CytoDyn Files for Breakthrough Therapy Designation for Leronlimab in Metastatic TNBC

January 13, 2020

The breakthrough therapy designation was filed for the use of leronlimab as an adjuvant therapy for patients with metastatic triple-negative breast cancer.

CytoDyn has filed for breakthrough therapy designation with the FDA for the use of leronlimab as an adjuvant therapy for the treatment of patients with metastatic triple-negative breast cancer (mTNBC).

Leronlimab is a C-C chemokine receptor type 5 (CCR5) antagonist that could potentially be listed for multiple therapeutic indications.

“Our thought leaders believe that leronlimab may have the potential to treat over 20 different cancer indications and at least 10 autoimmune diseases, including graft-versus-host disease (GvHD) and (nonalcoholic steatohepatitis),” Nader Pourhassan, PhD, president and chief executive officer at CytoDyn, said in a press release. “Based on the number of indications we intend to pursue, we believe we have 1 of the broadest platform technologies in biotech and are extremely excited to accelerate development of future indications.”

The breakthrough therapy designation filing is based on data from the first patient in the company’s mTNBC phase Ib/II trial, as well as an additional single-patient trial under an emergency investigational new drug (IND) protocol evaluating leronlimab for the treatment of patients with HER2-positive metastatic breast cancer that is stage IV. 

Data from the first patient in the phase Ib/II trial suggested that the patient had no detectable circulating tumor cells or putative metastatic tumor cells in the peripheral blood and additional large reductions in CCR5 expression on cancer-associated cells after 11 weeks of treatment with leronlimab. Moreover, the patient’s data also indicated tumor shrinkage of >20% after just a few weeks of treatment. The patient under the emergency IND protocol with HER2-positive metastatic breast cancer that is stage IV, showed no sign of new metastatic spots in the liver, lung, and brain during the treatment with leronlimab.

“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,” Bruce Patterson, MD, an advisor to CytoDyn, said in a press release. “Our collective team of key opinion leaders believes that all patients with similar cancers in regard to CCR5 expression may also benefit from the use of leronlimab, including [patients with] melanoma, brain, throat, lung, stomach, breast, ovarian, uterine, pancreatic, bladder, and thyroid cancer. 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.”

The FDA previously granted fast track designation for 2 potential indications of leronlimab for deadly diseases. The first was as a combination therapy with highly active antiretroviral therapy (HAART) for HIV-infected patients, and the second was for metastatic triple-negative breast cancer (mTNBC).

Reference:

CytoDyn Files for Breakthrough Therapy Designation with the FDA for the Use of Leronlimab for the Treatment of Metastatic Triple-Negative Breast Cancer [news release]. Vancouver, Washington. Published January 13, 2020. cytodyn.com/newsroom/press-releases/detail/372/cytodyn-files-for-breakthrough-therapy-designation-with-the. Accessed January 13, 2020.