IP Development Strategy


Competition

The current leading therapies for melanoma include targeting BRAF and immunotherapy.  The pharmaceutical agent, Vemurafenib, (manufactured by Genentech) is designed to treat patients with a point mutation in BRAF which is found in approximately 50% of melanoma patients. The drug does not work on patients without a BRAF mutation. Furthermore, the patients develop resistance as caused by the cancer cells using alternative signaling pathways. Thus, the melanoma has a high recurrence rate and the patients usually die from the cancer.

In addition to Vemurafenib, Immunotherapy is being developed to prolong the life of melanoma patients. Immunotherapy using agents such as Pembrolizumab (developed by Merck Oncology) and Atezolizumab (developed by Genentech) does not attack cancer cells directly but enables the cancer cells to come into contact with killer T cells in the patient’s immune system.

Although likely to be effective in treating melanoma by working with the immune system, there is a risk associated with this therapy. Immunotherapy can cause the immune system to attack normal organs and tissues in many areas of the body and can affect the normal functions. These problems can sometimes become serious or life-threatening and can lead to death.

In contrast, the combination therapy being developed by Haniva shows high selectivity and is not likely to affect normal tissues.

The competition for glioblastoma is not very effective at extending the lifespan. Glioblastoma is the most aggressive form of brain cancer. The treatment includes surgery followed by chemotherapy including temozolomide and radiation. Temozolomide is used to increase the efficacy of radiation therapy. However, despite the current treatment, the average length of survival is 12-15 months with only a 3-5% survival beyond 5 years. There is a greater than 90% recurrence at the original tumor site. This suggests that using our novel patented combination treatment as an adjuvant therapy may help to reduce recurrence at the tumor site.


Market.

The market for our novel devices will be physicians. We are currently creating small, easy to handle devices that physicians can use in their office. The market for treating melanoma will be dermatologists, plastic surgeons, general surgeons, oncologists, hospitals, and Cancer Centers. The devices for delivery are also likely to have a broad international market, particularly in areas where there is a high prevalence of melanoma.

The preliminary laboratory results indicate a great potential for treating brain tumors including glioblastoma and medulloblastoma. The therapeutic approach is likely to be effective as both an adjuvant and a solid tumor treatment. We have also received positive feedback from surgeons that the device may be useful in a broad range of tumor types as an adjuvant therapy, following surgical resection in order to prevent metastasis and local recurrence.

We will also modify our devices for use in colonoscopies as well as upper and lower endoscopies. In addition, there is a high probability for treatment of endolumenal lung tumors.

The number of new Melanoma in US 2018: Approximately 91,270 new melanomas will be diagnosed (about 55,150 in men and 36,120 in women). Of these, 12.5% are stage II and 25% are stage III. This totals 34, 226 potential new cases to target per year. Approximately 9,320 people are expected to die of melanoma (about 5,990 men and 3,330 women).

The number of new Glioblastoma in US 2018: Glioblastoma represents 14.9% of all primary brain tumors, and 56.1% of all gliomas. Glioblastoma has the highest number of cases of all malignant tumors, with an estimated 12,760 new cases predicted in 2018.

The potential customer base of melanoma and glioblastoma patients for 2018 in the United States is 46,986.