Dr. Garo H. Armen | 04-27-25

Thank you very much, Roger. It's a pleasure to be here.

Thank you. I mean there is a lot of truth to what you're saying. Of course there are good doctors and not so good doctors who don't do their homework before they decide on a treatment regimen. But in reality, if you look at the last five decades, the estimated costs to get us to here in terms of cancer research, that includes discovery of new molecules as well as clinical trials, is estimated to be at $1 trillion over five decades. So if you look at the reality of where we are today, having spent $1 trillion, we still don't have cures for cancer, at least for some of the most challenging cancers, we don't. And as you said, chemotherapy and radiation, which are quite poisonous to the system, are still the standards. Now to change that in the last 10 years or so there has been a resurgence of natural remedies. When I say natural remedies, these are still drugs but they work through the natural immune system and one of the areas of great success in the last 10 years have been with those drugs. So to your question specifically, is there a concerted effort to suppress positive developments? Probably not. To give the benefit of the doubt to the industry and regulators, but the realities still are such that we are way behind.

So I am a big fan of AI as you may know, and AI, while it's not perfect, is going to change all of this and catapult the speed with which we develop drugs and test them and get them approved. But if you look still today, it takes on average about five years from the first injection or pill given to the patient to drug approval where the drug is made widely available. And clearly the FDA has evolved over time, I'd say, but still the rules and regulations have not caught up to the innovation that the field is experiencing right now. Look, I should say I'm not a medical doctor and nothing I say in this conversation should be construed as medical advice. I'm merely telling you the experience that my wife and I have had personally, but also the testimony of literally thousands of people who contacted me when I went on radio and talked about my wife's situation. The number of people who contacted me through email, through text messages, people would just write Roger Stone, the name of the city I live in and the zip code, and it would reach me. All of them telling me positive stories about Fenbendazole, which was actually a drug that began, I believe, as a dog dewormer, just as Ivermectin was a horse dewormer. And you know, all of those thousands of people cannot possibly be lying nor can they be wrong.

Certainly. If you look at the major advances, when Commissioner McCary talks about going after cures rather than marginal treatments, if we look at what are the curative treatments for patients today, I think it's reasonable to assume that activating the immune system to target the cancer specifically is the way to go long term. Cancer is a very complicated disease. It's different from person to person. We classify cancers by the organ in which they are present. For example, we say lung cancer. But it is a fact that no two lung cancers are exactly alike. So in order for us to be able to target these nasty cells in the body in a very precise manner, we must be able to activate the immune system so that what we infuse or inject into the body allows the immune system to be programmed to recognize its own target in a very specific way. Our drugs are activators of the immune system and we call them second or third generation activators of the immune system because the first generations were CTLA4 antibodies that were discovered in the 2000s and finally made it to patients in 2011, and PD1 antibodies that started getting to patients around 2015-2016. These first generation compounds did not do a good job in activating what we call cold cancers. For example, colon cancer is a cold cancer whereas melanoma is a hot cancer. The difference is that cold cancers are relatively invisible to the immune system whereas hot cancers are much more visible. Getting back to your question, our agents are specifically designed and we have demonstrated in clinical trials of over a thousand patients that they go after cold and hot cancers, and by making cold cancers hot, they make them much more visible to the immune system. Those are what we are pursuing right now as our next generation of compounds, and there's a whole pipeline behind that as well.

Thank you very much, Roger. It's always a pleasure.

You said this spot on, Roger, because all of a sudden colorectal cancer has become the number one killer of men under the age of 50. And not only that, but in the context of our product development with our drug, we get inquiries for compassionate use. About six months ago, sadly, we got a compassionate use request for an 8-year-old little girl with advanced metastatic colorectal cancer. Never heard of that before. And because of red tape and bureaucracy, it stands to say the regulatory process prohibited us from treating this girl under compassionate use, which is absolutely heartbreaking.

That's right. You're absolutely right. For example, in colorectal cancer, the most recent drug approved about a year ago is a drug that extends life by merely two months with no cures in sight. And the drug prior to that approved is another drug that extended life at that time by six weeks at a significant cost in quality of life to the patient. So all of these realities, I believe, are exactly the kind of crisis that the new leadership in Washington wants to stop. That's what we need to do, and that's one of the reasons we need to work very rapidly with the regulatory agencies and sometimes overcome some of the hurdles that are being erected, which Commissioner McCary spoke about most recently. For example, he pointed out that for drugs being sold in other countries, we still require going back to ground zero and doing animal tests including, sadly, dogs like beagles and monkeys, which have no merit. So some of these bureaucracies, both in the preclinical setting and in the postclinical setting, these older archaic rules need to be reformed, and that requires leadership who has the courage to do it, and that's what we're hoping for to progress very rapidly.

Okay, so in our trials, Roger, approximately 20% of the patients that are near their deathbed are looking like they will live a normal life for an extended period of time. What does that mean? I'm talking about well over two years. As we follow these patients, we look at the survival tale. At least 20% of the patients look like they're living a normal healthy life without chronic treatment required. In other words, we administer these drugs for a limited period of time, typically several weeks to several months, and beyond that, they're drug-free. As you go to earlier stages of disease, we've done a handful of patients in what we call the neoadjuvant setting. These are patients with late-stage 3 disease, and these patients are showing complete eradication of their tumors at least 50% of the time or more. What's remarkable is that when these patients get one injection of one of our drugs called botanylamab and two injections of the other drug, by the way these are infusions, that's all they need. Within 7 to 8 weeks, their tumor is gone. For those that have demonstrated complete disappearance of tumor within an 8-week period, some of the patients now are up to about 18 months and none of them have recurred. So this is a very exciting outcome. The message being the earlier we treat patients, the better the outcomes. Unfortunately, again because of archaic rules, we are generally stuck with treating patients that are near death instead of treating earlier-stage patients that are still very sick. But instead of treating them with the better drug options, we still generally treat them with chemotherapy and radiation, which in itself is inhumane as well.

They can go to the website that we have. It's genusbio.com, agnusbio.com. We have a fair amount of information there, including how patients can have access to our medicines through the compassionate use program.