VANCOUVER, Wash.—As it is said, the journey of a thousand miles begins with a single step. And CytoDyn Inc., a late-stage biotech developing the CCR5 antagonist leronlimab (PRO 140), announced recently the injection of the first patient with metastatic triple-negative breast cancer (mTNBC), marking the company’s first step into oncology.
The patient will be treated with leronlimab by Dr. Jacob Lalezari, currently CEO of Quest Clinical Research. Lalezari is also a principal investigator in CytoDyn’s HIV clinical trials with leronlimab.
“This patient has a particularly aggressive type of mTNBC and is being treated under emergency IND regulations of the FDA [U.S. Food and Drug Administration],” stated Lalezari. “With the exciting preclinical studies in cancer metastasis completed by the company, I believe that leronlimab represents a new potentially therapeutic modality in mTNBC.” Lalezari has authored more than 75 peer-reviewed articles and been a principal investigator in over 200 clinical trials, with a particular focus on first-in-man and proof-of-concept studies.
The use of leronlimab for mTNBC under the emergency IND by Lalezari is in addition to the Phase 1b/2 trial with leronlimab for treatment-naïve mTNBC patients under the supervision of Dr. Massimo Cristofanilli, who is an expert in translational research treatment of patients with mTNBC and a professor of medicine in the Division of Hematology/Oncology at Northwestern University Feinberg School of Medicine.
Results from the Phase 1b/2 trial for mTNBC will dictate the company’s regulatory pathway, including the potential to seek Breakthrough Therapy Designation and accelerated approval with the FDA for the use of leronlimab in mTNBC. Leronlimab has been granted Fast Track designation for mTNBC by the FDA based on a greater than 98-percent reduction of metastatic tumor volume in a murine xenograft model.
“Today marks a milestone in our company’s history, a first step into the oncology space,” stated CytoDyn President and CEO Dr. Nader Pourhassan. “It is equally important to note that leronlimab has already completed eight successful clinical trials and has been dosed in over 800 patients in our HIV programs, without any drug-related serious adverse events. With results from multiple preclinical studies in various cancer indications, including mTNBC, we are optimistic about the potential of leronlimab to provide a new therapeutic option to many patients.”