Jan. 13, 2020: Â CytoDyn Inc. announced that the Company has filed for Breakthrough Therapy designation (BTD) with the U.S. Food and Drug Administration (FDA) for the use of leronlimab as adjuvant therapy for the treatment of metastatic triple-negative breast cancer (mTNBC).
The BTD filing is based on data as of the first patient in the Company’s mTNBC Phase 1b/2 trial and an additional single-patient trial under an emergency investigational new drug (IND) protocol evaluating leronlimab for the treatment of HER2+ metastatic, stage 4, breast cancer (MBC).
Data from the first patient in the Phase 1b/2 trial showed that the patient had no detectable circulating tumor cells (CTCs) or putative metastatic tumor cells in the peripheral blood and additional large reductions in CCR5 expression on cancer-associated cells at 11 weeks of treatment with the leronlimab.
This patient’s data also demonstrated tumor shrinkage of >20% after just a few weeks of treatment. The data from the patient under the emergency IND protocol with HER2+ metastatic, stage 4, MBC showed no sign of new metastatic spots in the liver, lung and brain during the treatment with leronlimab.
Breakthrough Therapy designation is a process designed to accelerate the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may display substantial improvement over available therapy on a clinically significant endpoint(s).
Triple-negative breast cancer (TNBC) is a type of breast cancer characterized by the absence of the three most common types of receptors in the cancer tumor known to fuel most breast cancer growth are estrogen receptors (ER), progesterone receptors (PR) and the hormone epidermal growth factor receptor 2 (HER-2) gene.
