Background A Note to Potential Clinical Trial Participants:
Thank you for your interest in participating in a clinical trial that uses our unique approach for your cancer treatment. As you consider whether to participate in a trial, we want to educate you about this treatment option.
You will be undergoing an ablative procedure that will destroy one or more of your tumors. This is a routine procedure that is similar to surgery, except instead of removing tumor tissue, it destroys the tumor inside of the body. Our investigational treatment involves injecting a proprietary drug in the form of a solution directly into the ablated tumor(s) immediately after the ablation. This solution is intended to:
- capture the antigens, or unique genetic information about the cancer, released when the ablation destroys the tumor tissue; and
- activate the body’s natural immune system.
While our drug is the activating agent, your own immune system is the actual basis of your treatment. Effectively, the drug may create a personalized treatment just for you: We believe that following the injection of our drug, your immune system will process the captured tumor information found in the antigens. This allows your immune system to identify and train immune cells to recognize your cancer for what it is, ideally attacking the cancer wherever else in your body it may be. In other words, the injection of our drug after a routine tumor destruction procedure is intended to generate a patient specific, systemic immune system response. While not all patients will respond, we have observed patients that have experienced these responses after participating in clinical trials.
You may be able to maximize your potential benefit from this treatment by improving the state of your immune system. Previous treatments and a long battle with cancer may have weakened your immune system. You may be able to improve your immune system’s health by reducing stress, getting adequate sleep, eating healthy foods, and taking vitamin supplements. Please discuss such opportunities with those providing your medical care.
To further maximize the chances of successfully triggering a systemic immune response, we believe that ablating more than one tumor is ideal when more than one tumor is present. This will increase the exposure of your own antigens that could be used to stimulate your immune system. We also believe that, if proposed by your treating physician, multiple ablation procedures, approximately one month apart, may increase the likelihood of an immune response. Similar methodology is utilized by many vaccines requiring more than one dose to fully activate the immune system.
If you choose to participate in one of our trials, we respectfully request your assistance in collecting additional information, which will not contain personal information and will be anonymized to protect your personal health information. When appropriate, according to the protocol, please consider allowing your physician to take biopsies or blood draws both before and after treatment, which will help us quantify the immune response from your treatment and provide insights that have the potential to help patients like you for years to come. Additionally, such assessments will allow your physician to see the extent to which our treatment is succeeding in helping your immune system to combat your cancer, wherever it may have spread.
Above all, we realize you are very ill and wish you the best possible outcome. The goal of helping patients like you is at the heart of everything our company does, and we hope that by participating in our clinical trial you will be able to play a part in something we believe could forever change the way the medical community approaches the treatment of solid tumors.
With best wishes,
All of us at Immunophotonics
Background
What is Immunotherapy?
A type of therapy that uses substances to stimulate or suppress the body’s immune system to help a patient fight cancer, infection, and other diseases.
What is Immuno-oncology?
Immuno-oncology is an immunotherapy method for treating cancer that harnesses the power of a patient’s own immune system to create an immune response that targets and eliminates cancer cells throughout the body.
What is Tumor Ablation?
Tumor ablation is a minimally invasive, standard-of-care treatment that physically destroys tumors inside the body.
RFA stands for radiofrequency ablation, which is an approved and well-established thermal ablation technique that sends high-frequency energy through a needle, heating up the surrounding tissue and killing the nearby cells in the process. It is one of the most commonly used forms of tumor ablation and is readily available at most hospitals and clinics.
MWA stands for Microwave ablation, which is a form of thermal ablation that uses a thin probe to transmit microwaves into the tumor to destroy cancer cells with heat.
Cryoablation, in which a probe or other device is inserted using a thin needle or applied to tissue and supercooled with liquid nitrogen or argon. The cold gas flows through the tip of the probe, causing ice crystals to form and destroy the tissue.
Similar to ablation, radiation therapies like stereotactic body radiation therapy (SBRT) deliver a precise beam of radiation in the form of high-energy x-rays to a tumor to kill cancer cells while minimizing damage to surrounding tissue.
What is IP-001?
IP-001 is a type of immunotherapy and is designed to harness the ability of the patient’s own immune system to fight cancer throughout the body, potentially providing benefits to cancer patients with advanced disease.
Immunophotonics’s innovation is designed to work in conjunction with tumor ablation, activating the body’s immune system to attack and destroy cancer cells throughout the body and generating long-term memory in the immune system to protect against cancer recurrence.
How is IP-001 intended to synergize with tumor ablation?
