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Unburying The Treasure Chest - Tremendous Value ("Itus")

|Includes: Anixa Biosciences, Inc. (ANIX)
Summary

Major new developments have occured recently.

2 cancers have been identified as the commercial starters for the Cchek non-invasive liquid biopsy asset: prostate and breast cancers.

(18 other cancer types are still in the asset drawer, with actual positive results on hand.).

The CAR-T Therapy program is zooming ahead - one year ahead of its originally intended schedule - with some significantly positive results .

Pre-IND FDA meeting is scheduled for this month - July 2018.

Shareholder value is key: (we should see tremendous value very soon)

This company is definitely one which can be very valuable to its shareholders. I say this for many reasons. First, previously Itus cancelled its ATM which it scheduled some time back. Second, Itus has reiterated that it is in talks with commercial partners regarding its assets and as a result there is tremendous value as a shareholder. In other words, Itus is not trying to re-invent the wheel or acting like many other biotech companies that drain its shareholders value to pay for a whole range of unclear expenses. 

Next, let me highlight Itus CEO's background. (CEO is the name of the game in this industry)

DR. AMIT KUMAR, PH.D Chairman, President & Chief Executive Officer ("CEO")

Dr. Kumar, the inventor of our Cchek™ technology, has been an investor, founder, director and CEO of several technology enterprises, both public and private. As CEO, he took CombiMatrix Corporation public and ran it for a decade while listed on the NASDAQ Global Market. He has worked in venture capital with OAK Investment Partners, and has been an advisor to investment funds, venture capital firms, and Fortune 500 companies. He was on the Board of Directors of Acacia Research Corporation from 2002-2008. Dr. Kumar is currently Chairman, President and CEO of ITUS Corporation and he sits on the Board of other public and private companies. He received his AB in Chemistry from Occidental College. After graduate studies at Stanford University and Caltech, he received his Ph.D. from Caltech and followed that with a post-doctoral fellowship at Harvard.

Next, I would like to highlight the below press release: 

ITUS Accelerates Schedule for its CAR T Therapy and Provides Update

JUNE 26, 2018

SAN JOSE, Calif., June 26, 2018 /PRNewswire/ -- ITUS Corporation (NASDAQ: ITUS) today provided a status update and accelerated development timeline for its CAR T therapy for Ovarian Cancer, which is in development with Moffitt Cancer Center.

ITUS Logo (PRNewsfoto/ITUS Corporation)

Based on a number of factors, including the progress of the research discussed below, ITUS and Moffitt anticipate requesting a pre-IND meeting with the United States Food and Drug Administration (FDA) by the end of July of this year, roughly one year earlier than originally anticipated. The FDA recommends a pre-IND meeting as it enables the agency to review the development plan and provide useful recommendations. ITUS expects the meeting will be scheduled for the October/November timeframe. Assuming the FDA does not require significant additional animal studies, the Investigational New Drug (NYSE:IND) application can be filed during Q1 of 2019. Should this accelerated goal be achieved, human trials could begin as early as the first half of 2019, roughly a year ahead of schedule.

ITUS initiated a Cooperative R&D Agreement (CRADA) with Moffitt to advance a proprietary CAR T therapy for ovarian cancer in November 2017. The study is led by Jose Conejo-Garcia, M.D., Ph.D., Chair of the Department of Immunology at Moffitt. The aim of this CRADA is to complete the pre-clinical studies necessary for the submission of an IND application to the FDA, seeking approval to test the therapy in human patients. The previous goal for IND submission was the end of 2019 or early 2020, now it has been accelerated dramatically.

Additionally, Robert Wenham, M.D. has joined the team to lead the clinical trial. Dr. Wenham is the Chair of Gynecological Oncology at Moffitt. He received his MD from the University of Texas, Southwestern, completed his Obstetrics and Gynecological Residency at Harvard, and his Gynecological Oncology Fellowship at Duke.

Brief R&D Results

Several groups of tumor free, female mice were intra-peritoneally infused with increasing concentrations of the murine CAR T construct, and their health status was monitored for up to 5 months. The goal of this research is to determine if the CAR T construct would specifically target the ovaries of the mice, while not disturbing other healthy organs.

