CytoDyn Inc has announced a study for treating triple-negative breast cancer (TNBC) with its flagship drug leronlimab in a humanized TNBC xenograft model.
The late-stage biotechnology company said the investigator-initiated study is being led by Dr Jangsoon Lee, assistant professor of Breast Medical Oncology Research at The University of Texas MD Anderson Cancer Center.
It is intended to determine the potential synergistic therapeutic efficacy of leronlimab in combination with immune checkpoint blockade (ICB) to attempt to raise the standard of care for breast cancer patients.
READ: CytoDyn says Brazil approves pivotal Phase 3 clinical trial of leronlimab in critically ill coronavirus patients
“We anticipate this study will further evaluate the immunomodulatory effects of leronlimab in the tumor microenvironment,” CytoDyn president and CEO Dr Nader Pourhassan said in a statement.
“We are excited about the possibilities for leronlimab to offer a potential new treatment option for breast cancer patients. This could be an additional indication for which we are pursuing approval for leronlimab.”
Separately, the company announced the appointments of Dr Christopher Recknor as senior executive vice president of Clinical Operations and Dr Nitya Ray as its chief operating officer as it realigns its management structure to optimize its BLA (biological license application) resubmission process and to advance clinical development potential.
It said the team of Ray and Recknor will now hire additional professionals to complement Dr Seenu Srinivasan, executive director of CMC Regulatory Affairs, who recently joined CytoDyn from Regeneron.
Recknor and his clinical development team will manage the clinical and nonclinical activities, while Ray and his team will manage regulatory submissions, as well as all CMC (chemistry, manufacturing and control) activities, it added. Ray has over 30 years of experience in the biotech industry and was one of the original members of the leronlimab (PRO 140) product development team at Progenics.
“Our CMC package for the BLA is a direct reflection of the tremendous expertise of Dr Ray and his team,” Pourhassan concluded.
“This restructure will help maintain focus on the BLA, while providing the ability to rapidly pursue other indications in a fast-track development program.”
The US Food and Drug Administration (FDA) has granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat Human Immunodeficiency Virus (HIV) and metastatic cancer. The first indication is a combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC).
The company said it is working with the FDA for a new long-hauler’s trial, which it hopes to start in November. It intends to explore indications for stroke based upon its experiences and results from Right-to-Try patients.
Given that leronlimab crosses the blood brain barrier, the company said it is also exploring an indication for Alzheimer’s.
Contact the author at stephen.gunnion@proactiveinvestors.com