Tumor ablation physically destroys tumors inside the body, and when it does this, it leaves behind tumor debris that contains unique information about the cancer. Immunophotonics’s investigational treatment involves injecting a proprietary drug, IP-001, directly into the ablated tumor(s) immediately after the ablation. This drug is designed to capture the antigens (unique genetic information about the cancer) released during ablation and activate the body's natural immune system. By doing so, this is intended to induce a whole-body, long-term immune response against any remaining tumor cells, both at the site of the ablation treatment and those that are outside or distant from the treated area.
Potential impact of IP-001
- Improved control of treated tumor: reduction or elimination of residual tumor cells and reduction of post-ablation recurrence.
- Induced tumor control of distant tumors (metastases): The activated immune response is systemic and seeks out its targets throughout the body.
- An immune response can be long-lasting. Research to-date shows that the immune system surveillance and memory response can prevent cancer recurrence for a prolonged period.
- The IP-001 approach may help other cancer treatments be more effective. The tumor specific immune response from IP-001 may enhance the success of other treatments that activate the immune system, for example, checkpoint inhibitors.
Trial Summary
The goal of these clinical trials is to determine how safe and effective the study drug is following administration and thermal ablation of a solid tumor.
The use of IP-001 in this research study is considered experimental, meaning that the study drug is currently being tested and is not approved for use by the U.S. Food and Drug Administration (FDA) or any other Regulatory Authority. Therefore, it can only be used in research studies such as this one.
Injection of IP-001 following thermal ablation is currently being tested in other clinical trials. The study drug was tested in people with previously treated cancers that had reoccurred or spread to other parts of the body. In prior phase 1 studies, the drug was well-tolerated; however, the investigational product will continue to be assessed for safety and efficacy in on-going clinical trials.
The safety and efficacy of IP-001 will be studied by looking at:
- how a patient’s body handles the study drug (safety);
- how effective the study drug is in treating cancer;
- how the immune system responds to the study drug; and
- the amount of study drug in your blood over a period of time (pharmacokinetics).
Who can participate in our current trials?
If you are indicated for an ablation treatment, ask your physician if there are any trials available with IP-001. Your clinician will have access to trial databases or can contact us directly for more information.
What does the study involve?
Participants who provide written informed consent to their treating physician will undergo screening during the Pretreatment Period to determine eligibility for trial entry. The Pretreatment Period will include collection and recording of medical history, a list of medications being taken, baseline symptoms, previous therapies, and baseline assessments. A review of the participant’s baseline tumor burden will be recorded with radiological assessments, along with analysis of the location and size of tumors to identify and characterize target tumor(s) that will be treated or followed during the clinical trial.
If confirmed to be eligible for the study, the participant will advance into the Treatment Period. During the Treatment Period, participants will receive a routine ablation, followed by an injection of investigational product (IP-001 solution for Injection) into the tumor.
After treatment(s), a participant will move to the Follow-up Period. During the Follow-up Period, a participant will be asked to periodically meet with their treating physician to record any immune system or tumor activity.
All information collected during the Pretreatment Period will be anonymized or pseudonymized before being shared with us by your treating physician to maintain the confidentiality of your Personal Health Information (PHI). Immunophotonics does not collect, receive, or maintain PHI related to you and will not attempt to learn your identity as a patient in one of its clinical trials unless you choose to contact us directly. If you choose to contact us directly, then your personally identifiable information would be provided by you to us.
If at any time you wish to withdraw from a trial, you must contact your treating physician for information on how to withdraw. This is necessary since we do not maintain any personal information about you.
Please see the required Immunophotonics Notice of Privacy Practices included as part of your documents on file with your treating physician, which clearly indicates that no PHI or personally identifiable information is transmitted or maintained by us.
What are the possible benefits and risks for participating?
Participants may have side effects from the drug or procedures used in this study. Side effects may be mild to severe and even life threatening or fatal, and they may vary from person to person. Patients should talk to their treating physician administering their participation in the clinical trial right away if they experience any side effects during the study. There may be a risk in exposing an unborn child to a study drug, and not all risks are known at this time. Women and men must take precautions to avoid exposing an unborn child to study drug. If participants are pregnant, become pregnant, or are currently breastfeeding, they cannot take part in this study.
Interested in learning how to enroll?
Please follow the applicable link below to take you to the clinicaltrials.gov listing for each of our clinical trials:
SAKK 66/17 (Switzerland)
INJECTABL-1 (Switzerland and U.S.)
INJECTABL-2 CRC (Netherlands)
INJECTABL-2 HCC (U.S.)