  • No treated mice showed any signs of pain/stress, difficulty breathing or increased respiratory rate, reduced movement, reduced grooming or feeding, dehydration, anorexia or any other sign of distress. Control mice also did not show any distress.
  • Accordingly, the mice did not show any weight loss. Control mice did not show any weight loss.
  • One cohort also had blood drawn periodically for measurement of multiple markers including markers for liver function (AST-Aspartate transaminase/ALT-Alanine transaminase), kidney function (creatinine), and metabolic function (glucose). No abnormal values were observed, as was the case for control mice.
  • Serum IL-6 (interleukin-6) increased in the treated mice, as well as mice treated with control T-cells. This indicated that the T-cells were inducing the expected inflammatory response.
  • Histological analysis of the ovaries showed that 60 percent of the treated mice had significant damage to their ovaries, while the control mice exhibited no damage. This observation confirms that the CAR T was successfully attacking the ovaries, as hoped and expected.

Additional details will be included in filings for the US FDA and will eventually be published.

Dr. Amit Kumar, CEO of ITUS stated, "We are extremely pleased with the progress of our program, and we are thrilled at the prospect of beginning human trials considerably ahead of schedule. Should our technology be the first demonstration of CAR T efficacy in humans afflicted with a solid tumor, the benefit to patients could be tremendous and the value for ITUS shareholders could be equally dramatic."

"Moffitt is committed to advancing CAR T-cell therapy so that more patients can benefit from this breakthrough treatment. Ovarian cancer is difficult to treat because most women are diagnosed at the later stages of disease progression. Consequently, outcomes are often poor and there are few treatment options. Being able to bring CAR T to patients, even in an investigational setting, is a step in the right direction," stated Dr. Wenham, Chair of Gynecological Oncology at Moffitt.

Next, I would like to highlight the next press release:

ITUS Corporation Announces Second Commercial Focus for Cchek™ will be Breast Cancer

JULY 06, 2018

SAN JOSE, Calif., July 6, 2018 /PRNewswire/ -- ITUS Corporation (NASDAQ: ITUS) today announced that due to the significance of positive results as well as strong commercial interest, it has selected breast cancer as the next commercial focus, after prostate cancer, for its Cchek™ non-invasive liquid biopsy cancer detection platform.

ITUS Logo (PRNewsfoto/ITUS Corporation)

ITUS has previously reported that its Cchek™ technology, which utilizes immune-profiling using flow cytometry coupled with artificial intelligence, has demonstrated the ability to identify twenty different cancer types through a simple blood test. With prostate cancer and now breast cancer, as the primary focus of ITUS' liquid biopsy test development, Cchek™ is now targeting two of the most common cancers.

Breast cancer is the leading cause of cancer deaths in women who do not smoke. Additionally, it is well known that women who have mutations in two genes called BRCA-1 and BRCA-2, have a higher incidence of breast cancer than the general female population. For example, in the US, approximately 12% of women will develop breast cancer during their lifetimes. However, 72% of women with one or more mutations in the BRCA-1 and BRCA-2 genes, will develop breast cancer during their lifetimes.

Dr. Amit Kumar, CEO of ITUS stated, "We are announcing our interest in breast cancer, in addition to prostate cancer, for many reasons. One reason is that the connection between breast cancer incidence and BRCA-1 and -2 mutations is well known. In recent years, there have been a number of women who have had their breasts and ovaries removed upon learning of their mutation status. This fact was underscored recently by high profile celebrity, Angelina Jolie, undergoing these surgeries. We hope that Cchek™ will provide a simple, easy way to monitor the occurrence of breast cancer that might impact the decision by mutation positive women to undergo the painful and disfiguring surgeries. In addition, we feel Cchek™ could be a great way for the general female population to monitor their status, including the millions of breast cancer survivors."

I am long ITUS Corp. I believe this company can hit 50.00 dollars a share in the near future. 

Disclosure: I am/we are long ITUS.