CytoDyn announced today 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 an adjuvant therapy for the treatment of metastatic triple-negative breast cancer (mTNBC).
The BTD filing is based on data from 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 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 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.
Four patients are currently enrolled across the two trials: 2 in the Phase 1b/2 mTNBC trial and 2 under the emergency IND protocol (expanded access program).
“This strong data confirms the power of leronlimab as a CCR5 inhibitor for patients living with mTNBC, and is clearly replicating early animal study results that demonstrated 98% elimination of metastases,” said Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner of CytoDyn, and an advisor to CytoDyn. “Our collective team of key opinion leaders believes that all patients with similar cancers in regards to CCR5 expression may also benefit from the use of leronlimab, including melanoma, brain, throat, lung, stomach, breast, ovarian, uterine, pancreatic, bladder, and thyroid cancer patients. We also believe the mechanism of action for leronlimab may have potential indications in autoimmune diseases such as multiple sclerosis, polymyolitis, Crohn’s disease, inflammatory bowel syndrome and psoriasis.”
Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
About leronlimab (PRO140)
Leronlimab is a humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases including NASH.
About Triple-Negative Breast Cancer
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–estrogen receptors (ER), progesterone receptors (PR) and the hormone epidermal growth factor receptor 2 (HER-2) gene. TNBC cancer occurs in about 10 to 20 percent of diagnosed breast cancers and can be more aggressive and more likely to spread and recur. Since the triple-negative tumor cells lack these receptors, common treatments for breast cancer such as hormone therapy and drugs that target estrogen, progesterone, and HER-2 are ineffective. Currently, there are no targeted therapies approved to treat triple-negative breast cancer.