Cytodyn Inc (CYDY)

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CytoDyn Announces Plan to Develop PRO 140 for Metastatic Triple-Negative Breast Cancer as Initial Oncology Indication
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VANCOUVER, Washington, Sept. 05, 2018 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), a biotechnology company developing a novel humanized CCR5 monoclonal antibody for multiple therapeutic indications, announces its plan to develop PRO 140 (leronlimab) as a therapy for triple-negative breast cancer that has metastasized as its initial cancer indication. Previously announced findings from preclinical studies showed the ability of PRO 140 to block human breast cancer cellular invasion in a surrogate assay for metastatic breast cancer.

“Triple-negative breast cells test negative for estrogen receptors (ER-), progesterone receptors (PR-) and HER2 (HER2-) and thus do not respond to hormonal therapy or therapies that target HER2 receptors. Women with this breast cancer subtype typically have a very poor prognosis and new therapies are needed,” said Richard G. Pestell, Ph.D., M.D., Interim Chief Medical Officer of CytoDyn. “Our findings indicate that CCR5 is a crucial receptor in the growth and invasiveness of human malignancies and CCR5 antagonists such as PRO 140 may play a vital role in inhibiting cancer cell invasion and metastasis. PRO 140 may offer an important new therapy for women with metastatic triple-negative breast cancer who have limited therapeutic options.”

“We plan to aggressively pursue the development of PRO 140 as a therapy for women with metastatic triple-negative breast cancer, which is in keeping with our strategy to evaluate PRO 140 in certain cancers and immunological indications where CCR5 antagonism has shown initial promise,” said Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer. “In addition, we are continuing to move forward with plans to assess PRO 140 in metastatic colon cancer and remain committed to concurrently advancing our clinical programs with PRO 140 in human immunodeficiency virus (HIV) and graft-versus-host disease (GvHD). We are pleased with our recent progress toward filing a Biologics License Application (BLA) for PRO 140 as a combination therapy for HIV and are confident that two thirds of our BLA submission will be completed by the end of 2018 and the last section, Chemistry, Manufacturing and Controls (CMC), by first quarter of 2019.”

About PRO 140

PRO 140 is a humanized IgG4 monoclonal antibody that blocks CCR5, a cellular receptor that plays multiple roles with implications in HIV infection, tumor metastasis, and immune signaling.

In the setting of HIV/AIDS, PRO 140 belongs to a new class of therapeutics called viral-entry inhibitors; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. At the same time, PRO 140 does not appear to interfere with the normal function of CCR5 in mediating immune responses. PRO 140 has been the subject of seven clinical trials, each demonstrating efficacy by significantly reducing or controlling HIV viral load in human test subjects. PRO 140 has been designated a “fast track” product by the FDA. The PRO 140 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 a central role in tumor invasion and metastasis and that an increased CCR5 is an indicator of disease status in several cancers. Moreover, researchers have shown that drugs that block CCR5, can block tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. CytoDyn is conducting additional research with PRO 140 in the cancer setting and plans to initiate Phase 2 human clinical trials when appropriate.

The CCR5 receptor also plays a central role in modulating immune cell trafficking to sites of inflammation and it is crucial for the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others have shown 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 PRO 140 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 PRO 140 for the prevention of graft-versus-host disease (GvHD).

About CytoDyn

CytoDyn is a biotechnology company focused on the clinical development and potential commercialization of humanized monoclonal antibodies for the treatment and prevention of HIV infection. The Company has one of the leading monoclonal antibodies under development for HIV infection, PRO 140, which has completed Phase 2 clinical trials with demonstrated antiviral activity in humans and is currently in Phase 3 development. PRO 140 blocks the HIV co-receptor CCR5 on T cells, which prevents viral entry. Clinical trial results thus far indicate that PRO 140 does not negatively affect the normal immune functions that are mediated by CCR5. Results from seven Phase 1 and Phase 2 human clinical trials have shown that PRO 140 can significantly reduce viral burden in people infected with HIV. A recent Phase 2b clinical trial demonstrated that PRO 140 can prevent viral escape in patients during several months of interruption from conventional drug therapy. CytoDyn intends to continue to develop PRO 140 as a therapeutic anti-viral agent in persons infected with HIV and to pursue non-HIV, inflammatory indications where CCR5 and its ligand CCL5 may be involved. For more information on the Company, please visit http://www.cytodyn.com.