Cancer is one of the leading causes of death in the U.S. According to the National Cancer Institute, an estimated 1.7M new cases of cancer will be diagnosed in the U.S. and over 600K people will die from the disease. That in mind, there is a need to properly diagnose cancer patients. One way to increase the chances of cancer treatment and patient survival is to detect the disease early on.
According to the World Health Organization, “Recognizing possible warning signs of cancer and taking prompt action leads to early diagnosis. Increased awareness of possible warning signs of cancer, among physicians, nurses and other health care providers as well as among the general public, can have a great impact on the disease. Some early signs of cancer include lumps, sores that fail to heal, abnormal bleeding, persistent indigestion, and chronic hoarseness. Early diagnosis is particularly relevant for cancers of the breast, cervix, mouth, larynx, colon and rectum, and skin.”
Now, there is a need for technology that detects cancer in its early stages. In turn, the projections for the global cancer diagnostics market is expected to grow at 7.2% between 2018 and 2025, according to Grand View Research.
Source: Grand View Research
Currently, most screening tests generate high false positives, and are often risky or invasive. Companies developing advanced screening tests for cancer could see high growth rates due to the high projected growth rates.
ITUS Corporation (NASDAQ: ITUS)
ITUS Corporation (NASDAQ: ITUS) incorporated in 1982, and repositioned as a biotech company a couple of years ago, is a cancer-focused company. The company is working on two projects: The first is a liquid biopsy technology for early cancer detection, and the second is a Chimeric Antigen Receptor Technology (CAR-T) that is focused on ovarian cancer as well as other tumor types. Each of these programs have multi-billion dollar potential.
ITUS Corporation is Looking to Spot Cancer in Early Stages
The company is leveraging the power of the body’s immune system in the fight against cancer. ITUS is developing the Cchek™ platform, which is a series of non-invasive blood tests for the early detection of solid tumors. The platform is based on the body’s immunological response to the presence of a malignancy.
The ultimate goal will allow people to go to the doctor for a routine checkup, and get a blood test to check for early cancer. More than 10M people across the world are newly diagnosed with cancer annually. In many of these cancer cases, the cancer has already advanced and is at its strongest when doctors spot the tumor.
According to the American Cancer Society, the survival rates are much higher when cancer is diagnosed at an early stage.
The current market has screening tests that are often invasive, risky, painful and costly. However, with the Cchek™ platform, it could reduce or eliminate invasive, painful and risky procedures. Moreover, Cchek™ might be useful to monitor the effectiveness of cancer treatments, which should help doctors stay up to date or be a step ahead of the cancer. Since cancers are known to mutate and become resistant to certain treatments, as well as spread (metastasize), the platform could be extremely helpful.
Moreover, in the U.S. alone, there are more than 15M cancer survivors, and many live in constant fear their cancer may recur. Due to the high costs of testing and repeated exposure to radiation, cancer survivors may not have access to testing as often as they would like. The platform could put patients at ease. Consequently, there could be an astronomical demand for the Cchek™ platform.
The Preliminary Results Look Promising
As with any technology, there needs to be extensive testing, and ITUS Corporation (NASDAQ: ITUS) is well on their way to doing so. Cchek™ has been validated with 15 cancer types already, including:
ITUS believes the technology could eventually identify all types of cancer because the approach is to let the body’s immune system tell us that a tumor exists.
Preliminary results show tremendous accuracy, expressed in the form of sensitivity and specificity greater than 90%. It’s important to note that while the number of patients tested so far is only in the hundreds, the accuracy demonstrated by Cchek™ is better than other cancer screening techniques including mammograms, prostate specific antigen (PSA) testing and others.
ITUS is Implementing Artificial Intelligence
Artificial intelligence is useful in various industries, even in healthcare. Artificial intelligence is a computer system’s ability to simulate human intelligence in order to perform concurrent analyses quicker than humans.
Now, ITUS is developing a software application implementing a proprietary neural network focused on complex pattern recognition. The company’s neural network system is designed and trained specifically to distinguish between cancer and healthy patients’ immunological responses and relies on up to 15 quantitative parameters to analyze the test results.
Due to the nature of artificial intelligence, as more samples are processed, the neural network continues to learn, and ultimately makes more accurate and reliable distinctions. Additionally, the neural network is not subject to human bias or error, potentially leading to better results.
