry.”
Proactive: I know that you were in the Phase 2a clinical trial. Let's talk about CAN-2409 and what this trial was going to do.
Paul Peter Tak: What we've shown here in a patient population of patients with non-small cell lung cancer who had failed multiple lines of chemotherapy and treatment with immune checkpoint inhibitors, in most cases, Keytruda, who have a very poor prognosis and progressive disease—they have failed everything—that we can actually see doubling of the expected median overall survival in this population if you are able to give them two administrations of CAN-2409.
We've seen durable responses. We've also shown the so-called “long tail” of survival. That means that 37% of the patients were still alive two years after CAN-2409 treatment, which is much longer than you would expect. We even have several patients who lived beyond three or four years. Imagine that, with progressive metastatic lung cancer.
These patients are the sickest of the sick. These are the ones that have used a lot of treatments that aren't working. Is that right?
That's absolutely right. Think of it like fourth line or fifth line of treatment. There's basically nothing left for these patients. In 90% of the cases, they had metastatic stage four disease and had failed all available treatments. They have a very poor prognosis.
They would get docetaxel chemotherapy, which is the best standard of care and is associated with a median overall survival of no more than 10.8 months. So that's the population we are focused on. They also had very poor prognostic factors like low PD-L1 expression, which is a biomarker used in clinical practice, in a very large proportion of patients. Most patients were previous or current smokers—another unfavorable factor. And, as I mentioned, metastatic disease and failure of Keytruda and multiple lines of chemotherapy.
Now what should people take out of this type of data that you're showing here? Because obviously it reads very nicely and it gives people another chance at life, so to speak. What should people take from what you've been able to accomplish so far in the development of this?
This is a Phase 2a clinical trial where I believe we have shown data that nobody has seen before for any treatment in the industry pipeline. If you look at the press release, the quote from Professor Charu Aggarwal—who's a leading non-small cell lung cancer specialist at the University of Pennsylvania—she said literally, “These results are striking in light of what's available in standard of care and in the industry pipeline.”
So this gives us hope that we may have a potentially transformative treatment for patients who have run out of options. Of course, we will need to reproduce these findings in a larger, potentially registration-enabling clinical trial. That's the next step—we have to be aligned with our key academic experts and the FDA in a randomized clinical trial of CAN-2409 versus best standard of care, which is docetaxel chemotherapy.
How long does that take to put into action? When should people expect to see more information about the start date and how long it's going to run?
We've not announced that. We're going pretty fast, as you can see with other programs. We've been working very hard. We've started to engage with the key experts. We already have an idea of what the study is more or less going to look like. We will proceed to start with the best of the best in academia and, of course, make sure that we are aligned with the FDA. But we’ve not announced the timelines or when we expect that protocol.
And lastly, speaking about the patients that you were dealing with—these numbers that you're talking about, in essence saving someone's life, potentially, if this all works the way you want it to work—what does that mean for treatment of the last line of defense against cancer?
We are seeing a whole new concept in the application of CAN-2409, which we have now shown in therapy-resistant late-stage non-small cell lung cancer. But we've also seen the same in pancreatic cancer, another horrible disease.
Even in patients who we cannot cure—and nobody can cure them—we are able to extend overall survival so that these patients live longer with a reasonable quality of life. Our treatment is generally very well tolerated. It leads to flu-like symptoms that typically last less than 24 hours, comparable to, for example, COVID-19 vaccination. And that's it. It's only two administrations where we basically educate the patient's own immune system to control the tumor and extend life.
Quotes have been lightly edited for style and clarity