Fast Track designation is granted by the FDA to facilitate the development and expedite the review of drugs to both fill unmet needs and treat serious or life-threatening conditions. Through this, the FDA hopes to get therapeutic options into the hands of those who need them on a faster basis. Recently, the Cancer Network reported that the FDA granted Fast Track designation to IO-202. This therapy is designed for individuals with relapsed or refractory (R/R) acute myeloid leukemia (AML). 

About IO-202

Developed by Immune-Onc Therapeutics (“Immune-Onc”), IO-202 is:

a first-in-class monoclonal antibody that antagonizes LILRB4 with high binding affinity and specificity. It has broad potential in blood cancers and solid tumors and presents an opportunity to become a pipeline in a product.

Prior to Fast Track designation, IO-202 also earned Orphan Drug designation. 

According to preclinical data, IO-202 activates T-cells and helps the body better identify cancerous cells. Some cancerous cells produce “don’t kill me” or “don’t find me” signaling, allowing them to escape from immune attacks. In the case of AML, the protein LILRB4 helps the cancerous cells escape detection. IO-202 helps the body to detect and therefore kill these cells. 

Moving forward, Immune-Onc will enroll 44 patients in a Phase 1 clinical trial to better understand the impact of IO-202 for AML and chronic myelomonocytic leukemia. Throughout the trial, patients will receive intravenous IO-202. Researchers hope to understand the treatment’s safety, pharmacokinetic profile, and tolerability. 

To learn more about the specifics of Fast Track designation, take a look at the FDA website.

What is Acute Myeloid Leukemia (AML)?

Acute myeloid leukemia (or acute myelogenous leukemia) is a cancer which affects the blood and bone marrow, or the spongy tissue where blood cells are created. Damage to DNA of developing cells causes the production of immature cells which turn into myeloblasts, or leukemic white blood cells. Additionally, those with AML also produce immature or abnormal platelets and red blood cells. As these abnormal cells accumulate, they crowd out healthy blood cells, causing a number of health issues. Risk factors include prior chemotherapy or radiation treatment, older age (65+), being male, smoking cigarettes, or having other blood disorders.

Symptoms associated with AML include:

• Bone pain
• Lethargy and fatigue
• Shortness of breath
• Unintended weight loss and appetite loss
• Petechiae (pinhead-sized red spots on the skin)
• Recurrent infections
• Pallor (paleness)
• Fever
• Abnormal bleeding (gum bleeding, frequent or recurrent nosebleeds) 
• Easy bruising and bleeding