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Applied Clinical Trials
Dr. Riam Shammaa of INTELLiSTEM discusses his discoveries, how he plans to tackle clinical trial and therapy development challenges, and what the future development of cell-gene based cancer treatments look like.
Despite hesitations and risks involved with gene therapy development, novel stem cell-gene therapies are starting to break through and are moving to human trials. Dr. Riam Shammaa, Founder, and CEO of INTELLiSTEM and a pioneer in stem cell research will discuss his novel discoveries, and how he plans to tackle clinical trial and therapy development challenges, and what the future development of cell-gene based cancer treatments look like.
Moe Alsumidaie: What are Super Sentinel Cells, and how are they more effective than existing cancer treatments?Dr. Riam Shammaa: Super Sentinel Cells are a type of cell that we created that don't exist in nature. Super Sentinel Cells would be categorized under a new immuno-therapy; It's not regenerative, because we're not using the cells to repair something. We're using them to interact with the immune system, identify cancer in the body and destroy it. We took stem cells that exist in the body then genetically engineered them using the antigen-presenting capacities of Sentinel Cells. We created a new type of cell and named it the Super Sentinel Cell because it does what Sentinel Cells naturally do but at a much better function. It’s easier to work with stem cells, as they are easier to expand, grow and culture. They can migrate, can work under stress, and can proliferate quickly, which has allowed us to target cancer successfully, and offer the promise of cutting the cost of cancer treatment by at least 75%
One of the biggest challenges that we're facing right now with cell therapies, like CAR T cells, is the cost. The average cost of a CAR T cell therapy is between $350,000 and $450,000 (USD) per treatment. And that's an insane amount of money. No insurer can tolerate that cost, hindering the treatment and making it inaccessible to millions of patients.
Moe Alsumidaie: You've generated successful results in preclinical models. How will you apply this to humans? Dr. Riam Shammaa: Due to our preclinical success and the unmet need in the area of solid tumors, we are starting by targeting solid tumors with high mutational burdens. We are very optimistic because, just like CAR T cells, we also showed 80% to 100% success consistently with all the preclinical data we conducted in those tumors.
Moe Alsumidaie: Can you describe your study’s endpoint design in human trials?
Dr. Riam Shammaa: We're currently preparing a Phase I/II a dose-escalation clinical trial recruiting between 9-25 patients and are looking atthreemain metrics. The first and most important one is obviously safety, and the second one is early efficacy.The third is looking atthe immunogenic response of the cells in the patients and interacting with the cancer. We do this by conducting laboratory testing of specific biomarkers, inflammatory cytokinesand the functions ofthe immune cells such asT cells inpatients.
Moe Alsumidaie: Do you think that with cells like this you'll find that some patients taking some of those drugs cause a surge in the immune response, and that could act as an SAE?Dr. Riam Shammaa: Luckily, because Dendriticcells and CAR T cells trials were done in the past, we learned about cytotoxic release syndrome and their potential serious adverse effect. We wanted to mitigate those risks on multiple levels. scientific, business and technological levels. From a scientific standpoint, we’ll start with cancers that allow us to understand factors such as metastasis, size of tumor, and tumor microenvironment. That will allow us to understand the cancer while making sure the patients are safe, which is our top priority. From a business standpoint, we wanted to select a cancer that de-risks our first asset while reducing the cost of the first clinical trial. For example melanoma as our first target. From a technological standpoint, we wanted to deliver the appropriate dose through the best route of administration that triggers a specific anti-tumoral immune response in a safe and effective way.
Moe Alsumidaie: What challenges do you anticipate in your trials?
Dr. Riam Shammaa: One of the biggest challenges right now is patient recruitment, sometimes we facea shortage of patients that are treatment-naive or only post-surgery and are on chemotherapy, which excludes subjects. Recruiting the right patients may lead to selecting specific subpopulations and decreases our demographic pool. This translates to the second challenge, cost, because you're looking for a specific needle in a haystack. This means each patient recruited runs at a very high cost, even up to a million dollars per patient.
Also the lack of specialized centers that work in cell therapy. As you know, to do aclinical trial like this, we require a cGMP facility with experience in cell therapy. At the same time, one that has a phase one unit that has conducted cell therapy clinical trials in immuno-oncology-combining those challenges together on their own means that you may only have a handful of centers in North America that can run your trials successfully and with good confidence.
Moe Alsumidaie: Do you intend this to be a first-line or second-line or combination therapy?Dr. Riam Shammaa: It's going to be a combination therapy. It would count as a second to third line. If we're talking about solid tumors, for example, you would have to debulk bysurgery. After that either for metastasis or non-metastasis, you consider either chemotherapy, radiation therapyor going directly to immunetherapy. We are looking to use immune checkpoint inhibitors as well because of the substantial synergistic effects. We understand in cancer there is no magic bullet. There is no treatment that will solve all the problems. We need to combine technologies together to be able to offer outstanding efficacy to patients.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.