The cutting-edge concept in oncology is immunotherapy: treatments that use the power of the human immune system to defeat cancer without the side effects of other therapies and aim to cure, rather than fend off, the disease. Immunotheraopy is also one of biotech and pharma’s hottest areas and at the center is Dr. Arie Belldegrun, physician, professor, serial entrepreneur, and the CEO of NASDAQ listed Kite Pharma, now preparing to bring to market the next generation products. In an exclusive interview with The Octavian Report, Dr. Belldegrun explains the science behind what could be the greatest advance in medicine in decades and the opportunity for investors.
Octavian Report: Could you lay out in basic terms for an intelligent layperson how immunotherapy works on cancer, and why it's different from previous treatments.
Arie Belldegrun: First, I have three decades of immunotherapy experience. It's not something new. Now, everyone wants to position their product as an immunotherapy product -- because that's the buzz. But for years, it was not so. It was hard work, just working at the bench, creating data and providing what today is modern immunotherapy.
Essentially, over the last five decades, the approach to cancer was to hit the cancer cells wherever they are, in a non-specific way. Which means chemotherapy. It kills the good cells and the bad cells. You treat 100 percent of the patients for a 15 to 20 percent response.
A lot of people are getting all the side effects, very few are benefiting. But you couldn't personalize who should be getting what. So the field moved to what's called targeted cancer therapy, meaning: learn the basic mechanisms and pathways by which the cancer cell operates, and try to block these roads, either by blocking their blood supply or blocking their way of proliferating and growing.
Immunotherapy is something completely different. You do not attack the cancer. You manipulate the immune system. The immune system works in a simple way, asking: “Are you mine or you are not mine? Do you belong to my body or you do not? If you do not belong to my DNA, my body, I will reject you.” And who is rejecting it? Killer cells called T-cells. And these are kind of at the center of everything that's happening today: they recognize “mine” and “not mine.”
Now, cancer is quite smart. After a while, it learns to shield itself from the immune system by building kind of a fence around itself. Then the body cannot recognize the cancer as foreign, as not part of the system. And therefore, for years, immunotherapy did not get attention. But recently, with new genetic engineering technologies, you can take those very same T-cells and engineer them to do whatever you want them to do, rather than what the cancer wants them to do. Suddenly, everything has changed.
And that's also part of what Kite is doing. Engineering your own T-cells. We take your T-cells out of the body. We engineer them very specifically. And we give you, the patient, your own T-cells but now super-charged -- and with a sort of GPS designed to take the engineered T-cell, the killer cell, directly to its target. They have an antenna that tells them, "This is a cell that needs to be killed." And it is killed. So you are not using chemicals to kill the cancer. You are using your natural immunity in a more activated way to kill the cancer. That's what's special about it. Potentially, immunotherapy can be combined with everything. It can combine with surgery, combine with any other treatment existent up to now. One stream of the new immunotherapy, checkpoint inhibitors, is becoming an industry of $20 to $50 billion. And we have the technology, today.
OR: Do you think this will work with every kind of cancer?
Belldegrun: I cannot say every, but many types of cancer, because this is not specific to a single type. Let me back up and say that, for years, the notion was two types of cancers are most sensitive to immunotherapy. One was melanoma. You saw a rush to develop a melanoma treatment. The second one was kidney cancer. And while the immunotherapy was developed first for them, suddenly we realized that it actually works for lung cancer. It works for prostate cancer. It is now moving to many other tumor types -- even bladder cancer, where we never thought that it would work. It's using the immune system to reject your own cancer. And the immune system doesn't care if the cancer originates from a melanoma cell or from the brain. It's like a professional killer.
OR: So is it a matter of identifying the right target on the cancer cell? Is that what's at the heart of what's making this therapy work?
Belldegrun: That's the key. And that's where all the IP is running to. The whole world is looking to find targets for cancer immunotherapy. That is the bottleneck of the industry. We signed a huge deal with Amgen, a multi-year, multi-product deal, through which they are providing us just those targets. We provide the technology; together we will use it to develop the next generation of drugs. We needed them because they own now both deCODE and Micromed's genetics, among others, which they bought for $1.6 billion precisely to acquire these targets. Each target is a specific target.
These targets allow the engineered T-cells, the killer T-cells, to make sure they are acting only on cells of cancerous origin, and not on normal cells. If, for example, somewhere in your body, in the biliary tract or in the brain, there is an antigen similar to the cancer, the new T-cell will destroy it immediately as it destroys the cancer. We need to make sure that the T-cells attack tumor-specific antigens that do not exist in any normal tissue in the body. One such antigen was found in an area in the bowel, and what happened? The T-cells melted the cancer but also created a hole in the bowel. This also occurred during the treatment of a brain cancer --- a hole in the brain. So you have to go very slowly, very carefully. And that's the reason why the FDA so far has not yet approved any drug.
This is a new type of cancer therapy that we are moving very rapidly, but at the same time, very cautiously into approval. Our plan at Kite is to start the first ever multi-center trial of this tech this year and submit the data to the FDA in 2016. If all goes well, the product will be on the market in 2017. And our competitor, Novartis, has a similar timeline.
Dr. Arie Belldegrun is the founder and CEO of Kite Pharma (NASDAQ: KITE).