CytoDyn Submits Breakthrough Application for Leronlimab for Triple-Negative Breast Cancer

 Ongoing analysis of data from 28 mTNBC patients following 12 months of treatment with leronlimab is very encouraging given little-to-no effective treatment options currently

CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it has submitted to the U.S. Food and Drug Administration (“FDA”) an application for Breakthrough Therapy designation (“BTD”) for leronlimab as a potential treatment for mTNBC. This BTD application is based on the data analysis reported by the Company on November 3, 2021.

The Company’s Chief Medical Officer, Scott Kelly, M.D., shared early findings from this study with the medical and scientific communities at the Triple-Negative Breast Cancer Drug Development Digital Summit in April 2021. Dr. Nitya Ray, CytoDyn’s COO and CTO, has led the BTD effort in collaboration with experts in Oncology, Biostatistics, and Regulatory affairs.

As previously reported, these findings represent the analysis of data from 28 pooled patients, 16 from our Compassionate Use Study, 10 from the Phase 1b/2 Study, and 2 from the Basket Study. All subjects received ≥1 dose of leronlimab (range 1-51 doses) subcutaneously in conjunction with standard of care (SOC) systemic chemotherapy. Of the 28 subjects, 9 subjects received 350mg weekly dose and 19 subjects received 525mg or 700mg weekly dose (4 subjects had dose escalation from 350mg to 525mg and were included in the higher dose cohort). The median age of the subjects was 52 years (range 33-84 years). All subjects were diagnosed with Stage IV mTNBC. Of the 28 subjects, 17 (61%) subjects started with visceral metastases, 6 (21%) subjects started with brain metastases, and 3 (11%) had bone-only metastases.

https://finance.yahoo.com/news/cytodyn-submits-breakthrough-therapy-designation-110000722.html