Cytodyn Inc (CYDY)

[JPG77]

CytoDyn’s Final mTNBC Report Indicates as Much as 980% Increase in 12-Month Overall Survival and Up to 660% in 12-Month Modified Progression Free Survival

VANCOUVER, Washington, Aug. 25, 2021 (GLOBE NEWSWIRE) -- 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 an update to previously reported preliminary results from its Phase 1b/2 trials and compassionate use with leronlimab to treat a total of 30 metastatic triple-negative breast cancer (mTNBC) patients.

Decrease in Circulating Tumor Cells (CTC) as reported using the LifeTracDx™ test developed by Creatv MicroTech, Inc., after induction with leronlimab was associated with a 400%-660% increase in mPFS (modified Progression Free Survival)/12-month PFS (Progression Free Survival) and a 570%-980% increase in mOS (modified Overall Survival) /12-month OS (Overall Survival). Decreases in CTC after leronlimab induction were seen in 73% of the 30 patients in the study. LifeTracDx™ appears to aid as a parallel diagnostic tool in identifying patients that respond to leronlimab.

Data from these 30 patients are aligned with the premise that a majority of mTNBC patients respond to leronlimab if CTC reduction is observed following one leronlimab dose.

Scott Kelly, M.D., CytoDyn’s Chief Medical Officer and Chairman of the Board, commented, “We are delighted with the results of both mPFS and mOS when compared to the Standard of Care treatment for mTNBC across Emergency Use, Compassionate Use, mTNBC, and our Basket Trial. We anticipate the demand for new therapeutic options with limited toxicity and enhanced convenience for the patient to grow exponentially over the next decade. We believe this is further evidence that leronlimab has a promising role in the future of oncology to help alleviate the burden of cancer on patients and their loved ones. We are exploring opportunities to enhance our oncology platform through pharmacological partnerships, academic partnerships, and research on combining synergistic benefits of leronlimab in the tumor microenvironment.”

Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, added, “This report of results for 30 patients suggests that, with one blood test, we may be able to predict which mTNBC patients will respond well to leronlimab, which is a truly remarkable finding. These exploratory findings will now enable us to proceed for further regulatory review. With today’s report, we are delighted that we are presented with the possibility of achieving first approval with HIV, COVID-19 or possibly now cancer. We are grateful for the multiple opportunities we have had to create and explore as possible uses for this wonderful drug, leronlimab. The testimonies of physicians and patients about the use of leronlimab in cancer, COVID-19, and HIV has been nothing short of a dream come true for me.”

https://www.cytodyn.com/investors/news-events/press-releases/detail/551/cytodyns-final-mtnbc-report-indicates-as-much-as-980