California-based Anixa Biosciences, in a statement, confirmed that the company has received the first U.S. patent for its novel ovarian cancer vaccine technology. This technology was invented and developed at Cleveland Clinic, with Anixa is the worldwide licensee. [1] A European patent covering this technology was issued by the European Patent Office in March 2021.

Epithelial ovarian carcinoma (EOC) is the most prevalent form of ovarian cancer in the United States, representing approximately 85% of all cases and causing more deaths than any other gynecologic malignancy. The technology was invented by a research team led by Vincent Tuohy, MD, of Cleveland Clinic’s Lerner Research Institute.

“The ovarian cancer vaccine targets a protein (the Extracellular Domain of the Anti-Mullerian Hormone Receptor 2, AMHR2-ED) that is normally expressed only in the ovaries of pre-menopausal women. After menopause, the target protein is no longer expressed in normal tissues and is only found again in ovarian cancer cells. Our vaccine targets the AMHR2-ED protein and trains the immune system to destroy ovarian cancer cells as they arise,” Tuohy explained.[2]

Tuohy’s team optimized control of EOC which requires the incorporation of a vaccine capable of inducing safe and effective preemptive immunity in cancer-free women. They believe that ovarian-specific self-proteins that are “retired” from autoimmune-inducing expression levels as ovaries age but are expressed at high levels in emerging EOC may serve as vaccine targets for mediating safe and effective primary immunoprevention.[2]

Pre-clinical research indicates that AMHR2-ED vaccination may be particularly useful in providing safe and effective preemptive immunity against EOC in women at high genetic or familial risk who have the greatest need for a preventive vaccine and ultimately in cancer-free postmenopausal women who account for 75% of all EOC cases.[1]

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“We are looking forward to working together to further develop this technology,” he added, commenting on the relation with Anixa.

“Our vision with this technology is to eliminate ovarian cancer worldwide, especially since women who suffer from ovarian cancer tend to have poor outcomes,” Cleveland Clinic’s Tuohy said, noting that the five-year survival statistics for ovarian cancer are poor.

“We are pleased that the U.S. Patent and Trademark Office has issued this patent. This technology is now patented in Europe and the U.S., and we continue to prosecute the intellectual property in other jurisdictions,” Amit Kumar, Ph.D, President and Chief Executive Officer of Anixa Biosciences.

“This ovarian cancer vaccine has the potential to prevent one of the deadliest malignancies in women. Ovarian cancer is often diagnosed after it has reached stage 3 or 4, when it is difficult to effectively treat. Outcomes for ovarian cancer patients are poor, so if this vaccine is able to eliminate the onset of ovarian cancer, the impact for women and for our healthcare system would be significant. We are also pleased that the National Cancer Institute’s PREVENT program will collaborate and financially support the development of this vaccine,” Kumar concluded.

[1] Ovarian Cancer Vaccines and the inventors are Drs. Vincent K. Tuohy, Suparna Mazumder, and Justin M. Johnson, all of Cleveland Clinic.
[2] Mazumder S, Johnson JM, Swank V, Dvorina N, Martelli E, Ko J, Tuohy VK. Primary Immunoprevention of Epithelial Ovarian Carcinoma by Vaccination against the Extracellular Domain of Anti-Müllerian Hormone Receptor II. Cancer Prev Res (Phila). 2017 Nov;10(11):612-624. doi: 10.1158/1940-6207.CAPR-17-0154. PMID: 29093011.

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