Immunotherapy for Cold Tumors: New Approaches for Hard-to-Treat Cancers

Brad Power February 14, 2024 “It's an unusual treatment because it is unique in the history of cancer therapy, in that it is the first treatment that so far has worked on every tumor type we have tried it on.” – Gary Onik “We're priming the immune system to react to the drugs that it didn't react to before and to unmask the tumor, so it can be recognized.” - Gary Onik

Advanced cancer patients with solid tumors which don’t respond to immunotherapies (“cold” tumors), such as prostate, breast, and pancreatic cancer patients, look with envy at blood cancer patients with "hot" tumors, who can access immunotherapies and often get amazing results. In traditional immunotherapy the medications are given “systemically” (into a patient’s vein).

The tumors of a patient with a solid tumor can see minimal amounts of the medication, and the patient’s normal tissues are exposed to the same levels of medications as the cancer. The result is that many solid tumors don’t respond to the treatment, and there is a significant risk that the patient’s normal tissues can be damaged.

Gary Onik, MD, a physician, researcher, medical device inventor, and a cancer patient and survivor, has developed several innovative techniques and instrumentation to treat cancer, including an ultrasound-guided cryosurgery (freezing) tumor ablation procedure for the prostate and for the liver. He has also developed a unique approach to immunotherapy that creates a cancer vaccine within the patient’s body.

The “Onik Method” stimulates the immune system to do what it is supposed to do: recognize and eliminate the tumor. This approach enables immunotherapy for "cold" tumors such as prostate, breast, and pancreatic tumors, that usually do not respond to traditional immunotherapy. He successfully treated his own terminal prostate cancer using this invention. What are the steps in this new internal cancer vaccine process?

Image the body (with PSMA, CT, or other techniques) to find a target tumor for the procedure. Apply extreme cold with needle-like probes to freeze ("cryoablate") the target tumor, which damages the tumor, releasing proteins/antigens near the tumor.

Inject the tumor with immunologic medications that interact with the antigens from the dead tumors, which creates an internal vaccine, revving up the immune system to do its natural job of killing cancer cells. This vaccine circulates around the body and reaches other tumors to hopefully kill/shrink tumors elsewhere (the "abscopal effect"). Large volume tumors will sometimes need adjuvant traditional therapy, or systemic immunotherapy.

Some patients will need other therapies later on. What have been the results? The results have been unique in the history of cancer therapy – it is the first treatment that so far has worked on every tumor type it has been tried on. In a published study, of 18 prostate cancer patients, 50% had a complete response. Patients with other cancers, such as pancreatic cancer, also showed encouraging results.

Of six patients with non-prostate cancer: 33% that had a partial response. The side effects were more limited than expected or seen with systemic immunotherapy. Responses have been durable; in Dr. Onik’s case, five years, and others have lasted many years. How can you access this internal cancer vaccine?

This approach is currently available under “off label use” – the drugs and techniques are safe, but they are not being applied in the same way as when the drug or technique was approved. A clinical trial has been approved by the FDA with a focus on pancreatic cancer. They are looking for funding now. Three centers have joined the program. Until the trial is completed, a major limitation will be the cost to the patient.

The information and opinions expressed on this website or platform, or during discussions and presentations (both verbal and written) are not intended as health care recommendations or medical advice by Cancer Patient Lab, its principals, presenters, participants, or representatives for any medical treatment, product, or course of action.

You should always consult a doctor about your specific situation before pursuing any health care program, treatment, product or other course of action that might affect your health. Cancer patient support and medical advice. Cancer treatment options with a focus on immunotherapy. Immunotherapy for hard-to-treat cancers. Cancer treatment outcomes and immunotherapy. Immunotherapy for cancer treatment with low side effects.

Prostate cancer treatment options and genetic testing. Prostate cancer treatment with a focus on immunotherapy. Immunotherapy for cancer, including cold cryoablation and systemic immune cocktails. Immunotherapy customization for cancer treatment.

Amit Gattani I got treated by Dr. Gary Onik in the middle of January this year. I'm in active treatment with him now. You may know from various posts in the community that I had reached the end of the line on the standard of care treatments. They haven't been working for me for quite some time, but they kept giving me some extensions.

