Healthcare CEO Discusses an Imaging Agent That Lights Up Lung Cancer During Surgery

On Target Laboratories recently announced that the U.S. Food and Drug Administration (FDA) has cleared an expanded indication for the use of CYTALUX™ (pafolacianine) injection in lung cancer. This is the company’s second indication, expanding from use in adults with ovarian cancer to now adult patients with lung cancer.

DocWire News spoke with Chris Barys, President and CEO of On Target Laboratories, about how this innovation can enhance surgeons’ ability to see cancer in real time as they operate.

DocWire News: Can you provide us with some background on yourself?

Chris Barys: First of all, my name is Chris Barys, and I am the President and CEO of On Target Laboratories. I’ve been with On Target for about three and a half years. I’ve been in healthcare my entire career, much of which has been in the medical device sector. My passion is to work with companies that have groundbreaking innovations that can improve patient care. And most of my career has been working with those types of companies that have moved the field of healthcare forward, specifically as it pertains to patient care.

Talk to us about On Target Laboratories. What is the company’s mission?

On Target Laboratories is a privately held biotechnology company that develops targeted molecular imaging agents that illuminate cancer during surgery in real time. The company is based out of West Lafayette, Indiana. The technology was founded by Dr. Phil Low, who is a Professor at Purdue University, who also sits as our Chief Technology Officer.

Now, our mission, we consider this to be foundational to our company. Our mission is very simple, and everything we do here at On Target begins and ends with the patient.

Let’s first just take a moment and talk about the staggering statistics that exist for patients that suffer from lung cancer. Lung cancer is the leading cause of cancer deaths period, with nearly 240,000 diagnoses in the United States alone and 2.2 million diagnoses globally. Over 130,000 people will die this year from lung cancer alone in the United States and 1.8 globally.

So it’s this next statistic that I think really helps us formulate the foundation of why we do what we do at On Target, and it helped us to formulate our mission. And that is up to 55% of people who undergo surgery with a curative intent will have a recurrence. And I think you’ll all agree that these statistics are just simply unacceptable and hard to digest.

So our mission here at On Target is very simple. We’re here to light up cancer in real time during surgery, so surgeons can achieve a more complete resection. And when you talk to surgeons about their goals in surgery, their goal is simply to resect as much cancer as possible. And Cytalux, which is our first molecule for approval that has an indication in ovarian cancer and lung cancer, now serves as a new tool for surgeons to identify lung lesions that may otherwise be missed.

What is CYTALUX, and how can it be used in lung cancer?

So Cytalux is now approved as the first and only targeted molecular imaging agent that illuminates lung cancer inter-operatively. So it enables the detection of more cancer for removal. The imaging agent is given prior to surgery to adult patients who have ovarian and suspected lung cancer. Those are our first two indications. It helps surgeons visualize cancer during surgery.

So let me make an analogy that might be helpful. It lights up cancer cells like bright shiny stars against the backdrop of a pitch black sky. So for those of you out there who enjoy looking at stars and then go out in a mid-summer evening when it’s pitch dark outside and you look at those beautiful stars against a pitch black sky, it’s quite remarkable to see.

So let me peel this back just a little bit deeper. Cytalux is administered by an IV given before surgery. And for those of us who’ve had surgery before, no [inaudible 00:03:46] or fluids one to two hours before surgery, our indication allows the surgeon the flexibility to dose the patient anywhere between one to 24 hours, providing a very user friendly window. So the surgeon or hospital can administer the IV one to two hours before surgery or the night before.

So how does it work? Cytalux contains a folic acid analog that identifies and basically searches out folate receptors. So when the drug is infused via the IV, it quickly goes into the system systemically and it searches out these folate receptors that are found in lung cancer cells. And the drug is taken up very rapidly. And anything that does not find a receptor is quickly evacuated from the body, which makes the drug very specific in its action.

So then when the surgeon is working in the operating room and they turn on the near infrared fluorescent light, this is when the lesions light up, like that analogy that I shared earlier, like those shiny stars against the backdrop of a pitch black sky.

What data back the efficacy of CYTALUX?

That’s a great question. And so our phase three ELUCIDATE results, which was basically our phase three lung trial, were quite remarkable. And Cytalux has now been evaluated in over 400 patients in all clinical trials. And the results are as follows. With Cytalux, surgeons were able to detect lung lesions that they were not able to detect or see with traditional surgical methods in 24% of patients. So let me break that down a bit. In 19% of those patients, Cytalux located the primary lesion when surgeons could not detect it with current standards.

The next statistic was the one that generated the most discussion amongst our PIs. And in 8% of patients, Cytalux detected one or more additional cancerous lesions or synchronous lesions that were not previously identified either by, say, CT scan or PET scan. So as you can imagine, many surgeons were very excited about this technology and really saw the utility of this product in over 50% of their patients. But when they learned that it was picking up cancer that was not seen on their CT scans, many of them quickly believed that this should become standard of care.

And then ultimately, the last piece, surgeons indicated in the trial that they changed the scope of their surgical plan or intent nearly 30% of the time when using Cytalux as an adjunctive tool, which tells us this really had a powerful impact on a surgeon’s decision-making in these procedures.

How does the development of targeted intraoperative molecular imaging agents change cancer care?

It’s a great question. So the introduction of Cytalux is a game changer, in my opinion. Cytalux is now the first of its kind and only approved targeted molecular imaging agent that eliminates both ovarian and lung cancer in real time. So our innovation does not stop here. Our platform will target three-fourths of all inpatient cancer procedures, including prostate and colon. So with the first two indications approved of ovarian, lung, and then we’re working on prostate and colon, these agents will serve, in my opinion, as an important tool for surgeons as they strive to get a complete resection.

So targeted molecular imaging agents are, in my opinion, the future as it relates to visualizing cancer during surgery, offering the type of precision that I think every patient would want. And the real time component is the critical aspect that allows surgical decision-making to happen in the moment when it matters the most. Whether it’s finding additional cancer in the surgical arena that was missed or verifying and evaluating margins in real time on the back table, molecular imaging is here to stay.

So with these powerful results from phase three, our phase three lung trial ELUCIDATE, I believe that these new tools should become the new standard of care for all patients who suffer from cancer. After all, I think at the end of the day, what patient would not want the addition of this information as surgeons begin to plan out their surgery?