ITUS Corporation, cancer-focused biotechnology company, has entered into a Cooperative Research and Development Agreement (CRADA) with Moffitt Cancer Center to advance – toward human clinical testing — the development of a Chimeric Antigen Receptor T-Cell (CAR-T) technology initially aimed at ovarian cancer, and eventually additional solid tumors.

The technology was developed at The Wistar Institute and licensed by ITUS through its majority-owned subsidiary corporation, Certainty Therapeutics, Inc.

“Our program with Moffitt will be led by a group of stellar scientists and physicians. We are excited to advance this program which we hope will be the first or one of the first CAR-T technologies that shows efficacy for solid tumors,” noted Amit Kumar, Ph.D, President and CEO of ITUS.

The National Cancer Act signed in 1971 officially started what is commonly referred to as the ?war against cancer.? Since the signing of the bill, billions of dollars have been used towards ?a total national commitment towards the conquest of cancer? with a stated goal of ?finding a cure.? Government spending has been tremendously beneficial, providing funding for basic cancer research which is the foundation for new cancer treatments. As a result of ongoing research we now have a tremendous wealth of information, a better understanding of cancer biology and many novel treatments. But there is still a lot of work ahead of us. Although considerable progress has indeed been made in the treatment of some cancers, treatment of others remains elusive. A definite cure for cancer has not yet been found… The first part of a new documentary series “Changing Strategies in the “War on Cancer” discusses the importance and the impact of early diagnosis. The program includes an interview with Amit Kumar, Ph.D, President and CEO of ITUS Corporation, discussing CchekTM,? a series of non-invasive blood tests for the early detection of solid tumor based cancers based on the body’s immunological response to the presence of a malignancy, being developed by Anixa Diagnostics Corporation, ITUS Corporation’s wholly owned subsidiary. To watch the video, click on the link.

CAR-T Technology
CAR-T technology is a new adoptive cell therapy that has shown tremendous efficacy for refractory cancer patients suffering from B-cell cancers. However, to date, there have been no reports of success on solid tumors in humans.”

Moffitt Cancer Center in Tampa, Florida is one of the top cancer centers in the country with tremendous pre-clinical and clinical expertise with CAR-T technology. Moffitt has conducted many of the highest profile CAR-T trials in the world.

Ovarian Cancer
This CAR-T technology is initially focused on Ovarian Cancer, by engineering killer T-cells with the Follicle Stimulating Hormone (FSH) to target ovarian cells that express the FSH-Receptor (FSHR+). The FSH-Receptor was shown to be a very exclusive protein found on a large percentage of ovarian cancer cells, but not on other healthy tissue.

Study-results published earlier this year in Clinical Cancer Research shows that T cells redirected against FSHR+ tumor cells with full-length FSH represent a promising therapeutic alternative against a broad range of ovarian malignancies, with negligible toxicity even in the presence of cognate targets in tumor-free ovaries. [1]

Completing studies
“Moffitt researchers will work with us to complete all of the studies necessary to submit an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). Successive to the FDA’s review and permission, we hope to take this therapy into human clinical testing for patients suffering from ovarian cancer” Kumar further stated.

“We are pleased to work with ITUS and Kumar and his team to take this technology to the next stage. We are looking forward to eventually seeing this technology tested in human patients against ovarian cancer, for which there are few good options,” said Jose Conejo Garcia, M.D. Ph.D., the Principal Investigator and co-inventor of this technology at the Wistar Institute, who is now at Moffitt.

“As someone that’s worked on both the pre-clinical and clinical development of CD19-targeted CAR-T cells I have seen first-hand the power of gene-engineered T cell therapies,” noted Marco Davila, M.D., Ph.D., an oncologist with extensive experience in CAR-T cell therapies, who will co-lead the IND enabling work.

“However, a major obstacle to the adaptation of this technology, especially to solid tumors, is the safety of the protein targets. The FSH-receptor is an ideal tumor target similar to CD19 since it is widely expressed on tumor cells, but has minimal expression on normal cells. We are hopeful that this could represent the first non-B cell, malignancy that responds to a CAR-T cell therapy,” Davila added.

Other scientists involved in the translation of this technology at Moffitt are Linda Kelley, Ph.D., Director of the Cell Therapy Facilities and Daniel Abate-Daga, Ph.D., an expert of cellular therapies.

Solid Tumors
“We want to leverage the years of work and millions of R&D investment that has gone into this technology at The Wistar Institute as well as the expertise and infrastructure of Moffitt, to take this therapy into human clinical testing, for a modest cost, ” Kumar said.

“If we truly are able to demonstrate that this is the first or one of the first CAR-T approaches that works as a therapy for solid tumors in humans, the value to cancer patients and to our shareholders would be tremendous. This initiative conforms to our business strategy of working with top academic centers to develop technologies and products, followed by partnering with corporate allies for further development and commercialization. Such a strategy enables us to get to inflection points in value with modest capital expenditures,” Kumar concluded.

Other projects
In addition to innovative treatment options designed to meet the need of patients with unmet medical needs, ITUS Corporation’s wholly owned subsidiary, Anixa Diagnostics Corporation, is developing the CchekTM platform, a series of non-invasive blood tests for the early detection of solid tumor based cancers, which is based on the body’s immunological response to the presence of a malignancy.


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