ITUS Corporation First Commercial Focus for Cchek™
ITUS Corporation’s first commercial focus for the Cchek™ platform will be prostate cancer. According to Research and Markets, the prostate cancer treatment market was valued at over $5B in 2016, and it’s expected to reach over $18B by 2025, growing at a compound annual growth rate of over 12% between 2017 and 2015. That said, there’s a high degree of demand for products like Cchek™.
According to ITUS, “Our recent studies with prostate cancer demonstrate excellent sensitivity and specificity. One highlight is the recent study completed with Memorial Sloan Kettering Cancer Center (MSK) and Serametrix Corporation. This study achieved 92% sensitivity and 92% specificity using 121 prostate cancer and 125 healthy donor samples. The Cchek™ artificial intelligence was trained on 85 late-stage, biopsy verified, prostate cancer samples and 88 healthy donor samples. After training, ITUS was provided an additional 73 unlabeled (blinded) samples, and ITUS correctly identified 33 of 36 prostate cancer samples and 34 of 37 healthy donor samples. “
Although the company is focused on prostate cancer initially, it does not mean it will not test other tumor types.
According to ITUS Corporation CEO Dr. Amit Kumar, “While we have chosen prostate for our first commercial effort, we will continue to test other tumor types as they come in from our collaborators. However, our goal is to create a bolus of data on prostate cancer with which we can engage in discussions with regulators. A key component of this data package is going to be how well Cchek™ is able to classify benign conditions like benign prostate hyperplasia (BPH). BPH is the most common inflammatory disease of the prostate, and while it is a disease of the prostate gland, it is not a malignancy requiring a biopsy. We hope our results with benign conditions are as good as our results with cancer.”
That in mind, if the company is successful with its focus on prostate cancer, it could expand its focus to other types of cancers, and could potentially grow its net income and revenues, which could attract greater interest from investors.
ITUS’s CAR-T Project, A Potential Blockbuster
Despite the fact that early cancer detection is a key enabler of saving lives, ITUS knows that there will always be a need for cancer therapies for late stage cancer patients. Therefore, ITUS is also developing CAR-T based immuno-therapy drugs which genetically engineer a patient’s own immune cells to fight cancer. CAR-T stands for Chimeric Antigen Receptor T-cell technology. The first indication the company is targeting is ovarian cancer, but other cancers will follow once human testing of the ovarian drug is in progress. The CAR-T R&D is being conducted in collaboration with the Moffitt Cancer Center in Tampa, Florida. Moffitt is one of the top CAR-T centers in the world.
CAR-T techniques have demonstrated tremendous cures and responses on certain liquid cancers (leukemia and lymphoma) for patients that really had no hope. Such results are rare for cancer therapy, so these data have created tremendous interest in this technique as a method for curing many tumors. In fact, over the last few months two of the leading companies in this space Kite Pharma and Juno Therapeutics were acquired by Gilead (GILD:NASDAQ) and Celgene (CELG:NASDAQ) for $12 billion and $9 billion respectively.
Despite the notable success for liquid tumors, nobody has been able to make CAR-T work for solid tumors, which is a much larger market. The medical and scientific team at Moffitt and ITUS believe they have a unique twist on CAR-T that will make it work on solid tumors, with ovarian cancer being the first target.
We believe investors have not focused on this asset because there has not been a lot of news, despite preclinical results having already been published. The collaborative project at Moffitt is focused on completing all of the studies needed to file an application with the FDA called a Investigational New Drug application (IND). The goal is to have the FDA approve the IND, that will allow the team to test the therapy on human cancer patients. If the initial studies show that this therapy is working on even a few ovarian cancer patients, this could be extremely valuable to ITUS and its shareholders. And of course of immeasurable value to patients.
The Bottom Line
ITUS Corporation (NASDAQ: ITUS) is raising the standards for early stage cancer detection. The company has developed an accurate, reliable, easy and affordable blood test that could be used at the doctor’s office during routine checkups. The company has already shown the test is robust in its preliminary results. Moreover, it is implementing artificial intelligence, which could further increase demand for the platform.
The company also has a drug platform that could be worth a lot. If the company continues to successfully execute on it’s vision this could dramatically increase interest in this company from investors and the broad medical community. Additionally, with it’s innovative product platforms, it could attract potential acquirers, like Johnson & Johnson, Pfizer or Merck.
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