Cancer Patient Lab Expert Webinar

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

Featuring: Gary Onik, MD

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Gary Onik, MD

A Novel Immunotherapy Approach for 'Cold' Cancers” (Gary Onik, MD) [#86] 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 Meeting Summary 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? 1.Image the body (with PSMA, CT, or other techniques) to find a target tumor for the procedure. 2.Apply extreme cold with needle-like probes to freeze ("cryoablate") the target tumor, which damages the tumor, releasing proteins/antigens near the tumor. 3.

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.

ic 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

“A Novel Immunotherapy Approach for 'Cold' Cancers” (Gary Onik, MD) [#86] 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.

“A Novel Immunotherapy Approach for 'Cold' Cancers” (Gary Onik, MD) [#86] Meeting Notes KEYWORDS patients, tumor, immunotherapy, treatment, response, give, disease, adt, onic, cancer, talk, lesion, psa, liver, years, treated, working, bone, question, respond SPEAKERS Gary Onik (65%), Amit Gattani (13%), Allen Morris (9%), Gitte Pedersen (3%), Brad Power (3%), Ian Lewington (3%), Robert Gurmankin (2%), Paul Van Camp (2%), Brian McCloskey (2%) OUTLINE 1.

Cancer patient support and medical advice. (0:03) 2.Cancer treatment options with a focus on immunotherapy. (1:03) 3.Immunotherapy for hard-to-treat cancers. (4:51) 4.Cancer treatment outcomes and immunotherapy. (11:49) 5.Immunotherapy for cancer treatment with low side effects. (18:44) 6.Prostate cancer treatment options and genetic testing. (25:27) 7.

Prostate cancer treatment with a focus on immunotherapy. (33:43) 8.Immunotherapy for cancer, including cold cryoablation and systemic immune cocktails. (42:42) 9.Immunotherapy customization for cancer treatment. (48:12) SUMMARY ●Cancer treatment options with a focus on immunotherapy. 1:03 ○Amit Gattani is undergoing active treatment with Dr.

unotherapy for cancer, including cold cryoablation and systemic immune cocktails. (42:42) 9.Immunotherapy customization for cancer treatment. (48:12) SUMMARY ●Cancer treatment options with a focus on immunotherapy. 1:03 ○Amit Gattani is undergoing active treatment with Dr.

Onik after reaching an impasse with standard of care treatments for his advanced prostate cancer, which has spread to his bone marrow and transformed to neuroendocrine disease. ○He shares his experience with Dr. Onik's immunotherapy treatment for prostate cancer, discussing his initial research and decision to pursue the treatment. ●Immunotherapy for hard-to-treat cancers.

4:51 ○Gary Onik describes a new method of immunotherapy, the "Onik Method," which involves releasing tumor antigens using non-ablative freezing and injecting medications into the treated area. ○He discusses using a combination of immunotherapies to treat cold tumors, including pancreatic, breast, and prostate cancer, which have shown no previous response to immunotherapy.

[AM editorial: This is not true. Remember, Provenge the only FDA approved therapeutic cancer vaccine, period.

“A Novel Immunotherapy Approach for 'Cold' Cancers” (Gary Onik, MD) [#86] ○A patient with metastatic pancreatic cancer experienced complete response to treatment. ●Cancer treatment outcomes and immunotherapy. 11:49 ○A patient with aggressive prostate cancer went from near death to 8 years cancer-free after treatment.

○Researchers found complete or partial responses in 63% of prostate cancer patients, with fewer side effects than expected. ○A patient with pleomorphic sarcoma and liver metastases had complete response to immunotherapy, but recurred two years later. ●Immunotherapy for cancer treatment with low side effects.

18:44 ○Unique treatment has worked on every tumor type tried, with low morbidity and durable responses. ○Gary Onik discusses off-label use of FDA-approved drug for pancreatic cancer treatment, seeking funding for clinical trials. ○Autoimmune side effects are limited, but myocarditis is a concern. ●Prostate cancer treatment options and genetic testing.

25:27 ○Gary Onik discusses genetic testing to predict cancer progression and potential treatments. ○He discusses treatment options for advanced prostate cancer, including ADT. ○He advises Ian Lewington to consider second-line therapy if PSA is rising despite Enzalutamide treatment. ●Prostate cancer treatment with a focus on immunotherapy.

33:43 ○Gary Onik discusses their formula for treating prostate cancer, including cryosurgical lysis, Leukine injection, and immune checkpoint inhibitors. ○Leukine dose for subcutaneous injection is 500 micrograms per 1.9 sq m, but it's too expensive for widespread use.

○Amit Gattani and Allen Morris discuss the use of ADT in prostate cancer treatment, with Amit suggesting it's not part of their protocol for auto vaccination.

rams per 1.9 sq m, but it's too expensive for widespread use. ○Amit Gattani and Allen Morris discuss the use of ADT in prostate cancer treatment, with Amit suggesting it's not part of their protocol for auto vaccination. ○Allen Morris explains that the exocrine pancreas may be immune privileged, potentially explaining why cancer recurrence occurs locally rather than elsewhere.

●Immunotherapy for cancer, including cold cryoablation and systemic immune cocktails. 42:42 ○Dr. Onik discusses the effectiveness of cold cryoablation versus heat-based approaches for solid tumors. ○Dr. Paul Van Camp inquires about the use of a systemic immune cocktail after treatment to augment a more body-wide response. ●Immunotherapy customization for cancer treatment.

48:12 ○Brian McCloskey and Gary Onik discuss customizing immunotherapy cocktails with proteomics and other diagnostics to improve treatment outcomes. ○Researchers are eager to collaborate and share data to improve cancer treatment outcomes.

○The innate immune system plays a crucial role in cancer treatment, but its effectiveness is difficult to assess due to lack of understanding of its function in individual patients.

“A Novel Immunotherapy Approach for 'Cold' Cancers” (Gary Onik, MD) [#86] TRANSCRIPT 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. Who else does this approach?

” I explored that idea with a few of those that I could find that use this type of approach. I finally concluded that Dr.

As Dr. Onik will explain, this is an immunotherapy treatment. But it is a different approach to treatment. Then I started to ask, “Okay. Who else does this approach?” 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.

“A Novel Immunotherapy Approach for 'Cold' Cancers” (Gary Onik, MD) [#86] 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.

“A Novel Immunotherapy Approach for 'Cold' Cancers” (Gary Onik, MD) [#86] 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”. 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. 1.

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. 2.Piece #2: Once that thaws, and we have these released antigens, we inject medications into that area: a.

GM-CSF (Granulocyte-macrophage colony-stimulating factor ), also known as Leukine, also known as sargramostim (an immune system stimulator), b.a PD-1 inhibitor, (Programmed cell Death protein 1, a “checkpoint inhibitor,” prevents the “off” signal from being sent, allowing the immune system T-cells to kill the cancer cells), c.

“A Novel Immunotherapy Approach for 'Cold' Cancers” (Gary Onik, MD) [#86] d.Sometimes we add in a PDL-1 (another checkpoint inhibitor). We can talk about why we might want to have both of them involved. e.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. 3.

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