But given my disease has spread in the bone marrow, my myelosuppression is very, very high, which means hemoglobin below 8 platelet counts. Generally my hemoglobin would hover between 6 and 7. With a little bit of blood transfusion, it'll go up. But what it meant is that I was not going to be accepted in any of the trials. The trials want hemoglobin about 8 typically.

Another complexity has been that my disease has also evolved into a neuroendocrine disease. With neuroendocrine disease, it's not pure adenocarcinoma. Trials generally don't accept mixed cancer types because they are trying to prove a particular point in a particular direction. The hemoglobin is a cutoff that I couldn't meet. So for the past four or five months, I've been searching for various alternative treatment options, and I came across Dr.

Onik through a conversation that happened here in CPL originally. His name came up, and I started to look into that, and what this could mean to me. I had already gone through an immunotherapy trial, which didn't work with Keytruda. As Dr. Onik will explain, this is an immunotherapy treatment. But it is a different approach to treatment. Then I started to ask, “Okay.

” I explored that idea with a few of those that I could find that use this type of approach. I finally concluded that Dr. Onik is my best choice for treatment. I put my eggs in that basket, so to say. My treatment was five weeks back. We're still in the process of figuring out how effective it is. We'll know in a couple of weeks. Two things will happen: my PSMA scans will be back, and then my biopsy from NextGen in Germany will be back.

That will give us a forward-looking direction. I'll hand it over to Dr. Onik to introduce his specialty and the treatment that he is providing. Gary Onik 4:51 We're doing intratumoral immunotherapy. We feel that it is the next frontier in immuno-oncology versus giving the medication systemically, like they are doing right now. Let me show you what the process includes. For now, we're going to call this the “Onik Method”.

It's got other names, but for this forum, let's call it the “Onik Method”. Piece number one is a release of the tumor antigens. We do that using something called a “non-ablative freeze”. By the way, all of this is covered in a patent that was just issued in March of 2023. I can present it to you without any worries.

We use this very special type of freezing, and we release the tumor antigens without killing the vasculature and the mechanisms for immune cells to get into the lesion. If you do a regular freeze, it's an avascular lesion, and it doesn't do anything. Sometimes we add in a PDL-1 (another checkpoint inhibitor). We can talk about why we might want to have both of them involved.

Sometimes we'll use a LAG-3 inhibitor (Lymphocyte-Activation Gene 3, another immune checkpoint drug) if our genetic testing shows that that might be of any value. We stick all of these things together in one place. Piece #3: That hopefully will trigger what is called an “abscopal effect” that will train the lymphocytes to go to other areas in the body and kill tumors that are throughout the body. We only treat one small lesion.

Hopefully we'll get numerous lesions to react to that. There are three tumor types that are called “cold tumors”, and these are three very important tumors: pancreatic cancer, breast cancer and prostate cancer. There are no approved immunotherapy regimens for these cancers. ] They have tried all sorts of ways to get a positive reaction, including adding other chemotherapies to the immunotherapy.

There are no responses for these three very important cancers. What do we do with these cancers that have never been shown to react to immunotherapy? Here is a patient, an 83-year-old lady who had metastatic pancreatic cancer, adenocarcinoma of the pancreas. Because of her age and her medical condition, she really wasn't a candidate for other treatments and the FOLFIRINOX major chemotherapeutic agents.

Here's her primary cancer in the tail of the pancreas. This is just one slice of her scan. She has numerous lesions within her liver. Her lifespan, literally, was measured in months, if not weeks, with this tumor burden in her liver. At one month, you can see that the activity in the PET scan has markedly decreased. The tumor looks like it's a little bit smaller, and the lesions in the liver have markedly decreased in their intensity.

Here at three months you can see that the tumor is gone. These are kidneys, so don't worry about those, and there are no lesions left in her liver. In a tumor that doesn't respond to immunotherapy, this is a complete response. She had a recurrence in her pancreas at one year, and we are working on dealing with that. But her liver remains disease- free. Here's a patient with a very rare cancer, metastatic squamous adenocarcinoma.

Just a handful each year. No known treatment. You can see here is her primary. This is a disease that's throughout her peritoneum (abdominal lining), and you can see a marked response, and in the primary tumor. This is the first patient we did with a pancreatic cancer node in the chest, primary tumor here. The primary tumor has no activity, and the node in the chest has shrunk and has no activity.

This was a complete response in the first patient we treated with pancreatic cancer.