Oral Small Molecule Targeting of Cancer with Cantex' Stephen Marcus

Dr. Stephen Marcus boasts drug development experience across various routes of administration targeting varied therapeutic areas. Now as Cantex CEO, he leans on his background as an oncologist to drive his passion for effectively treating cancer while easing the patient experience. In this episode of Sit and Deliver, host Tom von Gunden asks Dr. Marcus about innovations in small molecule delivery for complex, life-threatening conditions.

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Episode Transcript

Tom von Gunden, Chief Editor, Drug Delivery Leader:

Welcome to another episode of Sit and Deliver, the series that offers timely insights from leading thinkers in the drug delivery industry. My name is Tom von Gunden, Chief Editor and Community Director at online information exchange Drug Delivery Leader. Today I am joined by Dr. Stephen Marcus, CEO at Cantex Pharmaceuticals, a clinical-stage pharmaceutical company focusing on treatments for cancer and other serious, life-threatening diseases.

Welcome, Steve.

Stephen Marcus, CEO, Cantex Pharmaceuticals:

It's good to be here. Thank you.

Great. So first up, can you share with us… Well, first of all, I should let our audience know that you have a history in drug development that has taken you through treatments that have gone through a variety of routes of administration for delivery — from, for example, injectable Betaseron for EMS to, now in the Cantex pipeline, orally administered small molecules for various cancers and other conditions.

So, can you share with us a little bit about, just generally speaking, what key considerations need to go into any formulator’s or device engineer’s mind when it comes to choosing a route of administration and a delivery avenue?

Sure. Well, the first consideration is, what route of administration is most likely to prove effective? But the proof of efficacy also involves a method of delivery that makes sense for the patient, makes sense for the disease the patient has and the need for some kind of intervention, [some] treatment.

So, just to give as an example, early on in my career, I developed Betaseron [interferon beta-1b] for the treatment of multiple sclerosis. And at the time, it was thought that the best way of delivering interferon would be into the spinal fluid, so-called intrathecal injection.

But the patients had multiple sclerosis. The patients did not have cancer. They were primarily young people with a lifetime ahead of them. So, giving patients monthly and critical or weekly intrathecal injections makes absolutely no sense, even though it may prove to be more effective in terms of controlling the disease. So, we gave the drugs subcutaneously so patients could take this like an insulin shot.

So, it's just one example of, you have to think about what makes sense for the patient population. If it's a group of patients who have a long life and for whom quality of life is extremely important, that's one set of considerations. If it's patients with a lethal disease, such as malignant brain tumors, which must be put under control in a short period of time, that's a different consideration.

So, in the context of the Cantex pipeline, where you're targeting various cancers and other conditions with orally administered small molecules, can you tell us a little bit about that choice of delivery? Why orally administered small molecule in these contexts?

It has always been one of my dreams as an oncologist. I practiced oncology for several years before going into the pharmaceutical industry. It has always been one of my dreams that a simple-to-administer, daily, oral drug would make a lot of sense if it could prove effective. The oral route gives the advantage of a drug that can be given literally every day, provided it is safe and tolerable.

Also, if you're dealing with cancers involving the central nervous system, it's also important that the compound cross the blood-brain barrier. And so, looking for orally available drugs that cross the blood-brain barrier that could be administered every day would enable the tumor, in this case, to be exposed every day to the therapeutic entity.

The same would be true for treatments of any central nervous system [CNS] disease. Where, really, a pill where the active ingredient within the pill crosses the blood-brain barrier would be ideal.

So finally, Steve, as we look toward the horizon of advancements that will come our way down the road, hopefully sooner rather than later, what are any of the additional challenges in targeting life-threatening diseases, like cancer and others, with delivery mechanisms in terms of the feasibility and effectiveness of those delivery avenues?

Sure. Well, the method of delivery has to be a practical one. One which is acceptable to the patient while at the same time proving safe and effective. So, for example, in the context of subcutaneous injections, there may be slow delivery technologies for localized infection. For localized diseases, such as brain tumors, there are considerations such as, how do you get the drug across the blood-brain barrier?

And in that area, there's intensive work now looking at ways of either altering the blood-brain barrier, or getting drugs that by their nature will cross the blood-brain barrier. Or there have been a number of groups that are looking at ways of injecting the drug directly into the brain, but through the use of infusion pumps or specially created catheters.

But in the end, simpler is better, if it's equally effective. And so, finding a way of administering a drug that is effective yet simpler would really be of great benefit to patients.

Well, Dr. Stephen Marcus, thank you for sharing your perspectives for the audience on Drug Delivery Leader through this episode of Sit and Deliver. Thanks again.

Thank you.