OBR Daily Commentary


CytoDyn Files for Breakthrough Therapy Designation with the FDA for the Use of Leronlimab for the Treatment of Metastatic Triple-Negative Breast Cancer

(CytoDyn) Jan 13, 2020 - CytoDyn Inc., a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, 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).

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Dean Gesme, MD (Posted: January 13, 2020)


C-C Chemokine Receptors (CCR5 or CD195) are ubiquitous on immune cells and play a significant role in inflammatory disorders and cancer. Antibodies targeting CCR5 are a welcome addition to our antineoplastic armamentarium.



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