West Hills-based ImmPACT Bio USA Inc. a clinical-stage company developing chimeric antigen receptor T-cell therapies for treating cancer and autoimmune diseases, has received fast-track designation from the Food and Drug Administration for its leading drug to treat specific types of lupus.
Fast-track designation is designed to help drugs reach patients faster by facilitating the development and expediting the review of drugs with the potential to fill an unmet medical need and treat serious or life-threatening conditions. Drug candidates receiving this designation benefit from early and frequent interactions with the FDA during the clinical development process.
ImmPACT Bio was founded in Rehovot, Israel, in 2017, and a couple of years later became a United States-based company, setting up its first office in Camarillo, which had about 5,400 square feet of space. Earlier this year the company moved its headquarters and lab space to a 21,000-square-foot facility in West Hills.
ImmPACT Bio is one of several local companies pursuing chimeric antigen receptor T-cell immunotherapy; another more well-known one is Santa Monica-based Kite, which is now a unit of Foster City-based Gilead Sciences Inc.
ImmPACT Bio’s lead drug candidate that has now received fast-track designation is targeting lupus, a chronic, often severe systemic autoimmune disease in which immune cells attack healthy tissues, resulting in inflammation and tissue damage throughout the body.
Despite various therapies targeting lupus, including biologics, there remains a significant unmet need for safe and highly effective therapies for this disease, which is why the federal regulators have assigned fast-track designation to ImmPACT Bio’s drug, which goes by the temporary name IMPT-514.