CytoDyn Reports Early Results from First Patient in its Phase 1b/2 CCR5+ Metastatic Triple-Negative Breast Cancer Trial

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VANCOUVER, Washington, Dec. 03, 2019 (GLOBE NEWSWIRE) -- , (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today additional early Phase 1b/2 clinical trial results evaluating leronlimab (PRO 140) patients with CCR5+ metastatic triple-negative breast cancer (mTNBC). Data from the first patient enrolled show no detectable circulating tumor cells (CTC) or EMTs in the peripheral blood and additional reductions in CCR5 expression on cancer-associated cells at eight weeks. A second patient with metastatic breast cancer has been enrolled in the trial under an emergency use investigational new drug (IND).

The first patient in the open label study was given a weekly injection of leronlimab at 700mg along with carboplatin. The patient was enrolled in the trial with CCR5-positive, mTNBC and naïve to chemotherapy in metastatic setting. The patient was previously exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings.

“The fourth blood sample from the mTNBC patient, drawn following eight weeks of treatment, demonstrates a notably sustained response to leronlimab,” said Bruce Patterson, M.D., chief executive officer of IncellDx. “Other cancer-associated macrophage-like (CAML) cells in the blood sample were found at the lower limits of detection and were also decreased in size. Most importantly, the CAML cells had reduced CCR5 staining compared to samples taken from the patient three weeks earlier, reflecting an ongoing blockade of the CCR5 receptor by leronlimab.”

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, stated: “It is very exciting to see additional preliminary results that demonstrate leronlimab’s potential as a therapeutic option to treat mTNBC. We are also pleased to have enrolled a second patient with metastatic breast cancer under an emergency IND. If the results of the second patient are similarly impressive, we plan to file for Breakthrough Therapy designation before the end of January 2020. We have had many patients contact us for treatment under our expanded access protocol and another hospital has opened enrollment for our mTNBC trial. We look forward continuing our research in furtherance of this clinical development plan.”

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 plays an important role in tumor invasion and metastasis. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98 percent in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. Additional research is being conducted with leronlimab in the setting of cancer and NASH with plans to conduct additional clinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be important in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted “orphan drug” designation to leronlimab for the prevention of graft-versus-host disease (GvHD).

More news and information about CytoDyn, Inc.

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Globe Newswire: 13:00 GMT Tuesday 3rd December 2019

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