According to a news release in BioSpace, the biotech company Indapta Therapeutics, Inc., announced recently that the US Food and Drug Administration (FDA) has granted Fast Track designation to IDP-023, the company’s lead investigational therapy. This designation was granted for the treatment of melanoma and non-Hodgkin’s lymphoma. Indapta is committed to the development of differentiated cell therapies for the treatment of immune-mediated conditions and cancer.
About Fast Track Designation
The FDA’s Fast Track designation is intended to accelerate the drug development process. In order to receive this designation, the drug must be intended to treat a serious, life-threatening disease and fulfill an unmet medical need, such as treating a disease that has no current approved options. If the disease does have other treatments, the drug must have potential advantages over current treatments in order to receive Fast Track. Fast Track designation confers several benefits to the recipient, such as more frequent meetings and written communications with the FDA, Rolling Review, which allows the company to submit sections of the New Drug Application (NDA) or Biologics License Application (BLA) as they are completed rather than having to wait until completing the full application, and potential eligibility for Accelerated Approval and Priority Review (if other criteria are satisfied).
IDP-023
IDP-023 is a unique differentiated cell therapy consisting of specialized G-NK cells, a type of killer cell derived from the immune system that has the potential to have potent antitumor properties. Enrollment is currently underway for the company’s phase I trial. This trial will include three doses of IDP-023, which will be administered in combination with interleukin-2 and on its own. Future trials will aim to evaluated additional combination approaches with other drugs.
About Melanoma
Melanoma is a form of skin cancer which develops from pigment cells, which are called melanocytes. This cancer also less commonly affects the eyes, intestines, or mouth. The lesions often appear on the legs of women and backs of men and develop from atypical moles in some cases. The cause of this skin cancer can be traced to DNA damage as a result of UV radiation as well as certain genetic characteristics. Signs and symptoms include changes in the color or shape of a mole or the appearance of a lump on the skin. Moles may itch or bleed in later stages. In metastatic disease, symptoms such as fatigue, appetite loss, vomiting, and nausea may appear. This cancer may be treated in a variety of ways, such as surgery, radiation, chemotherapy, immunotherapy, and targeted therapies. Rates of this disease are increasing, and it is most common in areas with predominantly white European populations. To learn more about melanoma, click here.
About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s lymphoma is a group of blood cancers that, in some cases, can grow rapidly. This cancer affects a type of white blood cell called a lymphocyte. As non-Hodgkin’s lymphoma can include any type of lymphoma that is not Hodgkin’s lymphoma, they have a diverse array of causes. Risk factors for the development of these cancers include infections by certain viruses and bacteria, exposure to chemicals such as herbicides, prior autoimmune diseases, prior radiation or chemotherapy, and some genetic conditions. Symptoms may include itching, swollen lymph nodes, fatigue, fever, weight loss, and night sweats. Treatment often includes chemotherapy, stem cell transplant, and, less commonly, immunotherapy. The five-year survival rate for these cancers is around 71 percent in the US. To learn more about non-Hodgkin’s lymphoma, click here.
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Last modified: March 28, 2024
