Our lead Cell-Based Immunotherapy product candidate, TBX-3400, uses a patient’s own immune cells to help fight against cancer and infectious disease. TBX-3400 is an autologous cell product made from peripheral blood mononuclear cells that are treated ex vivo with our fusion protein and then delivered intravenously back to the patient the following day.
Our Cell-Based Immunotherapy technology has several advantages over current immunotherapy approaches.
We do not need to expand T-cells in the laboratory to generate enough T-cells for treatment.
We do not limit the response to the tumor based by engineering the specificity of the T-cell.
We do not require genetic modification of the T-cells to enable anti-tumor activity.
We are moving TBX-3400 into human clinical trials to evaluate the safety and efficacy in patients with cancer. Our first cancer target will focus on patients with Stage III or IV Melanoma who did not respond or who have relapsed after receiving treatment with immune checkpoint inhibitors. We are also studying TBX-3400 for the treatment of other solid tumors and infectious disease.
TBX-3400 has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of Malignant Melanoma Stages IIB to IV.
Malignant melanoma is a cancer that develops from melanocytes located in the epidermis. It is also referred to as melanoma or cutaneous melanoma. Melanoma commonly occurs in the visible areas of the skin, however, it can also develop in other less visible parts of the body, including eyes, mouth, and genitals.
The first signs of melanoma usually manifest as a new or existing mole that is abnormal in appearance and has changed over weeks or months. Spots or pigmented areas are inconsistent in appearance with other moles on the body. Existing moles may change size, color or shape, appear asymmetrical, have irregular edges, or borders, itch, bleed, appear red or swollen or are ulcerated. Melanoma can then spread along the epidermis before invading deeper layers (dermis) and eventually spreading to the lymph nodes and distant areas of the body (metastasis) – including vital organs.
Melanoma is diagnosed using physical exams, skin and lymph node biopsies, and blood and imaging tests. In a physical exam, the patient’s health history is evaluated and the skin examined for signs of lesions and abnormal tissue. Samples of tumor tissue may be taken from the skin lesion for microscopic determination of cancer using a skin biopsy. Following diagnosis of disease, a surgical or fine-needle biopsy of lymph node may be done to determine cancer spread, followed by pathological examination of cancer cells.
Melanoma is classified into one of four clinical stages and divided into seven substages: 0, IA, IB, IIA, IIB, IIC, III and IV. Classification is based on the following anatomical characteristics: tumor thickness, ulceration status, number of metastatic nodes and the site of metastases. Melanoma diagnosed as stages I and II are generally referred to as localized, whereas melanoma diagnosed at stages III and IV are referred to as metastatic. Stage III is characterized by regional metastases, while stage IV exhibits distant metastases.
Current treatment options for melanoma are:
Targeted therapy (BRAF Inhibitors)
Immunotherapy (Checkpoint Inhibitors, Cytokines)
Melanoma accounts for less than 5% of all dermatologic cancers, however, it is responsible for more than 80% of all deaths from skin cancers, and only 16% of metastatic malignant melanoma patients survive beyond five years. Excision of early tumors is highly effective, with observed 5-year relative survival rates of 98.5% for localized melanoma. However, with progressive disease, survival rates decrease.
5-year survival rates: